The following case example explores factors contributing to a wrong-site procedure in interventional radiology and highlights strategies that can help practitioners mitigate risk and increase safety.
A patient over 50 years of age presented for a CT-guided cryoablation. The patient’s history included hepatitis B and cirrhosis, hypertension, and kidney transplant for end-stage renal failure with two native nonfunctioning kidneys. An MRI revealed a lesion within the lower pole of the left nonfunctioning kidney concerning for renal cell carcinoma.
The interventional radiologist began the procedure for the left renal mass with images taken at 5.0 mm slices. After initial review, the radiologist asked the technician to reconstruct the images at 3.75 mm intervals to provide a better view of the lesion. The images reconstructed by the radiology technician incorrectly showed the upper pole of the kidney rather than the lower pole, where the mass was located.
Based on the incorrect images, the radiologist interpreted a contour irregularity consistent with a mass in the upper pole of the kidney and performed a standard cryoablation protocol.
The radiologist told the family that the procedure had gone well. After reviewing the final post-procedure images later that day, the radiologist realized that the ablation had been performed at the wrong site. The mass in the lower pole of the kidney had not been removed. The radiologist decided to wait until the next morning to tell the family about the error and inform them that the patient would need a second ablation procedure.
In the hours following the procedure, the patient developed chest pain, with labs suggestive of a heart attack. The patient was transferred to the cardiac unit and started on a heparin drip. An hour later, a CT of the abdomen and pelvis showed no evidence of bleeding and the patient’s partial thromboplastin time (PTT) was within normal limits.
The next day, the patient’s hemoglobin was normal, but the PTT was not checked as required by heparin protocol. The hospitalist noted the patient’s renal function had worsened.
Early the next morning, the patient’s BP was 110/60. Labs showed that the patient’s hemoglobin, hematocrit, and red blood cell count had all dropped, and the PTT was very high. The hospitalist ordered stopping the heparin for three hours, rechecking the PTT, and then restarting the heparin at a lower dose. When the BP was checked, however, it was 90/50. A fluid bolus was ordered, but records were unclear about the amount given.
A rapid response was called when the patient’s BP dropped to 80/40. A CT scan revealed an intra-abdominal/retroperitoneal bleed.
The patient was transferred to the ICU and a code blue was called shortly after arrival. The patient was diagnosed with cardiopulmonary arrest and hypovolemic shock due to active bleeding in the abdomen and was taken to surgery for an exploratory laparotomy with evacuation of the intra-abdominal blood, left nephrectomy (pathology showed renal cancer), and splenectomy due to blood oozing from the base of the spleen.
The patient was readmitted to the ICU, placed on a ventilator, and started on hemodialysis. As a result of the prolonged code, the patient was diagnosed with hypoxic encephalopathy and now receives tube feedings and assistance in all activities of daily living at a skilled nursing facility.
Case Review and Patient Safety Considerations
The patient sued the interventional radiologist, claiming wrong-site procedure with a delay in notifying the patient and family.
Wrong-site procedure: According to a study in the journal Patient Safety, of 368 wrong-site events, interventional radiology was associated with several types of error: wrong side (37 percent, 19 of 52), wrong site (37 percent, 19 of 52), and wrong procedure (23 percent, 12 of 52).
The Journal of Vascular and Interventional Radiology (JVIR) published a Standards of Practice document for verifying the interventional procedural treatment site as a supplement to The Joint Commission’s Universal Protocol for “Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.” While it may not be possible to mark the procedure site in most interventional radiology procedures, taking time out to verify the patient, procedure, and site should be implemented as part of every pre-procedure process.
According to JVIR, wrong-site errors can occur with equipment that does not ensure correct orientation or labeling of the images, so a time out should confirm the correspondence between the image guidance system and the patient’s orientation.
In the case scenario, the interventional radiologist’s failure to recognize that the cryoablation was performed on the wrong pole on the kidney could have been avoided if a time out had taken place to verify that the image’s table location information matched the order. (The table location of the lower pole of the kidney would have been indicated by -175.25. The table location on the reconstructed images was, however, -115.25—indicating that the image was of the upper pole.) Additionally, a review of the preprocedural MRI could have reminded the radiologist that the lesion was located in the lower pole and highlighted the discrepancy in the technician’s reconstruction of the images.
By not conducting a preprocedural verification process, the radiologist was susceptible to confirmation bias—a tendency to selectively gather and interpret evidence that confirms beliefs while ignoring contradictory evidence. In this case, the radiologist misinterpreted the contour irregularity as a lesion because it was assumed that the image was the correct view.
Communication: The technician’s reconstruction of the CT images—which included only the upper pole of the kidney—could have resulted from communication issues between the radiologist and the technician. Any verbal order given by the radiologist should have been written down by the technician and read back to be confirmed or corrected by the radiologist. A verbal readback could have prevented the misunderstanding from occurring.
Error disclosure: The delay in notifying the patient and family about the wrong-site cryoablation was problematic for the defense. Jurors may think that not telling the patient and family earlier was an indication of guilt or an attempt by the radiologist to cover it up. Disclose medical errors as soon as information indicates that an error has occurred.
Although in this case, the radiologist may not have had sufficient information to answer all questions, it is still important to disclose what is known and focus on the patient’s immediate care and treatment plan. Disclosure may take multiple discussions as an investigation unfolds. Maintaining trust and open communication are paramount, so proactively informing the patient and family at regular intervals is essential. If a medical error occurs at a hospital, disclosure to the patient and family may be provided in conjunction with a hospital risk manager.
Informed consent: Bleeding, a known risk of undergoing a CT-guided cryoablation, was included in the informed consent signed by the patient. Because the kidney is a highly vascularized organ, bleeding would be an elevated risk factor. In situations involving a patient who is at higher risk of experiencing a known complication due to the nature of the procedure or because of the patient’s preexisting comorbidities, the physician should have emphasized the elevated risks during the informed consent discussion and documented the conversation. Neither action was taken in this case.
Additional Information and Guidance
For more information, see our Diagnostic and Interventional Radiology Closed Claims Study and the short video, “Interventional Radiology Malpractice Claims Study.” For additional guidance and assistance, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.