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Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event Description
Gurakuqi, gc, stadlbauer, v. Et as: fatal hemobilia resulting from iatrogenic arteriobiliary fistula as a rare complication of transjugular liver biopsy. European journal of gastroenterology & hepatology; 20:83-86, 2008. The above referenced journal article stated that a patient underwent a transjugular liver biopsy for evaluation for a liver transplantation. The biopsy procedure was performed via the right internal jugular vein under ultrasound guidance. An angled multipurpose catheter was guided into the right hepatic vein under fluoroscopy. Three biopsy samples were obtained using an 18g quick-core biopsy needle. No complications were noted, however, the patient¿s hemoglobin dropped 24 hrs post procedure and was stabilized by administration of 2 units of packed cells. The patient then developed hematemesis and melena on post-op day 2. Emergent gi endoscopy identified spurting bleeding from the papilla of vater; no other sources of hemorrhage were identified. Abdominal ct scan revealed extravasation of contrast medium into the bile ducts suggesting an iatrogenic arteriobiliary fistula. Intra-arterial catheter angiography revealed an arteriovenous fistula from a peripheral branch of the right hepatic artery which was embolized with coils. Hemoglobin dropped again 24 hours later. Emergent angiography revealed an arteriobiliary fistula at a more proximal section of the right hepatic branch that was already embolized; the branch was re-embolized. Further hemorrhage and melena occurred; emergent gastroscopy failed to reveal any other source of bleeding. The patient subsequently developed acute-on-chronic liver failure with circulatory failure, progressive hepatic encephalopathy and coagulopathy and mechanical ventilation necessitated respiratory failure. The patient expired on transjugular liver biopsy post procedure day 6. Autopsy did not identify any recent gi bleeding. There is no indication in the journal article that any device malfunctioned causing the reported event.
Manufacturer Narrative
Investigation - evaluation: a review of the documentation, instructions for use (ifu) and quality control was conducted during the investigation. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly a review of the device history record could not be conducted. It was stated by a physician on this case that the patient did not die because of the biopsy which was made by the quick core needle. Rather, the patient died due to other unrelated complications which occurred after the biopsy. Based on these details from the end user, the root cause is procedure related, patient condition related to occurrence. We will continue to monitor for similar complaints. Per the risk assessment no further action is required.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
MDR Report Key6355427
MDR Text Key68209584
Report Number1820334-2017-00400
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/23/2017 Patient Sequence Number: 1