MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a biliary stent placement procedure performed in the bile duct on (b)(6) 2017.According to the complainant, the guide catheter stretched causing difficulty in releasing the stent and leading to the distal end of the guide catheter breaking off from the device.The stent and broken guide catheter were removed using forceps.Another flexima rx biliary stent was successfully implanted in the left hepatic bile duct.The complaint device was repositioned and implanted in the right hepatic bile duct using the remainder of the second delivery catheter and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the push catheter was bent t at distal end and was kinked at guidewire port and the pullwire was also kinked in the same location.The guide catheter was detached, proximal section was also stretched and kinked in several locations.Based on the product analysis, most likely some anatomical or procedural factors were encountered during the procedure could have affected the device performance and its integrity.It is most likely that during the procedure the device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device by the user, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database revealed that no similar complaints exist for the specified lot.Labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a biliary stent placement procedure performed in the bile duct on (b)(6) 2017.According to the complainant, the guide catheter stretched causing difficulty in releasing the stent and leading to the distal end of the guide catheter breaking off from the device.The stent and broken guide catheter were removed using forceps.Another flexima rx biliary stent was successfully implanted in the left hepatic bile duct.The complaint device was repositioned and implanted in the right hepatic bile duct using the remainder of the second delivery catheter and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7049693
• Report Number: 3005099803-2017-03476
• Device Sequence Number: 13749617
• Product Code: FGE
• UDI-Device Identifier: 08714729337881
• UDI-Public: 08714729337881
• Combination Product (Y/N): N
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/21/2020
• Device Model Number: M00545580
• Device Catalogue Number: 4558
• Device Lot Number: 0020672433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention