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

Model Number	M00545550
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 drainage in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, the guide catheter became separated during attempted stent deployment.The broken guide catheter remained inside the stent which was placed in the bile duct.The physician thought the stent was pushed by a stricture and there was a severe resistance when the inner catheter was removed.A pair of forceps was used to remove the broken guide catheter and the stent from the patient.The procedure was successfully completed with another flexima rx biliary stent.There were no patient complications reported on this event.
Additional Manufacturer Narrative
Block e1: initial reporter stateprovince: (b)(6).Block h6: device code 1069 captures the reportable event of guide catheter broken.Block h10: the returned flexima rx biliary stent was analyzed, and a visual evaluatio noted that he guide catheter was not broken it was detached from pull wire, the push catheter was kinked, the proximal section of the guide catheter was kinked and it was detached from the pull wire and could be what the customer perceived as guide catheter break.The stent was not returned.No other issues with the device were noted.The reported event was confirmed.Based on the product analysis, the failure found (guide catheter detached and kink, also push catheter was kinked) could cause the guide catheter to be detached.The failure was observed inside the patient and based on the condition of the device the failure found could had been generated by the manipulation of the device or due to the interaction with the endoscope during advancing of the device also advancing was not using short and deliberate movements as per instructions for use states.During the manufacturing process the units were 100% inspected in order to avoid the failure reported.Therefore the most probable root cause for this event is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used during a biliary drainage in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, the guide catheter became separated during attempted stent deployment.The broken guide catheter remained inside the stent which was placed in the bile duct.The physician thought the stent was pushed by a stricture and there was a severe resistance when the inner catheter was removed.A pair of forceps was used to remove the broken guide catheter and the stent from the patient.The procedure was successfully completed with another flexima rx biliary stent.There were no patient complications reported on this event.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10528797
• Report Number: 3005099803-2020-03881
• Device Sequence Number: 16923715
• Product Code: FGE
• UDI-Device Identifier: 08714729337850
• UDI-Public: 08714729337850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/19/2020

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: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: M00545550
• Device Catalogue Number: 4555
• Device Lot Number: 0025081870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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