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

Model Number	M00539230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).The returned flexima biliary stent with the delivery system was analyzed, and a visual evaluation noted the stent was returned loaded to the delivery system and did not present any damage.The proximal section of the guide catheter was severely kinked, torn/stretched and broken.The push catheter was kinked and stretched.The proximal part (plastic molded handle) was not returned.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the guide catheter had some kinks in the proximal section.Based on the all gathered information, the kink and the stretch present in the guide catheter would affect the indented use of the device.It is likely that operational factors as handling and technique caused the kink in the distal section of the guide catheter.Therefore the most probable root cause for this event is "adverse event related to procedure".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 biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure (ercp) in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, the physician used a flexima biliary stent for drainange, however, the delivery shaft malfunctioned, the stent could not be deployed.The procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was noted to be stable.Investigation results revealed that the guide catheter was detached/separated.Therefore this event has been deemed an mdr reportable event.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10522663
• Report Number: 3005099803-2020-03877
• Device Sequence Number: 11542744
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: 08714729162544
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: M00539230
• Device Catalogue Number: 3923
• Device Lot Number: 0024629244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 66