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

Model Number	M00539280
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.Block h11: the flexima biliary preloaded stent was received for analysis.Visual inspection was performed and revealed the following: the guide catheter was kinked, stretched and detached, and the suture was detached.No other damages were noted on the device.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors encountered during the procedure.Factors such as the anatomical conditions, the technique used by the physician, and the amount of force applied to the device, limited the performance of the device and contributed to the reported event and observed damages.Taking all available information into consideration, the most probable cause of is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the biliary tract for drainage of bile and reduction of bilirubin during a stent implantation procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed.Another flexima biliary stent was used to complete the procedure.There was no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the guide catheter was detached.Please see block h11 for full investigation details.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21060426
• Report Number: 3005099803-2024-06769
• Device Sequence Number: 20996772
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: 08714729162599
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 05/14/2026
• Device Model Number: M00539280
• Device Catalogue Number: M00539280
• Device Lot Number: 0031622559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 74 KG