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

Model Number	M00539260
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block h11: a flexima biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the guide catheter kinked, accordion buckled, stretched, detached, and with the guidewire stuck inside.Media inspection of a provided photo was performed, it was noted again that the guide catheter was kinked, and the stent was partially deployed.No other problems were noted with the delivery system.Product analysis confirmed the reported event of stent failure to deploy.The guidewire was found stuck within the delivery system.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The ifu states "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." the physician did not follow the steps cited in the instruction for use (ifu).The investigation concluded that the observed damages were likely due to the force applied when it was felt that the stent was not being deployed most likely due to the guidewire not being completely retracted.Therefore, a review and analysis of all available information indicates that the most probable cause of the events is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the bile duct to treat bile duct stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, the inner guide catheter was not easy to be pulled out.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that guide catheter was detached.Please see block h11 for the 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: 21357211
• Report Number: 3005099803-2025-00385
• Device Sequence Number: 8564314
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• 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): 02/11/2025

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 Model Number: M00539260
• Device Catalogue Number: M00539260
• Device Lot Number: 0033856575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: Female
• Patient Weight: 75 KG