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

Model Number	M00539230
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf impact code f2301 captures the reportable event of additional device required to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted in the biliary tract to treat a cholelithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, the stent broke into multiple pieces and was removed using forceps.There was no part of the stent that was left inside the patient.The procedure was completed using another of the same device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf impact code f2301 captures the reportable event of additional device required to remove the stent.Block h11: a flexima biliary stent and delivery system were returned for analysis.Visual examination of the returned device found that the push catheter was buckled and the push catheter suture hole was torn.No damage was noted to the stent, and no other problems were observed with the delivery system.Product analysis did not confirm the reported event of stent break; no damage was noted to the stent.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 technique used by the physician, and/or the anatomical conditions, limited the performance of the device and contributed to the observed problems.Therefore, the most probable cause of the reported event 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 to treat a cholelithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During procedure, the stent broke into multiple pieces and was removed using forceps.There was no part of the stent that was left inside the patient.The procedure was completed using another of the same device.There was no patient complication reported as a result of this event.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21645575
• Report Number: 3005099803-2025-01119
• Device Sequence Number: 12701620
• 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
• 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,Followup
• Report Date (Section B): 06/25/2025

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 Model Number: M00539230
• Device Catalogue Number: M00539230
• Device Lot Number: 0033736151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 62 KG