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	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6) hospital; reported here as facility name exceeded character limit for designated field.Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.Block h11: a flexima biliary stent and delivery system was received for analysis.Visual and microscopic inspection found the guide catheter detached, the push catheter suture hole torn, and the suture not broken.No other issues were noted with the stent and delivery system.Product analysis did not confirm the reported event of suture break, as the suture was not broken.However, the analysis confirmed the reported event of stent failure to deploy due to the damages encountered in the delivery system.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).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 gallbladder to treat gallladder stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, it was noted that the suture of the flexima biliary stent was fractured, and the stent could not be opened normally.Another of the same device was used to complete the procedure.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22659252
• Report Number: 3005099803-2025-03574
• Device Sequence Number: 18246926
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)270430(10)33935848
• 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): 07/29/2025

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: 0033935848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 64 KG