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

Model Number	M00539250
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted for biliary drainage after a choledocholithotomy, during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.The procedure was completed with another of the same device.Provided photographs of the device showed what appeared to be a twisted suture.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." note: this event has been deemed a reportable event based on the investigation finding of guide catheter detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block h11: a flexima biliary stent and delivery system was received for analysis.Visual and microscopic examination of the returned device found the guide catheter detached and the suture was not twisted.Media inspection was performed on provided photographs, it was observed again that the guide catheter was detached, and the suture was not twisted.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the guidewire was inside the patient during the attempted deployment and 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." because the ifu was not followed, this was most likely the reason why the stent wasn't able to be deployed.The event of suture material twisted was not confirmed, the suture was not in this condition.The investigation concluded that the additional observed damages on the delivery system were likely due to excessive force applied when it was felt that the stent wasn't deploying or due to other complications that could have appeared during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause of the reported event is failure to follow instructions.

• 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: 22682796
• Report Number: 3005099803-2025-03687
• Device Sequence Number: 8937617
• Product Code: FGE
• UDI-Device Identifier: 08714729162568
• UDI-Public: (01)08714729162568(17)270610(10)34207114
• 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): 07/31/2025

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: M00539250
• Device Catalogue Number: M00539250
• Device Lot Number: 0034207114
• 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: 07/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 76 KG