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

Model Number	M00539280
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation findings of guide catheter break.Block h11: a flexima biliary stent and its delivery system were received for analysis.Visual inspection found that the device was returned without the guide catheter, as it was detached.The push catheter suture hole was torn.No other problems were noted with the device.The reported event of stent unable to deploy was confirmed.The push catheter suture hole was observed torn, which likely resulted from pressure applied during the deployment attempt.This pressure may have been influenced by procedural tortuosity or physician technique.The torn suture hole likely caused the suture to become lodged, preventing the stent from being released.It is also possible that the same applied force contributed to the detachment of the guide catheter during the procedure.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.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." this deviation from the procedural steps outlined in the ifu is the most probable reason the stent was not deployed because the guidewire was inside the patient during the attempted deployment.Therefore, taking all available information into consideration, the overall root cause of the reported event 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 biliary tract during a biliary stent implantation procedure performed on (b)(6), 2025.During the procedure, the stent could not be deployed.The procedure was completed using another of the same device.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.

• 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: 22569972
• Report Number: 3005099803-2025-03504
• Device Sequence Number: 9220046
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: (01)08714729162599(17)260419(10)31464688
• 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): 07/22/2025

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: 04/19/2026
• Device Model Number: M00539280
• Device Catalogue Number: M00539280
• Device Lot Number: 0031464688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 63 KG