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

Model Number	M00539210
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted to treat stones in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, a 7 fr by 7 cm stent was advanced over a 0.035" jagwire guidewire and passed smoothly through the working channel.When the physician attempted to deploy the stent, significant resistance was encountered, and the stent failed to release.The entire stent and introducer assembly was withdrawn, at which point the introducer was found to be bunched.The guidewire could not be removed because it remained jammed inside the introducer, as the release thread had not disengaged.Another flexima biliary preloaded stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation finding of guide catheter detached.Please see block h11 field for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached/separated.Block h11: invesitigation summary: boston scientific corporation confirmed the events of catheter guide kinked and device guidewire stuck.The media analysis identified the guidewire stuck, the guide catheter broken, stretched and kinked, and the touhy borst detached.However, the additional reported events of suture deployment issue and stent failure to deploy were not, media analysis was insufficient to do.Without proper evaluation of the device, it is unknown if the reported events were due to the technique used during the procedure, anatomical conditions or related to device malfunction.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event.Device technical analysis: the device was not returned; therefore, product analysis could not be performed.However, media analysis was performed on photographs provided by the complainant.The media analysis identified the guidewire stuck, the guide catheter broken, stretched and kinked, and the touhy borst detached.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25250425
• Report Number: 3005099803-2026-02021
• Device Sequence Number: 21457786
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: (01)08714729162520(17)280313(10)36069207
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: M00539210
• Device Catalogue Number: M00539210
• Device Lot Number: 0036069207
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• 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 Sex: Unknown