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

Model Number	M00539230
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (initial reporter city) the reported health care facility's city is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the device could not be pulled out and a fracture occured.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the device could not be pulled out and a fracture occurred.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6 has been corrected.Block e1: (initial reporter city) the reported health care facility's city is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Block h11: investigation results: based on the available information, boston scientific confirmed the reported event of catheter guide break.The returned flexima biliary stent was analyzed and it was found with the push catheter suture hole torn, the stent damaged and the guide catheter broken at the distal end.These issues may have occurred if the device was subjected to excessive pressure during an attempt to deploy the stent, potentially related to the physician's technique or the tortuosity of the vessel.It is likely that the device was unable to deploy the stent, resulting in damage to the push catheter's suture hole due to the pressure exerted by the suture.Furthermore, manipulation of the device during the procedure may have contributed to the observed stent damage (torn stent) and the breakage of the guide catheter.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device analysis findings.A flexima biliary stent was returned for analysis.Visual examination of the returned device found the push catheter suture hole torn, the stent damaged and the guide catheter broken at the distal end.No other damages were noted to the device.Risk review: a risk review was completed and confirmed that the event of catheter guide break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on events.

• 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: 24183523
• Report Number: 3005099803-2026-00298
• Device Sequence Number: 9649807
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: (01)08714729162544(17)270114(10)33210321
• 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): 03/11/2026

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: M00539230
• Device Catalogue Number: M00539230
• Device Lot Number: 0033210321
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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 Sex: Male