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	07/31/2025
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 transduodenal to the biliary tract to treat a biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device could not be deployed normally.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event.Note: this event has been deemed reportable based on the investigation finding that the guide catheter detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures of the reportable event of guide catheter break which was found during investigation.Block h11: the flexima biliary delivery system was received for analysis.Visual examination of the returned device found the push catheter kinked and a part of the guide catheter was missing as it was detached was not returned.Also, the push catheter suture hole was torn.Additionally, media analysis was performed on provided documentation that includes photograph of a kinked push catheter.Product analysis confirmed the reported event of stent failure to deploy as the device was returned with the push catheter kinked, a part of the guide catheter was missing, it was detached and did not return.Also, the push catheter suture hole was torn.The investigation concluded that this could have happened if the device had pressure when trying to deploy the stent, possibly due to the physician technique or tortuosity of the procedure, it's most likely that the device couldn't deploy the stent and damaging the push catheter suture hole by the pressure that the suture was adding to the suture hole.Additionally, a part of the guide catheter was missing, it was detached, and the push catheter was kinked.It's most likely that this could have happened as a result of the device being pulled with too much force or handling of the device during procedure.Therefore, taking all available information into consideration, the most probable root cause of the events 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 transduodenal to the biliary tract to treat a biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the device could not be deployed normally.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event.Note: this event has been deemed reportable based on the investigation finding that the guide catheter detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures of the reportable event of guide catheter break which was found during investigation.Block e1 initial reporter initial reporter zip/post code has been corrected block h11: the flexima biliary delivery system was received for analysis.Visual examination of the returned device found the push catheter kinked and a part of the guide catheter was missing as it was detached was not returned.Also, the push catheter suture hole was torn.Additionally, media analysis was performed on provided documentation that includes photograph of a kinked push catheter.Product analysis confirmed the reported event of stent failure to deploy as the device was returned with the push catheter kinked, a part of the guide catheter was missing, it was detached and did not return.Also, the push catheter suture hole was torn.The investigation concluded that this could have happened if the device had pressure when trying to deploy the stent, possibly due to the physician technique or tortuosity of the procedure, it's most likely that the device couldn't deploy the stent and damaging the push catheter suture hole by the pressure that the suture was adding to the suture hole.Additionally, a part of the guide catheter was missing, it was detached, and the push catheter was kinked.It's most likely that this could have happened as a result of the device being pulled with too much force or handling of the device during procedure.Therefore, taking all available information into consideration, the most probable root cause of the events is adverse event related to procedure.

• 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: 23418732
• Report Number: 3005099803-2025-05666
• Device Sequence Number: 13364148
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: (01)08714729162575(17)270821(10)34683155
• 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): 12/03/2025

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: 0034683155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 72 KG