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

Model Number	M00539300
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
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 during a procedure performed on an unknown date.During the procedure, the inner catheter broke, but no fragment fell into the patient.The procedure was completed with another stent of a different model.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.
Additional Manufacturer Narrative
Block b5 has been updated for the additional information received.Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Block h11: a flexima biliary stent was received from analysis.Visual inspection found that the push catheter suture hole was torn.The suture did not return and was detached.The guide catheter was observed to be in good condition, and it was possible to extend and retract.No other damage was noted to the device.Product analysis could not confirm the reported event of catheter guide break as it was able to extend and retract during functional testing.The investigation concluded that the observed torn of the push catheter suture hole could be due to the physician's technique or tortuosity of the procedure.It was also possible that the same force applied when trying to deploy the stent made the suture to detach from the device.These damages were classified as adverse event related to the procedure.Based on all available information, the investigation selected that the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted during a procedure performed on an unknown date.During the procedure, the inner catheter broke, but no fragment fell into the patient.The procedure was completed with another stent of a different model.There were no patient complications as a result of this event.***additional information received on november 9, 10, and 20, 2025: it was later confirmed that the stent was to be implanted in the porta hepatis (hilum of the liver) to achieve biliary drainage at the hilum and treat a severe stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in october 2025.The specific date is unknown.It was further reported that the broken inner catheter remained within the push catheter during removal from the patient.

• 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: 23380683
• Report Number: 3005099803-2025-05620
• Device Sequence Number: 8815667
• Product Code: FGE
• UDI-Device Identifier: 08714729162612
• UDI-Public: (01)08714729162612(17)280601(10)36655222
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/04/2025

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: M00539300
• Device Catalogue Number: M00539300
• Device Lot Number: 0036655222
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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