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

Model Number	M00539280
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a4: (weight) patient's weight is 78.3 kg; reported here as the reporting field does not permit entry of decimal values, the weight has been reported in accordance with system limitations.Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was attempted to be implanted in the gallbladder during a gallstone lithotripsy procedure performed on (b)(6) 2026.During the procedure, the plastic stent was broken.The procedure was completed with another of the same device.There were no patient complications reported as a results of this event and 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 attempted to be implanted in the gallbladder during a gallstone lithotripsy procedure performed on (b)(6) 2026.During the procedure, the plastic stent was broken.The procedure was completed with another of the same device.There were no patient complications reported as a results of this event and the patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on february 25, 2026: it was reported that the device was attempted to be implanted in the gallbladder for stones treatment.
Additional Manufacturer Narrative
Block b5 has been updated due to additional information received on february 25, 2026.Block a4: (weight).Patient's weight is 78.3 kg; reported here as the reporting field does not permit entry of decimal values, the weight has been reported in accordance with system limitations.Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent break.Visual examination of the returned stent identified no damage.There is no indication of the reported event as it happened during the procedure and there are no objective evidence or descriptive conditions to confirm it.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 technical analysis: a flexima biliary stent was received for analysis.The delivery system was not returned.Visual examination of the stent did identify any damage.Risk review: a risk review was completed and confirmed that the event of stent 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 no problem detected.

• 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: 24437264
• Report Number: 3005099803-2026-00721
• Device Sequence Number: 18695168
• Product Code: FGE
• UDI-Device Identifier: 08714729162599
• UDI-Public: (01)08714729162599(17)280514(10)36525638
• 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): 03/23/2026

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: M00539280
• Device Catalogue Number: M00539280
• Device Lot Number: 0036525638
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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 Age: 68 YR
• Patient Sex: Female