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

Model Number	M00539310
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat obstructive jaundice in the common bile duct procedure performed on (b)(6) 2025.During the procedure, severe resistance was encountered at the mid bile duct stenosis.The device was removed for balloon dilatation, during which a snapping sound was heard.The stent and delivery system could not be retrieved together; the delivery system was removed first, followed by the stent.The inner catheter appeared to have extended several centimeters without intentional release.Another flexima biliary stent was used to complete the procedure there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima biliary stent was returned for analysis.A visual examination of the returned device revealed that the push catheter suture hole was torn, and the suture did not return as it had detached.The guide catheter was returned without any observed damage.Additionally, the stent that accompanied the device was not the one originally included for upn m00539310.The returned stent measured approximately 0.0945 inch (equal 2.4 mm), whereas the expected stent size was 3.3 mm.A dimensional inspection was performed, and the measurements confirmed the discrepancy in stent size.No other damages were noted to the stent or the delivery system.Product analysis cannot confirm the reported event of catheter guide break and device difficult to advance in anatomy.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to severe resistance encountered at the stenotic site during insertion and removal, which caused stress on the device components, resulting in suture detachment and catheter damage.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to patient condition.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be implanted to treat obstructive jaundice in the common bile duct procedure performed on (b)(6) 2025.During the procedure, severe resistance was encountered at the mid bile duct stenosis.The device was removed for balloon dilatation, during which a snapping sound was heard.The stent and delivery system could not be retrieved together; the delivery system was removed first, followed by the stent.The inner catheter appeared to have extended several centimeters without intentional release.Another flexima biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 23145327
• Report Number: 3005099803-2025-04850
• Device Sequence Number: 8846882
• Product Code: FGE
• UDI-Device Identifier: 08714729162629
• UDI-Public: (01)08714729162629
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: M00539310
• Device Catalogue Number: M00539310
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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