MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Flexima? Biliary; catheter, biliary, diagnostic

Model Number	M00539230
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted during a stent placement procedure performed on an unknown date.During the procedure, the guidewire ruptured inside the introducer, resulting in difficulty actuating and properly deploying the flexima biliary stent.The stent was deployed at an incorrect location and was not possible to be removed and additional measures were required to address the event.Another of the same device was used to complete the procedure.The patient the experienced hemodynamic instability, progressing to a drop in hb, and the patient subsequently died.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf patient code e2401 captures the reportable event of hemodynamic instability, progressing to a drop in hb.Imdrf impact code f02 captures the reportable event of death.

• 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 ; +1(914)571-6918
• MDR Report Key: 50936049
• Report Number: 3005099803-2026-03963
• Device Sequence Number: 10734853
• Product Code: FGE
• UDI-Device Identifier: 08714729162544
• UDI-Public: (01)08714729162544(17)270918(10)34876960
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K965147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00539230
• Device Catalogue Number: M00539230
• Device Lot Number: 0034876960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 09/18/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown