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

Model Number	M00539290
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	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Initial reporter facility name: (b)(6) medical university.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 implanted to treat biliary stenosis in the bile duct during a biliary stenosis procedure performed on (b)(6) 2025.During the procedure, the stent detached from the biliary tract.Another flexima biliary stent was used to complete the procedure.There were no patient complications as a result of this event.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 to be implanted to treat biliary stenosis in the bile duct during a biliary stenosis procedure performed on (b)(6) 2025.During the procedure, the stent detached from the biliary tract.The device was removed, and no fragments were left inside the patient.Another flexima biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient condition after the procedure was reported to be stable.Additional information received on may 06,2025.It was reported that the flexima biliary stent was to be implanted during an endoscopic ultrasound guided biliary stent implantation procedure.
Additional Manufacturer Narrative
Block b5 have been corrected and updated with the additional information received on may 06, 2025.Block e1: initial reporter address: (b)(6).Initial reporter facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.
Additional Manufacturer Narrative
Block b5 have been corrected and updated with the additional information received on may 06,2025.Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: a flexima biliary stent was returned for analysis.Visual examination of the returned device found the guide catheter was kinked and the push catheter suture hole was torn.No other problems were noted to the delivery system.The reported event of stent break was not confirmed.Taking all available information into consideration, the investigation concluded that the observed failures were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician, limited the performance of the device and contributed to the observed failures.Therefore, a review and analysis of the all the available information indicated that the most probable cause 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 to treat biliary stenosis in the bile duct during a biliary stenosis procedure performed on (b)(6) 2025.During the procedure, the stent detached from the biliary tract.The device was removed, and no fragments were left inside the patient.Another flexima biliary stent was used to complete the procedure.There were no patient complications as a result of this event.The patient condition after the procedure was reported to be stable.***additional information received on may 06,2025*** it was reported that the flexima biliary stent was to be implanted during an endoscopic ultrasound guided biliary stent implantation 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21633377
• Report Number: 3005099803-2025-01038
• Device Sequence Number: 15328165
• Product Code: FGE
• UDI-Device Identifier: 08714729162605
• UDI-Public: (01)08714729162605(17)260920(10)32477583
• 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,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 09/20/2026
• Device Model Number: M00539290
• Device Catalogue Number: M00539290
• Device Lot Number: 0032477583
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 05/13/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/14/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 66 KG