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

Model Number	M00539250
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation result of stent barb torn.Block:h11 a flexima biliary stent was returned for analysis.A visual examination of the returned device confirmed that the stent barb was torn.No other damages were noted with the stent.Product analysis confirmed the reported event of stent failure to deploy.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the labeled indications.The instructions state, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." however, it was reported that the guidewire remained inside the patient during the attempted deployment.The investigation concluded that the stent failure to deploy, along with the torn stent barb, was likely due to not following the instructions for use - specifically, failing to fully retract the guidewire into the delivery system.Additionally, the force applied when the stent was not deploying as expected may have contributed to the tearing of the stent barb.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the flexima biliary stent could not be deployed.The procedure was competed with another of the same device.The patient's condition at the conclusion of the procedure was reported to be stable.It was reported that the guidewire was in the patient's bile duct during the attempted deployment.However, the flexima biliary preloaded stent instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the physician did not follow the steps cited in the ifu.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent barb was torn.Please see block h11 for full investigation details.

• 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: 21637118
• Report Number: 3005099803-2025-01009
• Device Sequence Number: 20959905
• Product Code: FGE
• UDI-Device Identifier: 08714729162568
• UDI-Public: 08714729162568
• 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
• Report Date (Section B): 03/18/2025

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: 05/22/2025
• Device Model Number: M00539250
• Device Catalogue Number: M00539250
• Device Lot Number: 0029454292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 56 KG