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

Model Number	M00539200
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was to be used to treat multiple stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was bent and could not be deployed.The device was removed from the patient and the procedure was completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable based on the investigation result which revealed that the stent barb was torn.Please see block h11 for the full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation result of stent barn torn.Block h11: only the flexima biliary stent was received for analysis; the delivery catheter was not returned.Visual inspection was performed and found the stent barb torn and the stent kinked.The reported event of stent failure to deploy could not be confirmed.The observed damages were most likely a result of difficulties encountered while trying to deploy the stent.It could be that the technique used by the physician, and the tortuosity of the procedure contributed to the tearing of the stent barb and kinking of the stent.However, due to the lack of evidence and without proper evaluation of the device as only the stent was returned, the overall root cause of the reported event cannot be established.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19652155
• Report Number: 3005099803-2024-03125
• Device Sequence Number: 6737516
• Product Code: FGE
• UDI-Device Identifier: 08714729337362
• UDI-Public: 08714729337362
• 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): 07/01/2024

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: 09/15/2024
• Device Model Number: M00539200
• Device Catalogue Number: 3920
• Device Lot Number: 0028034345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG