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

Model Number	M00539270
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: age at time of event: the patient age is 38 years old.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a0406 captures the reportable investigation results of guide catheter detached or separated.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was returned out of the push catheter.The guide catheter returned stretched, detached and kinked; these conditions could have contributed to the failure to deploy the stent.The push catheter suture hole was torn, and the touhy borst was not returned.The functional test was not performed due to the conditions in which the device returned.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failures were due to procedure factors encountered during the procedure.User technique applied by the customer during the procedure may have led to the issues with the guide catheter and push catheter.The observed failures found, suggest that the device may have had difficulties when deploying.Therefore, the most probable cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the ampulla of vater, performed on (b)(6) 2023.During the procedure, the pusher and the guidewire got stuck inside the delivery system and the stent failed to deploy.A second flexima biliary stent was used, and the same incident occurred.A third flexima biliary stent (10f) was used, and the procedure was successfully completed.There were no patient complications reported as a result of this event.Investigation results revealed that the guide catheter was detached, therefore this event has been deemed an mdr reportable event.Please see block h10 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16950256
• Report Number: 3005099803-2023-02540
• Device Sequence Number: 6916042
• Product Code: FGE
• UDI-Device Identifier: 08714729162582
• UDI-Public: 08714729162582
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/17/2023

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: 08/24/2025
• Device Model Number: M00539270
• Device Catalogue Number: 3927
• Device Lot Number: 0030024384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 65 KG