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

Model Number	M00539210
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 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 separated.A microscope inspection did not identity a problem with the suture.During functional testing, the stent was able to be separated from the suture without any problem.No other problems with the device were noted.Device evaluation could not confirm the reported event of suture deployment issue.Considering all available information, device evaluation did not identify a problem with the suture and the stent was able to be separated from the suture without any issue through functional testing, the most probable cause is no problem detected related to the reported event of suture deployment issue.The condition identified through device evaluation of the guide catheter being separated, most probably cause is adverse event related to procedure since this could have been caused during the retraction of this component during the procedure.
Event or Problem Description
It was reported to boston scientific that a flexima biliary stent was used during an endoscopic retrograde biliary drainage (erbd) procedure in the common bile duct, performed on (b)(6) 2023.During the procedure, after the guide catheter was removed, the suture did not release.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Investigation results revealed that the guide catheter was detached or separated, therefore this event has been deemed an mdr reportable event.

• 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: 17430409
• Report Number: 3005099803-2023-03872
• Device Sequence Number: 2584794
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/31/2023

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: 03/09/2024
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0026944957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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: 81 YR
• Patient Sex: Female