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

Model Number	M00539220
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	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter broken.
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, when the guide catheter was pulled, it was found broken.The broken guide catheter was removed in one piece and 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.
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, when the guide catheter was pulled, it was found broken.The broken guide catheter was removed in one piece and 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.
Additional Manufacturer Narrative
Correction to block d4: updated lot number and expiration date block h6: imdrf device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned flexima biliary stent was analyzed, and a visual evaluation noted that the guide catheter was separated, and the push catheter was jammed in the middle section.A microscopic inspection was performed and noted that the guide catheter was pulled from the distal section, and it was found separated.No other problems with the device were noted.The reported event of guide catheter break was confirmed.Considering all available information, the device problems identified during evaluation could have been caused by operational factors such as the technique used by the physician during the guide catheter retraction and/or device manipulation during the procedure.Therefore, the most probable cause is adverse event related to the 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17122447
• Report Number: 3005099803-2023-03088
• Device Sequence Number: 12374219
• Product Code: FGE
• UDI-Device Identifier: 08714729162537
• UDI-Public: 08714729162537
• 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,Followup
• Report Date (Section B): 07/10/2023

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: 07/30/2024
• Device Model Number: M00539220
• Device Catalogue Number: 3922
• Device Lot Number: 0027759345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• 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: 76 YR
• Patient Sex: Female