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

Model Number	M00539240
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the hepatoportal bile ducts to treat a hepatic portal bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp), bile duct brushing, and biliary stenting procedures performed on (b)(6) 2024.During the procedure, the inner guide catheter of the delivery system was fractured.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima biliary stent was received for analysis.Visual analysis of the returned device found the push catheter was buckled, the guide catheter was detached, the push catheter suture hole was torn, the stent barb was deformed, and the guide wire was stuck in between the device push catheter and the detached guide catheter.Media inspection was performed and found the guide wire stuck inside the device and the push catheter buckled accordion.No damages were found on the touhy borst.Product analysis confirmed the reported event of guide catheter break, stent failure to deploy and push catheter buckled material.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use)/product label.The ifu cited: "completely retract the guidewire into the endoscope.If the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." however, the physician did not follow the step cited in the ifu.The guidewire was inside the patient during the attempted deployment.The guide catheter was most likely detached due to the force applied when it was felt that the stent wasn't being deployed.This could have also happened due to the fact that the instructions for use weren't followed during the procedure, making the guide catheter unable to handle the amount of pressure.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instruction.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be used in the hepatoportal bile ducts to treat a hepatic portal bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp), bile duct brushing, and biliary stenting procedures performed on (b)(6) 2024.During the procedure, the inner guide catheter of the delivery system was fractured.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event, and the patient's condition after the procedure was reported to be stable.

• 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: 19075631
• Report Number: 3005099803-2024-01590
• Device Sequence Number: 20014154
• Product Code: FGE
• UDI-Device Identifier: 08714729162551
• UDI-Public: 08714729162551
• 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,Followup
• Report Date (Section B): 06/24/2024

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 Model Number: M00539240
• Device Catalogue Number: 3924
• Device Lot Number: 0032665751
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 73 KG