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

Model Number	M00539240
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name(b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a flexima plus biliary stent was received for analysis.The guide catheter was kinked, buckled accordion and detached.The stent was stuck with a piece of the detached guide catheter.The push catheter suture hole was torn, the suture was broken, and the push catheter was kinked.Additionally, the device returned with a guide wire stuck within the guide catheter.No other damages were noted with the device.Product analysis confirmed the reported event of stent failure to deploy.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".It was seen that the guide wire returned completely stuck within the device, meaning that the stent was tried to be deployed while the guide wire was still inside the delivery system.The guide catheter was most likely buckled, kinked and detached due to the force applied when it was felt that the stent wasn't being deployed.This could have also happened since the instructions for use weren't followed or also due to the complications that could have also appeared during the procedure, making the guide catheter unable to handle the amount of pressure that was being used on it.If the device was not deploying the stent due to the guide wire not being retracted, there is a possibility that the same force applied when trying to deploy the stent made the push catheter suture hole get torn by the suture also getting it detached as well as getting the push catheter kinked by the amount of force applied to deploy the stent.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in the common bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable based on the investigation result which revealed the guide catheter broke.Please see block h11 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: 20135062
• Report Number: 3005099803-2024-04315
• Device Sequence Number: 20633933
• 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
• Report Date (Section B): 09/04/2024

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: 10/30/2025
• Device Model Number: M00539240
• Device Catalogue Number: 3924
• Device Lot Number: 0030451048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 62 KG