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

Model Number M00539260

Device Problems Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a flexima biliary preloaded stent was to be implanted in the biliary tract for stent placement during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the touhy borst was broken, and 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, and the patient's condition after the procedure was reported to be stable.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.This event has been deemed an mdr-reportable event based on the investigation finding of the guide catheter break.Please see block h10 for the full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation finding of a guide catheter break.Block h10: the flexima biliary preloaded stent and delivery system were returned for analysis along with a non-boston scientific guidewire.The touhy borst was not received for analysis.Visual inspection found that the stent was still attached to the delivery system, but the guide catheter had detached, was kinked and buckled, and was stuck to the non-boston scientific guidewire.No other damages were noted with the stent or delivery system.Product analysis confirmed the reported events of stent failure to deploy and device user error; however, the reported event of a touhy borst breakage was not confirmed because it was not returned for analysis.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." thus, the user did not follow the manufacturer's instructions.The investigation further concluded that the inability of the stent to be deployed and the additional investigation findings of guide catheter buckled, detached, and kinked were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied).Therefore, taking all available information into consideration the overall root cause of the reported event is adverse event related to procedure.

• Brand Name: FLEXIMA BILIARY
• Type of Device: 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: 18912919
• MDR Text Key: 337766226
• Report Number: 3005099803-2024-01056
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729162575
• UDI-Public: 08714729162575
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K965147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00539260
• Device Catalogue Number: 3926
• Device Lot Number: 0032467392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 58 KG