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

Model Number M00523500

Device Problems Break (1069); Mechanical Problem (1384); Stretched (1601); Use of Device Problem (1670); Material Deformation (2976)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a flexima plus biliary stent was implanted in the left side of the common bile duct during an endoscopic biliary drainage procedure performed on (gb)(6) 2023.During the procedure, the touhy borst was too stiff to disengage before release, and the guide catheter was stretched.The procedure was completed with the original device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima plus duodenal bend 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 a detached guide catheter.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 plus biliary stent delivery system was returned for analysis.Visual inspection found that the guide catheter was detached from the push catheter.Microscopic and visual inspections found that the guide catheter was stretched and kinked, the suture hole of the push catheter was torn, and the touhy borst was damaged and detached.No other damages were noted with the delivery system.Product analysis confirmed the reported event of a guide catheter being stretched; however, the reported event of a touhy borst failure to loosen was not confirmed because the condition of the returned device indicated that the physician loosened the incorrect section of the device.Additionally, 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 plus duodenal bend 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." the investigation concluded that the stretching of the guide catheter and the additional investigation findings of guide catheter detachment and kinking and push catheter suture hole torn 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, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: FLEXIMA PLUS 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: 18866935
• MDR Text Key: 337319758
• Report Number: 3005099803-2024-00859
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00523500
• Device Catalogue Number: 2350
• Device Lot Number: 0028011394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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