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

Model Number M00523430

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that a flexima plus biliary stent was used during a procedure in the common bile duct, performed on (b)(6) 2023.During the procedure, the suture could not be unfastened.Another flexima plus biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; the guide catheter was detached.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation result of guide catheter detached/separated.Block h10: the returned flexima plus biliary stent was analyzed, and a visual evaluation noted that the guide catheter was separated into two parts.A functional test could not be performed due to the returned condition of the guide catheter.The suture appeared in good condition.No other problem was noticed.Therefore, the reported complaint of suture deployment issue cannot be confirmed.Based on the product analysis, the returned condition of the guide catheter, separated into two parts, could have been caused by operational factors such as user technique during the deployment attempts.Based on all the available information, including product analysis of the returned device and product record review, boston scientific concluded that the most probable cause of the reported complaint is cause not established.

• 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: 17228653
• MDR Text Key: 318206437
• Report Number: 3005099803-2023-03524
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00523430
• Device Catalogue Number: 2343
• Device Lot Number: 0031093376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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