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

Model Number M00523470

Device Problem Break (1069)

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

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of guide catheter broken.

Event Description

It was reported to boston scientific that a flexima biliary stent was attempted to be placed in the common bile duct on (b)(6) 2023.During the procedure, the guide catheter came out naturally while inserting the delivery system into the guidewire.It was reported that the guide catheter may have become separated from the delivery system due to friction with the guidewire.The procedure was successfully completed with another flexima biliary stent.There were no patient complications reported as a result of this event.

• 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: 17368463
• MDR Text Key: 319592625
• Report Number: 3005099803-2023-03758
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00523470
• Device Catalogue Number: 2347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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