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

Model Number M00523500

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that a flexima plus biliary stent was attempted to be used to treat bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2023.During the procedure, after the stent was deployed, the physician used grasping forceps to reposition the stent.While adjusting the stent, the stent was torn.The torn stent was removed from the patient using the grasping forceps.Another flexima plus biliary stent was opened and used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent break.

• 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: 17469088
• MDR Text Key: 320483204
• Report Number: 3005099803-2023-04153
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: M00523500
• Device Catalogue Number: 2350
• Device Lot Number: 0026520518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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