MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00533570

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6), 2023.During the procedure, as the physician pushed the delivery system down the scope and pulled back the controller of the guide catheter, the guide catheter did not pull back.The guide catheter had separated from the delivery system.A non-boston scientific device was opened and used to complete the procedure.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the guide catheter was detached.

Manufacturer Narrative

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

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• 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: 17757342
• MDR Text Key: 323523102
• Report Number: 3005099803-2023-04877
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787099
• UDI-Public: 08714729787099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00533570
• Device Catalogue Number: 3357
• Device Lot Number: 0031338167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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