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

Model Number 16595360

Device Problem Break (1069)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used for stent placement during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct on (b)(6) 2023.During the use of the naviflex rx delivery system, the stent was successfully deployed, however, part of the guide catheter detached.The piece of the detached guide catheter was not noticed and left in the patient.Post procedure, exact date unknown, the stent and the detached piece of the guide catheter were passed by the patient, naturally, during a bowel movement.A new stent was not implanted in place of the naturally passed stent.There were no patient complications reported as a result of this event.The patient condition was reported to be stable.

• 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: 17012006
• MDR Text Key: 316044374
• Report Number: 3005099803-2023-02762
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101314
• 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: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16595360
• Device Catalogue Number: 3356
• Device Lot Number: 0030674434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female