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

Model Number M00533560

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/06/2023

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 common bile duct, performed on (b)(6) 2023.During the procedure and outside the patient, the guide catheter broke when the stylet was pulled back.Another naviflex rx delivery system was opened and used to successfully 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 guide catheter break.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the returned naviflex rx delivery system was analyzed, and a visual evaluation noted that it was returned with a non-bsc stent attached to the device.The push catheter was accordioned; however, the guide catheter was not detached therefore, the reported event of guide catheter break was not confirmed.Based on all the gathered information and product analysis, the investigation concluded that the problems found restrict the functional capabilities of the device to advance the guide catheter.Most likely the reported event and observed problems were due to operational factors encountered during the procedure such as user manipulation of the device during the guide catheter retraction and exposure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2023.During the procedure and outside the patient, the guide catheter broke when the stylet was pulled back.Another naviflex rx delivery system was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.

• 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: 17436088
• MDR Text Key: 320167303
• Report Number: 3005099803-2023-04024
• Device Sequence Number: 1
• Product Code: FGE
• 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,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: 3356
• Device Lot Number: 0031846272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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