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

Model Number M00533560

Device Problem Break (1069)

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

Event Date 07/27/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the cystic duct, performed on (b)(6) 2023.During preparation, when the physician started to push the stent over the guidewire, it was noticed that the guide catheter separated in two pieces from the push catheter.The device was removed and another naviflex rx delivery system was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the reported lot number 31811519 could not be matched to the reported device upn.Therefore, the lot expiration and device manufacture dates are unknown at this time.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 without any visible and functional failure on it.However, when the guide catheter was pulled from the distal section, the guide catheter was found detached.No other problems with the device were noted.Based on the gathered information, the failure found could have been caused by operational factors such as the deployment technique of the stent and excess force was applied during the pull wire retraction, causing friction between the push catheter and guide catheter, and have caused the torn on the push catheter and the kink on the pull wire.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Block h11: block d4, lot number and expiration date; and block h4 has been corrected.

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the cystic duct, performed on (b)(6) 2023.During preparation, when the physician started to push the stent over the guidewire, it was noticed that the guide catheter separated in two pieces from the push catheter.The device was removed and another naviflex rx delivery system was used to 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: 17511801
• MDR Text Key: 321254407
• Report Number: 3005099803-2023-04337
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 0031815519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2023
• 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