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 01/08/2024

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device required to remove the broken guide catheter.

Event Description

It was reported to boston scientific corporation that a naviflex rx delivery system was to be used to implant a stent in the duodenum and the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2024.During the procedure, the push catheter could be normally shortened without using more tension; however, the guide catheter of the naviflex rx delivery system was completely detached from the entire delivery system.The detached guide catheter was removed from the patient using a non-boston scientific grasper.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 a guide catheter break.Imdrf impact code f2301 captures the additional device required to remove the broken guide catheter.Block h10: the naviflex rx delivery system was returned for analysis.Visual inspection found that the guide catheter was detached from the delivery system, the pull wire was bent, and the push catheter was kinked.No other damages were noted with the delivery system.Product analysis confirmed the reported event of guide catheter break, and the investigation concluded that this event and the additional investigation findings of pull wire and push catheter kinking were most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician, which could have resulted in the damages noted in the device.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a naviflex rx delivery system was to be used to implant a stent in the duodenum and the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2024.During the procedure, the push catheter could be normally shortened without using more tension; however, the guide catheter of the naviflex rx delivery system was completely detached from the entire delivery system.The detached guide catheter was removed from the patient using a non-boston scientific grasper.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: 18630448
• MDR Text Key: 334428633
• Report Number: 3005099803-2024-00216
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: 3356
• Device Lot Number: 0032843342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• 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
• Patient Outcome(s): Required Intervention