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

Model Number M00533560

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

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

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf device code f2301 captures the forceps used to retrieve the detached catheter-guide.

Event Description

It was reported to boston scientific corporation that a naviflex rx delivery system was used to treat choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the introducer was pulled back to release the stent; however, it became stuck and was tore off.Consequently, both the guide catheter and the push catheter were broken.The guide catheter was removed using forceps and the procedure was completed with a different device.There were no patient complications reported as result of this event.

Manufacturer Narrative

Blocks d4 (lot number, expiration date) and h4 have been updated with additional information received on february 08, 2024.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf device code f2301 captures the forceps used to retrieve the detached catheter-guide.Block h10: a naviflex rx delivery system was received for analysis.The delivery system was received with the guidewire being stuck.Visual inspection found the guide catheter detached from the delivery system.No other problems were noted with the delivery system.Product analysis confirmed the reported event of catheter-guide break.However, the reported events of pull wire retraction problem and push catheter break were not confirmed because the push catheter was found in good condition and the pull wire was completely used.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the catheter-guide being detached from the delivery system and the guidewire being stuck in the delivery system.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a naviflex rx delivery system was used to treat choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the introducer was pulled back to release the stent; however, it became stuck and was tore off.Consequently, both the guide catheter and the push catheter were broken.The guide catheter was removed using forceps and the procedure was completed with a different device.There were no patient complications reported as 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: 18616830
• MDR Text Key: 334229569
• Report Number: 3005099803-2024-00182
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 0031244943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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