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

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdr impact code f2301 captures the used of rat tooth forceps to remove the broken guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with the naviflex rx delivery system was used to treat a tight hilar stricture of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure with stent placement, performed on (b)(6) 2024.During the procedure, a 10fr center-bend advanix stent was positioned in the bile duct.The assistant deployed the stent by pulling on the blue handle.Once the handle reached its maximum point, they noticed that the inner guide catheter had detached from the delivery system and remained inside the stent.A rat-tooth forceps was used to remove the inner guide catheter from the stent.The stent placement was maintained, and the procedure was successfully completed the original device.There were no patient complications associated with this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with the naviflex rx delivery system was used to treat a hilar tight stricture of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure with stent placement, performed on (b)(6) 2024.During the procedure, a 10fr center-bend advanix stent was positioned in the bile duct.The assistant deployed the stent by pulling on the blue handle.Once the handle reached its maximum point, they noticed that the inner guide catheter had detached from the delivery system and remained inside the stent.A rat-tooth forceps was used to remove the inner guide catheter from the stent.The stent placement was maintained, and the procedure was successfully completed using the original device.There were no patient complications associated with this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdr impact code f2301 captures the used of rat tooth forceps to remove the broken guide catheter.Block h11: an advanix- naviflex rx delivery system was returned for analysis.Visual inspection found that the guide catheter was kinked, damaged, and detached from the delivery system and the pull wire was also found broken.No other problems were noted in 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 kinked guide catheter and pull wire break and were most likely due to procedural factors as lesion characteristics, handling of the device, the technique used by the physician, which could have resulted in the damage noted to the device.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• Common Device Name: 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: 20751896
• Report Number: 3005099803-2024-05932
• Device Sequence Number: 20834261
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: 08714729787105
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2026
• Device Model Number: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0034727566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose