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

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable findings of catheter-guide break.Block h11: a naviflex rx delivery system was received for analysis.Visual and microscopic inspections found that the guide catheter was kinked and detached.No other problems were noted with the device.Product analysis confirmed the reported event of device damaged/defective.The observed events of catheter-guide kinked, and break were most likely due to the way the stent was deployed during the procedure, the tortuosity of the procedure, or the physician's technique not being able to deploy the stent, which consequently caused the physician to apply more force to deploy the stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the delivery system was damaged, and the stent could not be deployed.It is unknown which part of the device was damaged, the nature of the damage, and the outcome of the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the guide catheter was detached.Please see block h11 for full investigation details.

• 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: 20714678
• Report Number: 3005099803-2024-05841
• Device Sequence Number: 15506780
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: 08714729787105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 11/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Model Number: M00533580
• Device Catalogue Number: 3358
• Device Lot Number: 0033632480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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
• Patient Sex: Unknown