MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534690
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: an advanix stent with naviflex delivery system was received for analysis, the device was returned without the suture.Visual inspection of the returned device found the push catheter suture hole torn, the pull wire kinked; and the guide catheter detached and bent.Destructive analysis was then performed, and it was found the hypo tube from the pull wire outside of the guide catheter.No other problems were noted with the delivery system.Product analysis confirmed the reported event of suture deployment issue.The investigation concluded that the reported event and additional observed damages noticed were related to procedural factors.It's most likely that when it was tried to deploy the stent, the tortuosity of the procedure or the physician technique made the suture not able to deploy from the push catheter suture hole, which consequently made the physician use excessive force to deploy the stent and by this manipulation, causing the additional observed damages.Therefore, taking all available information into consideration, the overall root cause of the events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex delivery system was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the suture could not be released.The procedure was then completed using another of the same device.There were no patient complications as a result of this event.Note: no further information has been obtained despite good faith efforts.

• Brand Name: ADVANIX BILIARY
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21690196
• Report Number: 3005099803-2025-01166
• Device Sequence Number: 9282001
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: 07/20/2026
• Device Model Number: M00534690
• Device Catalogue Number: M00534690
• Device Lot Number: 0034530623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2024
• 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