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

Model Number	M00534650
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.K101314, k203162 - reported here as it exceeded the maximum character limit for the designated field.Block h6: imdrf device code g0401 captures the reportable event of catheter guide break.An advanix-naviflex stent was received for analysis; the device was returned.Visual inspection of the returned device found the pull wire kinked and the guide catheter detached and kinked.After the destructive test, it was seen that the pull wire was broken, and which caused the guide catheter detachment.No other problems were noted with the delivery system.Product analysis confirmed the reported events of "stent failure to deploy", "catheter - guide detached/separated", "catheter - guide bent/kinked", "wire pull bent/kinked" and "wire pull detached/separated".The investigation concluded that the adverse event was related to the procedure.It was reported that the guide wire could not be released during the stent deployment, leading the physician to forcibly remove the inner sheath, which damaged the delivery system.The returned device showed a kinked pull wire and a detached, kinked guide catheter.Destructive testing revealed a broken pull wire, which caused the guide catheter detachment.The likely cause was the tortuosity of the procedure or the physician's technique, which required excessive force to deploy the stent, resulting in the pull wire detachment and guide catheter breakage.Alternatively, the guide catheter may have already been kinked before the deployment attempt due to the technique used.Taking all available information into consideration, the overall root cause of the reported event is "adverse event related to procedure".
Event or Problem Description
It was reported to boston scientific corporation that an advanix naviflex stent was used for drainage in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when the physician removed the guidewire in preparation for releasing the stent, he noticed that the stent could not be released.The inner sheath was forcibly pulled out that caused the delivery system damage.The procedure was completed with another of the same device.There was no known patient complication reported as a result of this event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21201945
• Report Number: 3005099803-2025-00134
• Device Sequence Number: 8285300
• Product Code: FGE
• UDI-Device Identifier: 08714729787204
• UDI-Public: 08714729787204
• 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): 01/21/2025

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: 03/28/2025
• Device Model Number: M00534650
• Device Catalogue Number: M00534650
• Device Lot Number: 0033741467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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