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

Model Number	M00532180
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary double pigtail stent was to be implanted in the common bile duct to treat a common bile duct stone during an endoscopic retrograde biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guide catheter could not be deployed.Another advanix biliary stent was used to complete the procedure.There were no patient complications reported as a result of this even.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the push catheter was torn, and that the stent was torn and bent.Please see block h11 for the full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter facility address: (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation findings of push catheter torn and stent break.Imdrf device code a0406 captures the reportable investigation finding of stent kinked.Block h11: the advanix-naviflex delivery system was received for analysis.Visual examination of the returned device found the push catheter torn and buckled, the pull wire kinked and dislocated out of the push catheter, and the stent torn and bent.No other damages were noted to the delivery system.The reported event of stent failure to deploy was confirmed.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to operational factors such as the deployment technique of the stent.Possibly an excess of force was applied during the pull wire retraction due to the inability of deploying the stent, which caused friction between the push catheter and guide catheter, causing the accordioning on the push catheter and the kink on the pull wire.Furthermore, the observed failure of stent bent and torn was also most likely related due to the deployment technique of the device and the procedural factors such as the tortuosity of the anatomy.Therefore, the most probable cause of the reported event is adverse event related to procedure.

• 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: 19707128
• Report Number: 3005099803-2024-03154
• Device Sequence Number: 6557798
• Product Code: FGE
• UDI-Device Identifier: 08714729786979
• UDI-Public: 08714729786979
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101786
• 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): 07/09/2024

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: 08/21/2024
• Device Model Number: M00532180
• Device Catalogue Number: 3218
• Device Lot Number: 0029997030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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