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

Model Number	M00534330
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded double bend was used in the common bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, upon deploying the stent, the guide catheter was kinked and could no longer be withdrawn into the push catheter.Subsequently, the physician pulled the delivery system and the guide catheter broke.A snare was then used to remove the broken guide catheter.The stent was successfully placed, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded double bend was used in the common bile duct to treat a choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, upon deploying the stent, the guide catheter was kinked and could no longer be withdrawn into the push catheter.Subsequently, the physician pulled the delivery system and the guide catheter broke.A snare was then used to remove the broken guide catheter.The stent was successfully placed, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: an advanix biliary preloaded double bend stent was received for analysis.Visual inspection found that the push catheter was bent.The guide catheter was kinked and detached, and the push catheter suture hole was torn.No other problems were noted with the device.Product analysis confirmed the reported events of catheter-guide kinked and catheter-guide break.The investigation concluded that the reported events were due to excessive force being applied when the device was pulled.The tortuosity of the procedure may have made the device to be in a position in which it was hard to pull resulting in the observed damaged of push catheter bent.Furthermore, the observed damage of push catheter suture hole torn was likely due to difficulties when deploying the stent.If the device had pressure when deploying the stent due to the physician's technique or tortuosity of the procedure, it is most likely that the device could not deploy the stent, and the push catheter suture hole was damaged by the pressure that the suture was adding to the suture hole.Therefore, taking all available information into consideration, the overall root cause of the reported events is adverse event related to procedure.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the ifu states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed.".

• 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: 20718033
• Report Number: 3005099803-2024-05820
• Device Sequence Number: 6489539
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/17/2025

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: 08/15/2026
• Device Model Number: M00534330
• Device Catalogue Number: M00534330
• Device Lot Number: 0034724299
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: Unknown