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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of the two advanix biliary stents with naviflex rx delivery system that were used during the same procedure.Please refer to mfr report# 3005099803-2024-03847 and mfr report# 3005099803-2024-03849 for the associated device.It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was used in the bile duct to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, upon deployment of the stent, the guide catheter broke.The procedure was completed using another of the same device.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: an advanix biliary stent with naviflex delivery system was received for analysis.Visual inspection found the guide catheter kinked and detached.After destructive testing, it was found that the device hypotube from the pull wire wasn't connected to the guide catheter.The pull wire was found bent near its cap, and during the analysis, the hypotube got detached at the bent area.Additionally, the stent and push catheter holes were torn, and the push catheter was bent.No other problems were noted with the device.The reported event of catheter guide break was confirmed.The investigation concluded that the reported event and the additional observed device problems were most likely due to procedural factors encountered during use.Contributing factors may have included the patient's tortuous anatomy, the handling and manipulation of the device, the physician's technique, or the amount of force applied.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
Note: this report pertains to one of the two advanix biliary stents with naviflex rx delivery system that were used during the same procedure.Please refer to mfr report# 3005099803-2024-03847 and mfr report# 3005099803-2024-03849 for the associated device.It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was used in the bile duct to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, upon deployment of the stent, the guide catheter broke.The procedure was completed using another of the same device.There was no patient complications 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 ; EI 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19967885
• Report Number: 3005099803-2024-03847
• Device Sequence Number: 8897408
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/15/2024

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: 03/10/2026
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0033599085
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown