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

Model Number	M00534330
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	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was used in the duodenum to treat stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on july 9, 2024.During the procedure, the inner catheter broke off and the stent was damaged.The stent was pulled out using rescue grasping forceps, and the procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was used in the duodenum to treat stones during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, the inner catheter broke off and the stent was damaged.The stent was pulled out using rescue grasping forceps, and the procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes) has been updated based on the media analysis finding of pull wire break.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.

• 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: 19888237
• Report Number: 3005099803-2024-03660
• Device Sequence Number: 15225569
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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: 05/18/2025
• Device Model Number: M00534330
• Device Catalogue Number: 3433
• Device Lot Number: 0034097367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/02/2024
• Date Device Manufactured: 05/18/2024
• 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