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

Model Number	M00534300
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent and naviflex rx delivery system were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6), 2023.During the procedure, the handle was found broken, and the release mechanism of the delivery system was not functioning properly.There was difficulty in deploying the stent and the stent and guide catheter were noticed to be broken near the sheath.The advanix biliary stent was implanted successfully in this procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g2: voluntary medwatch mdr report # mw5144789.Block h6: imdrf device code a0401 captures the reportable event of stent break and guide catheter break.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code) have been updated based on the additional information received on october 3, 2023.Updated b5 based on the additional information that was received from the complainant on october 03, 2023, that the handle/release mechanism was broken not the stent.Based on this new information, the manufacturer has determined this event no longer meets reporting criteria for the device in question.Block g2: voluntary medwatch mdr report # mw5144789.Block h6: imdrf device code a0401 captures the reportable event of stent break and guide catheter break.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent and naviflex rx delivery system were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct, performed on (b)(6) 2023.During the procedure, the handle was found broken, and the release mechanism of the delivery system was not functioning properly.There was difficulty in deploying the stent and the stent and guide catheter were noticed to be broken near the sheath.The advanix biliary stent was implanted successfully in this procedure.There were no patient complications reported as a result of this event.Additional information received on (b)(6) 2023: it as reported that it was the handle/release mechanism that was broken and not the stent.

• 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: 17845367
• Report Number: 3005099803-2023-05117
• Device Sequence Number: 15249564
• Product Code: FGE
• UDI-Device Identifier: 08714729787396
• UDI-Public: 08714729787396
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 05/22/2024
• Device Model Number: M00534300
• Device Catalogue Number: 3430
• Device Lot Number: 0029455267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 86 KG