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

Model Number	M00534710
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2023.During the procedure, there was no resistance during the release of the stent.The stent did not appear to be attached to the system.The procedure was successfully completed with a new advanix biliary stent.The procedure was completed and there were no reported patient complications.Investigation results revealed that the guide catheter was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a150203 captures the reportable investigation results of guide catheter detached/separated.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached, and the detached section has evidence of tension forces being applied.The stent was returned attached to the guide catheter.The reported event of the stent being difficult to deploy can be confirmed.Taking all available information into consideration, most likely this was caused by an excess of force applied to the device during the stent deployment attempt.Based on the product analysis, the guide catheter was detached the stent was returned attached to the guide catheter.A microscopic inspection noted that the detached section of the guide catheter has evidence of tension forces applied.Therefore, the most probable cause is adverse event related to the 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: 17669568
• Report Number: 3005099803-2023-04626
• Device Sequence Number: 7088237
• Product Code: FGE
• UDI-Device Identifier: 08714729787266
• UDI-Public: 08714729787266
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: 09/13/2024
• Device Model Number: M00534710
• Device Catalogue Number: 3471
• Device Lot Number: 0030145232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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