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

Model Number	M00534220
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150201 captures the reportable investigation results of guide catheter detached/separated.Block h10: the returned advanix biliary stent with naviflex rx delivery system was analyzed.A visual and microscopic evaluation noted the guide catheter was detached from the distal section and the stent remained attached to the naviflex rx delivery system.The pull wire was found kinked and fully retracted, and the pull wire cap and guide catheter were detached.The reported event of stent did not deploy was confirmed.Based on all the gathered information and product analysis, the investigation concluded that most likely the reported event and observed problems were most likely due to operational factors encountered during the procedure.Stent deployment technique and/or excess of force applied during pull wire retraction may result in friction between the push catheter and guide catheter.This may have caused the pull wire to kink and the pull wire cap and guide catheter detachment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific (bsc) that an advanix biliary stent with naviflex rx delivery system was selected for use in the papilla/duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During the procedure, although the guidewire and inner catheter were retracted as instructed per the device's instructions for use, the stent did not deploy.The advanix biliary stent was removed from the patient, and the procedure was completed with another advanix biliary stent.No patient complications were reported as a result of this event.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.

• 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: 17844612
• Report Number: 3005099803-2023-05126
• Device Sequence Number: 14549672
• Product Code: FGE
• UDI-Device Identifier: 08714729787310
• UDI-Public: 08714729787310
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/29/2023

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: 04/30/2025
• Device Model Number: M00534220
• Device Catalogue Number: 3422
• Device Lot Number: 0031528699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: 67 YR
• Patient Sex: Female