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

Model Number	M00534230
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct on (b)(6) 2023.During the procedure and inside the patient, when the physician attempted to deploy the stent, it was noticed that the push catheter kinked, and the stent failed to deploy.Another advanix biliary stent was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; guide catheter detached/separated.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block d4, h4: the reported lot number (28928525) could not be matched to the reported device upn.Therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable investigation result of guide catheter detached.Block h10: the returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the push catheter was kinked and torn near the handle, and the pull wire was kinked.During a disassembled inspection, when the guide catheter was pulled back, it was detached from the pull wire.No other problems with the device were noted.The reported event was confirmed.Taking all available information into consideration, the investigation concluded that most likely the observed failures were caused by an unsuccessful attempt of stent deployment.These observed failures could have been caused anatomical or procedural factors such as, the technique used by the user, excess force may have been applied in order to release the stent causing kinks on the pull wire.Therefore, the most probable root cause is adverse event related to 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: 16913593
• Report Number: 3005099803-2023-02420
• Device Sequence Number: 6555510
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 05/11/2023

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 Model Number: M00534230
• Device Catalogue Number: 3423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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