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

Model Number	M00534230
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
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 that an advanix biliary stent was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat obstructive jaundice in the orifice of the common bile duct, performed on (b)(6) 2023.During the procedure and inside the patient, the guide catheter was fractured upon deploying the stent.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the advanix-naviflex biliary stent was returned without the stent.A visual evaluation of the delivery system noted that the pullwire was kinked, the guide catheter was detached and the push catheter suture hole was torn.No other problems with the device were noted.Based on all the gathered information, the failures found could have been caused by operational factors such as the deployment technique of the stent, and excess force was applied during the pull wire retraction, which caused friction between the push catheter and guide catheter, causing the torn on the push catheter and the kink on the pull wire.Therefore, adverse event related to procedure is selected as the most probable cause for the complaint.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat obstructive jaundice in the orifice of the common bile duct, performed on (b)(6) 2023.During the procedure and inside the patient, the guide catheter was fractured upon deploying the stent.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.

• 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: 17469445
• Report Number: 3005099803-2023-04140
• Device Sequence Number: 12237287
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/25/2023

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: 02/26/2025
• Device Model Number: M00534230
• Device Catalogue Number: 3423
• Device Lot Number: 0031126278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG