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

Model Number	M00534580
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded center bend stent was used in the biliary duct to treat stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was unable to separate from the introducer.Subsequently, the introducer broke off when it was removed and was retrieved.The procedure was completed with another advanix biliary preloaded stent.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 catheter-guide break.Block h11: the advanix stent with naviflex delivery system was received for analysis.Visual and microscopic inspection found that the guide catheter was kinked and detached, and the push catheter suture hole and stent suture hole were torn.The push catheter was damaged (torn) near the lock mechanism, and the stent barb was torn and deformed.No other problems were noted with the device.Product analysis confirmed the reported events of catheter guide break and suture deployment issue.The investigation concluded that the reported events and additional investigation findings were most likely caused due to procedural factors.The way the device was inserted into the scope, the physician's technique, and the tortuosity of the procedure, most likely contributed to the device being unable to deploy the stent.As a result, the manipulation and excessive force used to deploy the stent caused the encountered damages found on the device.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded center bend stent was used in the biliary duct to treat stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was unable to separate from the introducer.Subsequently, the introducer broke off when it was removed and was retrieved.The procedure was completed with another advanix biliary preloaded stent.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: 19656249
• Report Number: 3005099803-2024-03114
• Device Sequence Number: 6483905
• Product Code: FGE
• UDI-Device Identifier: 08714729787136
• UDI-Public: 08714729787136
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: M00534580
• Device Catalogue Number: 3458
• Device Lot Number: 0033248551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown