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

Model Number	M00534330
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	04/26/2024
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 corporation that an advanix-naviflex rx biliary stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, the guide catheter was broken.The procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, the guide catheter was broken.The procedure was completed with another advanix biliary 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 guide catheter break.Block h11: the advanix-naviflex delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the pull wire was actuated and the guide catheter was detached.It was also found that the hypo tube was not inserted within the guide catheter, the hypo tube was found inside the push catheter.The guide catheter and the wire from the hypo tube were kinked.No other damages were noted to the delivery system.The reported events of guide catheter break and stent failure to deploy were confirmed.Taking all available information into consideration, the investigation concluded that the observed damages were most likely due to the physician technique at the time of the stent deployment caused the guide wire and the pull wire to get kinked, and/or it is possible that the excessive force applied to pull the device led to the guide catheter detachment.However, from a product analysis point of view, this cannot be determined.Therefore, the most probable cause was unable to be established.

• 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: 19323936
• Report Number: 3005099803-2024-02271
• Device Sequence Number: 2569214
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/15/2024

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: 01/14/2026
• Device Model Number: M00534330
• Device Catalogue Number: 3433
• Device Lot Number: 0033209680
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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
• Patient Sex: Unknown