BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TORQVUE LP

    MDR report key: 21668681 · Received March 21, 2025

    Report

    Report Number
    2135147-2025-01500
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K131063
    Removal / Correction Number
    3007113487-03/19/25-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, ABBOTT IS ISSUING THIS IMPORTANT FIELD SAFETY NOTICE FOR THE AMPLATZER¿ TORQVUE¿ LP (TVLP) AND AMPLATZER¿ TORQVUE¿ LP CATHETER (TVLPC) DELIVERY SYSTEM(S). ABBOTT IS VOLUNTARILY RECALLING CERTAIN 4F AMPLATZER¿ TORQVUE¿ LP DELIVERY SYSTEM (TVLP) AND 4F AMPLATZER¿ TORQVUE¿ LP CATHETER (TVLPC) DEVICES, WHICH WERE IMPACTED BY A MANUFACTURING ANOMALY. LEAKING CATHETERS WERE NOTED DURING USE AND AN INVESTIGATION OF THE RETURNED DEVICES IDENTIFIED A SMALL BREACH IN THE PROXIMAL END OF THE SHAFT UNDER THE STRAIN RELIEF OF THE DELIVERY SYSTEM. THE BREACH WAS INADVERTENTLY IMPARTED FROM A MANUFACTURING MOLDING TOOL. ABBOTT IS COMMUNICATING TO BRING AWARENESS AND SHARE THE ACTIONS ABBOTT IS IMPLEMENTING TO RESOLVE THIS ISSUE. EXCEPTION ISSUE-133573 WAS INITIATED ON 09-DEC-2024 FOR FURTHER INVESTIGATION OF THESE FAILURE MODES. CAPA INVESTIGATION HAS CONFIRMED THAT THE BREACH IN TUBING WAS BEING INADVERTENTLY IMPARTED THROUGH A MOLDING PROCESS DUE TO DAMAGED TOOLING. SEE ATTACHED LIST OF MDR REPORTS ALREADY SUBMITTED THAT ARE INCLUDED IN THE FIELD SAFETY NOTICE.

    Description of Event or Problem · 0

    ABBOTT IS ISSUING THIS IMPORTANT FIELD SAFETY NOTICE FOR THE AMPLATZER¿ TORQVUE¿ LP (TVLP) AND AMPLATZER¿ TORQVUE¿ LP CATHETER (TVLPC) DELIVERY SYSTEM(S). ABBOTT IS VOLUNTARILY RECALLING CERTAIN 4F AMPLATZER¿ TORQVUE¿ LP DELIVERY SYSTEM (TVLP) AND 4F AMPLATZER¿ TORQVUE¿ LP CATHETER (TVLPC) DEVICES, WHICH WERE IMPACTED BY A MANUFACTURING ANOMALY. LEAKING CATHETERS WERE NOTED DURING USE AND AN INVESTIGATION OF THE RETURNED DEVICES IDENTIFIED A SMAL L BREACH IN THE PROXIMAL END OF THE SHAFT UNDER THE STRAIN RELIEF OF THE DELIVERY SYSTEM. THE BREACH WAS INADVERTENTLY IMPARTED FROM A MANUFACTURING MOLDING TOOL. ABBOTT IS COMMUNICATING TO BRING AWARENESS AND SHARE THE ACTIONS ABBOTT IS IMPLEMENTING TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907514 AMPLATZER TORQVUE LP CATHETER, PERCUTANEOUS DQY ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown