BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5MM)

    MDR report key: 19665918 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00008
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    September 6, 2023
    Report Date
    July 3, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    PMA / PMN Number
    P190027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H3/H6: THE TACK DEVICE WAS NOT RETURNED, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    THE TACK ENDOVASCULAR SYSTEM (TES) WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, AN ADDITIONAL TACK WAS INADVERTENTLY DEPLOYED. NO ADDITIONAL INTERVENTION REQUIRED AND NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE TACK INADVERTENTLY DEPLOYED. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801319 TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 154150041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK MFG AND SIZE: GUIDE CATHETER.| UNK MFG AND SIZE: GUIDE WIRE.| UNK MFG AND SIZE: INTRODUCER SHEATH.