BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19665856 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00006
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    March 7, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A: THE PATIENT'S DOB OR AGE AT TIME OF EVENT, SEX, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. BLOCK B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. BLOCK D4/H4: THE LOT NUMBER WAS NOT PROVIDED; THUS, THE FOLLOWING INFORMATION ARE UNKNOWN: UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. 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, A TACK INADVERTENTLY DEPLOYED 1-2 CM OFF THE TARGET AREA. 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
    800366 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