BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACK ENDOVASCULAR SYSTEM

    MDR report key: 19666143 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00011
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 3, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 B3/D10: THE DATE OF EVENT IS UNKNOWN; HOWEVER, SINCE THIS IS A REQUIRED FIELD, 1/1/2024 WAS ENTERED. 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: MODEL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE BLOCK E: THE FACILITY CONTACT NAME, FACILITY SITE NAME, FACILITY PHONE NUMBER, AND FACILITY ADDRESS ARE UNKNOWN. BLOCK G4: THE MODEL NUMBER WAS NOT PROVIDED, THUS THE PMA NUMBER IS UNKNOWN. 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 OFF THE DESIGNATED 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
    757075 TACK ENDOVASCULAR SYSTEM SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC.

    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