BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM)

    MDR report key: 19671629 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00017
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    April 22, 2022
    Report Date
    July 3, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00863328000127
    PMA / PMN Number
    P180034
    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 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 H3/H6: THE TES DEVICE WAS INFECTIOUS AND NOT RETURNED BY THE FACILITY, 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 0.035" NON-PHILIPS GUIDEWIRE LOOPED INSIDE THE TES AND WOULD NOT EXIT THE DISTAL END. DURING REMOVAL, IT WOULD NOT BUDGE, THUS REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW TES. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959559 TACK ENDOVASCULAR SYSTEM (6F, 3.5-6.0MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 156135061 271181 00863328000127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO: 0.035" GLIDE ADVANTAGE GUIDEWIRE.| UNK MFG AND SIZE: GUIDE CATHETER.| UNK MFG AND SIZE: INTRODUCER SHEATH.