BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19671540 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00016
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    November 17, 2021
    Report Date
    July 3, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    UDI-DI
    00863328000196
    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

    THE PATIENT'S DOB OR AGE AT TIME OF EVENT, SEX, GENDER, WEIGHT, ETHNICITY, AND RACE ARE UNKNOWN. PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. THE TES CATHETER WAS RETURNED INTACT TO AN 0.014" NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION OF THE CATHETER FOUND THE STAINLESS-STEEL PUSHER SHAFT SEPARATED FROM THE CATHETER. VISUAL INSPECTION OF THE GUIDEWIRE FOUND SEVERAL KINKS WITH MISSING COATING OBSERVED IN MULTIPLE AREAS. DURING FUNCTIONAL TESTING, THE OUTER SHEATH WAS FLUSHED WITH NO OCCLUSIONS NOTED. AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE WITH SLIGHT MOVEMENT FELT, BUT WAS UNABLE TO RELEASE EVEN WITH EXTREME FORCE APPLIED. HOWEVER, THE FORCE APPLIED TO ATTEMPT REMOVAL, DAMAGED THE INNER CORE WHICH PREVENTED THE GUIDEWIRE COMPATIBILITY TESTING. A PROBABLE ROOT CAUSE MAY BE DUE TO THE DAMAGED OBSERVED ON THE NON-PHILIPS GUIDEWIRE; HOWEVER, THE CAUSE COULD NOT BE ESTABLISHED. 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, THE TES WAS ABLE TO ADVANCE WELL AND 3 OF THE 4 TACKS WERE DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL, THE TES GOT STUCK HALFWAY OUT, AND HAD TO PULL THE TES AND GUIDEWIRE AS A UNIT. A NEW GUIDE WIRE WAS INSERTED TO COMPLETE THE PROCEDURE. 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
    1132724 TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 154150041 258492 00863328000196

    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