BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19665700 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00003
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    August 29, 2022
    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

    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: THE TACK DEVICE WAS RETURNED FOR EVALUATION. THE INNER CORE SHAFT AND THE CORRESPONDING STAINLESS STEEL PUSHER FEATURE ON THE PROXIMAL END OF THE DEVICE WAS IN A FULLY DEPLOYED POSITION. THIS DISPLAYED THE FULL RANGE OF THE DISTAL PORTION OF INNER CORE SHAFT AND DISTAL INNER CORE MARKERS. VISUAL INSPECTION FOUND A KINK ON THE DISTAL PORTION OF THE INNER CORE SHAFT, APPROX. 3 INCHES PROXIMAL TO THE FIRST INNER CORE MARKER. ADDITIONALLY, THE OUTER BRAID SHEATH WAS KINKED, APPROX. 5 INCHES DISTAL TO THE STRAIN RELIEF WITH DEFORMITY OBSERVED ON THE MIDPOINT OF THE STRAIN RELIEF. THE STRAIN RELIEF WAS CUT, REMOVED, AND THE OUTER BRAIDED SHAFT WAS INSPECTED. UPON REMOVAL, THE OUTER BRAID SHEATH HAD A KINK AND PARTIAL SHAFT BREAKAGE IN THE LOCATION OF THE STRAIN RELIEF DEFORMITY. DURING FUNCTIONAL TESTING, AN ATTEMPT WAS MADE FOR TACK DEPLOYMENT BUT WAS UNSUCCESSFUL BECAUSE THE STAINLESS-STEEL PUSHER FEATURE BOND WAS BROKEN AT THE INNER CORE SHAFT. THE PIN AND PULL TACK DEPLOYMENT MECHANISM WAS NOT IN FUNCTIONAL WORKING ORDER DUE TO THE INABILITY TO RETRACT THE OUTER BRAIDED SHEATH OVER THE INNER CORE SHAFT. AFTER THE STRAIN RELIEF AND SHAFT DISSECTION, THE OUTER BRAIDED SHEATH WAS ABLE TO RETRACT OVER THE INNER CORE SHAFT WITH RESISTANCE NOTED WHEN THE DISTAL TIP KINK RETRACTED THROUGH THE OUTER BRAIDED SHEATH. THE HEMOSTATIC VALVE WAS TESTED IN THE LOCKED POSITION AND THE LOCKING MECHANISM WAS IN WORKING ORDER, NOT ALLOWING THE PIN AND PULL TACK DEPLOYMENT MECHANISM WHEN LOCKED. BLOCK H6: BASED ON THE DEVICE ANALYSIS, THE ROOT CAUSE OF THE INADVERTENT TACK DEPLOYMENT 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. UPON ENTERING THE SHEATH, A TACK WAS INADVERTENTLY DEPLOYED BUT WAS ABLE TO BE REMOVED FROM THE ENTRANCE OF THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A STENT. 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
    507145 TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 154150041 273658 00863328000196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO: 6F INTRODUCER SHEATH| UNK MFG AND SIZE: GUIDE CATHETER| UNK MFG AND SIZE: GUIDE WIRE