BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCAFFOLD, DISSECTION REPAIR

    MDR report key: 20782454 · Received November 26, 2024

    Report

    Report Number
    3012608866-2024-00030
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 25, 2024
    Manufacturer
    INTACT VASCULAR, INC.
    Product Code
    QCT
    Adverse Event
    Yes
    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. THE DATE OF EVENT WAS NOT PROVIDED, THUS (B)(6) 2024 WAS LISTED. BLOCK B6/B7: PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY DATA OR MEDICAL HISTORY ARE UNKNOWN. BLOCK D4/G4/H4: THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION ARE UNKNOWN: BRAND NAME, MODEL NUMBER, CATALOG NUMBER, UNIQUE ID, EXPIRATION DATE, MANUFACTURE DATE, AND PMA NUMBER. 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 AN EARLY REINTERVENTION OF A CLI CASE, A PREVIOUSLY IMPLANTED TACK (APPROX. 1 WEEK LATER) WAS DISPLACED WHILE CROSSING THROUGH THE TACK WITH OTHER DEVICES. THE DISPLACED TACK WAS REMOVED WITH THE USE OF FORCEPS. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE OF THE TACK DISPLACEMENT, RESULTING IN ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569650 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