BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19671930 · Received July 3, 2024

    Report

    Report Number
    3012608866-2024-00020
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    November 3, 2022
    Report Date
    July 25, 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
    OTHER HEALTH CARE PROFESSIONAL
    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 A 0.014¿ NON-PHILIPS GUIDEWIRE. VISUAL INSPECTION OF THE CATHETER FOUND NO UNUSUAL CHARACTERISTICS OF THE DEVICE. VISUAL INSPECTION OF THE GUIDEWIRE FOUND A SLIGHT KINK. DURING FUNCTIONAL TESTING, AN ATTEMPT TO DISLODGE THE GUIDEWIRE FROM THE CATHETER WAS UNSUCCESSFUL. THE ROOT CAUSE COULD NOT BE ESTABLISHED SINCE THE GUIDEWIRE COULD NOT BE DISLODGED FROM THE CATHETER. A REVIEW OF THE LHR AND MANUFACTURING PROCESS COULD NOT CONFIRM A CAUSE RELATED TO DESIGN AND/OR PROCESS FAILURE. 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.

    Additional Manufacturer Narrative · 0

    BLOCK D4: UNIQUE IDENTIFIER (UDI#) UPDATED TO INCLUDE FULL UDI NUMBER. 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 WAS DEPLOYED SUCCESSFULLY. HOWEVER, DURING REMOVAL, THE TES GOT STUCK ON A 0.014" NON-PHILIPS GUIDEWIRE AND HAD TO BE REMOVED AS A SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE IN ORDER TO DELIVER A BALLOON FOR POST DILATION. 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
    616180 TACK ENDOVASCULAR SYSTEM (4F, 1.5-4.5MM) SCAFFOLD, DISSECTION REPAIR QCT INTACT VASCULAR, INC. 154150041 238717 00863328000196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BOSTON SCIENTIFIC: 0.014" V-14 GUIDEWIRE| UNK MFG AND SIZE: GUIDE CATHETER| UNK MFG AND SIZE: INTRODUCER SHEATH