BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERLOCK 3CG+ TCS

    MDR report key: 18094134 · Received November 7, 2023

    Report

    Report Number
    MW5147913
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 28, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PICC ASSOCIATED THROMBUS LIKELY DUE TO INCORRECT PICC PLACEMENT. PICC PLACEMENT WAS VERIFIED BY SHERLOCK 3ICG TECHNOLOGY FROM BARD ACCESS SYSTEMS, PICC WAS DEEP IN THE RA LIKELY SHEERING WALL AND CAUSING MURAL THROMBUS, WHICH IS POSSIBLE CULPRIT FOR PARADOXICAL EMBOLI CAUSING STROKE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804366 SHERLOCK 3CG+ TCS CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Hospitalization