BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KGCA 4-80 WB PERFORMA W/BUMPER TIP W/STOPCOCK

    MDR report key: 218146 · Received April 7, 1999

    Report

    Report Number
    1628221-1999-00018
    Event Type
    Injury
    Date Received
    April 7, 1999
    Date of Event
    March 8, 1999
    Report Date
    March 12, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS CATHETER WAS INSERTED VIA A SHEATH IN THE LEFT BRACHIAL ARTERY FOR A DIAGNOSTIC PROCEDURE. WHEN THE CATHETER WAS TORQUED, NO RESISTANCE WAS FELT. REMOVAL OF THE CATHETER REVEALED THAT THE LEADING END OF THE CATHETER HAD SEPARATED AND REMAINED IN THE PT. THE LEADING END OF THE CATHETER WAS SUCCESSFULLY REMOVED VIA SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KGCA 4-80 WB PERFORMA W/BUMPER TIP W/STOPCOCK DIAGNOSTIC INTRAVASCULAR CATHETER DQO MALLINCKRODT MEDICAL, INC. NA MR18500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R 0.035" GUIDEWIRE.| 4 FRENCH TERUMO SHEATH AND A TERUMO RADIOFOCUS