BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIP-CATH BEACON TIP CATHETER

    MDR report key: 1000009 · Received February 12, 2008

    Report

    Report Number
    MW5005534
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 12, 2008
    Manufacturer
    COOK INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: IVC FILTER PLACEMENT. THE SLIP-CATH BEACON TIP CATHETER INADVERTENTLY PASSED THROUGH THE INTERNAL JUGULAR INTO THE RIGHT SUBCLAVIAN ARTERY. PT HAD A HIGH INR WHICH INCREASED THE PT'S POTENTIAL FOR BLEEDING UPON REMOVAL OF THE SLIP-CATH BEACON TIP CATHETER. THEREFORE, FOR THE SAFETY OF THE PT, THE PT WAS TAKEN TO THE OR FOR REMOVAL OF THE SLIP-CATH BEACON TIP CATHETER AND SUTURING OF THE SUBCLAVIAN ARTERY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: PLACEMENT OF IVC FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIP-CATH BEACON TIP CATHETER SLIP-CATH DQO COOK INC. G11993 G11993

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Disability