BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS REGATTA STEERABLE WIRE

    MDR report key: 2803260 · Received October 15, 2007

    Report

    Report Number
    2803260
    Event Type
    Injury
    Date Received
    October 15, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 10, 2007
    Manufacturer
    CORDIS CORP.
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PERIPHERAL INTERVENTION OF LEFT SFA - MD WAS USING OUTBACK CATHETER ON CORDIS REGATTA WIRE. WHEN MD ATTEMPTING TO ADVANCE OUTBACK, THE REGATTA WIRE PULLED BACK - MD PULLED OUT THE OUTBACK CATHETER. REMOVING CATHETER CAUSED SEPARATION OF REGATTA WIRE. IN WITH 4MM STENT SNARE TO SNARE WIRE. NO FURTHER TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS REGATTA STEERABLE WIRE GUIDE WIRE FOR INTERVENTIONAL PROCEDURE DQX CORDIS CORP. 90005048

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention CORDIS OUTBACK RENTRY CATHETER