BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANDLER TRANSLUMINAL V-PACING PROBE WITH AMC THROMBOSHIELD

    MDR report key: 1062676 · Received June 16, 2008

    Report

    Report Number
    6000002-2008-07570
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. THE PACING PROBE WAS RECEIVED IN ITS SEALED ORIGINAL PACKAGING. THE PACING PROBE WAS NOT ATTACHED TO THE ORANGE TUOHY-BORST ADAPTER.

    Description of Event or Problem · 1

    REPORTEDLY, GUIDE WIRE WAS NOT ABLE TO BE INSERTED INTO THE ORANGE CONNECTION BEFORE USE. NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHANDLER TRANSLUMINAL V-PACING PROBE WITH AMC THROMBOSHIELD TRANSLUMINAL BIPOLAR PACING PROBE DYG EDWARDS LIFESCIENCES, PR D98100H 236KC523

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other