BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR PACING CATHETER

    MDR report key: 1952465 · Received December 16, 2010

    Report

    Report Number
    1952465
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 12, 2010
    Report Date
    December 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MD AND RN WERE AT THE BEDSIDE PREPARING FOR BIPOLAR PACING CATHETER (TEMPORARY PACING WIRE) PLACEMENT FOR AN UNSTABLE PATIENT. TEST OF BALLOON FAILED PRIOR TO PATIENT INSERTION (BALLOON DID NOT INFLATE). IT IS STANDARD PRACTICE TO TEST BALLOON PRIOR TO INSERTION. A NEW CATHETER WAS OBTAINED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE MALFUNCTION - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR PACING CATHETER CATHETER, PACEMAKER, TEMPORARY DYG EDWARDS LIFESCIENCES * 58873562

    Patients

    Seq Age Sex Outcome Treatment
    1 * CARDIAC DRUGS