BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1220814 · Received October 30, 2008

    Report

    Report Number
    6000002-2008-09117
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORT CONFIRMED. BLOOD WAS FOUND INSIDE BALLOON LUMEN AND UNDERNEATH BALLOON. BALLOON WAS FOUND TO BE RUPTURED IN CENTRAL AREA. BALLOON WAS BAGGY AND APPEARED TO BE THIN AT THE SITE OF RUPTURE. BALLOON PROTRUDED TOWARDS RUPTURED SIDE.

    Description of Event or Problem · 1

    SALES REP REPORTS THAT THE BALLOON BURST WHILE POSITIONING THE PT. DOCTOR REMOVED DEVICE AND USED ANOTHER. NO PT PROBLEM RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 567540

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK