BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 1924140 · Received December 14, 2010

    Report

    Report Number
    3008500478-2010-00033
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIOUS INJURY DUE TO PRODUCT NEEDING TO BE SWICHED OUT DURING USE FOR A NEW ONE.MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET PRODUCT BACK FOR EVALUATION AS IT WAS ORIGINALLY REPORTED TO BE AVAILABLE FOR EVALUATION. ONCE PRODUCT IS RECEIVED IT WILL BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOPLEDGE BALLOON BROKE DURING USE. THE CUSTOMER INSERTED THE EP INTO THE HEART AND WHEN THEY WENT TO INFLATE, THE BALLOON WAS RUPTURED. THEY HAD TO SWITCH OUT FOR A NEW DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other