BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2791981 · Received October 16, 2012

    Report

    Report Number
    3008500478-2012-00311
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K961270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL PRIOR TO EVALUATION. THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE, A CAPA WAS NOT INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDOPLEGE CORONARY SINUS CATHETER WOULD NOT ADVANCE THROUGH THE PROVIDED SHEATH. THE HOSPITAL HAD TO OPEN THE ADDITIONAL KITS TO FIND A INTRODUCER THAT WOULD WORK. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES EP 975411

    Patients

    Seq Age Sex Outcome Treatment
    1