BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORONARY SINUS CATHETER

    MDR report key: 2082351 · Received May 9, 2011

    Report

    Report Number
    3008500478-2011-00094
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 27, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT SAVED BY THE CUSTOMER. THEREFORE THE PRODUCT WAS NOT RETURNED FOR EVALUATION 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 CUSTOMER HAD AN ENDOPLEGE BALLOON RUPTURE. DR. (B)(6) WAS THE ANESTHESIOLOGIST DURING THE CASE. PER DR. (B)(6): "PATIENT UNDERGOING AVR, CS BALLOON WAS UP WITH 0.75 ML GOING ON BYPASS, STARTED RETROGRADE CARDIOPLEGIA AND THE PRESSURE TRACING SUDDENLY DECREASE SO I ADDED MORE INTO THE CSC BALLOON BUT NOTED IT WENT IN EASY AND NO RESISTANCE, SUSPECTED CATHETER RUPTURE, AND THEN ASPIRATED CONFIRMING BLOOD ASPIRATED INTO CSC BALLOON SYRINGE. SURGEON USED ANTEGRADE INTO THE CORONARY OSTIA THE REST OF CASE, PATIENT DID WELL.".

    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