BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPLEGE CORNARY SINUS CATHETER

    MDR report key: 1923945 · Received December 14, 2010

    Report

    Report Number
    3008500478-2010-00030
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESISTANCE BETWEEN INTRODUCER AND CATHETER. DEVICE NOT EVALUATED: DEVICE NOT RETURNED; IT WAS USED SUCCESSFULLY IN THE CASE AND DISCARDED BY CUSTOMER. THE DEVICE WAS DISCARDED THEREFORE AN EVALUATION ON THE ACTUAL DEVICE COULD NOT BE PERFORMED. A CORRECTIVE ACTION IS OPEN TO ADDRESS RESISTANCE BETWEEN INTRODUCER AND CATHETER FIT. THIS EVENT IS APPLICABLE TO THE OPEN CORRECTIVE ACTION AND WILL BE TRACKED THROUGH THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WHERE THE ENDOPLEGE INTRODUCER WAS TOO TIGHT.. THE CUSTOMER WAS ABLE TO GET THE CATHETER TO WORK BUT IT WAS VERY DIFFICULT FOR THEM TO GET IT THROUGH THE INTRODUCER. HOWEVER THE DEVICE WAS USED SUCCESSFULLY THROUGH THE CASE AND THE DEVICE WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPLEGE CORNARY SINUS CATHETER CORNARY SINUS CATHETER DWF EDWARDS LIFESCIENCES EP 774333

    Patients

    Seq Age Sex Outcome Treatment
    1