BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY SINUS CATHETER

    MDR report key: 2930238 · Received January 25, 2013

    Report

    Report Number
    3008500478-2013-00372
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 11, 2013
    Report Date
    March 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE INTRODUCER WAS VISUALLY INSPECTED AND THE LEAKING WAS CONFIRMED. A TEAR WAS FOUND ON THE HEMOSTASIS VALVE. PER ASSESSMENT BY R&D AND QUALITY ENGINEERING, THE ROOT CAUSE OF THE LEAKING HAS BEEN DETERMINED TO BE A MATERIAL RELAXATION ISSUE. IT IS NOT KNOWN AT THIS TIME IF THE VALVE LEAKING IS A DESIGN OR A SUPPLIER MANUFACTURING ISSUE. R&D AND SUPPLIER QUALITY ENGINEERING ARE ACTIVELY INVESTIGATING THE ISSUE. A CAPA WAS INITIATED FOR THIS DEVICE. A PRODUCT RECALL WAS INITIATED FOR THIS DEVICE. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER. ONLY 1 DEVICE WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 3 EVENTS OF BACKBLEEDING WITH THE PR9, CORONARY SINUS CATHETER INTRODUCER. THE HOSPITAL WAS UNABLET TO RECALL THE OCCURRENCE DATES OR FURTHER PT INFORMATION. NO REPORTED INJURY WAS STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35238 CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9

    Patients

    Seq Age Sex Outcome Treatment
    1