BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER

    MDR report key: 3376545 · Received September 25, 2013

    Report

    Report Number
    8010762-2013-00047
    Event Type
    Death
    Date Received
    September 25, 2013
    Date of Event
    September 9, 2013
    Report Date
    September 19, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. SINCE THE DEVICE IS NOT AVAILABLE FOR RETURN A TECHNICAL EVALUATION CAN NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GUIDEWIRE WAS INSERTED IN THE INFERIOR VENA CAVA WHICH WAS CONFIRMED BY IMAGING. DILATION WAS PERFORMED PRIOR TO CANNULAE INSERTION. THE CANNULAE WAS THEN INSERTED WITHOUT IMAGING, HOWEVER, THE GUIDEWIRE HAD MIGRATED AND THE CANNULAE PERFORATED THE HEART. THE PHYSICIAN DID NOT EXPERIENCE ADDITIONAL RESISTANCE UPON INSERTION OF THE CANNULAE. SUBSEQUENTLY, THE PATIENT EXPIRED. NO SPECIFIC DEVICE MALFUNCTION HAS BEEN REPORTED IN ASSOCIATION WITH THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484687 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER CATHETER DWF MAQUET CARDIOPULMONARY AG 10027 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death