BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPOSE 4 DEVICE

    MDR report key: 3121944 · Received May 15, 2013

    Report

    Report Number
    2242352-2013-00466
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TREND DEVELOP. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AFTER A CORONARY ARTERY BYPASS PROCEDURE, THE XPOSE 4 WAS BEING WASHED WHEN IT WAS OBSERVED THAT THE SPONGE WAS MISSING AT THE CEILING OF THE INNER SUCTION CUP. UPON WATCHING THE VIDEO OF THE OPERATION, IT APPEARED THAT THE SPONGE FELL INSIDE THE PT'S BODY. THE HOSPITAL STATED THAT THEY WILL NOT RETRIEVE THE PIECE; IT STILL REMAINS INSIDE OF THE PT. THE DOCTOR IS POSITIVE THAT THE PIECE IN THE PT IS THE SPONGE. THE PT IS AWARE AND IS BEING MONITORED. AN MRI WAS PERFORMED, BUT THE PIECE OF SPONGE DID NOT APPEAR ON THE TOMOGRAPHIC EXAMINATION. THE HOSPITAL IS AWARE THAT THE XPOSER 4 DEVICE IS A DISPOSABLE DEVICE AND SHOULD NOT BE RESTERILIZED AND REUSED. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214506 XPOSE 4 DEVICE CLAMPLESS BEATING HEART MWS MAQUET CARDIOVASCULAR, LLC XP-4000 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other