BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7 XS EVH SYSTEM

    MDR report key: 1870856 · Received October 7, 2010

    Report

    Report Number
    2242352-2010-03036
    Event Type
    Injury
    Date Received
    October 7, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED FOR THE PRODUCT, AS THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP ON THE VASOVIEW 7 XS BROKE OFF IN THE PT'S LEG. THEY WERE ABLE TO RETRIEVE ALL PIECES THROUGH THE ORIGINAL INCISION WITH NO OTHER PT EFFECTS REPORTED. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE EVENT OCCURRED "SOME TIME LAST WEEK." THE LOT NUMBER IS UNK. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XS EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-3100 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other