BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 6

    MDR report key: 1800884 · Received August 10, 2010

    Report

    Report Number
    2242352-2010-02376
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR HAS NOT YET RECEIVED THE DEVICE FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SENT WHEN THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP ON THE VH-2000 BROKE OFF INSIDE THE PT'S LEG. A PIECE BROKE OFF FROM THE PROXIMAL END AND WAS RETRIEVED THROUGH THE ORIGINAL INCISION WITH NO OTHER PT EFFECTS REPORTED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 6 VV6 DISSECTION TIP GEI MAQUET CARDIOVASCULAR VH-2000 25011935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other