BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2230411 · Received August 15, 2011

    Report

    Report Number
    2242352-2011-01209
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CAN NOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, TWO OF THE HEMOPRO 2 DID NOT APPEAR TO BE SEALING THE BRANCHES CORRECTLY CAUSING BLOODY TUNNELS. THE SAME UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. REFER TO 2242352-2011-01208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other