BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3130211 · Received May 22, 2013

    Report

    Report Number
    2242352-2013-00475
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. THE SCOPE WASHER TUBE AND HALF OF THE C-RING WERE NOT RETURNED. THE RETURNED PORTION OF THE C-RING ASSEMBLY WAS INSPECTED UNDER A MICROSCOPE; IT DISPLAYED SIGNS OF EXPOSURE TO HEAT AT THE FRACTURE SITE. THIS TYPE OF FAILURE IS CONSISTENT WITH THE APPLICATION OF HEAT FROM THE HEMOPRO TOOL WHILE IN CLOSE PROXIMITY WITH THE C-RING ASSEMBLY. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR C-RING FRACTURE DUE TO HEAT EXPOSURE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE PLASTIC ON THE DISTAL END OF THE HEMOPRO SHEATH WAS CRACKED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL WAS UNABLE TO PROVIDE FURTHER INFO ON THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227303 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25074044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA