BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3893434 · Received June 5, 2014

    Report

    Report Number
    3893434
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 19, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AGO IN THE LATE FALL, PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT. A VESSEL WAS HARVESTED FROM THE RIGHT LEG AND USED SUCCESSFULLY IN THE GRAFT.APPROXIMATELY 16 MONTHS LATER, IN THE SPRING, THE PATIENT EXPERIENCED ITCHING AND DISCOMFORT IN HER RIGHT CALF. THE PATIENT EXPERIENCED DISCOMFORT THAT SHE DESCRIBED AS 'LIKE A SPLINTER' AND DISCOVERED A SMALL SPLINTER-OBJECT PROTRUDING FROM HER CALF. THE PATIENT USED A PAIR OF TWEEZERS TO REMOVE THE OBJECT AND REMOVED A PIECE OF TUBING APPROXIMATELY 4" LONG FROM HER CALF. THE PATIENT PRESENTED TO THE SURGEON FOR FOLLOW UP CARE APPROXIMATELY 4 DAYS LATER. NO OTHER ISSUES WERE NOTED.ORIGINALLY, THE PATIENT KEPT THE PIECE OF TUBING AND DID NOT TURN IT OVER TO THE HOSPITAL FOR INVESTIGATION. THE HOSPITAL RECEIVED THE TUBING TWO MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330247 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR