BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS, EVH

    MDR report key: 3848081 · Received May 16, 2014

    Report

    Report Number
    1124841-2014-00072
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT DURING VEIN HARVESTING PROCEDURE, THE V-CUTTER TIP BROKE OFF WHILE IN THE PATIENT'S LEG. THE PATIENT WAS SMALL, DIAGNOSED WITH RENAL FAILURE, AND HAD SOFT CONNECTIVE TISSUE. THE DISSECTION AND ADVANCEMENT OF BOTH THE LOWER AND UPPER LEG WERE UNEVENTFUL. THE FIRST BIFURCATED BRANCH OFF THE ORIGIN STUMP WAS CUT NORMALLY. THE SECOND BRANCH WAS LOADED, BUT THERE WAS NO ELECTRICAL ACTIVITY WHEN THE FOOT PEDAL WAS PRESSED. GROUND WAS STATED AS SECURE. THE V-CUTTER WAS WITHDRAWN TO THE FULLY RETRIEVED PARKED POSITION WITHOUT ANY RESISTANCE. THE V-PIN WAS OPENED TO DO A BRANCH CAPTURE. ONCE THE BRANCH CAPTURE WAS COMPLETE, THE V-CUTTER WAS ADVANCED FORWARD TO MEET THE BRANCH. BEFORE CONTACT TO THE BRANCH, THE OPERATOR VIEWED THE V-CUTTER HAD A BROKEN TIP AS VISUALIZED IN THE TUNNEL. THE BROKEN VSP WAS REMOVED FROM THE LEG. A REPLACEMENT VSP550 WAS INSERTED, YET ATTEMPTS TO REMOVE THE V-CUTTER BROKEN PIECE USING THE REPLACEMENT VSP500 WERE NOT SUCCESSFUL. ONE INCISION WAS MADE MID TO UPPER THIGH APPROXIMATE 1/2 TO 1 INCH. THE BROKEN PIECE WAS REMOVED THROUGH THIS INCISION. THE HARVESTING WAS COMPLETED WITH THE REPLACEMENT VSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293972 VIRTUOSAPH PLUS, EVH LAPAROSCOPE, GENERAL GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. VSP550 42K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other