BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIRTUOSAPH PLUS, EVH

    MDR report key: 2903504 · Received January 3, 2013

    Report

    Report Number
    1124841-2013-00001
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K092789
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING VEIN HARVESTING PROCEDURE, THE TIP OF THE V-CUTTER WAS MISSING. THE HARVESTER WAS INTRODUCED INTO THE INCISION WITHOUT THE TROCAR. AN (B)(4) RETRACTOR WAS USED TO OPEN THE INCISION SITE FOR THE HARVESTER TO PASS. THE HARVESTER WAS ENTERED INTO THE TUNNEL WITH THE V-CUTTER IN THE TOP POSITION NEAREST THE SKIN. THE V-KEEPER WAS ABOVE THE VEIN TO BE HARVESTED. THE HARVESTER WAS ADVANCED UP THE TUNNEL WITHOUT ANY DIFFICULTY. THE SAPHENOUS VEIN WAS CAPTURED WITH THE V-KEEPER. A BRANCH WAS SET UP WITH THE V-KEEPER NEAR THE AREA OF THE GROIN CREASE. THE V-CUTTER BUTTON WAS PUSHED FORWARD TO ENGAGE THE BRANCH. PRIOR TO TOUCHING THE BRANCH IT WAS NOTICED BY THE OPERATOR THAT PART OF THE V-CUTTER WAS MISSING. NO BRANCH CUT WAS ATTEMPTED. THE V-CUTTER WAS MOVED BACK TO PROXIMAL POSITION OR LANDING. THE HARVESTER WAS REMOVED FROM THE TUNNEL. THE MISSING PART OF THE V-CUTTER WAS NOT FOUND ON THE STERILE FIELD OR INSTRUMENT PACKAGING. THERE WERE NO REMAINING (B)(4) TO COMPLETE THE BRANCH CUTTING AND HARVEST. THE MAQUET HARVESTER KIT (CURRENT EVH SYSTEM) WAS USED TO COMPLETE THE OPERATION. A TEN MINUTE DELAY OCCURRED TO CHANGE OUT THE KIT AND ATTEMPT TO LOCATE THE MISSING PART. THE MAQUET EVH KIT WAS ALSO USED TO VIEW AND ATTEMPT TO FIND THE OBJECT IN THE LEG. THIS WAS ATTEMPTED SEVERAL TIMES WITHOUT SEEING THE OBJECT. THE PT DID NOT LEAVE THE OPERATING ROOM BEFORE THE OBJECT WAS RECOVERED. AT THE END OF THE CORONARY ARTERY BYPASS CHEST CLOSURE THE LEG WAS X-RAYED. THE PT WAS STILL INCUBATED AND UNDER STERILE DRAPES. THE X-RAY SHOWED THE V-CUTTER PART IN THE MID-SECTION OF THE OPERATIVE LEG. THE MAQUET EVH KIT WAS USED TO GRASP THE OBJECT AND REMOVE FROM THE TUNNEL. NO NEW INCISIONS WERE MADE. SOME MINOR INCISION LENGTHENING WAS NEEDED TO USE THE MAQUET INSTRUMENT. NO BLOOD LOSS OCCURRED WITH THIS. THE PT DID NOT RECEIVE A RE-OPERATION FOR THIS EVENT. THE RECOVERY WAS PERFORMED DURING THE ORIGINAL AND ONLY OPERATION. NO DIFFICULTY WAS DESCRIBED ON ENTRY WITH THIS METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3399 VIRTUOSAPH PLUS, EVH VIRTUOSAPH PLUS GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA 28K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention