BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISIGRIP VEIN STRIPPER

    MDR report key: 2185856 · Received June 30, 2011

    Report

    Report Number
    1220948-2011-00005
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    May 23, 2011
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GAF
    PMA / PMN Number
    K023688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WERE ABLE TO VERIFY THE FAILURE. THE NOSEPIECE WAS SEPARATED FROM THE WIRE. THE GRIPPER BLADES WAS PULLED OUT FROM SPRINGWIRE (THE SPRINGWIRE AND GRIPPER BLADES ARE OVERMOLDED IN ONE OPERATION). THE ROOT CAUSE OF THE FAILURE IS INCONCLUSIVE. IT IS POSSIBLE THE EXCESSIVE FORCE AND/OR CALCIFIED VESSEL CONTRIBUTED TO THE FAILURE. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. WE HAVE NOT SEEN THIS TYPE OF COMPLAINT BEFORE. THEREFORE, IT WAS AN ISOLATED INCIDENT. WE MADE AWARE OUR SUPPLIER OF SUBASSEMBLIES OF THIS INCIDENT. PLEASE NOTE THAT THE PT IS FINE AND WAS NOT INJURED DURING THIS INCIDENT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN PULL THE HANDLE OF THE DEVICE AFTER LOCKING THE VESSEL AT THE TIP OF THE NOSEPIECE. AT THIS MOMENT, THE NOSEPIECE SEPARATED FROM THE WIRE, AND LEFT IN THE VESSEL. THE PHYSICIAN CUT THE VESSEL AND REMOVED THE PIECE OUT OF IT. PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISIGRIP VEIN STRIPPER INVISIGRIP GAF LEMAITRE VASCULAR 1500-01 IVS1080

    Patients

    Seq Age Sex Outcome Treatment
    1