BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISIGRIP VEIN STRIPPER

    MDR report key: 2663410 · Received July 16, 2012

    Report

    Report Number
    1220948-2012-00011
    Event Type
    Injury
    Date Received
    July 16, 2012
    Report Date
    June 18, 2011
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GAF
    PMA / PMN Number
    K023688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION AND WERE NOT ABLE TO VERIFY THE FAILURE. BASED ON THE EVENT DESCRIPTION, THE MOST PROBABLE ROOT CAUSE OF THE INCIDENT WAS THE INCORRECT DOCTOR'S TECHNIQUE. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESS 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. PLEASE NOTE THAT THE PT IS RECOVERING, AN THIS INCIDENT WAS NOT REPORTED TO THE MANUFACTURER BY THE HOSPITAL. THE INCIDENT BECAME KNOWN THROUGH THE (B)(4) SOCIETY OF PHLEBOLOGY.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN PULLED OUT THE ARTERY (SFA) BY MISTAKE. ACCORDING TO THE PHYSICIAN, THE PT'S ARTERY WAS TINY AND THERE WAS A LITTLE BLOOD BACKFLOW. AFTER THE PROCEDURE, THE PT WENT HOME, BUT FELT PAIN AND "COLDNESS" OF LEG. NEXT DAY AFTER THE PROCEDURE, THE PT WAS TAKEN TO THE EMERGENCY ROOM WHERE IT WAS FOUND THAT THE PT HAD ACUTE ARTERIAL OCCLUSIVE DISEASE AND PERFORMED EMERGENCY RE-VASCULARIZATION WITH SYNTHETIC VESSEL (GRAFT). PT IS RECOVERING. THIS INCIDENT WAS REPORTED TO (B)(4) SOCIETY OF PHLEBOLOGY, AND IT WAS NOTED THAT THIS INCIDENT WAS UNRELATED TO THE DEVICE, BUT THE DOCTOR'S TECHNIQUE. THE INCIDENT HAPPENED IN (B)(6) 2011 - (B)(6) 2012 TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISIGRIP VEIN STRIPPER INVISIGRIP GAF LEMAITRE VASCULAR 1500-01 IVS1095

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R