BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VASCULAR PLUG

    MDR report key: 5033931 · Received August 26, 2015

    Report

    Report Number
    3007170829-2015-00004
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    October 2, 2013
    Report Date
    October 2, 2013
    Manufacturer
    REVERSE MEDICAL CORPORATION
    Product Code
    KRD
    PMA / PMN Number
    K123803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF DEVICE HISTORY RECORDS DID NOT DEMONSTRATE ANY NON-CONFORMITIES THAT COULD LEAD TO THE FIELD COMPLAINT. THE ONE DEVICE WAS RETURNED FOR DEVICE INVESTIGATION. THE MEMBRANE WAS SKIRTED AROUND THE MIDDLE OF THE DEVICE. IT COULD NOT BE DETERMINED THE AMOUNT OF ADHESIVE PRESENT ON THE MEMBRANE AT THE PROXIMAL MARKER BAND. THREE UNITS FROM THE SAME LOT WERE TAKEN FROM INVENTORY AND WERE REVIEWED UNDER THE M MICROSCOPE. THE SHEATH HAS UNEVEN CUTS BUT DID NOT HINDER RESHEATHING AND SHEATHING FORCES WERE STILL LOWER THAN HISTORICAL DATA. THE AMOUNT OF GLUE AT THE MEMBRANE AND STRUTS NEAR THE PROXIMAL MARKER BAND APPEARED TO BE ACCEPTABLE. FATIGUE TESTING WAS PERFORMED FOR THE THREE UNITS AND IT WAS DETERMINED THAT THERE WERE 30, 60, AND 35 RESHEATHING CYCLES REQUIRED TO CAUSE HOLES IN THE MEMBRANE. IT COULD NOT BE DETERMINED IF THE DETACHMENT OF THE MEMBRANE WAS DUE TO LACK OF ADHESION OF THE MEMBRANE AT THE STRUTS NEAR THE PROXIMAL MARKER BAND OR IF DURING RESHEATHING, THE PHYSICIAN HAD THE MVP DEVICE AT AN ANGLE (INSTEAD OF STRAIGHT) WHICH COULD CAUSE DAMAGE TO THE MEMBRANE DURING RESHEATHING. THIS REPORT WAS INADVERTENTLY PREVIOUSLY FILED UNDER THE (B)(4) REGISTRATION NUMBER OF MANUFACTURING SITE (MDR# 2029214-2015-002611). AS A RESULT WE ARE REFILING THE REPORT WITH THE CORRECT REVERSE MEDICAL CORP MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    DURING REVIEW OF THE MICRO VASCULAR PLUG ON THE PREPARATION TABLE, THE MVP WAS RESHEATHED. THE MEMBRANE WAS PUSHED OFF THE STRUTS AND MOVED TO THE MIDDLE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565486 MICRO VASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD REVERSE MEDICAL CORPORATION MVP-3 US 13307

    Patients

    Seq Age Sex Outcome Treatment
    1