BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840186 · Received June 26, 2012

    Report

    Report Number
    3004939290-2012-00166
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Date of Event
    March 31, 2012
    Report Date
    April 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI CLINICAL SPECIALIST THAT A (B)(6) MALE PT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED IN THE RIGHT GROIN, VIA A 6F ST JUDE SHEATH. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 6 MM. PERI-PROCEDURE THE PT WAS ANTI-COAGULATED WITH ANGIOMAX. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON LOST PRESSURE DURING PULL BACK. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PT TO 10 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS ACHIEVED. THE PT WAS REPORTED AS HOSPITALIZED (NOT MYNX RELATED). THE PT WAS DISCHARGED FROM THE HOSP ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR ANGIOMAX