BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3191882 · Received June 27, 2013

    Report

    Report Number
    3004939290-2013-00162
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT 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 VASCULAR CLOSURE SPECIALIST THAT A (B)(6) FEMALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE SUPERFICIAL FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH 6,000 UNITS OF HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 6MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT REQUIRED A TRANSFUSION OF ONE UNIT OF BLOOD DUE TO A DROP IN HEMOGLOBIN FROM 14.1 TO 8.5 OVER A PERIOD OF APPROXIMATELY 36 HOURS, SECONDARY TO AN INTERNAL BLEEDING FROM THE FEMORAL ACCESS SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292829 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Life Threatening| O| R 6,000 UNITS OF HEPARIN