BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2991720 · Received March 6, 2013

    Report

    Report Number
    3004939290-2013-00075
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE ACI CLINICAL SPECIALIST REPORTED THAT A PATIENT UNDERWENT A LEFT AND RIGHT HEART PROCEDURE (B)(6) 2013. PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH 3K OF HEPARIN. ACCESS WAS OBTAINED ON THE LEFT SIDE JUST ABOVE THE BIFURCATION VIA A 6F SHEATH (MODEL UNKNOWN). FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE LEFT ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED PER THE IFU. HEMOSTASIS ON THE ARTERY (LEFT SIDE) WAS ACHIEVED. DURING THE RIGHT HEART CATHETERIZATION THE SHEATH WAS REMOVED FROM THE VEIN AND HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION (DURATION UNKNOWN). THE PATIENT WAS MOVED OFF THE TABLE, INTO A BED. AT THIS POINT A FEMOSTOP WAS APPLIED ON THE ARTERY SIDE (LEFT SIDE) DUE TO THE PATIENT'S EXCESSIVE/HARD COUGHING. THE PATIENT WAS WHEELED UPSTAIRS TO THE NON CARDIAC FLOOR WHERE THE NURSE CHECKED THE PATIENT'S GROIN. IT WAS NOTED THAT THE GROIN WAS DRY AND SOFT. SOMETIME AFTER, THE PATIENT WAS NOTED TO HAVE AN "INTERNAL HEMATOMA" ON THE ARTERY SIDE (LEFT SIDE). THE HEMATOMA WAS DESCRIBED AS "A CANTALOUPE" IN SIZE. THE PATIENT WAS SENT TO SURGERY WHERE IT WAS NOTED THAT THE SURGEON DID NOT FIND ANYTHING IN THE ARTERY. THE HEMATOMA WAS EXPRESSED DURING THE SURGERY AND THE ARTERIOTOMY WAS CLOSED. THE PATIENT WAS REPORTED AS HOSPITALIZED BUT IN STABLE CONDITION. A PRE-SURGERY ANGIOGRAM WAS NOT TAKEN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94923 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 3K OF HEPARIN