BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2853069 · Received August 22, 2012

    Report

    Report Number
    3004939290-2012-00276
    Event Type
    Injury
    Date Received
    August 22, 2012
    Date of Event
    July 24, 2012
    Report Date
    July 24, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1213801) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE ACI SALES PROFESSIONAL REPORTED THAT A FEMALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 5F SHEATH (MODEL UNKNOWN). THE ACCESS WAS GAINED THROUGH THE LEFT GROIN (CFA), TOP 1/3 OF THE FEMORAL HEAD. THE PROCEDURE WENT PER THE IFU. FOLLOWING THE PROCEDURE THE PHYSICIAN WHO WAS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F FOR CLOSURE. THE TECHNICIAN HELD FOR AN ADDITIONAL 5 MINUTES OF MANUAL COMPRESSION DUE TO A SMALL RP BLEED FROM A REPORTED BACK WALL STICK. HEMOSTASIS WAS ACHIEVED. APPROXIMATELY 8-10 MINUTES AFTER THE CLOSURE, THE PATIENT SUFFERED FROM NAUSEA AND BECAME DROWSY. THE PATIENT WAS GIVEN ATROPINE 0.5 MG, NEOSYNEPHRINE AND 2 BOLUS OF RBC. THE PATIENT'S BP ELEVATED TO 160/100. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION DUE TO THE COMPLICATIONS FROM THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB ACCESSCLOSURE, INC. MX5021 F1213801

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R LOVONOX| NEOSYNEPHRINE| PLAVIX| ATROPINE 0.5 MG| ASA