BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNXGRIP

    MDR report key: 3230621 · Received July 16, 2013

    Report

    Report Number
    3004939290-2013-00176
    Event Type
    Death
    Date Received
    July 16, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 SALES PROFESSIONAL THAT A PATIENT UNDERWENT AN INTERVENTIONAL CAROTID PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED A MYNXGRIP VASCULAR CLOSURE DEVICE (MODEL/SIZE UNKNOWN) TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT LATER THAT EVENING (THE DAY OF THE PROCEDURE) THE PATIENT DIED OF A SUSPECTED RETROPERITONEAL BLEED. THE PATIENT WAS STILL IN THE HOSPITAL, RECOVERING FROM THE CAROTID PROCEDURE WHEN THE PATIENT DIED. THE ACI SALES PROFESSIONAL WAS TOLD THAT NO AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328073 MYNXGRIP MGB MGB ACCESSCLOSURE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| O| S