BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3222686 · Received July 12, 2013

    Report

    Report Number
    3004939290-2013-00172
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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 IS IFU NOT FOLLOWED. IT WAS REPORTED THAT THE SHUTTLE WAS ONLY ADVANCED HALFWAY. 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 51 YEAR OLD FEMALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE BIFURCATION VIA A 6F SHEATH (MODEL UNKNOWN). FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED A MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEVICE WAS IMPROPERLY DEPLOYED. THE PHYSICIAN NOTED THAT HE SHUTTLED HALFWAY DOWN AND ONCE THE SEALANT SLEEVE HIT THE SHEATH HE THOUGHT THE DEVICE HAD JAMMED. THEREFORE, THE PHYSICIAN DEFLATED THE BALLOON AND PULLED THE DEVICE OUT FROM THE PATIENT WITH SEALANT REMAINING ON THE CATHETER. THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION FOR 30 MINUTES. A HEMATOMA (SIZE UNKNOWN) WAS PRESENT AT THE ACCESS SITE WHICH THEN RESULTED IN A PSEUDOANEURYSM. THE PSEUDOANEURYSM CONTINUED TO GROW AND RESULTED BEING 35CM X 21CM IN SIZE. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE PSEUDOANEURYSM. THE ACI CLINICAL SPECIALIST NOTED THAT THE VASCULAR SURGEON STATED THAT DURING THE CUT DOWN/REMOVAL OF THE PSEUDOANEURYSM THERE WAS NO SEALANT PRESENT IN THE PATIENT'S GROIN/ACCESS SITE. THE PATIENT WAS HOSPITALIZED AND THE DISCHARGE DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323258 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| R