BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853119 · Received July 12, 2012

    Report

    Report Number
    3004939290-2012-00203
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFO PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1214504) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI REGIONAL SALES MGR THAT A (B)(6) FEMALE PT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE MID COMMON FEMORAL ARTERY, VIA A 6F SHEATH (MODEL UNK). THERE WAS ONE SHEATH EXCHANGE (8F VENOUS SHEATH). THE PT HAD ADEQUATE TISSUE TRACT, AND SHOWED GOOD ANATOMY ON GROIN SHOT. THE VESSEL SIZE WAS APPROX 6 MM. THE PT'S BP WAS 204/92. FOLLOWING THE PROCEDURE, THE TECH WHO IS TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. ALLEGEDLY, THE TECH USED PERFECT TECHNIQUE, AND DEPLOYED THE DEVICE PER THE IFU. POST DEPLOYMENT, SIGNIFICANT OOZING WAS NOTED AT THE SITE ("OOZING STARTED RIGHT AWAY, AFTER THE 2 MIN HOLD"). THE PT WAS CONVERTED TO MANUAL COMPRESSION FOR 15 MINS WITH THE ASSISTANCE OF A D-STAT PAD. THEN A FEMOSTOP WAS APPLIED AS A PRECAUTION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6721 F1214504

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ANGIOMAX