BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853085 · Received August 14, 2012

    Report

    Report Number
    3004939290-2012-00262
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 19, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 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 AFFAIRS MANAGER THAT A (B)(6) MALE PT UNDERWENT AN ATHERECTOMY PROCEDURE TO TREAT THE ANTERIOR TIBIAL ARTERY, ON (B)(6) 2012. THERE WERE 2 SHEATH EXCHANGES. THE PT DID NOT HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE ACCESS SITE. PERI-PROCEDURE THE PT WAS ANTI-COAGULATED WITH ASA, CLOPIDOGREL (PLAVIX), AND BIVALIRUDIN (ANGIOMAX). FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PT DEVELOPED A 5 CM HEMATOMA SHORTLY AFTER THE MANUAL COMPRESSION. THEN A MECHANICAL COMPRESSION DEVICE (MODEL UNK) WAS ALSO APPLIED. THE PT WAS AMBULATED AND DISCHARGED ON (B)(6) 2012. NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention BIVALIRUDIN (ANGIOMAX)| CLOPIDOGREL (PLAVIX)| ASA