BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2853045 · Received August 23, 2012

    Report

    Report Number
    3004939290-2012-00284
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    May 24, 2012
    Report Date
    July 27, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SALES PROFESSIONAL THAT A FEMALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY, VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTICOAGULATED WITH PLAVIX. FOLLOWING THE PROCEDURE THE PHYSICIAN WHO IS TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT POST DEPLOYMENT A SMALL HEMATOMA (<6CM) WAS PRESENT AT THE ACCESS SITE. MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES IN WHICH TIME THE HEMATOMA DID NOT RESOLVE. A FEMOSTOP WAS APPLIED (DURATION UNKNOWN) WITHOUT ANY FURTHER COMPLICATIONS NOTED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME ON (B)(6) 2012 WITH NO REPORTED CLINICAL SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLAVIX