BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840976 · Received November 20, 2012

    Report

    Report Number
    3004939290-2012-00433
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) AND OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) ARE BEING ADDED.

    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 VASCULAR CLOSURE SPECIALIST THAT A PATIENT UNDERWENT AN INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE RIGHT BIFURCATION VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE THE PATIENT WAS ANTICOAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE. 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 PATIENT COMPLAINED OF GROIN PAIN AND ONE DAY AFTER THE PROCEDURE A PSEUDOANEURYSM WAS FOUND UNDER ULTRA SOUND. THE PATIENT WAS AN INPATIENT STAYING POST CORONARY STENTING. THE PSEUDOANEURYSM WAS RESOLVED WITH MANUAL COMPRESSION (DURATION UNKNOWN). THE PATIENT REMAINS IN THE HOSPITAL FOR OBSERVATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R ANGIOMAX