BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 3230218 · Received July 16, 2013

    Report

    Report Number
    3004939290-2013-00178
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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 SALES PROFESSIONAL THAT A MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED IN THE COMMON FEMORAL ARTERY AND COMMON FEMORAL HEAD VIA A 5F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ASPIRIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE <5MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT WHILE THE PATIENT WAS IN RECOVERY, THE PATIENT DEVELOPED A 3 INCH X 3 INCH IN SIZE HEMATOMA. A CT SCAN RULED OUT A RETROPERITONEAL BLEED. MANUAL COMPRESSION (DURATION UNKNOWN) WAS USED TO TREAT THE HEMATOMA. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT DUE TO THE MYNX DEVICE/MYNX PROCEDURE AND DISCHARGED THE NEXT DAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328561 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB MGB ACCESSCLOSURE, INC. MX5021 UNKNOWN

    Patients

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