BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2822448 · Received June 6, 2012

    Report

    Report Number
    3004939290-2012-00128
    Event Type
    Injury
    Date Received
    June 6, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 INFO 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 PT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE APPROXIMATELY 6 MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN USED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F FOR FEMORAL ARTERIAL CLOSURE. IT WAS REPORTED THAT THE DEVICE HAD DIFFICULTY SHUTTING DOWN DURING DEPLOYMENT. HEMOSTASIS WAS ACHIEVED WITH THE MYNX DEVICE. ALLEGEDLY, AFTER THE PROCEDURE, THE PT DEVELOPED A HEMATOMA IN THE HOLDING AREA. THE PHYSICIAN PERFORMED AN ULTRASOUND ON THE PT AFTER THE PROCEDURE, AND FOUND AN EMBOLIZATION. IT WAS REPORTED THAT THE PHYSICIAN SPECULATES THE EMBOLIZATION WAS FROM THE MYNX SEALANT, BUT IT'S NOT CONFIRMED. THE PT WAS HOSPITALIZED AND DISCHARGED HOME ON (B)(6) 2012. IT WAS ALSO REPORTED THAT THE PT WAS NOT TREATED FOR THE EMBOLIZATION. THE PT WAS REPORTED AS ASYMPTOMATIC.

    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 Hospitalization HEPARIN