BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3083542 · Received April 29, 2013

    Report

    Report Number
    3004939290-2013-00116
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE REVIEW OF THE LHR (LOT F1302903) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE ACI SALES PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT A CATHETERIZATION PROCEDURE IN (B)(6) 2013. ACCESS WAS OBTAINED VIA A 6F SHEATH (MODEL UNKNOWN). A 50/50 CONTRAST AND SALINE MIXTURE WAS USED. PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH HEPARIN. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 5MM. FOLLOWING THE PROCEDURE, THE DEPLOYER (TRAINING STATUS IS UNKNOWN) SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT IMMEDIATELY AFTER THE DEVICE WAS DEPLOYED, A HEMATOMA (LESS THAN 6CM) FORMED AT THE ACCESS SITE. MANUAL COMPRESSION WAS APPLIED FOR APPROXIMATELY 20-25 MINUTES. HEMOSTASIS WAS ACHIEVED. THEN A 10 LB SANDBAG WAS APPLIED AT THE ACCESS SITE PER THE HOSPITAL'S PROTOCOL. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME THE SAME DAY WITH NO CLINICAL SEQUELA NOTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184840 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1302903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN