BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2962272 · Received February 14, 2013

    Report

    Report Number
    3004939290-2013-00048
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1223601) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE APPROXIMATELY 7MM. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON RUPTURED BETWEEN THE FIRST AND SECOND STOP. A BUDDY WIRE (GUIDE WIRE) WAS BEING USED AND ACCESS WAS MAINTAINED. HOWEVER, THE PHYSICIAN ORDERED THE TECHNICIAN TO PULL THE GUIDE WIRE OUT AND APPLY A FEMOSTOP AT THE ACCESS SITE TO ACHIEVE HEMOSTASIS. THE PATIENT WAS SENT TO RECOVERY WITH NO FURTHER COMPLICATIONS REPORTED. THE PATIENT WAS REPORTED AS HOSPITALIZED FOR AN UNRELATED AND UNSPECIFIED REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64338 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1223601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX