BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2842916 · Received November 21, 2012

    Report

    Report Number
    3004939290-2012-00430
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE 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. HOWEVER, IT WAS REPORTED BY THE FACILITY THAT THE PRESENCE OF CALCIUM WAS ABUNDANT AND THAT WAS WHAT CAUSED THE BALLOON TO RUPTURE. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. PER THE MYNX INSTRUCTIONS FOR USE (IFU), THE SAFETY AND EFFECTIVENESS OF MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    THE ACI VASCULAR CLOSURE SPECIALIST REPORTED THAT HE WAS INFORMED THAT THE ACCOUNT HAD EXPERIENCED A BALLOON RUPTURE. THE FACILITY DIDN'T KEEP THE DEVICE NOR DID THEY REMEMBER ANY DETAILS FROM THE PROCEDURE OTHER THEN MANUAL COMPRESSION WAS APPLIED AT THE ACCESS SITE FOR 20 MINUTES AT WHICH TIME HEMOSTASIS WAS ACHIEVED. WHAT THEY DID SAY WAS THAT IT WAS A 5F (MYNXGRIP VASCULAR CLOSURE DEVICE 5F) DIAGNOSTIC CASE AND THAT THE PATIENT WAS DISCHARGED THE SAME DAY WITH NO COMPLICATIONS. THE FACILITY ALSO MENTIONED THAT THE PRESENCE OF CALCIUM WAS ABUNDANT AND THAT WAS WHAT CAUSED THE BALLOON TO RUPTURE. THE PHYSICIAN WHO DEPLOYED THE DEVICE IS A TRAINED USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1