BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840230 · Received May 9, 2012

    Report

    Report Number
    3004939290-2012-00099
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Report Date
    April 18, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND A DEPLOYMENT JAM WAS CONFIRMED. VISUAL INSPECTION OF THE DEVICES SHOWED THE SHUFFLE CARTRIDGE DISENGAGED FROM THE HANDLE WITH THE SEALANT FLARED OVER THE BALLOON PROXIMAL TAPER. WHEN AN ATTEMPT WAS MADE TO RETRACT THE SHUTTLE, SIGNIFICANT RESISTANCE WAS NOTED AND THE SHUFFLE DID NOT MOVE. THE INTRODUCER SHEATH WAS REMOVED DISTALLY. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE DEVICE DEPLOYMENT JAM COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1202003) INDICATED THAT THE DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES ASSOCIATE THAT A PATIENT UNDERWENT A DIAGNOSTIC PERIPHERAL PROCEDURE ON AN UNKNOWN DATE, IN WHICH THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F WAS USED TO CLOSE THE FEMORAL ARTERY. IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE SALES ASSOCIATE IN A PLASTIC BIO-HAZARD BAG AND THE ONLY EXPLANATION GIVEN TO HIM WAS THAT "THE SEALANT DIDN'T DEPLOY PROPERLY." NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB ACCESSCLOSURE, INC. MX5001 F1202003

    Patients

    Seq Age Sex Outcome Treatment
    1