BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840219 · Received June 28, 2012

    Report

    Report Number
    3004939290-2012-00172
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH THE SHUTTLE CARTRIDGE ENGAGED TO THE HANDLE AND THE INTRODUCER SHEATH WAS PULLED BACK AGAINST THE HANDLE. THE SEALANT WAS FLARED OVER THE BALLOON PROXIMAL BOND. THE BALLOON HAD A SEVERELY INVERTED TIP. THE ADVANCER TUBE WAS COMPRESSING AGAINST THE SEALANT. THE PROXIMAL TAMP LOCK OF THE RETURNED DEVICE WAS DISLODGED RESULTING IN OVER SHUTTLING. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE CAUSE FOR THE TAMP LOCK DETACHMENT IS DUE TO A BOND FAILURE AT THE POLYIMIDE SHAFT. THE REVIEW OF THE LHR (LOT F1208801) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT A PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE SOMETIME IN THE WEEK OF (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 5F SHEATH (MODEL UNKNOWN). A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED THE VESSEL SIZE TO BE APPROXIMATELY 6 MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE "SEALANT FAILED TO DEPLOY PROPERLY." THE DEVICE WAS REMOVED AND THE PT WAS CONVERTED TO APPROXIMATELY 20 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS ACHIEVED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB, PRODUCT CODE: MGB MGB ACCESSCLOSURE, INC. MX5001 F1208801

    Patients

    Seq Age Sex Outcome Treatment
    1