BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840211 · Received June 28, 2012

    Report

    Report Number
    3004939290-2012-00178
    Event Type
    Malfunction
    Date Received
    June 28, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED THAT THE SHUTTLE WAS ENGAGED TO THE HANDLE AND WITH THE PROCEDURAL SHEATH PULLED BACK AGAINST THE SHUTTLE. THE ADVANCER TUBE WAS LOCATED APPROXIMATELY 15 MM FROM THE BALLOON PROXIMAL TIP (ENGAGED TO THE PROXIMAL TAMP LOCK). THE SEALANT WAS NOT RETURNED WITH THE DEVICE. A SMALL PIECE OF SEALANT WAS FOUND WEDGED BETWEEN THE DISTAL TIP OF THE ADVANCER TUBE AND THE CATHETER. ANOTHER SMALL PIECE OF SEALANT WAS FOUND AT THE SLIT OF THE SHUTTLE CARTRIDGE. THE CATHETER, SHUTTLE CARTRIDGE AND ADVANCER TUBE WERE INSPECTED FOR ANOMALIES (I.E. KINKS, DEFORMITY). NO ANOMALIES WERE OBSERVED. THE SEALANT MAY HAVE BEEN DRAGGED OUT OF THE TISSUE TRACT DURING SHUTTLE RETRACTION. HOWEVER, WITHOUT RETURN OF THE SEALANT A COMPLETE PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (LOT F1212204) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. NO FILES ATTACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 5F ST. JUDE SHEATH. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PHYSICIAN ACHIEVED TEMPORARY HEMOSTASIS, AND THEN THE PHYSICIAN DETACHED THE GREEN SHUTTLE AND ADVANCED THE SHUTTLE. RESISTANCE WAS FELT AS THE SHEATH WAS WITHDRAWN AND BROUGHT UP TO THE BLACK HANDLE WITH THE SHUTTLE. ONCE THE PHYSICIAN WITHDREW THE SHEATH AND WAS RETRACTING, THE SEALANT WAS NOTICED TO BE LAYING ON THE PT'S SKIN SURFACE. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PT TO MANUAL COMPRESSION (MINUTES UNKNOWN). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP VASCULAR CLOSURE DEVICE 5F MGB, PRODUCT CODE: MGB MGB ACCESSCLOSURE, INC. MX5021 F1212204

    Patients

    Seq Age Sex Outcome Treatment
    1