BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    MDR report key: 2840229 · Received May 4, 2012

    Report

    Report Number
    3004939290-2012-00097
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 12, 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 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. THE REVIEW OF THE LHR (LOT F1131103) INDICATED THAT THE DEVICE 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 MALE PATIENT UNDERWENT A CORONARY DIAGNOSTIC PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 5F SHEATH (UNKNOWN MODEL). A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED NO PRESENCE OF PVD/CALCIUM WITHIN THE VICINITY OF THE PUNCTURE SITE. POST PROCEDURE, THE DEPLOYER, WHO IS A TRAINED USER OF THE MYNX, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 5F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT DURING DEPLOYMENT, THE BALLOON LOST PRESSURE; AS A RESULT ACCESS WAS LOST TO THE ARTERY. THE PHYSICIAN REMOVED THE DEVICE AND CONVERTED THE PATIENT TO 20 MINUTES OF MANUAL COMPRESSION. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED TO HOME WITH NO REPORTED CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 5F MGB ACCESSCLOSURE, INC. MX5001 F1131103

    Patients

    Seq Age Sex Outcome Treatment
    1