BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2840290 · Received April 25, 2012

    Report

    Report Number
    3004939290-2012-00096
    Event Type
    Malfunction
    Date Received
    April 25, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED DEVICE IS CURRENTLY IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI DISTRIBUTOR THAT A (B)(6) FEMALE UNDERWENT A CORONARY DIAGNOSTIC PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED WITH A 6F SHEATH (UNKNOWN MODEL). FOLLOWING THE PROCEDURE, THE PHYSICIAN, WHO IS A TRAINED USER OF THE MYNX DEVICE, CHOSE THE MYNX VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO PULL THE SHEATH BACK AFTER THE PHYSICIAN SHUTTLED DOWN UNTIL IT CLICKED. THE PHYSICIAN DEFLATED THE BALLOON AND REMOVED THE DEVICE. THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS REPORTED AS HOSPITALIZED (NOT DEVICE RELATED) OVERNIGHT AND RELEASED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE 6F/7F MGB ACCESSCLOSURE, INC. MX6700 F1127009

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR