BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5871214

    MDR report key: 5871214 · Received August 12, 2016

    Report

    Report Number
    5871214
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    May 29, 2016
    Report Date
    August 8, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS FACILITY HAS HAD THREE EVENTS WITH THIS DEVICE WITHIN APPROXIMATELY 2 MONTHS. EVENT 1 - AT THE END OF THE CARDIAC CATH PROCEDURE A MYNX DEVICE WAS ATTEMPTED IN THE RIGHT FEMORAL ARTERY. THE PHYSICIAN DID ALL OF THE CORRECT STEPS FOR A SUCCESSFUL CLOSURE DEVICE, BUT THE MYNX DID NOT DEPLOY CORRECTLY. THE UNDEPLOYED DEFECTIVE MYNX DEVICE WAS REMOVED AND MANUAL PRESSURE WAS HELD. MANUAL PRESSURE WAS HELD ON GROIN, AFTER MYNX FAILURE, TO CONTROL BLEEDING. EVENT 2 - MYNX DID NOT DEPLOY. MANUAL PRESSURE HELD UNTIL HEMOSTASIS OBTAINED. LONGER (25 MIN) MANUAL PRESSURE HELD UNTIL HEMOSTASIS OBTAINED. EVENT 3 - MYNX BALLOON RUPTURE UPON ATTEMPTED DEPLOYMENT. A SECOND MYNX DEVICE USED SUCCESSFULLY. MANUFACTURER RESPONSE FOR MYNX, (BRAND NOT PROVIDED) (PER SITE REPORTER): THEY WILL EVALUATE ALL THREE ONCE THEY RECEIVE THEM.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO KNOWN