BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 2548613 · Received April 13, 2012

    Report

    Report Number
    2548613
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    February 21, 2012
    Report Date
    April 13, 2012
    Manufacturer
    ACCESS CLOSURE INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETING MULTIPLE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTIES (PTA) AND STENTS ON THIS PATIENT, THE MYNX CLOSURE DEVICE WAS DEPLOYED BY THE DOCTOR TO THE RIGHT FEMORAL ACCESS ARTERY. HOWEVER, INSTEAD OF THE SEAL (MYNX) STAYING INSIDE THE ARTERY, IT CAME RIGHT OUT. THE PATIENT HAD AN ANTICOAGULANT (ANGIOMAX) DURING THE PROCEDURE, SO THE DOCTOR ORDERED A FEMSTOP BE APPLIED. THE PATIENT'S RIGHT LEG BECAME MOTTLED A FEW MINUTES AFTER THE APPLICATION OF THE DEVICE, IT WAS LOOSENED, EVENTUALLY TAKEN OFF AND MANUAL DIGITAL PRESSURE WAS APPLIED TO OBTAIN HEMOSTASIS. THE PATIENT ALSO REPORTED NUMBNESS OF THE RIGHT LEG, WITH A TRANSIENT DROP IN BP, TIBIAL AND DISTAL PULSES WENT FROM THREADY (IMMEDIATELY AFTER APPLICATION OF THE DEVICE), TO VERY WEAK EVEN WITH A DOPPLER. THE DOCTOR ACCESSED THE LEFT (FEMORAL) LEG TO CHECK THE STATUS OF THE RIGHT ILIAC AND RIGHT LEG VASCULATURE. THE MOTTLING OF THE RIGHT LEG STARTED TO IMPROVE AND EVENTUALLY RETURNED TO NORMAL COLOR WITH PALPABLE TIBIAL PULSE AND DOPPLER PEDAL PULSE, AS WELL ABSENCE OF NUMBNESS AT THE END OF THE CASE. THE PATIENT SUBSEQUENTLY TRANSFERRED WITH VITAL SIGNS STABLE. NO GROIN COMPLICATIONS. AMBULATED THE NEXT MORNING WITHOUT TROUBLE. BOTH GROINS SOFT AND WITHOUT BLEEDING OR HEMATOMA. DISCHARGED HOME THE NEXT DAY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE INC. * F1129001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR