BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS MYNX CLOSURE DEVICE

    MDR report key: 20106655 · Received August 29, 2024

    Report

    Report Number
    MW5159045
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 26, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A PERIPHERAL ANGIOGRAPHY CASE, DR. DEPLOYED A MYNX CONTROL (6/7F) TO CLOSE THE ARTERIAL ACCESS SITE IN THE PATIENT'S L GROIN. THE FIRST MYNX BALLOON POPPED UNEXPECTEDLY, CAUSING FAILURE OF THE DEVICE. THE DEVICE WAS BAGGED IN A BIOHAZARD BAG WITH THE APPROPRIATE LOT AND SERIAL NUMBER ATTACHED. A SECOND MYNX CONTROL (6/7F) WAS OBTAINED AND USED TO CLOSE THE PATIENT'S ARTERIAL SITE. UNFORTUNATELY, THIS SECOND MYNX ALSO FAILED RESULTING IN THE CATH LAB STAFF HAVING TO BEGIN HOLDING MANUAL PRESSURE TO THE ARTERIAL SITE. APPROPRIATE ARTERIAL PRESSURE WAS HELD, THE PATIENT REMAINED HEMODYNAMICALLY STABLE, AND NO HEMATOMA WAS PRESENT. DR. ASSESSED THE SITE AND DISTAL PULSES FOLLOWING MANUAL PRESSURE AND THE PATIENT WAS TAKEN BACK TO THE PREP AND RECOVERY AREA FOR FURTHER MONITORING." REFERENCE REPORT #MW5159044.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341841 CORDIS MYNX CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention