BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    MDR report key: 16294354 · Received February 3, 2023

    Report

    Report Number
    2124215-2023-03673
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 10, 2023
    Report Date
    February 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006264
    PMA / PMN Number
    K183361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET 510(K) # K183361; K182324.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE PACKAGING SEAL WAS BROKEN, AND STERILITY WAS COMPROMISED. AN EKOSONIC ENDOVASCULAR DEVICE, 135X12CM WAS SELECTED FOR THE PULMONARY EMBOLISM PROCEDURE. DURING DEVICE PREPARATION, IT WAS DISCOVERED THAT THE OUTER BOX WAS DAMAGED, AS THOUGH THE CORNER HAD BEEN CRUSHED. ADDITIONALLY, THE SEAL OF THE DEVICE PACKAGING WAS TORN. THE DEVICE STERILITY WAS QUESTIONED, AND THE DEVICE WAS DISCARDED. THE PROCEDURE WAS COMPLETED USING A NON-BSC MECHANICAL THROMBECTOMY DEVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786640 EKOSONIC ENDOVASCULAR DEVICE, 135X12CM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION 500-56112 0010173696 00858593006264

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown