BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    MDR report key: 16462391 · Received March 1, 2023

    Report

    Report Number
    2124215-2023-09342
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 4, 2023
    Report Date
    March 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) # K183361; K182324.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRUG PORT WAS CRACKED, AND THE PATIENT DID NOT RECEIVE THE TOTAL AMOUNT OF LYTIC THERAPY. AN EKOSONIC ENDOVASCULAR DEVICE 106X12CM WAS SELECTED FOR USE TO TREAT THE PATIENT'S PULMONARY EMBOLISM. THE DEVICE WAS PLACED WITHOUT ANY REPORTED ISSUES AND THE PATIENT WAS TRANSFERRED TO THE ICU, WHERE THE INCISION WAS DRESSED. THE PHYSICIAN REPORTED THAT A DEVICE WAS A BEEPING, AND IT WAS OBSERVED THAT THE CATHETER DRUG PORT WAS CRACKED. THE SOURCE OF THE BEEPING NOISE WAS NOT CONFIRMED. THE CATHETER WAS REMOVED, AND THERAPY WAS DISCONTINUED. THERE WAS NO PATIENT INJURY, BUT THE PATIENT DID NOT RECEIVE THE FULL AMOUNT OF LYTIC THERAPY. THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292563 EKOSONIC ENDOVASCULAR DEVICE, 106X12CM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION 500-55112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown