BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8013603 · Received October 29, 2018

    Report

    Report Number
    3001627457-2018-00031
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 2, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006318
    PMA / PMN Number
    K140151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH EKOSONIC DEVICES WERE RETURNED FOR EVALUATION. THE DEVICE EVALUATION OF MSD (B)(4) REVEALED IT WAS FRACTURED BETWEEN THE MSD TUBING SECTION AND THE TREATMENT ZONE SECTION. THE PROXIMAL END WAS 91.3 CM IN LENGTH AND WAS ATTACHED TO THE CABLE. THE SECOND SECTION WAS THE TREATMENT ZONE WHICH WAS LODGED IN THE IDDC COOLANT LUMEN. THE IDDC REVEALED DAMAGE INCLUDING ACCORDION SECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PRODUCT WAS MANUFACTURED PER STANDARD PROCESSES AND MET ALL ACCEPTANCE CRITERIA. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FROM MSDS OF THE SAME LOT. THE IFU WARNS THE USER TO NOT ADVANCE IF RESISTANCE IS MET. EXCESSIVE FORCE AGAINST RESISTANCE MAY RESULT IN DAMAGE TO THE DEVICE OR VASCULATURE. USER ERROR WAS NOT CONFIRMED, BUT COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTING FACTOR TO THE MSD FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN ARTERIAL OCCLUSION WAS TREATED WITH EKOS ON (B)(6) 2018. THE COMPLAINT INITIALLY REPORTED THAT THE USER COULD NOT ADVANCE THE CATHETERS OVER THEIR WIRE AND STATED THAT "THE CATHETER BUCKLED". TWO 50 CM EKOS CATHETERS WOULD NOT ADVANCE, BUT A THIRD CATHETER WAS USED SUCCESSFULLY WITHOUT ISSUE. THE PATIENT WAS REPORTED AS "DOING WELL AND ALL IS FINE". UPON INVESTIGATION OF THE RETURNED DEVICES ON (B)(6) 2018, ONE MSD (SERIAL (B)(4) WAS FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855239 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION 500-56150 00858593006318

    Patients

    Seq Age Sex Outcome Treatment
    1