BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7122868 · Received December 15, 2017

    Report

    Report Number
    3001627457-2017-00035
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 23, 2017
    Report Date
    December 1, 2017
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006134
    PMA / PMN Number
    K140151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MSD WAS NOT RETURNED WITH THE CATHETER. THE INVESTIGATION OF THE CATHETER ON 01 DEC 2017 CONFIRMED THE FOLLOWING IDDC DAMAGE: KINK AT 1005 CM, FLATTENED PROXIMAL MARKER BAND, PUNCTURE IN THE INNER AND OUTER DRUG WALL AT 91.4 CM, KINK IN THE STIFFENING WIRE AT 89.4 CM, WAVY WIRES, KINK AT 25 CM, KINK AT THE DISTAL END OF THE STRAIN RELIEF (LOCATIONS WERE MEASURED FROM THE DISTAL END OF STRAIN RELIEF). THE CAUSE OF THE IDDC PUNCTURE COULD NOT BE DETERMINED. A DEVICE MALFUNCTION WAS NOT CONFIRMED, BUT COULD NOT BE RULED OUT. NO SERIOUS INJURY WAS REPORTED. IF A DEVICE MALFUNCTION CAUSED THIS EVENT AND THE MALFUNCTION WAS TO RECUR, IT COULD RESULT IN SERIOUS INJURY. THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION. THE IFU WARNS THE USER TO NOT ADVANCE IF RESISTANCE IS MET WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKING ANY NECESSARY REMEDIAL ACTION. 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 THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2017, IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE ULTRASOUND WIRE (MSD) THROUGH THE CATHETER. IT WAS REPORTED THAT A STANDARD 6 FR SHEATH WAS USED AND THERE WAS NO KINK IN THE CATHETER OR TORTUOUS ANATOMY NOTED. A SECOND CATHETER WAS USED WITHOUT ISSUE AND IT WAS REPORTED THAT THE PATIENT RECEIVED A FULL THERAPY WITH A GOOD OUTCOME. NO ADVERSE EVENTS WERE REPORTED IN ASSOCIATION WITH THIS EVENT. THE COMPLAINT-RELATED CATHETER (WITHOUT THE MSD) WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900543 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION 500-55112 00858593006134

    Patients

    Seq Age Sex Outcome Treatment
    1