BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 8153567 · Received December 11, 2018

    Report

    Report Number
    3001627457-2018-00035
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 13, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006264
    PMA / PMN Number
    K140151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT LOG SHOWS THE THERAPY WAS RUN WITH A 12CM CATHETER (SN (B)(4)) FOR ABOUT 10 HOURS STARTING ON (B)(6) 2018. AFTER 9.7 HOURS OF THERAPY, ON (B)(6) 2018, PHASE ANGLE FOR BOTH MSD GROUPS WENT ABOVE THRESHOLD 35 DEGREE CAUSING NO_GROUPS_ENABLED ALARM AND THE ALARM PERSISTED. THE EVENT LOG CONFIRMED THAT THE CONTROL UNIT FUNCTIONED AS INTENDED. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE INVESTIGATION ON 13 NOV 2018, DAMAGE WAS NOTED TO BOTH THE MSD AND THE IDDC. THE MSD TREATMENT ZONE SHOWED NORMAL SIGNS OF USE. THE MSD TUBING WAS PULLED APART AT 8.7CM LEAVING ONE OF THE BRAIDED STAINLESS STEEL WIRES AND ONE NATURAL COLORED RF WIRE HOLDING THE TWO PIECES OF TUBING TOGETHER. DAMAGE TO THE IDDC INCLUDED TC WIRES DOUBLED OVER WITHIN THE DRUG LUMENS, KINK IN THE STIFFENING WIRE AND IN THE TUBING, AND BROKEN TC WIRES AT THE DISTAL END OF THE STRAIN RELIEF. THE BROKEN TC WIRES LINED UP WITH THE AREA OF THE MSD TUBING THAT HAD BEEN PULLED APART. THERE WAS NO EVIDENCE OF SHORTED WIRES OR OTHER BURN MARKS IN THE MSD OR IDDC. THE DAMAGE ON THE MSD CORRESPONDS TO THE DAMAGED AREA OF THE IDDC WHICH SUGGESTS THE DEVICES WERE CONNECTED (MSD INSERTED IN IDDC) WHEN THE DAMAGE OCCURRED. THE MSD IS NOT INSERTED IN THE IDDC DURING THE MANUFACTURING PROCESS; THEREFORE, IT IS LIKELY THAT THE DAMAGE/FRACTURE OCCURRED DURING HANDLING/USE. 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 REPORTED PATIENT NON-COMPLIANCE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTING FACTOR TO THE MSD AND IDDC DAMAGE. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A RIGHT UPPER ARM EXTREMITY DVT WAS TREATED WITH EKOS ON (B)(6) 2018. DURING THERAPY, ALARM CODE 'ALL MSD FAILURE' OCCURRED. EKOS WAS DISCONTINUED AND TREATMENT WAS CONTINUED AS STANDARD CDT (CATHETER DIRECTED THROMBOLYSIS). THE PATIENT WAS REPORTED AS BEING NONCOMPLIANT WITH THE INSTRUCTIONS/ADVICE OF THE STAFF AND PHYSICIAN. THE PATIENT WAS GETTING UP, WALKING AROUND THE ROOM, SITTING UP BEDSIDE AND "THRASHING ARM ABOUT" DURING THERAPY. THE PATIENT DID RECEIVE THE FULL DOSE OF THERAPY AND IS DOING VERY WELL. THE DEVICE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989481 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION 500-56112 00858593006264

    Patients

    Seq Age Sex Outcome Treatment
    1