BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7126465 · Received December 18, 2017

    Report

    Report Number
    3001627457-2017-00036
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 28, 2017
    Report Date
    November 28, 2017
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETERS WERE NOT RETURNED FOR EVALUATION. DUE TO THE CATHETERS HAVING PARTIALLY PULLED OUT [USER ERROR], THE PHYSICIAN DECIDED TO TERMINATE THE THERAPY AND REMOVE THE CATHETERS. THE FOLLOWING DAY THE PATIENT WAS RETURNED TO THE CATH LAB FOR REINSERTION OF EKOS CATHETERS. THE PATIENT RECEIVED A FULL TREATMENT. THE USER ERROR [CATHETERS PARTIALLY PULLED OUT] REQUIRED MEDICAL INTERVENTION INCLUDING ADDITIONAL EXPOSURE TO X-RAY AND NEW CATHETER PLACEMENT. THE CAUSE OF THE REPORTED ARRHYTHMIAS REMAINS UNKNOWN. THE PATIENT WAS REPORTED AS DOING WELL. THE REQUIRED MEDICAL INTERVENTION INCLUDING ADDITIONAL EXPOSURE TO X-RAY AND A NEW CATHETER PLACEMENT WAS DUE TO USER ERROR AND NOT A RESULT OF A DEVICE MALFUNCTION. ADDITIONAL DEVICE: CATALOG # - 500-55118, SERIAL # - (B)(4), EXPIRATION DATE - 06/05/2020, (B)(4), MANUFACTURE DATE - 07/05/2017.

    Description of Event or Problem · 1

    ON (B)(4) 2017, A HELPLINE CALL WAS RECEIVED FROM AN ICU NURSE REPORTING A CONTROL UNIT ALARM WITH AN IDLE SCREEN INDICATOR. THE PATIENT CAME INTO THE ER WITH SHORTNESS OF BREATH, WENT TO IR/IV FOR TREATMENT OF A BILATERAL PE WITH IJ ACCESS AND THEN WENT BACK TO THE ER BEFORE BEING TRANSPORTED TO THE ICU. AT THE TIME OF THE HELPLINE CALL, THE THERAPY HAD BEEN RUNNING FOR 2 HOURS AND 18 MINUTES. WHILE TROUBLESHOOTING, THE CALLER STATED THAT THE PHYSICIAN WAS ON THE WAY BECAUSE THE PATIENT WAS HAVING ARRHYTHMIAS. IT WAS ALSO REPORTED THAT DURING TRANSPORT, THE CATHETERS WERE PULLED PARTIALLY OUT. FOLLOW UP INFORMATION WAS RECEIVED ON 29 NOV 2017 REPORTING THAT THEY WILL BE REDOING THE CASE. THE CATHETERS WERE REMOVED ON (B)(6) 2017 AND THE PATIENT WAS RETURNED TO THE CATH LAB ON (B)(6) 2017 FOR REINSERTION OF EKOS CATHETERS. ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED ON 05 DEC 2017 REPORTING THAT THE PATIENT IS DOING WELL AND THAT THE PHYSICIAN COULD NOT DETERMINE WHAT CAUSED THE ARRHYTHMIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904967 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention