BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER LONG CUFF PROBE

    MDR report key: 7125943 · Received December 18, 2017

    Report

    Report Number
    2522007-2017-00051
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 20, 2017
    Report Date
    March 22, 2018
    Manufacturer
    COOK VASCULAR INC
    Product Code
    ITX
    PMA / PMN Number
    K022649
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF SUMMARY: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, NOR WERE ANY PICTURES PROVIDED; THEREFORE, NO PHYSICAL INVESTIGATION COULD BE CONDUCTED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE COMPLAINT WAS CONFIRMED VIA CUSTOMER TESTIMONY ONLY AS THIS IS A KNOWN FAILURE MODE OF THE DEVICE AND WILL CONTINUE TO BE MONITORED PER THE MANUFACTURER'S POST-MARKET SURVEILLANCE PROCESS.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE CUFF LENGTH OF THE COOK-SWARTZ DOPPLER LONG CUFF PROBE WAS NOT APPROPRIATE FOR USE IN THE PATIENT'S HEAD AND NECK. ADDITIONALLY, THE PROBE REPORTEDLY DETACHED TOO EARLY POST IMPLANTATION; IT DETACHED APPROXIMATELY 2 HOURS POST IMPLANTATION. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR A PROBE REPLACEMENT, AND THE CUSTOMER WAS CONCERNED REGARDING POTENTIAL ADDED RISK TO WHICH THE PATIENT WOULD BE EXPOSED AS A RESULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE IS YET AVAILABLE. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905082 COOK-SWARTZ DOPPLER LONG CUFF PROBE ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention