BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 11348808 · Received February 19, 2021

    Report

    Report Number
    2522007-2021-00004
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Report Date
    December 19, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO CVI, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE LOT WAS NOT PROVIDED. THIS COMPLAINT WILL BE MONITORED, TRACKED/TRENDED THROUGH THE CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. PER IFU (D00078672 REV003): "AVOID USE OF EXCESSIVE FORCE TO REMOVE THE TRANSDUCER ASSEMBLY FROM THE PATIENT, WHICH MAY CAUSE INJURY TO THE BLOOD VESSEL. IF THE TRANSDUCER ASSEMBLY CAN NOT BE REMOVED USING GENTLE TRACTION, THE TRANSDUCER ASSEMBLY SHOULD BE REMOVED SURGICALLY." , "CAUTION: DO NOT REMOVE THE PROBE CONDUCTOR WIRE AND CRYSTAL ASSEMBLY (LEAVING ONLY THE CUFF IN SITU ON THE VESSEL), UNTIL VESSEL MONITORING IS COMPLETED (COMMONLY 3-5 DAYS). PROBE CONDUCTOR WIRE AND CRYSTAL ASSEMBLY PLACEMENT MUST NOT EXCEED 29 DAYS. CUFF ALONE MAY REMAIN WITHIN THE PATIENT INDEFINITELY." , "DEVICE SPECIFIC RISKS INCLUDE SEPARATION OF THE DOPPLER CRYSTAL FROM THE CUFF, INABILITY TO PERCUTANEOUSLY REMOVE THE CRYSTAL AFTER MONITORING IS COMPLETE, LOSS OF RECEPTION OR TRANSMISSION OF ULTRASOUND MONITORING SIGNAL." , "TO REMOVE THE COOK-SWARTZ DOPPLER FLOW PROBE, FIRST FREE THE RETENTION TAB AND BRAIDED WIRES TO THE SKIN BY CUTTING THE SUTURES (AND/OR REMOVING THE TAPE). REMOVE THE PROBE BY APPLYING GENTLE TRACTION TO THE BRAIDED WIRES AT THE SKIN ENTRY SITE UNTIL THE TRANSDUCER ASSEMBLY IS WITHDRAWN. (THE SILICONE CUFF REMAINS IN SITU.)" AND "UPON REMOVAL OF THE COOK-SWARTZ DOPPLER FLOW PROBE, EXAMINE THE DISTAL TIP OF THE PROBE TO ENSURE THAT THE TRANSDUCER ASSEMBLY IS PRESENT. IN THE UNLIKELY EVENT THAT THE TRANSDUCER ASSEMBLY HAS BECOME DETACHED AND REMAINS IN THE CUFF IN THE PATIENT, THE TRANSDUCER ASSEMBLY SHOULD BE REMOVED SURGICALLY." THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: ITX. PMA/510(K): K171272. (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.

    Description of Event or Problem · 1

    THE LITERATURE FINDING SPECIFIES THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WHICH INVOLVED THE COOK-SWARTZ DOPPLER FLOW PROBE STANDARD CUFF (DP-SDP001), IN WHICH AN UNKNOWN PORTION OF WIRE BROKE OFF DURING ATTEMPTED REMOVAL OF THE DEVICE ON POST-OPERATIVE DAY TEN. AN X-RAY WAS PERFORMED, WHICH SHOWED A SMALL SEGMENT OF THE WIRE REMAINED IN THE PATIENT'S NECK. THE PATIENT WAS INFORMED, AND THE FRAGMENTED SEGMENT WAS LEFT IN PLACE. THE AUTHORS SUGGEST THAT THE COMPLICATION IS DUE TO THEIR METHOD OF COILING THE WIRE LOOP UNDER THE SKIN, WHICH IS NOT A STANDARD PRACTICE. THIS PRACTICE IS ALSO NOT RECOMMENDED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252226 COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER ITX COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention