BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 11304624 · Received February 9, 2021

    Report

    Report Number
    2522007-2021-00003
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    December 13, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    UDI-DI
    00827002213630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO CVI, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND THERE WERE NO SIGNS TO INDICATE THAT NONCONFORMING PRODUCT WAS MANUFACTURED AND SHIPPED TO THE FIELD. 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THE PROBE BY APPLYING GENTLE TRACTION TO THE BRAIDED WIRES AT THE SKIN ENTRY SITE UNTIL THE TRANSDUCER ASSEMBLY IS WITHDRAWN.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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A 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. THE MALFUNCTION WAS NOT OBVIOUS TO THE PROVIDER WHO REMOVED THE DEVICE. THE FRAGMENT OF WIRE REMAINING IN THE PATIENT WAS DISCOVERED SEVERAL DAYS LATER AND REMAINS IN THE PATIENT, BASED ON THE INFORMATION PROVIDED TO THE MANUFACTURER. THE FRAGMENT WAS LEFT IN PATIENT DUE TO RISK OF REMOVAL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: CUSTOM PERSON (ADDRESS LINE 1): (B)(6). 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A 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. THE MALFUNCTION WAS NOT OBVIOUS TO THE PROVIDER WHO REMOVED THE DEVICE. THE FRAGMENT OF WIRE REMAINING IN THE PATIENT WAS DISCOVERED SEVERAL DAYS LATER AND REMAINS IN THE PATIENT, BASED ON THE INFORMATION PROVIDED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY REGARDING THE PATIENT OUTCOME AND DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202388 COOK-SWARTZ DOPPLER PROBE DIAGNOSTIC ULTRASONIC TRANSDUCER ITX COOK VANDERGRIFT INC G21363 N172688 00827002213630

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention