BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 13423143 · Received February 2, 2022

    Report

    Report Number
    2522007-2022-00001
    Event Type
    Injury
    Date Received
    February 2, 2022
    Report Date
    May 5, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: ITX. PMA/510(K): K171272. 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 · 0

    D2B: PRODUCT CODE: ITX. G5: PMA/510(K): K171272. A DEVICE WAS NOT RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED OTHER THAN TESTIMONY/LITERATURE. THE COMPLAINT ENTERED WITHIN TRACKWISE: "LEVINE ET AL 2013: DOPPLER PROBE CREATED A KINK IN THE VEIN." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE DEVICE HAD AN UNKNOWN LOT. THE COMPLAINT WILL BE MONITORED PER THE CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB WITHIN TRACKWISE. 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

    LITERATURE REVIEW IDENTIFIES FLAP FAILURES IN A RETROSPECTIVE STUDY CONDUCTED BETWEEN 2001 AND 2011. THE COOK DOPPLER WAS USED TO MONITOR ALL BURIED FLAP PROCEDURES, WHERE THREE OF THE FLAPS FAILED. IN REVIEW OF THE 134 BURIED FREE FLAPS PERFORMED BY LEVINE AND HIS TEAM, FOR SINGLE-STAGE BREAST RECONSTRUCTION MASTECTOMY, THE INCIDENCE OF SIGNIFICANT COMPLICATIONS WAS LOW. FOUR FLAPS UNDERWENT REEXPLORATION FOR VENOUS OBSTRUCTION. OF THOSE, THREE FLAPS(2.2%) ULTIMATELY FAILED AND WERE DEBRIDED. TISSUE EXPANDERS WERE PLACED AT THE TIME OF THE FLAP TAKE-BACK. TWO FAILED FLAPS WERE ULTIMATELY REPLACED WITH IMPLANTS AND THE OTHER FLAP UNDERWENT TRANSVERSE UPPER GRACILIS FLAP RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232597 COOK-SWARTZ DOPPLER PROBE ITX COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention