BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 15673461 · Received October 26, 2022

    Report

    Report Number
    2522007-2022-00023
    Event Type
    Injury
    Date Received
    October 26, 2022
    Report Date
    January 9, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K961992. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. 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 · 0

    BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. G5 - PMA/510(K): K961992. 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 BY CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED INTO TRACKWISE: "SNARE TORE THE PATIENTS SVC VEIN." THE COMPLAINT INFORMATION STATES: "AS THE CUSTOMER WAS MANIPULATING THE SNARE TRYING TO EXTRACT A PACE MAKER OR FIBULAR THE SNARE SOMEHOW TORE THE PATIENTS SVC VEIN." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE THE LOT WAS UNKNOWN. 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

    REPORTED BY THE DISTRICT MANAGER ON BEHALF OF THE CUSTOMER VIA PHONE CALL - AS THE CUSTOMER WAS MANIPULATING THE SNARE TRYING TO EXTRACT A PACE MAKER OR FIBULAR THE SNARE SOMEHOW TORE THE PATIENTS SUPERIOR VENA CAVA VEIN.

    Description of Event or Problem · 0

    REPORTED BY THE DISTRICT MANAGER ON BEHALF OF THE CUSTOMER VIA PHONE CALL - AS THE CUSTOMER WAS MANIPULATING THE SNARE TRYING TO EXTRACT A PACE MAKER OR FIBULAR THE SNARE SOMEHOW TORE THE PATIENTS SUPERIOR VENA CAVA VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479999 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE CATHETER, EMBOLECTOMY DXE COOK VANDERGRIFT INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other