BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 11555352 · Received March 23, 2021

    Report

    Report Number
    2522007-2021-00013
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    February 24, 2021
    Report Date
    July 9, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DXE
    UDI-DI
    10827002265179
    PMA / PMN Number
    K961992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. 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

    THIS LITERATURE FINDING SPECIFIES A MAJOR ADVERSE EVENT ATTRIBUTED TO THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION (LR-NES001) FOR TWO PATIENTS DURING A STUDY BY (B)(6), ET AL. THE TWO PATIENTS DEVELOPED PERICARDIAL TAMPONADE FROM ATRIAL PERFORATION AFTER SUCCESSFUL LEAD REMOVAL. BOTH PERFORATIONS OF THE ATRIAL WALL OCCURRED AFTER EXTRACTING THE LEAD WITH A NEEDLE¿S EYE SNARE AND THE PATIENTS WERE IMMEDIATELY OPERATED ON AND RECOVERED COMPLETELY LATER. THIS REPORT REPRESENTS PATIENT #2.

    Additional Manufacturer Narrative · 1

    PMA/510(K): K961992. 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.

    Description of Event or Problem · 1

    THIS LITERATURE FINDING SPECIFIES A MAJOR ADVERSE EVENT ATTRIBUTED TO THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION (LR-NES001) FOR TWO PATIENTS DURING A STUDY BY BRACKE, ET AL. THE TWO PATIENTS DEVELOPED PERICARDIAL TAMPONADE FROM ATRIAL PERFORATION AFTER SUCCESSFUL LEAD REMOVAL. BOTH PERFORATIONS OF THE ATRIAL WALL OCCURRED AFTER EXTRACTING THE LEAD WITH A NEEDLE¿S EYE SNARE AND THE PATIENTS WERE IMMEDIATELY OPERATED ON AND RECOVERED COMPLETELY LATER. THIS REPORT REPRESENTS PATIENT #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450680 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE CATHETER, EMBOLECTOMY DXE COOK VANDERGRIFT INC N97422 10827002265179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention