BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 20495292 · Received October 21, 2024

    Report

    Report Number
    2522007-2024-00038
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    October 17, 2024
    Report Date
    January 9, 2025
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DXE
    PMA / PMN Number
    K961992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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. D2B ¿ PRODUCT CODE: DXE. G5 ¿ PMA/510(K):  K961992. 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. THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "PATIENT EXPERIENCED PERICARDIAL EFFUSION DURING PROCEDURE." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN THE COMPLAINT SUMMARY TAB OF TRACKWISE. E3 - OCCUPATION: 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

    THE DM CALLED IN TO REPORT AN ADVERSE EVENT THAT OCCURRED DURING A PROCEDURE WHERE A COOK DEVICE WAS USED. A G26517-LR-NES001 FROM AN UNKNOWN LOT NUMBER WAS USED DURING A PACEMAKER ICD LEAD EXTRACTION. AFTER THE DEVICE WAS USED AND REMOVED, THE PHYSICIAN NOTED THE PATIENT HAD A PERICARDIAL EFFUSION AND DECIDED TO OPEN THE PATIENT'S CHEST TO REPAIR. THE DM NOTED THE PHYSICIAN REPORTED THERE WAS OF TISSUE OVER THE LEAD.

    Description of Event or Problem · 0

    THE DM CALLED IN TO REPORT AN ADVERSE EVENT THAT OCCURRED DURING A PROCEDURE WHERE A COOK DEVICE WAS USED. A G26517-LR-NES001 FROM AN UNKNOWN LOT NUMBER WAS USED DURING A PACEMAKER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD EXTRACTION. AFTER THE DEVICE WAS USED AND REMOVED, THE PHYSICIAN NOTED THE PATIENT HAD A PERICARDIAL EFFUSION AND DECIDED TO OPEN THE PATIENT'S CHEST TO REPAIR. THE DISTRICT MANAGER NOTED THE PHYSICIAN REPORTED THERE WAS OF TISSUE OVER THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220644 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE CATHETER, EMBOLECTOMY DXE COOK VANDERGRIFT INC G26517 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O