BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 17434504 · Received August 1, 2023

    Report

    Report Number
    2522007-2023-00009
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 3, 2023
    Report Date
    October 16, 2023
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DXE
    UDI-DI
    10827002265179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5: PMA/510(K): K141148. ONE DEVICE (LR-NES001 N189960) WAS RETURNED ON THIS COMPLAINT. THE QUALITY ASSURANCE DEPARTMENT INVESTIGATED THE RETURNED DEVICE VISUALLY AND FUNCTIONALLY. VISUALLY THE DEVICE HAD BLOOD PRESENT THROUGHOUT THE DEVICE. THE SNARE WAS BROKEN AT THE POINT WHERE ALL FOUR WIRES COME TOGETHER. THERE WAS SOME DISCOLORATION AT THE BROKEN END OF THE SNARE WHERE THE WIRE DID NOT HAVE THE SHINY APPEARANCE ANYMORE. THERE WERE A FEW "SMASHES" WITHIN THE TUBING ITSELF. FUNCTIONALLY, THE DEVICE DID NOT MOVE WHEN THE BLACK KNOB WAS PULLED BACK AND FELT AS IF THE INNER WIRES WERE TRYING TO MOVE BUT WERE RESTRICTED. THE INVESTIGATION DID INDEED CONFIRM THE CUSTOMER'S COMPLAINT THAT THE DEVICE WAS BROKEN AND BY CUSTOMER'S TESTIMONY THAT IT OCCURRED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, INCLUDING MANUFACTURING AND QUALITY CONTROL RECORDS AND THERE ARE NO SIGNS TO INDICATE THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN 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.

    Additional Manufacturer Narrative · 0

    G5 ¿ PMA/510(K): K141148. 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.

    Description of Event or Problem · 0

    THE NEEDLE EYE SNARE (NES) BROKE IN THE PATIENT. CC FORM: THE NES SYSTEM WAS USED ACCORDING TO THE INSTRUCTION OF USE WITH THE SELDINGER TECHNIQUE. AFTER THE DR. INSERTED THE NES SYSTEM VIA THE OUTER SHEATH UP TO THE RIGHT VENTRICLE THEY SAW ON THE X-RAY THAT THERE WAS A SHARP END. THE NES SYSTEM WAS REMOVED A REPLACED BY A NEW SYSTEM.

    Description of Event or Problem · 0

    THE NEEDLE EYE SNARE BROKE IN THE PATIENT. CC FORM, THE NES SYSTEM WAS USED ACCORDING TO THE INSTRUCTION OF USE WITH THE SELDINGER TECHNIQUE. AFTER THE DR. INSERTED THE NES SYSTEM VIA THE OUTER SHEATH UPTO THE RIGHT VENTRICLE THEY SAW ON THE X-RAY THAT THERE WAS A SHARP END. THE NES SYSTEM WAS REMOVED A REPLACED BY A NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343783 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE CATHETER, EMBOLECTOMY DXE COOK VANDERGRIFT INC N189960 10827002265179

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other