BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION

    MDR report key: 10099249 · Received May 28, 2020

    Report

    Report Number
    2522007-2020-00015
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 15, 2020
    Report Date
    September 29, 2020
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DXE
    UDI-DI
    10827002265155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6- EC METHOD CODE DESC - 1: CHANGED TO TESTING OF ACTUAL/SUSPECTED DEVICE (10). H6- EC METHOD CODE DESC - 2: CHANGED TO HISTORICAL DATA ANALYSIS (4109). H6- EC RESULTS CODE DESC - 1: CHANGED TO FRACTURE PROBLEM (3252). H6- EC CONCLUSIONS CODE DESC - 1: CHANGED TO CAUSE NOT ESTABLISHED (4315). INVESTIGATION-EVALUATION: ONE USED DEVICE WITH A DETACHED NEEDLE'S EYE (NITINOL TIP) WAS RETURNED. THE COMPLAINT/EVENT ENTERED INTO TRACKWISE: "PART OF THE LASSO BROKE IN THE PATIENT." THE SIDE ARM TUBING APPEARED TO HAVE SOME UNIDENTIFIED LIQUID INSIDE THE TUBING. THE ENDS OF THE DETACHED NEEDLE'S EYE (NITINOL TIP) APPEAR TO HAVE A FLAT SHEARED SURFACE. THE NEEDLE'S EYE (NITINOL TIP) IS APPROXIMATELY SIX TO SEVEN INCHES OF UNBENT LENGTH. (THIS IS AN ESTIMATION OF THE RETURNED DETACHED NEEDLE'S EYE.) DURING THE FUNCTIONAL TEST, THE DEVICE FUNCTIONED AND IT WAS POSSIBLE TO PULL THE CRIMP JOINT PAST THE END OF THE SHEATH. THE SIDE ARM STOPCOCK WAS FUNCTIONAL. THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED AND THERE WERE NO SIGNS TO INDICATE THAT NONCONFORMING PRODUCT WAS MANUFACTURED AND SHIPPED TO THE FIELD. THIS COMPLAINT TYPE WILL CONTINUE TO BE MONITORED, TRACKED AND TRENDED PER CVI'S COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. CAPA 306710 HAS BEEN OPENED TO INVESTIGATE THIS FAILURE MODE. 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

    IT WAS REPORTED THAT THE NEEDLES EYE PORTION OF THE NEEDLE'S EYE SNARE (LR-NES002) BROKE OFF INSIDE THE PATIENT DURING A TWISTING MANEUVER WITHOUT PULLING THE LEADS OR PUSHING THE SHEATH. THE BROKEN PORTION WAS RETRIEVED FROM INSIDE THE PATIENT USING ANOTHER NEEDLE'S EYE SNARE OF THE SAME MODEL. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.CONSTRAINT ON THE NES.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DXE. PMA/510(K): K961992. PATIENT CODE DESCRIPTION : DEVICE FRAGMENTS IN PATIENT. DEVICE CODE DESCRIPTION: MATERIAL FRAGMENTATION. 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

    PART OF THE LASSO BROKE IN THE PATIENT. THE DEVICE COULD BE RECOVERED WITH ANOTHER EXTRACTOR OF THE SAME MODEL NUMBER. THE DEVICE IS AVAILABLE FOR RETURN TO MANUFACTURER. NO CONSEQUENCE TO THE PATIENT BUT SERIOUS RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559058 LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION DXE COOK VANDERGRIFT INC N168505 10827002265155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention