BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA FIDUCIAL NEEDLE

    MDR report key: 4945788 · Received July 24, 2015

    Report

    Report Number
    1037905-2015-00313
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 29, 2015
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    NEU
    PMA / PMN Number
    K141356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE DEVICE FOR INVESTIGATION ON 07/08/2015, A SEVERE BEND WAS NOTED M THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH TWO OF THE FOUR FIDUCIALS SUPPLIED WITH THE DEVICE STILL IN THE NEEDLE. THE DEVICE WAS RETURNED WITH THE NEEDLE EXPOSED OUT OF THE SHEATH APPROXIMATELY 2 CM. APPROXIMATELY 1 MM OF THE THIRD FIDUCIAL WAS EXTENDED FROM THE DISTAL TIP. A BEND WAS NOTED APPROXIMATELY 8 CM FROM THE DISTAL END WHEN THE NEEDLE WAS FULLY EXTENDED OUT OF THE SHEATH. THE STYLET WAS RETURNED WITH THE DEVICE AND DID NOT HAVE ANY BENDS OR KINKS. APPROXIMATELY 8.7 CM FROM THE DISTAL END OF THE HANDLE, THE NEEDLE WAS BENT WITHIN THE SHEATH. THE VERY DISTAL TIP OF THE NEEDLE WAS INTACT, BUT WAS SLIGHTLY BENT INWARD 1 MM A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTIONS FOR USE STATE,"VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." "DEVICE MAY NOT BE USED PRIOR TO TRAINING BY MANUFACTURER." THE INSTRUCTIONS FOR USE STATE,"NEEDLE MUST BE RETRACTED INTO SHEATH AND THUMBSCREW ON SAFETY RING MUST BE LOCKED TO HOLD NEEDLE IN PLACE PRIOR TO INTRODUCTION, ADVANCEMENT OR WITHDRAWAL OF DEVICE". THE INSTRUCTIONS FOR USE STATE, "SLOWLY INTRODUCE NEEDLE INTO ACCESSORY CHANNEL OF ENDOSCOPE AND ADVANCE IN SHORT INCREMENTS. ENSURE NEEDLE IS COMPLETELY RETRACTED AND LOCKED IN PLACE NOTE. BENDS OR KINKS IN NEEDLE CAUSED BY IMPROPER INTRODUCTION MAY RESULT IN THE INABILITY TO DEPLOY FIDUCIALS." THE INSTRUCTIONS FOR USE STATE, 'TO PLACE A FIDUCIAL, DEPRESS THUMB RING WHILE STABILIZING STYLET. CONTINUE APPLYING PRESSURE UNTIL TACTILE FEEDBACK AND ULTRASOUND VISUALIZATION INDICATES FIDUCIAL HAS BEEN DEPLOYED. FLUOROSCOPY MAY ALSO BE USED TO AID IN VISUALIZING PLACEMENT OF FIDUCIALS. NOTE DEPENDING ON ENDOSCOPE POSITION AND SEVERITY OF ANGULATION, MORE THAN ONE FIDUCIAL MAY DEPLOY PER SITE." IT IS POSSIBLE THAT IF THE NEEDLE IS AGAINST OR INSIDE OF A HARD MASS WHILE THE USER APPLIES FORCE AND MANIPULATES THE DIRECTIONAL CONTROLS OF THE ENDOSCOPE THAT THIS COULD CONTRIBUTE TO SEVERE BENDING OF THE NEEDLE NEAR THE DISTAL END. THIS COULD CONTRIBUTE TO ADVANCEMENT AND/OR RETRACTION DIFFICULTIES. KINKS IN THE NEEDLE CAN OCCUR IF THE DEVICE EXPERIENCES EXCESSIVE PRESSURE DURING PRODUCT HANDLING/PREPARATION. PRIOR TO DISTRIBUTION, ALL ECHOTIP ULTRA FIDUCIAL NEEDLES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE WITH FIDUCIAL PLACEMENT, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUDAL NEEDLE. THE PHYSICIAN WAS ATTEMPTING TO MARK A LESION AND THE STYLET DID NOT ENGAGE CORRECTLY TO EJECT THE FIDUCIAL NEEDLE. THE PHYSICIAN STATED IT FELT AS THOUGH IT WAS SLIPPING AND THE PHYSICIAN WAS THEREFORE UNABLE TO EJECT THE FIDUCIAL NEEDLE. THE PHYSICIAN USED TWO NEEDLES CONSECUTIVELY AND HAD THE SAME DIFFICULTY. SEE MDR 1037905-2015-00312. THEREFORE, THE PHYSICIAN CHANGED TO THE CONVENTIONAL METHOD OF FIDUCIAL PROCEDURES. THERE WAS NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES OR INTERVENTION REQUIRED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481698 ECHOTIP ULTRA FIDUCIAL NEEDLE NEU WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE (UNK MAKE OR MODEL)