BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE

    MDR report key: 2765476 · Received September 25, 2012

    Report

    Report Number
    3001845648-2012-00054
    Event Type
    Death
    Date Received
    September 25, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 12, 2012
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K092359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ECHO-HD-19-A DEVICES OF LOT C731890 IN STOCK AT THE TIME OF THE INVESTIGATION. A 1 X ECHO-HD-19-A DEVICE OF LOT C731890 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGE AND AWS OPEN ON RECEIPT. THE COMPLAINT INFO STATED THAT USER OF THE DEVICE WAS "IT WAS IMPOSSIBLE TO GET THE GUIDE TO SLIDE OUT WHEN THE DEVICE WAS REMOVED. THE GUIDE WIRE PEELED OFF." THE ECHO-HD-19-A DEVICE AND THE WIRE GUIDE THAT WAS USED IN THE PROCEDURE WERE RETURNED TO CIRL FOR EVALUATION. ON EVALUATION OF THE RETURNED DEVICE, THE RELEVANT ENGINEER CONFIRMED THAT THE WIRE GUIDE COATING HAD PEELED OFF AND WAS COILED FROM APPROX 6.5CM FROM ITS END. THE ECHO DEVICE WAS RETURNED WITH THE THUMBSCREW UNSCREWED FROM THE SHEATH EXTENDER. THE THUMBSCREW WAS RETURNED ALSO. THE RELEVANT ENGINEER NOTED THAT THE NEEDLE COULD RETRACT AND ADVANCE WITHOUT DIFFICULTY. THERE WAS A SLIGHT BEND ON THE NEEDLE AT APPROX 5CM FROM THE TIP. THE WIRE GUIDE USED WITH THE ECHO DEVICE WAS CONFIRMED TO BE A JAGUWIRE NOT A COOK IRELAND MANUFACTURED GUIDE WIRE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE WIRE GUIDE COATING HAD PEELED OFF. THE PHYSICIAN ADVISED THAT THE DEVICE DEFECT WAS A CONTRIBUTING FACTOR TO THE PT DEATH. COMMENT/FEEDBACK RECEIVED FROM THE RELEVANT ENGINEER AT CIRL REGARDS A POSSIBLE CAUSE "IT APPEARS THAT THE COATING ON THE WIRE GUIDE WAS STRIPPED BY THE NEEDLE CANNULA WHEN THEY TRIED TO RETRACT THE WIRE GUIDE. THE COATING ON THE GUIDE WIRE IS A POLYMER WHICH CAN POTENTIALLY BE STRIPPED BY A METAL. THE INSTRUCTIONS FOR USE FOR THE ECHO-HD-19-A DEVICE STATES THAT: "THIS DEVICE CAN BE USED TOGETHER WITH ALL ECHO COMPATIBLE PRODUCTS." THE WIRE GUIDE PEELING WAS AN UNEXPECTED FAILURE MODE AND IS MOST LIKELY AS A RESULT OF A NON ECHO COMPATIBLE WIRE GUIDE BEING USED. FROM THE INFO PROVIDED A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY, THE PT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE- DRAINAGE OF THE BILE DUCT. THE PT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE - HIGH PAINS NAME BILOM. THE PT'S PRE EXISTING CONDITIONS WAS VERY POOR SUFFERING THE FOLLOWING: ASCITIS, LIVER METASTASIS AND RENAL FAILURE. THE PT DIED. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THE OCCURRENCE OF THIS COMPLAINT TYPE "GUIDE WIRE PEELING" IS LOW. HOWEVER CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    BECAUSE THE PT HAD A PANCREAS TUMOR (AMPULOME) WITH HEPATIC METASTATIC, THEY DECIDED DO DRAIN HIM IN ORDER TO MAKE HIM LESS YELLOW BEFORE CHEMICAL THERAPY. BECAUSE OF THE GROWTH OF THE TUMOR IN THE PAPILLA WITH A CHOLEDOC DILATED TO 12MM THEY COULDN'T PASS THE NORMAL WAY WITH A SPHINCTEROTOME, THEY DECIDED TO TRY TO PUT A METALLIC FULLY COVERED STENT IN TRANS BULBAR WITH AN ACCESS NEEDLE. AT THE TIME THEY ENTERED INTO THE CHOLEDOC, THEY TRIED TO PUT A WIRE GUIDE INTO IT AND QUICKLY FELT SOME FRICTIONS WHEN THE MOVED THE WIRE GUIDE. IT WAS IMPOSSIBLE TO MOVE IT IN ANY WAY. THEY PULLED THE NEEDLE BACK INTO THE SHEATH WITHOUT MOVING THE WIRE GUIDE ANYMORE, RETRIED THE WHOLE PART OF THE ENDOSCOPE. THEY SAW THAT THE WIRE GUIDE WAS PEELED OFF. THEY NEEDED TO DRAIN THE PT ABSOLUTELY BECAUSE OF THE HIGH RISKS OF INFECTIONS SO THEY TRIED WITH A CYSTOTOME FROM ANOTHER COMPANY OF 8.5 FR BUT THE PRIOR PONCTION HAD CREATED A FISTULA AND THE BILE CAME OUT FROM THE CHOLEDOC AND IT WAS NOT POSSIBLE ANYMORE TO DRAIN, THE CHOLEDOC WAS DEFLATED. THE BILE WAS IN THE HEPATIC HILUM WITH HIGH PAINS FOR THE PT (PAINS NAMES BILOM). THE NEXT STEP IS TO TRY TO DRAIN THE PT IN RADIOLOGY DEPARTMENT BUT FOR THAT THEY NEED THE FISTULA TO DISAPPEAR. THE ENDOSCOPE DURING THE PROCEDURE WAS NOT BENDED TOO MUCH. THE DOCTOR MENTIONED THAT IT WAS NOT THE FIRST TIME THE WIRE GUIDE PEELED OFF WITH THE ACCESS EVEN IN A NORMAL DRAINAGE. THE HOLE IN THE CBILE DUCT IS A LEAKAGE, THE BEVEL OF THE NEEDLE STRIPPED THE COATING OF THE GUIDE WIRE SO IT WAS IMPOSSIBLE TO LET IN PLACE THE GUIDE WIRE AND IT WAS A BILE LEAKAGE. (CBILE DUCT AFTER THE PROCEDURE). THE WIRE GUIDE WAS A JAGUWIRE FROM BOSTON SCIENTIFIC COMPANY. THE FOLLOWING IS A SUMMARY OF THE EVENT DESCRIPTION: WIRE GUIDE PEELED LEADING TO INCOMPLETE PROCEDURE TO DRAIN COMMON BILE DUCT. PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C731890

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death