BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3042789 · Received April 2, 2013

    Report

    Report Number
    3001845648-2013-00031
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT ISSUE WAS CONFIRMED AS FOLLOWS: "AFTER PUNCTURING THE LESION THEY COULDN'T RETRACT THE NEEDLE INTO THE SHEATH. BECAUSE THEY HAD NO OTHER CHANCE THEY PULLED BACK THE NEEDLE THROUGH THE WORKING CHANNEL AND DAMAGED THE WORKING CHANNEL." ADD'L INFO WAS REC'D FROM THE REP AS FOLLOWS: "THE PHYSICIAN TOLD ME THAT, BECAUSE OF HIS EXPERIENCE WITH OUR NEEDLES, THE NEEDLE MUST BE BROKEN IN THE HANDLE. THE PHYSICIAN CANNOT REMEMBER AT WHAT POINT OR POSITION HE COULD NOT RETRACT THE NEEDLE. HIS FEELING WAS, THAT HE COULD ONLY PUSH FORWARD THE NEEDLE. AS HE TRIED TO PULL BACK THE NEEDLE NOTHING HAPPENS. SO THE NEEDLE WAS MORE AND MORE PUSHED FORWARD, BECAUSE HE COULDN'T BELIEVE IT AND TRIED SEVERAL TIMES TO PULL BACK THE NEEDLE... IT WAS THE FIRST PASS AND THEY GOT SOME CELLS (CYTOLOGY, NOT HISTOLOGY)." THERE WERE NO ECHO-HD-19-C (ECHO) DEVICES OF LOT # C764403 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE 1 X ECHO DEVICE OF C764403 WAS RETURNED FOR EVAL. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. UPON INITIAL RECEIPT OF THIS ECHO DEVICE A PORTION OF THE NEEDLE WAS EXTENDING FROM THE SHEATH TIP AND IT WAS NOTED THAT THE TIP OF THE EXPOSED NEEDLE WAS COVERED WITH TAPE. THIS TAPE WAS REMOVED FROM THE NEEDLE PRIOR TO THE DECONTAMINATION PROCESS. SUBSEQUENT TO THE DECONTAMINATION PROCESS IT WAS NOTED THAT APPROX 36 CM OF THE NEEDLE HAD BECOME REMOVED FROM THE SHEATH. IT IS UNK IF THE NEEDLE WAS BROKEN PRIOR TO THE DECONTAMINATION PROCESS OR IF INITIALLY THE NEEDLE WAS BROKEN WITHIN THE SHEATH AND DUE TO THE HANDLING OF THE ECHO DEVICE DURING THE DECONTAMINATION PROCESS IT BECAME REMOVED FROM THE SHEATH. IT WAS NOTED THAT THE DISTAL TIP OF THE NEEDLE WAS BEN BUT FULLY INTACT. DURING THE EVAL OF THE ECHO DEVICE IT WAS NOTED THAT THE STYLET WAS RETURNED FULLY INSERTED. IT WAS POSSIBLE TO REMOVE THE STYLET BUT IT WAS NOT POSSIBLE TO RE-INSERT THE STYLET FULLY. THE SHEATH WAS MEASURED WITH SHEATH EXTENDER AT REFERENCE '5' AND FOUND TO BE WITHIN SPECIFICATION. DAMAGE WAS NOTED TO SHEATH AT APPROX 9 CM FROM THE SHEATH EXTENDER. UPON ADVANCEMENT OF THE NEEDLE, THE NEEDLE PROTRUDED FROM THE SHEATH WHERE THE DAMAGE TO THE SHEATH OCCURRED. IT WAS CONFIRMED THAT THE NEEDLE WAS BROKEN AT APPROX 13 CM FROM THE SHEATH EXTENDER. UPON CLOSER INSPECTION OF THE SHEATH IT WAS CONFIRMED THAT APPROX 103 CM OF THE NEEDLE REMAINED IN THE SHEATH. IT WAS CONFIRMED THAT THE NEEDLE WAS BROKEN IN 3 SEPARATE PARTS (INCLUDING THE PORTION OF NEEDLE BROKEN FOLLOWING THE DECONTAMINATION PROCESS). UPON REVIEW OF THE RETURNED DEVICE A POSSIBLE SEQUENCE OF EVENTS THAT LEAD TO THE NEEDLE FAILING IN 3 PLACES WAS DETERMINED AS FOLLOWS: THE NEEDLE KINKED DISTAL TO THE SHEATH EXTENDER (THIS KINK MAY HAVE OCCURRED DURING REMOVING THE DEVICE FROM THE SCOPE OR DURING SAMPLE RETRIEVAL). DURING THE NEXT NEEDLE PASS THE NEEDLE BROKE BELOW THE SHEATH EXTENDER AS THE NEEDLE WAS BEING ADVANCE BACK AND FORTH IN THE LESION. ONCE THE NEEDLE WAS BROKEN BELOW THE SHEATH EXTENDER THE DISTAL TIP OF THE NEEDLE COULDN'T BE RETRACTED BACK INTO THE SHEATH LEAVING THE NEEDLE EXPOSED. THE USER CONTINUED TO ADVANCE THE HANDLE CAUSING THE SHEATH TO BE TORN BELOW THE SHEATH EXTENDER AS THE BROKEN SECTION OF NEEDLE DIGS INTO THE SHEATH. THE OTHER TWO FAILURES OCCURRED AS THE DEVICE WAS REMOVED FROM THE PT AND/OR THE SCOPE. THE CAUSE OF THE USERS' INABILITY TO RETRACT THE NEEDLE DURING THE PROCEDURE HAS BEEN ATTRIBUTED TO THE NEEDLE BEING BROKEN. IT IS POSSIBLE THE NEEDLE BROKE DUE TO A KINK THAT OCCURRED TO THE SHEATH BELOW THE SHEATH EXTENDER; THIS KINK MOST LIKELY OCCURRED DURING USE OF THIS ECHO DEVICE. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED DURING THE LABORATORY EVAL IT IS NOT POSSIBLE TO CONCLUSIVELY STATE A DEFINITIVE CAUSE FOR THE CUSTOMERS' COMPLAINT. INFO REC'D CONFIRMED A SECTION OF THE ECHO DEVICE DID NOT REMAIN INSIDE THE PT'S BODY AND THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MFG RECORDS FOR THIS ECHO DEVICE DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS REQUIRED AS A RESULT OF THIS COMPLAINT. INFO REC'D CONFIRMED NO SECTION OF THE DEVICE REMAINED IN THE PT. THE 2 YR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS SPECIFIC RPN AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    "AFTER PUNCTURING THE LESION THEY COULDN'T RETRACT THE NEEDLE INTO THE SHEATH. BECAUSE THEY HAD NO OTHER CHANCE THEY PULLED BACK THE NEEDLE THROUGH THE WORKING CHANNEL AND DAMAGED THE WORKING CHANNEL." ADD'L INFO REC'D AS FOLLOWS: THE PHYSICIAN CANNOT REMEMBER AT WHAT POINT HE COULD NOT RETRACT THE NEEDLE. HIS FEELING WAS, THAT HE COULD ONLY PUSH FORWARD THE NEEDLE. AS HE TRIED TO PULL BACK THE NEEDLE NOTHING HAPPENS. SO THE NEEDLE WAS MORE AND MORE PUSHED FORWARD, BECAUSE HE COULDN'T BELIEVE IT AND TRIED SEVERAL TIMES TO PULL BACK THE NEEDLE... IT WAS THE FIRST PASS AND THEY GOT SOME CELLS (CYTOLOGY, NOT HISTOLOGY). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134466 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C764403

    Patients

    Seq Age Sex Outcome Treatment
    1