BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3368342 · Received September 11, 2013

    Report

    Report Number
    3001845648-2013-00087
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 14, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS REPORTABLE TO THE FDA ON THE BASIS OF A PREVIOUS ADVERSE EVENT FOR AN ECHO-HD-19-C (PR77485). THE REPORTING PRECEDENCE COVERS THE ENTIRE PRODUCT FAMILY. THEREFORE, ALL ECHO DEVICES INVOLVING A PROXIMAL NEEDLE BREAKAGE AND/OR THE NON RETRACTION OF THE NEEDLE ARE REPORTABLE REGARDLESS OF THE PT OUTCOME. THE COMPLAINT INFORMATION PROVIDED WAS AS FOLLOWS: ONE PASS WAS MADE TO DRAIN CYST, 70 CC OF FLUID WAS REMOVED. NEEDLE HAD BEEN TAKEN OUT TO RETRIEVE SAMPLE. THE DOCTOR DECIDED HE WANTED ANOTHER SAMPLE AND WENT BACK DOWN THE SCOPE WITH THE DEVICE. ONCE IN POSITION THEY WERE UNABLE TO GET THE NEEDLE OUT OF THE SHEATH. THEY DECIDED TO PULL THE NEEDLE OUT OF THE SCOPE AND WHEN THEY DID THE DEVICE BROKE APART. THERE WERE NO ECHO-HD-19-C (ECHO) DEVICES OF LOT # C861066 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE 1 X ECHO DEVICE OF LOT C861066 WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND WAS OPEN ON RECEIPT. THIS ECHO DEVICE WAS RETURNED BROKEN IN THREE SEPARATE PARTS. THE NEEDLE AND SHEATH HAD BROKEN APART FROM THE HANDLE APPROXIMATELY 4.5 CM BELOW THE SHEATH EXTENDER (WITH SHEATH EXTENDER SET AT REFERENCE '5') THE NEEDLE WAS NOTED TO BE APPROXIMATELY 1.8 CM EXPOSED FROM THE SHEATH ON RETURN (WITH OUTER HANDLE SET AT REFERENCE '6'). A PIECE OF NEEDLE MEASURING APPROXIMATELY 4 CM WAS ALSO RETURNED. IT WAS POSSIBLE TO MOVE THE HANDLE OF THE DEVICE FREELY WITHOUT ANY RESISTANCE. THE NEEDLE REMAINING IN THE HANDLE ADVANCED/RETRACTED WITHOUT ISSUE. THE POINT AT WHICH THE NEEDLE BROKE BELOW THE SHEATH EXTENDER WAS NOTED TO BE SEVERELY BENT/KINKED. THE PIECE OF NEEDLE RETURNED WAS DETERMINED TO HAVE ORIGINATED FROM THIS PART OF THE NEEDLE INDICATING THE NEEDLE WAS KINKED IN TWO PLACES CAUSING THIS PORTION OF THE NEEDLE TO HAVE BECOME SEPARATED. THE SHEATH/NEEDLE THAT HAD BEING RETURNED SEPARATE TO THE DEVICE WAS EXAMINED. THE NEEDLE WAS REMOVED FROM THE SHEATH. THE DISTAL NEEDLE TIP WAS CONFIRMED INTACT. THE SHEATH WAS NOTED TO BE DAMAGED WHERE IT HAD SEPARATED FROM THE REMAINDER OF THE DEVICE. IT WAS DETERMINED THAT THIS DAMAGE TO THE SHEATH MOST LIKELY OCCURRED WHEN THE NEEDLE PROTRUDED THE SHEATH AFTER THE INITIAL BREAKAGE. THIS WOULD HAVE PREVENTED THE USER FROM RETRACTING THE NEEDLE AS REPORTED. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE DEVICE WAS RETURNED WITH THE NEEDLE BROKEN DISTAL TO THE SHEATH EXTENDER. THE MOST LIKELY CAUSE OF THIS NEEDLE BREAKAGE MAY BE ATTRIBUTED TO THE NEEDLE KINKING BELOW THE SHEATH EXTENDER. THIS KINK MAY HAVE OCCURRED DUE TO PRODUCT HANDLING WHEN REMOVING THE DEVICE FROM THE PACKAGING OR DUE TO PRODUCT HANDLING DURING THE PROCEDURE. IF THE HANDLE OF THE ECHO DEVICE IS NOT APPROPRIATELY HANDLED IT IS POSSIBLE FOR THE SHEATH TO BECOME KINKED DUE TO THE WEIGHT OF THE HANDLE. AS THE NEEDLE WAS ADVANCED/RETRACTED DURING THE PROCEDURE IT IS POSSIBLE THIS KINK RESULTED IN A BREAKAGE WHICH SUBSEQUENTLY PROTRUDED FROM THE SHEATH. FURTHER HANDLING OF THE DEVICE AFTER THE PROCEDURE AND CONDITIONS OF TRANSPORT/STORAGE MAY HAVE RESULTED IN THE SHEATH/NEEDLE SEPARATING FROM THE DEVICE AND THE SEPARATION OF THE 4 CM PIECE OF NEEDLE. AS THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED DURING THE LABORATORY EVALUATION IT IS NOT POSSIBLE TO DEFINITIVELY STATE IF THIS IS THE ROOT CAUSE OF THIS COMPLAINT. ALL PARTS OF THE NEEDLE WERE ACCOUNTED FOR DURING THE LABORATORY EVALUATION. THE COMPLAINT INFORMATION RECEIVED INDICATED NO PART OF THE NEEDLE REMAINED IN THE PT. NO ADVERSE EFFECTS TO THE PT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. THE COMPLAINT INFORMATION RECEIVED INDICATED THIS ECHO DEVICE WAS USED FOR DRAINAGE PURPOSES. AS PER THE INSTRUCTIONS FOR USE FOR THIS DEVICE, IFU0077-2, THE INTENDED USE OF THIS DEVICE IS STATED AS FOLLOWS: "THIS DEVICE IS USED WITH AN ULTRASOUND ENDOSCOPE FOR FINE NEEDLE BIOPSY, (FNB), OF SUBMUCOSAL LESIONS, MEDIASTINAL MASSES, LYMPH NODES AND INTRAPERITONEAL MASSES WITHIN OR ADJACENT TO THE GASTROINTESTINAL TRACT." THIS ECHO DEVICE WAS USED IN A MANNER DEEMED AS 'OFF-LABEL USAGE'. HOWEVER, IT WAS DETERMINED THAT THIS 'OFF-LABEL' USE DID NOT CONTRIBUTE TO THE NEEDLE BREAKAGE THAT OCCURRED IN THIS COMPLAINT. PRIOR TO DISTRIBUTION, ALL ECHO DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS FOR THIS ECHO DEVICE DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS EVENT DID NOT IMPACT THE PT OR USER. THE 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS RPN AND THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS LOW. THE OVERALL RISK ASSOCIATED WITH THIS INCIDENT HAS BEEN ASSESSED AND DETERMINED TO BE LOW. A HEALTH RISK ASSESSMENT WAS CARRIED OUT TO ASSESS THE RISK OF NEEDLE BREAKAGE ACROSS THE ECHO PRODUCT FAMILY AND WAS DETERMINED TO BE LOW RISK.

    Description of Event or Problem · 1

    ONE PASS WAS MADE TO DRAIN CYST, 70 CC OF FLUID WAS REMOVED. NEEDLE HAD BEEN TAKEN OUT TO RETRIEVE SAMPLE. THE DOCTOR DECIDED HE WANTED ANOTHER SAMPLE AND WENT BACK DOWN THE SCOPE WITH THE DEVICE. ONCE IN POSITION THEY WERE UNABLE TO GET THE NEEDLE OUT OF THE SHEATH. THEY DECIDED TO PULL THE NEEDLE OUT OF THE SCOPE AND WHEN THEY DID THE DEVICE BROKE APART. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL 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
    455521 ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C861066

    Patients

    Seq Age Sex Outcome Treatment
    1