BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3663170 · Received January 30, 2014

    Report

    Report Number
    3001845648-2014-00015
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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. 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 PT'S OUTCOME. THE COMPLAINT ISSUE WAS REPORTED AS FOLLOWS: "THE NEEDLE WAS NOT ABLE TO BE FULLY RETRACTED INTO THE CATHETER. ANOTHER NEEDLE WAS OPENED AND USED TO COMPLETE THE PROCEDURE." THERE WERE NO ECHO-HD-19-C (ECHO) DEVICES OF LOT #C940772 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE 1X ECHO DEVICE OF UNK LOT NUMBER WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH AN ECHO DEVICE RELATED TO (B)(4). THE DEVICES WERE NOT RETURNED IN THE ORIGINAL PACKAGES; THEREFORE, THE LOT NUMBERS COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED WITHOUT THE STYLET IN PLACE. THIS ECHO DEVICE WAS RECEIVED WITH THE NEEDLE ADVANCED APPROX 4MM FROM THE SHEATH ON RECEIPT. THE SHEATH WAS NOTED TO BE SEVERELY KINKED ALONG THE LENGTH AND AT THE SHEATH EXTENDER. IT WAS NOT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH. ON ATTEMPT TO RETRACT THE NEEDLE, THE NEEDLE BROKE AT THE SHEATH EXTENDER, DUE TO THE SEVERE KINKING. THE DISTAL NEEDLE TIP WAS EXAMINED UNDER THE MICROSCOPE AND CONFIRMED TO BE INTACT. IT WAS CONFIRMED THAT THE NOTCH OF THE NEEDLE WAS CAUGHT IN SHEATH TIP. THE TIP OF THE NEEDLE WAS NOTED TO BE SLIGHTLY BENT BACK. THIS DAMAGE TO THE NEEDLE TIP WAS DETERMINED AS THE CAUSE FOR THE NOTCH OF THE NEEDLE GETTING STUCK ON THE SHEATH AND NOT FULLY RETRACTING. IT MAY BE NOTED THAT THE SEVERE KINKING NOTED ALONG THE LENGTH OF THE SHEATH AND AT THE SHEATH EXTENDER WERE DETERMINED TO HAVE MOST LIKELY OCCURRED IN TRANSIT DURING THE DEVICE RETURN. THIS KINKING HAD NO BEARING UPON THE REPORTED FAILURE OF THE NEEDLE NOT RETRACTING. THE CUSTOMER COMPLAINT WAS CONFIRMED ON EVAL OF THE DEVICE AS IT WAS NOT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH DUE TO THE NOTCH OF THE NEEDLE BEING CAUGHT IN SHEATH TIP AND THE NEEDLE TIP WAS NOTED TO BE SLIGHTLY BENT BACK. THE MOST LIKEY CAUSE OF THIS COMPLAINT IS THAT THE NEEDLE TIP MAY HAVE BEEN BENT DURING ITS INTRODUCTION INTO THE ENDOSCOPE OR DURING USE IF THE STYLET WAS NOT IN PLACE DURING ADVANCEMENT OF THE NEEDLE OR IF THE DEVICE WAS BEING USED IN A TORTUOUS ANATOMY. THE NEEDLE NOTCH MOST LIKELY GOT CAUGHT ON THE SHEATH WHEN THE USER WAS RETRACTING THE NEEDLE INTO THE SHEATH. HOWEVER, AS THE CONDITIONS OF DEVICE USAGE CANNOT BE REPLICATED DURING THE DEVICE EVAL IT IS NOT POSSIBLE TO DEFINITIVELY STATE IF THIS IS THE ROOT CAUSE OF 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 MFG RECORDS DID NOT REVEAL A DISCREPANCY WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE IFU0077-2 THAT ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BRAKES. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE NEEDLE WAS NOT ABLE TO BE FULLY RETRACTED INTO THE CATHETER. ANOTHER NEEDLE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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
    66638 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C940772

    Patients

    Seq Age Sex Outcome Treatment
    1