BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 3554035 · Received December 19, 2013

    Report

    Report Number
    3001845648-2013-00143
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 4, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 OUTCOME. THE COMPLAINT INFO REPORTED WAS AS FOLLOWS: AT (B)(6), THE USER ATTEMPTED TO PUNCTURE THE NEEDLE AT THE TARGET SITE IN THE PANCREAS, BUT FIXATION OF THE TARGET SITE WAS DIFFICULT. STRAIGHT PUNCTURE INTO THE TUMOR WAS DIFFICULT BECAUSE THE TUMOR WAS HARD, AND THE NEEDLE BENT. THE NEEDLE WOULD NOT BE RETRACTED INTO THE SHEATH, SO THE USER REPLACED IT WITH ANOTHER ECHO-HD-22-C TO COMPLETE THE PROCEDURE. THERE WERE NO ECHO-HD-22-C (ECHO) DEVICES OF LOT NUMBER: C924242 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE ECHO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVAL TO DATE. THEREFORE, THE CUSTOMER'S COMPLAINT REMAINS UNCONFIRMED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE MOST LIKELY CAUSE OF THIS COMPLAINT IS THAT THE NEEDLE BENT DURING USE PREVENTING RETRACTION OF THE NEEDLE. THE NEEDLE CAN KINK/BEND DUE TO PRODUCT HANDLING WHEN REMOVING THE DEVICE FROM THE PACKAGING OR DUE TO PRODUCT HANDLING DURING THE PROCEDURE. IN THIS INCIDENT THE NEEDLE KINK/BEND WAS MOST LIKELY ATTRIBUTED TO PATIENT ANATOMY AS THE TUMOR BEING PUNCTURED WAS HARD AND THE TARGET SITE WAS DIFFICULT. AS THE CONDITIONS OF USE CANNOT BE REPLICATED 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 FOR THIS ECHO DEVICE DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. IT WAS CONFIRMED THAT HE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. 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. 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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    AT (B)(6), THE USER ATTEMPTED TO PUNCTURE THE NEEDLE AT THE TARGET SITE IN THE PANCREAS, BUT FIXATION OF THE TARGET SITE WAS DIFFICULT. STRAIGHT PUNCTURE INTO THE TUMOR WAS DIFFICULT BECAUSE THE TUMOR WAS HARD, AND THE NEEDLE BENT. THE NEEDLE WOULD NOT BE RETRACTED INTO THE SHEATH, SO THE USER REPLACED IT WITH ANOTHER ECHO-HD-22-C TO COMPLETE THE PROCEDURE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666132 ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C924242

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK