BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ULTRASOUND ASPIRATION NEEDLE

    MDR report key: 1910600 · Received November 19, 2010

    Report

    Report Number
    3001845648-2010-00023
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 25, 2010
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K934356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE THE ECHO-HD-19-C DEVICE OF LOT # CP589932 INVOLVED IN THIS COMPLAINT REPORT WAS SHIPPED TO THE US AS PART OF A LIMITED LAUNCH UNDER PMA/510(K) #K934356. THERE WERE NO ECHO-HD-19-C DEVICES OF LOT NUMBER CP589932 IN STOCK AT THE TIME OF THE COMPLAINT EVAL. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE TO BE RETURNED FOR EVAL; THEREFORE, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFO PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. HEMORRHAGE IS ONE OF THE POTENTIAL COMPLICATIONS OF ENDOSCOPIC ULTRASOUND GUIDED NEEDLE BIOPSY AND IS LISTED IN OUR INSTRUCTIONS FOR USE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-19-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE INTEGRITY OF THE PRODUCT. A REVIEW OF THE MFG RECORDS FOR THE ECHO-HD-19-C DEVICE INVOLVED IN THIS COMPLAINT REPORT DID NOT REVEAL ANY DISCREPANCIES, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE 2-YR COMPLAINTS HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS TYPE OF REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THE REVIEW, THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. COMPLAINTS OF THIS NATURE WILL BE MONITORED FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A DEFINITIVE CAUSE FOR THIS OBSERVATION WAS UNABLE TO BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING AND THE DEVICE WAS NOT RETURNED FOR EVAL. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY OR PROGRESSION OF DISEASE STATE, COOK IRELAND COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF DEVICE USAGE.

    Description of Event or Problem · 1

    FOLLOWING A REGULAR EUS, THE PHYSICIAN PROCEEDED WITH A FNA (BIOPSY) OF THE GIST WITH A 19 GAUGE PROCEDURE NEEDLE. ONLY ONE PASS WAS NECESSARY (WITH 3-4 NEEDLE MOVEMENTS). NO ABNORMALITY WAS NOTED AT THE PUNCTURE SITE AND THE PROCEDURE WAS CONSIDERED A SUCCESS. TWO DAYS LATER (OCT 23), THE PT WAS ADMITTED TO THE HOSP SUFFERING OF HEAVY BLEEDING THAT WAS DETERMINED TO BE ORIGINATING FROM THE NEEDLE'S PUNCTURE SITE. BLOOD TRANSFUSIONS WERE NEEDED, AND PT WAS TRANSFERRED TO THE ICU. THE PT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: IT IS UNK IF THE PRODUCT CAUSED THE ADDITIONAL PROCEDURES WHICH INCLUDED TWO ENDOSCOPIES (HEPI INJECTION/CLIPPING). THERE WERE ADVERSE EFFECTS ON THE PT DUE TO THIS OCCURRENCE.: THE PT WAS INTUBATED AND ADMITTED TO THE ICU FOR MONITORING FOLLOWING THE DIAGNOSED HEMORRHAGE. THE PT HAS BEEN RELEASED FROM HOSP AND HAS BEEN SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHOTIP ULTRA ULTRASOUND ASPIRATION NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD CP589932

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L