BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 11698895 · Received April 21, 2021

    Report

    Report Number
    3001845648-2021-00323
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    July 1, 2020
    Report Date
    June 17, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ECHO-19 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. COMPLAINT FILES (B)(4), WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE OFF-LABEL USE. REFERENCE "FACCIORUSSO ET AL 2020". DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE ECHO-19 DEVICE IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION, ALL ECHO-19 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0101-1, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE, AS THE ECHO-19 DEVICE WAS USED TO GAIN AN ACCESS AND TO INJECT CONTRAST MEDIA. AS PER MEDICAL ADVISOR "IT WAS OFF-LABEL USE." ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE JOURNAL ARTICLE IT IS KNOWN THAT THE USER USED THE DEVICE OFF-LABEL, THE ECHO-19 WAS USED TO GAIN AN ACCESS AND TO INJECT CONTRAST MEDIA. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FACCIORUSSO ET AL 2020 - SARCOPENIA REPRESENTS A NEGATIVE PROGNOSTIC FACTOR IN PANCREATIC CANCER PATIENTS UNDERGOING EUS CELIAC PLEXUS NEUROLYSIS UNDER SEDATION WITH PROPOFOL, EUS WAS CONDUCTED WITH A PENTAX FG-36UA ULTRASOUND ENDOSCOPE (PENTAX EUROPE, LTD., HAMBURG, GERMANY) USING A CURVED-ARRAY TRANSDUCER. ONCE INTO THE STOMACH, THE EUS PROBE WAS LOCATED IN CONTACT WITH THE GASTRIC WALL, AND THE AORTA WAS IDENTIFIED IN AN ELONGATED CROSS SECTION AND SUCH A FINDING WAS CONFIRMED BY COLOR DOPPLER IMAGERY. THE SCOPE WAS THEN SLOWLY ADVANCED TO IDENTIFY THE CELIAC TRUNK. A 19 G NEEDLE (ECHOTIP 19, COOK MEDICAL, WINSTON-SALEM, NC, USA) WAS INTRODUCED THOUGH THE ENDOSCOPE¿S WORKING CHANNEL TO INJECT THE MEDICATION TO THE CELIAC REGION. ONCE THE INJECTION NEEDLE WAS TARGETED IN THE DESIRED AREA, AN ASPIRATION SYRINGE WAS USED TO CONFIRM THAT A BLOOD VESSEL WAS NOT PUNCTURED. IF BLOOD WAS NOT ASPIRATED, 10 ML 2.0% LIDOCAINE AND 20 ML 95% ETHANOL WERE INJECTED INTO THE BASE OF THE CELIAC TRUNK AT ITS ORIGIN FROM THE AORTA (CENTRAL APPROACH). THIS COMPLAINT WAS OPENED TO CAPTURE THE OFF-LABEL USE OF THE ECHO-19 DEVICE - A 19 G NEEDLE (ECHOTIP 19, COOK MEDICAL, WINSTON-SALEM, NC, USA) WAS INTRODUCED THOUGH THE ENDOSCOPE¿S WORKING CHANNEL TO INJECT THE MEDICATION TO THE CELIAC REGION. NO SEVERE TREATMENT-RELATED AES WERE REPORTED IN THE WHOLE STUDY POPULATION AS A RESULT OF THE OFF-LABEL USE. MINOR ADVERSE EFFECTS INCLUDED FEVER AND MILD ABDOMINAL PAIN. -26 (18.7%) AND 17 (22.3%) PATIENTS EXPERIENCED GRADE 1/2 FEVER IN THE TWO GROUPS, RESPECTIVELY (P = 0.5). -POSTPROCEDURAL MILD ABDOMINAL PAIN WAS RECORDED IN 48 (34.5%) PATIENTS IN GROUP 1 AND 23 (30%) PATIENTS IN GROUP 2 (P = 0.47).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597824 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR