BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 11736773 · Received April 28, 2021

    Report

    Report Number
    3001845648-2021-00349
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    June 18, 2019
    Report Date
    April 28, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CANCELLATION REPORT BEING SUBMITTED AS THE DEVICES IN THIS INCIDENT DID NOT CAUSE / CONTRIBUTE TO THE DEATHS IN THIS FILE. 2 OF THE 4 PATIENTS WHO DEVELOPED ACLF DIED WITHIN 1 MONTH FROM THE PROCEDURE, WHEREAS THE OTHER 2 PATIENTS RECOVERED BUT EXPERIENCED DEEP WORSENING OF LIVER FUNCTION WITH RESPECT TO THE BASELINE. THIS IS ALREADY CAPTURED IN (B)(4) (EMDR 3001845648-2021-00348). THEREFORE THIS FILE IS NO LONGER REQUIRED

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED AS THE DEVICES IN THIS INCIDENT DID NOT CAUSE / CONTRIBUTE TO THE DEATHS IN THIS FILE AS CONFIRMED BY CLINICAL INPUT RECEIVED ''I CAN CONFIRM THAT 2 PATIENTS DEATHS WERE AS RESULTS OF THE PATIENTS¿ PRE-EXISTING CONDITIONS.'' 2 OF THE 4 PATIENTS WHO DEVELOPED ACLF DIED WITHIN 1 MONTH FROM THE PROCEDURE, WHEREAS THE OTHER 2 PATIENTS RECOVERED BUT EXPERIENCED DEEP WORSENING OF LIVER FUNCTION WITH RESPECT TO THE BASELINE. THIS IS ALREADY CAPTURED IN (B)(4) (EMDR 3001845648-2021-00348). THEREFORE THIS FILE IS NO LONGER REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FACCIORUSSO 2019 - CIRRHOSIS IS A PREDICTOR OF ADVERSE EVENTS IN ENDOSCOPIC ULTRASOUND FINE-NEEDLE ASPIRATION: A PROPENSITY-SCORE ANALYSIS. PROCEDURE: UNDER SEDATION WITH PROPOFOL (DIPRIVAN¿, ASTRAZENECA, LONDON, UK), 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 IMAGING. THE SCOPE WAS THEN SLOWLY ADVANCED UP TO DUODENUM WHEN NECESSARY. A 22 G NEEDLE (ECHO- TIP ULTRA, COOK MEDICAL INC., BLOOMINGTON, IN, USA) WITH A CENTRAL STYLET TO PROTECT THE ASPIRATION CHANNEL OF THE NEEDLE WAS INTRODUCED THOUGH THE ENDOSCOPES WORKING CHANNEL. DIRECTLY AFTER INSERTING THE NEEDLE INTO THE LESION, THE STYLET WAS REMOVED. MORE THAN 10 TO-AND-FRO MOVEMENTS WERE MADE WITHIN THE SOLID LESION AND ASPIRATION WAS OBTAINED WITH A 10 CM3 VACUUM SUCTION SYRINGE APPLIED TO THE HUB OF FNA DEVICE. ALL CYSTIC LESIONS WERE ASPIRATED TO COMPLETE EVACUATION WITH A SINGLE PASS WHENEVER POSSIBLE, WHEREAS SOLID MASSES WERE TARGETED WITH THE NEEDLE AND SAMPLES WERE FIXED IN 95% ETHANOL SOLUTION AND PREPARED FOR CYTOLOGICAL EXAMINATION WITH PAPANICOLAOU STAINING. 4 SERIOUS INFECTIONS: 4 CIRRHOTIC PATIENTS EXPERIENCING SERIOUS INFECTIONS - 3 WERE CP C STAGE AND 1 CP B STAGE ALL SERIOUS INFECTIONS EXPERIENCED BY CIRRHOTIC PATIENTS LED TO THE OCCURRENCE OF ACLF. PATIENTS WHO EXPERIENCED ACLF WERE HOSPITALIZED AND TREATED WITH INTENSIVE SYSTEMIC IV BROAD-SPECTRUM ANTIBIOTICS, HIGH DOSES OF IV ALBUMIN AND DIURETICS. 2 OF THE 4 PATIENTS WHO DEVELOPED ACLF DIED WITHIN 1 MONTH FROM THE PROCEDURE, WHEREAS THE OTHER 2 PATIENTS RECOVERED BUT EXPERIENCED DEEP WORSENING OF LIVER FUNCTION WITH RESPECT TO THE BASELINE CAPTURING 2 PATIENT DEATHS - 2 OF THE 4 PATIENTS WHO DEVELOPED ACLF DIED WITHIN 1 MONTH FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636782 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death