BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE

    MDR report key: 9353049 · Received November 21, 2019

    Report

    Report Number
    3001845648-2019-00620
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    November 8, 2019
    Report Date
    November 21, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CAN BE NOTED THAT EUSN-20-CPN DEVICES ARE NOW OBSOLETE, HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' ECHO-20-CPN DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PRODUCT CODE: BSP. PMA/510(K) # K030618. THE RPN IS EUSN-20-CPN AND LOT NUMBERS FOR EACH ARE UNKNOWN. THIS FILE INVESTIGATES MILD BLEEDING INVOLVING 10 PATIENTS. THE EUSN-20-CPN DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED DOCUMENT BASED INVESTIGATION WAS CONDUCTED. EUSN-20-CPN IS NOW OBSOLETE. AS THE EUSN-20-CPN FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION, ALL EUSN-20-CPN DEVICES WOULD HAVE BEEN SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY AS PER QSI0975. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. IT IS NOT CLEAR WHAT CAUSED THE BLEEDING TO OCCUR FROM THE INFORMATION PROVIDED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE NATURE OF THE DEVICE (NEEDLE) WOULD CAUSE INEVITABLE BLEEDING, TUMOR ITSELF IS PRONE TO BLEEDING DUE TO THE ABUNDANT VESSEL WHEN PUNCTURED. OFF LABEL USE WOULD MEAN THE DEVICE NOT BEING USED AS INTENDED WHICH IN TURN COULD POTENTIALLY HAVE CAUSED THE MILD BLEEDING. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S 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

    XIUJIANG STUDY. TITLE: EUS-GUIDED ETHANOL INJECTION FOR TREATMENT OF PANCREATIC CANCER. 10 PATIENTS EXPERIENCED MILD BLEEDING AFTER THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    IT CAN BE NOTED THAT EUSN-20-CPN DEVICES ARE NOW OBSOLETE, HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' ECHO-20-CPN DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PRODUCT CODE: BSP. PMA/510(K) # K030618. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. [(B)(4)].

    Description of Event or Problem · 1

    (B)(6) STUDY. TITLE: EUS-GUIDED ETHANOL INJECTION FOR TREATMENT OF PANCREATIC CANCER. 10 PATIENTS EXPERIENCED MILD BLEEDING AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146371 ECHOTIP CELIAC PLEXUS NEUROLYSIS NEEDLE BSP COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention