BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH

    MDR report key: 4585072 · Received March 4, 2015

    Report

    Report Number
    3001845648-2015-00038
    Event Type
    Injury
    Date Received
    March 4, 2015
    Report Date
    February 6, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FDX
    PMA / PMN Number
    K052279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO DEVICE MALFUNCTION HAS BEEN REPORTED, THIS INCIDENT MEETS THE CRITERIA OF A SERIOUS INJURY REPORT BASED ON THE INTERVENTION TO TREAT THE REPORTED HAEMOSUCCUS PANCREATICUS THAT DEVELOPED FOLLOWING THE USE OF AN ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH.THIS COMPLAINT IS RELATED TO AN ECHO-19-CB DEVICE OF AN UNKNOWN LOT NUMBER. THE ECHO-19-CB DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE COMPLAINT IS CONSIDERED BASED ON THE CUSTOMER TESTIMONY. CLINICAL PERSONNEL WERE NOTIFIED OF THIS COMPLAINT AND THE FOLLOWING COMMENTS WERE PROVIDED: "HEMOSUCCUS PANCREATICUS IS A RARE ENTITY AND ESTIMATES OF ITS RATE ARE BASED ON SMALL CASE SERIES. IT IS THE LEAST FREQUENT CAUSE OF UPPER GASTROINTESTINAL BLEEDING (1/1500) AND IS MOST OFTEN CAUSED BY CHRONIC PANCREATITIS, PANCREATIC PSEUDOCYSTS, OR PANCREATIC TUMORS.." IT WAS THE CLINICIAN'S OPINION THAT THE REPORTED ADVERSE EVENT WAS RELATED TO THE CLINICAL PROCEDURE AND/OR PATIENT CONDITION." AS THE ECHO DEVICE WAS NOT RETURNED FOR EVALUATION AND NO SPECIFIC DEVICE MALFUNCTION WAS NOTED DURING THE PROCEDURE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT HOWEVER IT IS MOST LIKELY PROCEDURE AND/OR PATIENT CONDITION RELATED. AS STATED ON THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THIS DEVICE, POTENTIAL COMPLICATIONS WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THE MANUFACTURING RECORDS OF THE DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE REVIEWED AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED. IT WAS REPORTED THAT THE HAEMOSUCCUS PANCREATICUS WAS MANAGED CONSERVATIVELY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW OF THE PAPER 'SENDINO O, FERNANDEZ-ESPARRACH G, SOLE M ET AL. ENDOSCOPIC ULTRASONOGRAPHY-GUIDED BRUSHING INCREASES CELLULAR DIAGNOSIS OF PANCREATIC CYSTS: A PROSPECTIVE STUDY. DIGESTIVE AND LIVER DISEASE 2010; 42: 877-881' THE FOLLOWING INCIDENT WAS NOTED; IN AN EUS-GUIDED CYTOLOGY BRUSHING PROCEDURE, ONE PATIENT DEVELOPED A HAEMOSUCCUS PANCREATICUS WHICH WAS MANAGED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149700 ECHOBRUSH ENDOSCOPIC ULTRASOUND CYTOLOGY BRUSH FDX ENDOSCOPIC CYTOLOGY BRUSH FDX COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention