BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSHING CATHETER

    MDR report key: 15630281 · Received October 19, 2022

    Report

    Report Number
    3001845648-2022-00703
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    September 15, 2022
    Report Date
    November 3, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002217710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172044 AND K172057. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172044 AND K172057. DEVICE EVALUATION: 1 X PC-5 OF LOT NUMBER C1944086 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL PLASTIC BILIARY STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE "THIS DEVICE IS USED FOR ENDOSCOPIC BILIARY AND PANCREATIC STENT PLACEMENT". ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE IT STATED INTENDED USE, IT CAN RESULT IN OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. AS PER ADDITIONAL INFORMATION RECEIVED, IT WAS CONFIRMED THAT THE DEVICE WAS USED IN A BRONCHOSCOPIC PROCEDURES. THIS IS REGARDED AS OFF-LABEL USE AS IT IS OUTSIDE THE STATED INTENDED USE OF THE IFU. THE CATHETER BECOMING STUCK IS A CASCADING EFFECT AS WE CAN'T PREDICT HOW THE DEVICE WILL OPERATE IN AN ENVIRONMENT WHEN IT IS USED IN AN OFF-LABEL MANNER. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS PER SALES REP (B)(6) 2022: THIS CATHETER, INTENDED TO USE FOR ERCP-PROCEDURES, IS USED DURING BRONCHOSCOPIC PROCEDURES AS PER CUSTOMER COMPLAINT FORM: " THE CATHETER GOT STUCK WHILE INTRODUCING IN A LASER DURING BRONSCHOSCOPIC PROCEDURES - OFF LABEL." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175775 PUSHING CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C1944086 10827002217710

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown