BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMODILUTION CATHETER

    MDR report key: 975843 · Received July 2, 2007

    Report

    Report Number
    2025816-2007-00007
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 21, 2007
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED, REPORTING PLACEMENT DIFFICULTIES WERE ENCOUNTERED WITH USE OF TWO (2) 41231-05 CATHETERS AND .025 J-TIP WIRE. THE UFMW REPORT STATES "TO ASSIST THE ADVANCEMENT OF THE CATHETER A .025 J-TIP WIRE WAS INSERTED THROUGH THE PROPER LUMEN OF THE CATHETER. IT WAS NOTICED THAT THE WIRE WOULD NOT ADVANCE THROUGH THE TIP OF THE CATHETER. AFTER SEVERAL ATTEMPTS ANOTHER WIRE WAS USED....SAME PROBLEM ENCOUNTERED. THE USER FACILITY REPORT INDICATES THAT THE INVOLVED DEVICES WERE AVAILABLE TO BE RETURNED TO THE MFR. REPEATED ATTEMPTS TO CONTACT THE REPORTER AND SECURE THE INVOLVED DEVICES HAVE BEEN UNSUCCESSFUL. COMPLAINT ANALYSIS: A REVIEW OF THE MFG. LOT 44-752-R5 (MFG. 08/06) RECORDS SHOWS UNITS MFG, TESTED, INSPECTED AND RELEASED. A REVIEW OF THE CATHETER DEVICE LABELED DIRECTIONS FOR USE (DFU) WAS ALSO PERFORMED. THE DFU IDENTIFIES SPECIFIC PRE-TEST/SET-UP AND INSERTION INSTRUCTIONS THAT ARE DESIGNED TO IDENTIFY ANY POTENTIAL ISSUES. ADDITIONALLY THE CATHETER DFU STATES THE FOLLOWING "IF DIFFICULTY PERSISTS IN THE CORRECT POSITIONING OF THE FEMORAL CATHETER, A GUIDEWIRE OF SUITABLE SIZE MAY BE INSERTED TO STIFFEN THE CATHETER. TO AVOID POSSIBLE DAMAGE TO INTRACARDIAC STRUCTURES, SPECIAL CARE MUST BE EXERCISED TO ASSURE THAT THE GUIDEWIRE NOT BE ADVANCED BEYOND THE DISTAL TIP OF THE CATHETER." BASED ON THE INCIDENT INFO, ONCE THE INCORRECT USE OF THE J-WIRES WERE DISCONTINUED, THE CATHETER DEVICES WERE SUCCESSFULLY/PLACED AND USED. EXACT CAUSE(S) OF THE REPORTED INCIDENT REMAINS UNK AT THIS TIME. HOWEVER, THE REPORTED EXPERIENCE DOES NOT APPEAR TO HAVE BEEN CAUSED BY ANY CATHETER DEVICE NON-CONFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMODILUTION CATHETER CATHETER DYG ICU MEDICAL, INC. 41231-05 44-752-R5

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR J-TIP WIRE, MFGR, MODEL, LIST#UNK