BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER PLUS

    MDR report key: 1023549 · Received March 31, 2008

    Report

    Report Number
    1016427-2008-00093
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS AVAILABLE, BUT HAS NOT BEEN RECEIVED FOR ANALYSIS. ADDITIONAL INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER SEVERAL ATTEMPTS TO RE-ENTER THE TRUE LUMEN OF THE AORTA, IT WAS NOTICED THAT THE TIP OF THE STABILIZER PLUS WAS MISSING WHILE WITHDRAWING THE GUIDEWIRE INTO THE SHAFT OF THE OUTBACK-CATHETER. IT APPEARED THAT THE GUIDEWIRE TIP WAS INSIDE THE CANNULA OF THE OUTBACK. AFTER REMOVING THE COMPLETE OUTBACK SYSTEM INCLUDING THE GUIDEWIRE, THE WIRE AND THE LOOSE TIP WERE REMOVED. THE OUTBACK WAS FLUSHED AGAIN AND THE PROCEDURE CONTINUED WITH A NEW GUIDEWIRE. THE PERFORMING PHYSICIAN IMMEDIATELY ADMITTED BEING "PRETTY ENTHUSIASTIC" IN HANDLING THE GUIDEWIRE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER PLUS CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70407792

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OUTBACK CATHETER