BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER PLUS

    MDR report key: 1470441 · Received June 8, 2009

    Report

    Report Number
    1016427-2009-00138
    Event Type
    Malfunction
    Date Received
    June 8, 2009
    Date of Event
    May 13, 2009
    Report Date
    May 12, 2009
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: LAKE REGION LOT NUMBER 04400860 IS CORDIS LOT NUMBER 7078827. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 04400860. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE PRODUCT IS EXPECTED, BUT IT HAS NOT BEEN RECEIVED FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING AN UNDISCLOSED PROCEDURE, THE SGW .014 STABILIZER 300 CM GUIDEWIRE WAS PLACED INSIDE A STRAIGHT CATHETER THAT WAS IN THE SUB-INTIMAL SPACE ON THE RIGHT ILIAC/AORTA. THE CATHETER WAS TAKEN OFF AND THE OUTBACK DEVICE WAS USED SUCCESSFULLY. THE GUIDEWIRE WAS PLACED IN AORTA/TRUE LUMEN, AND CATHETER PLACED BACK OVER WIRE EXCHANGED FOR AN 0.035" GUIDEWIRE. HOWEVER, IT WAS NOTICED THAT THE END OF THE SGW .014 STABILIZER 300 CM GUIDEWIRE HAD SEPARATED PARTIALLY,WITH NO INJURY TO PT OR DETRIMENT TO CASE. ALL THE PRODUCTS WERE NEW. PRIOR AND AFTER REMOVAL, ONLY THE GUIDEWIRE WAS DAMAGED THE DISTAL TIP WAS NOT RE-SHAPED. ALL THE (IFU) INSTRUCTION FOR USE GUIDELINES WERE FOLLOWED WHEN DELIVERING AND REMOVING THE GUIDEWIRE FROM THE OUTBACK CATHETER. THE WIRE WAS NOT TRAPPED IN THE OUTBACK CATHETER. THE GUIDEWIRE WAS COMPLETELY RETRIEVED WITHOUT ANY PART OF IT SEPARATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER PLUS CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70708827

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR STRAIGHT CATHETER| OUTBACK CATHETER