BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW .014 STABILIZER 180CM

    MDR report key: 2659187 · Received July 18, 2012

    Report

    Report Number
    1016427-2012-00096
    Event Type
    Malfunction
    Date Received
    July 18, 2012
    Date of Event
    June 26, 2012
    Report Date
    June 27, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND IS ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2012-00095 AND 1016427-2012-00096.

    Additional Manufacturer Narrative · 1

    WHEN THE PHYSICIAN TOOK OUT THE SGW .014 STABILIZER 1 GUIDEWIRE FROM THE PACKAGE, HE FOUND THE COIL WAS STRETCHED. ANOTHER STABILIZER WAS OPENED AND THE SAME FAILURE WAS OBSERVED. THE GUIDEWIRES WERE NOT CLINICALLY USED INSIDE THE PATIENT. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COMPLAINT PRODUCTS WERE NOT HANDLED IN ANY WAY BEFORE THE REPORTED EVENT WAS FOUND AND WERE STORED AT THE FACILITY PER IFU. THERE WAS ALSO NO DAMAGE TO THE PACKAGING. ONE NON STERILE GUIDE WIRE SGW .014 STABILIZER 180CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. NO ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. THE RECEIVED GUIDE WIRE WAS OBSERVED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED FAILURE BY THE COSTUMER AS 'GUIDE WIRE - UNRAVELED/STRETCHED' COULD NOT BE CONFIRMED FOR ONE PRODUCT SINCE NO ANOMALIES OR DAMAGES WERE OBSERVED DURING THE PRODUCT ANALYSIS. HOWEVER, THE FAILURE WAS CONFIRMED IN THE SECOND RETURNED PRODUCT. THE CAUSE OF THE DAMAGES FOUND ON THIS DEVICE COULD NOT BE CONCLUSIVELY DETERMINED, BUT IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. NEITHER THE PRODUCT ANALYSES NOR THE DHR REVIEWS SUGGEST THAT THE EVENTS COULD BE RELATED TO THE GUIDE WIRE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND IS ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2012-00095 AND 1016427-2012-00096.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN TOOK OUT THE SGW .014 STABILIZER 1 GUIDEWIRE FROM THE PACKAGE, HE FOUND THE COIL WAS STRETCHED. IT WAS CHANGED ANOTHER ONE, FOUND THE SAME PROBLEM. IT WAS CHANGED THE 3RD ONE TO COMPLETE THE PROCEDURE. THE GUIDEWIRE WAS NOT INSERTED INTO THE PATIENT BODY. THE PRODUCTS WERE NOT HANDLED IN ANY WAY BEFORE THE REPORTED EVENT WAS FOUND AND WERE STORED AT THE FACILITY PER IFU. THERE WAS ALSO NO DAMAGE TO THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW .014 STABILIZER 180CM CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70710737

    Patients

    Seq Age Sex Outcome Treatment
    1