BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER RADIOLUCENT

    MDR report key: 1140562 · Received August 28, 2008

    Report

    Report Number
    1016427-2008-00232
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 30, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K873403
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REMOVING A STABILIZER STEERABLE GUIDEWIRE FROM ITS PROTECTIVE HOOP, THE DISTAL TIP WAS FOUND KINKED. THE PRODUCT WAS NOT USED AND NO PATIENT INJURY OCCURRED. ANALYSIS OF THE RETURNED PRODUCT CONFIRMED KINKS AND BENDS ON THE WIRE, AS WELL AS STRETCHED COILS, WHICH WERE NOT INCLUDED IN THE ORIGINAL REPORT. AS RECEIVED, THE SPECIMEN DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY. THE SPECIMEN IS VISUALLY AND DIMENSIONALLY CORRECT. THE IFU PROVIDES THE FOLLOWING DIRECTION: "TO PREVENT DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE AND TO PREVENT THE GUIDEWIRE FROM SPRINGING ONTO A NON-STERILE FIELD, CAREFULLY REMOVE THE GUIDEWIRE FROM THE DISPENSING TUBE. USE THE DISPENSER WINDOW TO ADVANCE THE GUIDEWIRE DISTAL TIP, SUCH THAT THE GUIDEWIRE CAN BE REMOVED BY GRASPING THE COATED SHAFT." TESTING HAS DEMONSTRATED THAT FAILURE TO COMPLY WITH THE PROCEDURE AS DESCRIBED WITHIN THE IFU INCREASES THE RISK OF DAMAGE TO THE FLEXIBLE DISTAL TIP REGION OF THE DEVICE, AS PRESENTED BY THIS SPECIMEN. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THIS PACKAGING LOT WAS FINAL INSPECTION TESTED AND DEEMED ACCEPTABLE FOR SHIPMENT. THE COMPLAINT WAS CONFIRMED. ALTHOUGH THE CAUSE FOR THE TIP DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED, REVIEW OF THE AVAILABLE INFORMATION SUGGESTS DEVICE HANDLING MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    THERE WAS A KINK NOTED ON THE TIP OF THE STABILIZER RADIOLUCENT GUIDE WIRE. IT WAS NOTICED AFTER IT WAS REMOVED FROM THE PACKAGE. THE PACKAGE WAS INTACT BEFORE IT WAS OPENED. PER THE ANALYSIS FINDINGS, IT WAS NOTED THAT THE PRODUCT WAS RECEIVED WITH STRETCHED COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER RADIOLUCENT CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70807761

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK