BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER RADIOLUCENT

    MDR report key: 1140563 · Received August 28, 2008

    Report

    Report Number
    1016427-2008-00233
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 26, 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 OF THE WIRE WAS FOUND "NOT STRAIGHTFORWARD BUT VERY TORTUOUS". THE WIRE WAS NOT USED AND NO PATIENT INJURY OCCURRED. NO PACKAGING ANOMALIES WERE NOTED PRIOR TO USE. THE DAMAGE WAS NOT NOTED UNTIL AFTER REMOVAL FROM THE HOOP. ANALYSIS OF THE RETURNED WIRE CONFIRMED KINKS AND BENDS, AS WELL AS STRETCHED COILS. AS RECEIVED, THE SPECIMEN DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY. THE IFU PROVIDES THE FOLLOWING INSTRUCTION: "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 OF THE WIRE DAMAGE CANNOT BE DETERMINED WITH CERTAINTY, REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT DEVICE HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE TIP OF A STABILIZER RADIOLUCENT GUIDEWIRE WAS NOT STRAIGHTFORWARD, BUT VERY TORTUOUS. THE TIP WAS FOUND VERY TORTUOUS WHEN OPENING THE PACKAGE; BEFORE USE IN THE PATIENT. THE PACKAGING WAS INTACT WHEN IT WAS OPENED. PER THE ANALYSIS FINDINGS, IT WAS NOTED THAT THE PRODUCT WAS RECEIVED WITH STRETCHED COILS AND PTFE COATING DAMAGE ON THE WIRE SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZER RADIOLUCENT CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA 70907738

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK