BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE GUIDEWIRE

    MDR report key: 1171330 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02681
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    June 24, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K011968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED FRACTURE OF THE CORE WIRE BETWEEN THE DISTAL AND INTERMEDIATE COIL TO CORE WIRE JOINTS. THE NON-DESTRUCTIVE NATURE OF THIS INVESTIGATION PREVENTS IDENTIFYING THE EXACT LOCATION AND CHARACTERIZATION OF THE FRACTURE. THE COIL WRAPS PRESENT BREAKS IN COIL ALIGNMENT AT 1.55CM, 1.56CM, 1.59CM, AND 1.82CM FOR THE DISTAL TIP, BETWEEN THE DISTAL AND INTERMEDIATE JOINTS. ADDITIONAL DAMAGE WAS NOTED OF MINUTE SCRATCHES ON THE COIL SURFACES, INDICATIVE OF TOOL MARKS-POSSIBLY FROM A FORCEPS OR OTHER CLAMPING DEVICE. THE COMPLAINT NARRATIVE DOES NOT INDICATE HOW THE DEVICE WAS REMOVED FROM THE DISPENSER ASSEMBLY. TESTING HAS DEMONSTRATED THAT REMOVING THE DEVICE FROM THE DISPENSER ASSEMBLY BY PULLING THE WIRE DISTALLY WHILE GRASPING THE COIL INCREASE THE RISK OF DAMAGE TO THE DISTAL COIL REGION. THE DEVICE INSTRUCTIONS FOR USE (IFU) ONLY CAUTIONS THE USER TO "REMOVE THE GUIDE WIRE CAREFULLY FROM THE CARRIER TO REDUCE THE POSSIBILITY OF DAMAGE TO THE DISTAL TIP," BUT DOES NOT PROVIDE A RECOMMENDED METHOD. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS ATTRIBUTED TO USER HANDLING.

    Description of Event or Problem · 1

    EVENT WAS DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON 08/20/2008. IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, THE SPRING TIP OF THE FORTE FLOPPY GUIDE WIRE WAS NOTED TO BE STRETCHED FOLLOWING REMOVAL FROM THE PACKAGING HOOP. THE DEVICE HAD NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. ANALYSIS REVEALED FRACTURED CORE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 0001998253

    Patients

    Seq Age Sex Outcome Treatment
    1