BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 1644386 · Received March 30, 2010

    Report

    Report Number
    1058196-2010-00080
    Event Type
    Malfunction
    Date Received
    March 30, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K001033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO USE IN THE PATIENT, THE TIP OF THE AGILITY 14 SOFT GUIDE WIRE WAS STRETCHED INITIALLY JUST LIKE A COIL STRETCHING. ADDITIONALLY IT WAS REPORTED THAT THERE NO ISSUES REMOVING THE GUIDEWIRE FROM THE PACKAGE. IT IS NOT KNOWN HOW THE WIRE WAS REMOVED FROM THE PACKAGING HOOP. THE DISTAL TIP WAS NOT RESHAPED. OTHER THAN THE REPORTED STRETCHING, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE. PER (B)(4) MEDICAL ANALYSIS REPORT, A SINGLE DEVICE WAS RETURNED. VISUAL INSPECTION AT 30X REVEALS THE DISTAL MOST (B)(4) COILS ARE STRETCHED BEYOND THEIR ELASTIC LIMIT, AND PERMANENTLY SET. THE INTERNAL COREWIRE HAS BEEN PULLED OUT OF THE ADHESIVE BOND ON THE DISTAL TIP. THE OVERALL DEVICE ITSELF IS COMPLETE. (B)(4) MEDICAL LOT NUMBER 323118 IS CORDIS LOT NUMBER 13471535. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. THE FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED. ALTHOUGH BASED ON THE REPORTED INFORMATION, NO CONCLUSION CAN BE MADE, IT IS POSSIBLE THAT THE DAMAGE TO THE DEVICE IS DUE TO HANDLING/REMOVAL TECHNIQUE. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NOTE: CONCERT MEDICAL LOT NUMBER 323118 IS CORDIS LOT NUMBER 13471535. PER CONCERT MEDICAL REPORT (B)(4): DHR REVIEW WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PRIOR TO USE IN THE PATIENT, THE TIP OF THE AGILITY 14 SOFT GUIDE WIRE WAS STRETCHED INITIALLY JUST LIKE COIL STRETCHING. ADDITIONALLY IT WAS REPORTED THAT THERE NO ISSUES REMOVING THE GUIDEWIRE FROM THE PACKAGE. THE DISTAL TIP WAS NOT RESHAPED. OTHER THAN WHAT WAS REPORTED, NO OTHER DAMAGES WERE NOTICED ON EITHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA 13471535

    Patients

    Seq Age Sex Outcome Treatment
    1