BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 3358918 · Received September 19, 2013

    Report

    Report Number
    1058196-2013-00257
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 5, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K991646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING USE, THE TIP OF THE AGILITY 10 GUIDEWIRE ((B)(4)) WAS NOT BROKEN INSTEAD IT STRETCHED AFTER SEVERAL TIMES OF RE-SHAPING. THE DISTAL TIP WAS RESHAPED WITH THE SHAPING MANDREL WHICH IS ENCLOSED IN THE PACKAGE, AND THE USER WAS TRAINED. THE ENTIRE GUIDEWIRE IS GOING TO BE RETURNED INCLUDING THE STRETCHED PIECE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE REPORTED ON THE DEVICE. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS. PER CONCERT MEDICAL REPORT: THE SAMPLE WAS OBSERVED AND THE REPORTED STRETCH WAS CONFIRMED. LOCATION WAS DISTAL TO THE MIDJOINT. THE DIAMETER AND COIL LENGTH WERE INDICATIVE OF AN AGILITY 14 SOFT, NOT AN AGILITY 10 SOFT, AS THE COMPLAINT AND PACKAGING STATE. DHR REVIEW WAS PERFORMED AND NO KNOWN NON-CONFORMITIES WERE FOUND. THE REPORTED FAILURE BY THE COSTUMER AS DISTAL TIP STRETCHED WAS CONFIRMED DUE TO PRODUCT RECEIVED CONDITIONS. THE DEVICE DID NOT FAIL. THE STRETCH RESULTED DUE TO THE DEVICE BEING USED IN A MANNER THAT EXCEEDED THE SPECIFICATION LIMITS. THE TIME AND PLACE OF THIS DAMAGED COULD NOT BE DETERMINATE, BUT IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED; NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. HOWEVER, THERE ARE POSSIBLE PROCEDURAL FACTORS, SPECIFICALLY THE RESHAPING OF THE DISTAL TIP THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURN FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT

    Description of Event or Problem · 1

    DURING USE, THE TIP OF THE AGILITY 10 GUIDEWIRE (614179/274101) WAS NOT BROKEN INSTEAD IT STRETCHED AFTER SEVERAL TIMES OF RE-SHAPING. THE DISTAL TIP WAS RESHAPED WITH THE SHAPING MANDREL WHICH IS ENCLOSED IN THE PACKAGE, AND THE USER WAS TRAINED. THE ENTIRE GUIDEWIRE IS GOING TO BE RETURNED INCLUDING THE STRETCHED PIECE. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE REPORTED ON THE DEVICE. THERE WAS NO ADVERSE EVENT REPORTED, AND THE COMPONENT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472305 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA 274101

    Patients

    Seq Age Sex Outcome Treatment
    1 SHAPING MANDREL