BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 2626589 · Received June 22, 2012

    Report

    Report Number
    1058196-2012-00242
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 7, 2012
    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

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE AGILITY 14 SOFT GUIDEWIRE ((B)(4)/ UNK) COATING WAS REMOVED DURING REMOVAL FROM THE PACKAGE; NOTHING OCCURRED OR WAS BEING DONE DURING REMOVAL FROM THE PACKAGE THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE GUIDEWIRE WAS STORED PER LABELING INSTRUCTIONS AND NO DAMAGES WERE NOTICED ON THE OUTER OR INNER PACKAGE THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE GUIDEWIRE INTRODUCER WAS NOT USED TO RE-SHAPE THE GUIDEWIRE. THE GUIDEWIRE WAS NOT EXPOSED TO ANY SHARP OBJECT, AND NO ADDITIONAL TORQUE OR MANIPULATION WAS PERFORMED WITH THE DISTAL TIP TRAPPED. THERE WAS NO PATIENT INJURY. PER CONCERT MEDICAL ANALYSIS THE DISTAL COIL WAS STRETCHED OUT REVEALING THE COREWIRE THAT WAS NOT ATTACHED TO THE TIP BOND. FURTHER EXAMINATION REVEALED THAT THE COREWIRE HAD PULLED OUT OF THE TIP BOND. THE TIP OF THE COREWIRE WAS MEASURED AND WAS FOUND TO BE WITHIN SIZE SPECIFICATIONS (.00095 X .0033, WITH .065 ABRADE LENGTH). THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE REPORTED LOT NUMBER WAS NOT VALID AND NO FURTHER VALID LOT NUMBER IS AVAILABLE. IT WAS CONFIRMED THAT THE DISTAL COIL WAS STRETCHED WITH THE COREWIRE PULLED OUT OF THE TIP BOND. THE DISTAL BOND HAS A TENSILE SPECIFICATION OF 0.6 LBS. AND ALL LOTS OF AGILITY GUIDEWIRES ARE TENSILE TESTED 100% TO 0.6 LBS PRIOR TO SHIPMENT. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE EVIDENCE STRONGLY SUGGESTS THAT THE DEVICE EXPERIENCED TENSILE FORCES THAT EXCEEDED THE DESIGN LIMITATIONS OF THE DEVICE WITH THE DEVICE FUNCTIONING AS DESIGNED. PROCEDURAL HANDLING/REMOVAL TECHNIQUES SUCH AS PULLING THE WIRE OUT OF THE HOOP BY THE DISTAL TIP ARE FACTORS THAT CAN CONTRIBUTE TO THIS TYPE OF DAMAGE. HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE AGILITY 14 SOFT GUIDEWIRE ((B)(4)/LOT# UNK) COATING WAS REMOVED DURING REMOVAL FROM THE PACKAGE, BUT NOTHING OCCURRED DURING REMOVAL FROM THE PACKAGE THAT MIGHT HAVE CONTRIBUTED TO THE EVENT OR BEING DONE WHEN THE EVENT OCCURRED, THE GUIDEWIRE WAS STORED PER LABELING INSTRUCTIONS, OR DAMAGES NOTICED ON THE OUTER OR INNER PACKAGE THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. AND THE GUIDEWIRE INTRODUCER WAS NOT USED TO RE-SHAPE THE GUIDEWIRE. AFTER THE EVENT, NO OTHER DAMAGES WAS NOTED ON THE DEVICE (GUIDEWIRE (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC). THERE WAS NO SERIOUS INJURY REPORTED AND THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1