BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 3902141 · Received June 30, 2014

    Report

    Report Number
    1058196-2014-00182
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K001033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DURING THE SURGERY, THE AGILITY GUIDEWIRE (614481/455486) ELONGATED. IT WAS REPORTED THAT PROWLER 14 MICROCATHETER WAS INSERTED INTO THE CRANIUM TOGETHER WITH THE AGILITY GUIDEWIRE, BUT BEFORE REACHING THE PROBLEMATIC ANEURYSM THERE WAS FEELING THAT THE GUIDEWIRE WAS ELONGATED AND TARGETING THE ANEURYSM COULD NOT BE MANAGED WITH THIS GUIDEWIRE. THEN, THE GUIDEWIRE WAS PULLED OUT, AND REPLACED WITH NEW ONE AND SUCCESSFULLY FINISHED THE EMBOLIZATION. IT WAS CONFIRMED THAT THE GUIDEWIRE WAS ELONGATED (STRETCHED), AND A PROWLER 14 MICROCATHETER WAS USED WITH THE GUIDEWIRES. AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH A NEW GUIDEWIRE. A CONSTANT AND DEDICATED SALINE SOURCE WAS USED AT ALL TIME, AND NO RESISTANCE WAS NOTED DURING ADVANCING. THE GUIDEWIRE MADE IT COMPLETELY OUT OF THE MICROCATHETER, AND DURING ADVANCING, THE GUIDEWIRE WAS NOT TORQUE/ADVANCED AGAINST ANY RESISTANCE. THE GUIDEWIRE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB. DURING INSERTION, THE Y CONNECTOR WAS OPENED SUFFICIENTLY TO ALLOW THE PASSAGE OF THE GUIDEWIRE, AND THE TUOHY OR Y CONNECTOR WAS CLOSED TO SECURE THE INTRODUCERS AND PREVENT MOVEMENT. THERE WAS NO POSSIBILITY THAT THE Y CONNECTOR WAS OVER TIGHTENED, AND THERE WERE NO DAMAGES NOTICED ON ANY SECTION OF THE GUIDEWIRE OR MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ISSUES OCCURRED DURING REMOVAL FROM THE PLASTIC HOOP THAT MIGHT HAVE CONTRIBUTED TO THE EVENT, AND BOTH, THE MICROCATHETER AND GUIDEWIRE DISTAL TIPS WERE RESHAPED. THE SHAPING MANDRELS WERE USED, AND TO SHAPE THE MICROCATHETER WARM STEAM WAS USED. NO DAMAGES WERE NOTICED ON EITHER DEVICE AFTER RESHAPING WAS COMPLETED. AFTER THE EVENT, OTHER THAN THE REPORTED EVENT, THE DEVICES WERE NOT DAMAGED (FRACTURE, SEPARATED, ETC.). THE INTENDED TARGET SITE WAS THE LEFT INTERNAL CAROTID WITH AN ANEURYSM SIZE OF 12X8 MM. NO FURTHER INFORMATION WAS AVAILABLE. NO CONSEQUENCES ON THE PATIENT' HEALTH, AND NO PATIENT OR VESSEL CODE INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING THE SURGERY, THE AGILITY GUIDEWIRE (614481/455486) ELONGATED. IT WAS REPORTED THAT PROWLER 14 MICROCATHETER WAS INSERTED INTO THE CRANIUM TOGETHER WITH THE AGILITY GUIDEWIRE, BUT BEFORE REACHING THE PROBLEMATIC ANEURYSM THERE WAS FEELING THAT THE GUIDEWIRE WAS ELONGATED AND TARGETING THE ANEURYSM COULD NOT BE MANAGED WITH THIS GUIDEWIRE. THEN, THE GUIDEWIRE WAS PULLED OUT, AND REPLACED WITH NEW ONE AND SUCCESSFULLY FINISHED THE EMBOLIZATION. IT WAS CONFIRMED THAT THE GUIDEWIRE WAS ELONGATED (STRETCHED), AND A PROWLER 14 MICROCATHETER WAS USED WITH THE GUIDEWIRES. AFTER THE EVENT, THE SAME MICROCATHETER WAS USED WITH A NEW GUIDEWIRE. A CONSTANT AND DEDICATED SALINE SOURCE WAS USED AT ALL TIME, AND NO RESISTANCE WAS NOTED DURING ADVANCING. THE GUIDEWIRE MADE IT COMPLETELY OUT OF THE MICROCATHETER, AND DURING ADVANCING, THE GUIDEWIRE WAS NOT TORQUE/ADVANCED AGAINST ANY RESISTANCE. THE GUIDEWIRE INTRODUCER WAS COMPLETELY SEATED IN THE MICROCATHETER HUB. DURING INSERTION, THE Y CONNECTOR WAS OPENED SUFFICIENTLY TO ALLOW THE PASSAGE OF THE GUIDEWIRE, AND THE TUOHY OR Y CONNECTOR WAS CLOSED TO SECURE THE INTRODUCERS AND PREVENT MOVEMENT. THERE WAS NO POSSIBILITY THAT THE Y CONNECTOR WAS OVER TIGHTENED, AND THERE WERE NO DAMAGES NOTICED ON ANY SECTION OF THE GUIDEWIRE OR MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO ISSUES OCCURRED DURING REMOVAL FROM THE PLASTIC HOOP THAT MIGHT HAVE CONTRIBUTED TO THE EVENT, AND BOTH, THE MICROCATHETER AND GUIDEWIRE DISTAL TIPS WERE RESHAPED. THE SHAPING MANDRELS WERE USED, AND TO SHAPE THE MICROCATHETER WARM STEAM WAS USED. NO DAMAGES WERE NOTICED ON EITHER DEVICE AFTER RESHAPING WAS COMPLETED. AFTER THE EVENT, OTHER THAN THE REPORTED EVENT, THE DEVICES WERE NOT DAMAGED (FRACTURE, SEPARATED, ETC.). THE INTENDED TARGET SITE WAS THE LEFT INTERNAL CAROTID WITH AN ANEURYSM SIZE OF 12X8 MM. NO FURTHER INFORMATION WAS AVAILABLE. NO CONSEQUENCES ON THE PATIENT' HEALTH, AND NO PATIENT OR VESSEL CODE INFORMATION WAS PROVIDED. PER CONCERT MEDICAL REPORT, THE COREWIRE SURFACE FINISH APPEARED NORMAL. SAMPLE WAS EXAMINED UNDER MAGNIFICATION, AND COREWIRE BREAK WAS EVIDENT IMMEDIATELY PROXIMAL TO THE MIDJOINT. APPEARANCE OF BREAK WAS CONSISTENT WITH CYCLICAL BENDING FROM CONTINUAL ROTATION AND/OR TENSILE FAILURE. NO EVIDENCE OF TORSIONAL FAILURE COULD BE SEEN IN THE DISTAL SEGMENT. THE COREWIRE DIAMETER AT THE POINT OF BREAK MEASURED 0.0028" WHICH IS THE NOMINAL OF THE COREWIRE SPECIFICATION. DEVICE HISTORY REVIEW WAS PERFORMED AND NO KNOWN NONCONFORMITIES WERE FOUND. THE REPORTED FAILURE TIP UNRAVELED WAS CONFIRMED. THE CAUSE OF CAUSE OF THIS FAILURE AS WELL AS THE FRACTURE OBSERVED ON THE CORE DISTAL SECTION OF THE GUIDE WIRE, APPEARED TO BE RELATED TO PROCEDURAL FACTORS, SINCE THE DEVICE APPEARED TO HAVE BEEN SUBJECTED TO FORCES THAT EXCEEDED THE DESIGN SPECIFICATION. ADDITIONALLY, IT WAS REPORTED THAT OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTED ON THE DEVICE INCLUDING FRACTURE, FOR THAT REASON THE FRACTURE GUIDEWIRE MIGHT HAVE OCCURRED DURING THE SHIPPING PROCESS. REVIEW OF THE LOT WAS PERFORMED AND NO KNOWN NONCONFORMITIES WERE FOUND. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE SURGERY, THE AGILITY GUIDEWIRE (614481/455486) ELONGATED. IT WAS REPORTED THAT UNKNOWN MICROCATHETER WAS INSERTED INTO THE CRANIUM TOGETHER WITH THE AGILITY GUIDINGWIRE, BUT BEFORE REACHING THE PROBLEMATIC ANEURYSM THERE WAS FEELING THAT THE GUIDINGWIRE WAS ELONGATED AND TARGETING THE ANEURYSM COULD NOT BE MANAGED WITH THIS GUIDEWIRE. THEN, THE GUIDEWIRE WAS PULLED OUT, AND REPLACED WITH NEW ONE AND SUCCESSFULLY FINISHED THE EMBOLIZATION. NO CONSEQUENCES ON THE PATIENT' HEALTH, AND NO PATIENT OR VESSEL CODE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379029 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA 455486

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR UNKNOWN MICROCATHETER