BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 2062879 · Received April 19, 2011

    Report

    Report Number
    1058196-2011-00171
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 1, 2011
    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

    ORIGINALLY NO PRODUCT WAS RECEIVED, HOWEVER ON (B)(4) 2011 A SAMPLE WAS RECEIVED WITH A LOOP OR KNOT IN TIP AND HAD COILS UNRAVELED ABOUT THE MIDJOINT, WHICH INCREASED THE DIAMETER TO EXCEED THE OD SPECIFICATION. NO FOREIGN MATTER WAS OBSERVED. MUCH OF THE COATING WAS REMOVED FROM THE COILED SECTION. MOST REMAINED INTACT. COREWIRE HAD LONG, GENTLE IN COREWIRE AT APPROXIMATELY 40CM FROM THE TIP. A DHR WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. THE REPORTED FAILURE BY THE CUSTOMER AS "GUIDEWIRE- DAMAGED" WAS CONFIRMED DUE TO RECEIVED CONDITION OF THE DEVICE; HOWEVER IT APPEARS THAT THE GUIDEWIRE WAS HIGHLY USED SUCH THAT THE COATING WAS REMOVED FROM THE COILED SECTION, LEADING TO THE UNRAVELING AT THE MIDJOINT. THE FAILURE GUIDEWIRE- IMPEDED COULD NOT BE EVALUATED OWING TO DAMAGES THAT PRESENTED THE DEVICE. THE CAUSE OF THE FAILURES REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED, BUT THEY DO NOT APPEARS TO BE MANUFACTURING RELATED OF THE PRODUCT; THEREFORE NO ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AN AGILITY 10 SOFT GUIDE WIRE COULD NOT GO THROUGH A NON-CORDIS MICROCATHETER. FOREIGN MATERIAL WAS SEEN APPROXIMATELY 5 CM FROM THE DISTAL DIP. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER SUCCESSFULLY. THERE WAS NO INJURY TO THE PATIENT. THE FOREIGN MATERIAL WAS NOT PRESENT WHEN THE GUIDEWIRE WAS REMOVED FROM THE STERILE PACKAGE/PLASTIC LOOP, NOT SEEN AFTER THE PRODUCT WAS WIPED WITH A WET GAUZED. THE FOREIGN MATERIAL SEEN AFTER THE PRODUCT WAS INSERTED IN THE MICROCATHETER AT APPROXIMATELY 5CM FROM THE DISTAL TIP. PRIOR TO THIS GUIDEWIRE, NO OTHER DEVICE WENT THROUGH THE MICROCATHETER. A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES. THE PRODUCT WAS RECEIVED FOR EVALUATION. THE DISTAL TIP WAS FOUND TIED IN A LOOP. THE WIRE HAD COILS UNRAVELED AT THE MIDPOINT EXCEEDING THE OUTER DIAMETER SPECIFICATION. NO FOREIGN MATTER WAS OBSERVED. MUCH OF THE COATING WAS REMOVED FROM THE COILED SECTION. MOST REMAINED INTACT. THE COREWIRE HAD LONG, GENTLE CURVE IN COREWIRE AT APPROXIMATELY 40CM FROM THE TIP. A DHR WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. THE REPORTED FAILURE BY THE CUSTOMER AS "GUIDEWIRE- DAMAGED" WAS CONFIRMED; HOWEVER THE CAUSE OF THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. IT APPEARS THAT THE GUIDEWIRE WAS HIGHLY USED SUCH THAT THE COATING WAS REMOVED FROM THE COILED SECTION, LEADING TO THE UNRAVELING AT THE MIDPOINT. THE FAILURE GUIDEWIRE- IMPEDED COULD NOT BE EVALUATED OWING TO DAMAGES THAT PRESENTED THE DEVICE. NEITHER THE DHR NOR THE INFORMATION PROVIDED FROM THE PRODUCT ANALYSIS INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION; ONLY A PICTURE WAS RECEIVED TO BE EVALUATED; THE PICTURE SHOW WHAT APPEAR TO BE AN AGILITY 10 SOFT; SINCE THE IMAGE IS NOT CLEAR ENOUGH THE DAMAGE REPORTED BY THE CUSTOMER COULD NOT BE DISTINGUISHED. THEREFORE, BASED ON THE PICTURED RECEIVED A RELIABLE ANALYSIS COULD NOT BE PERFORMED. PER (B)(4) MEDICAL REPORT (B)(4): A DHR WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. THE REPORTED FAILURE BY THE CUSTOMER AS "GUIDEWIRE- DAMAGED" WAS NOT CONFIRMED SINCE THE INVOLVED PRODUCT WAS NOT RETURNED AND THE PICTURE PROVIDED IS NOT CLEAR ENOUGH TO DISTINGUISH THE DAMAGE. THE FAILURE GUIDEWIRE- IMPEDED COULD NOT BE EVALUATED SINCE NO PRODUCT WAS RETURNED. THE CAUSE OF THE FAILURES REPORTED BY THE CUSTOMER COULD NOT BE DETERMINATE SINCE THE INVOLVED PRODUCT WAS NOT RETURNED AND THE PICTURE PROVIDED IS NOT CLEAR ENOUGH TO DISTINGUISH THE DAMAGE; THEREFORE NO ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE AGILITY 10 SOFT GUIDE WIRE WAS NOT GOT THROUGH THE MICROCATHETER DUE TO A FOREIGN MATERIAL ATTACHED TO THE GUIDE WIRE ORIGINALLY. THE FOREIGN MATERIAL WAS NOT PRESENT WHEN THE GUIDEWIRE WAS REMOVED FROM THE STERILE PACKAGE/PLASTIC LOOP, NOT SEEN AFTER THE PRODUCT WAS WIPED WITH A WET GAUZED. THE FOREIGN MATERIAL SEEN AFTER THE PRODUCT WAS INSERTED IN THE MICROCATHETER AT APPROXIMATELY 5CM FROM THE DISTAL TIP. THE FOREIGN MATERIAL WAS SAVED AND A PICTURE WAS PROVIDED. PRIOR TO THIS GUIDEWIRE, NO OTHER DEVICE WENT THROUGH THE MICROCATHETER. A CONSTANT AND DEDICATED FLUSH WAS MAINTAINED AT ALL TIMES. AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA 13471630

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER.