BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 2062674 · Received April 19, 2011

    Report

    Report Number
    1058196-2011-00170
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 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

    ADDITIONAL INFROMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 IN THEIR COIL DISPENSER; THE PICTURE SHOWS RED SPOT AT THE DISTAL END OF THE COIL DISPENSER, NO OTHER ANOMALIES WERE OBSERVED IN THE PICTURE. 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 COMPLAINT REPORTED BY CUSTOMER LIKE "PACKAGING/POUCH/BOX- FOREIGN MATERIAL-IN STERILE PACKAGE" WAS CONFIRMED ACCORDING WITH THE PICTURE EVALUATION; HOWEVER THE EXACT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE AGILITY 10 SOFT MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PRIOR TO USE, UPON OPENING THE INNER PACKAGE, A RUST-LIKE MATERIAL WAS FOUND ON THE DISPENSER TUBE AND THE PROXIMAL PART OF THE AGILITY 10 SOFT MICRO WIRE. THE PRODUCT WAS NEW; IT HAD NOT BEEN RESTERILIZED. IT WAS STORED PER LABELING INSTRUCTIONS. THE PRODUCT WAS NOT EXPOSED TO EXCESSIVE HEAT OR HUMIDITY. PRIOR TO OPENING AND REMOVING FROM THE STERILE PACKAGE, NO CONDENSATION WAS NOTICED IN THE INNER STERILE PACKAGE. ADDITIONAL INFORMATION REPORTED THAT THE DEVICE WAS FLUSHED WITH NORMAL SALINE. THE DEVICE WAS NOT USED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THE RETURNED DEVICE WAS OBSERVED IN THE HOOP. PROXIMAL END OF THE HOOP HAD RUST LIKE COLOR AS DID THE PROXIMAL END. THIS MATCHES THE PHOTOGRAPH PROVIDED BY THE CUSTOMER. SEVERAL DROPS OF LIQUID WERE OBSERVED INSIDE THE HOOP. THE DISTAL TIP OF THE GUIDE WIRE APPEARED UNUSED. A DHR WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. THE DEVICE WAS SENT TO FT-IR AND X-RAY ANALYSIS, IN ORDER TO IDENTIFY THE FOREIGN MATTER PRESENTED IN THE HOOP AND IN THE GUIDE WIRE AND THE FINDINGS WERE THE FOLLOWING: CONTAMINATION WAS CHARACTERIZED BY INFRARED SPECTROSCOPY; THIS ANALYSIS CONFIRMS PRESENCE OF (B)(4) THAT COULD BE FORMED DURING THE RUSTY REACTION. X-RAY RESULTS: THE DEPOSITED MATERIAL WAS COMPOSED OF (B)(4); THESE ARE THE MAIN ELEMENTAL COMPONENTS OF STAINLESS STEEL. IT IS POSSIBLE THAT SOME OF THE ELEMENTS FOUND (SODIUM, CHLORINE) COULD HAVE COME FROM SALINE SOLUTION. THE X-RAY ANALYSIS CONFIRMED THAT THE CONTAMINATION PROBABLY CAME FROM RUST OF THE WIRE WHICH IS MADE OF STAINLESS STEEL. IN ADDITION HIGH CONCENTRATION OF OXYGEN WAS ALSO FOUND WHICH SUPPOSE THE PRESENCE OF THE IRON OXIDES DUE THE OXIDATION. THE REPORTED FOREIGN MATERIAL ON THE DISPENSER TUBE AND GUIDEWIRE WERE CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICE. ACCORDING TO THE RESULTS OBTAINED FOR FT-IR AND X-RAY TESTS THE FOREIGN MATTER WAS IDENTIFY AS APPEARING AS CORROSION. IT WAS CONFIRMED THAT THE DEVICE WAS FLUSHED BY THE USER. HOWEVER, CORROSION FROM LIQUID WOULD HAVE OCCURRED OVER TIME; THEREFORE THE LIQUID USED TO FLUSH THE DEVICE WOULD NOT HAVE BEEN THE CAUSE OF THE CONTAMINATION NOTED BY THE USER PRIOR TO USE. BASED ON THE REPORTED CLINICAL USE OF THE DEVICE, REVIEW OF THE MANUFACTURING PROCESS, DHR, AND ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING ROOT CAUSE. A RISK ASSESSMENT HAS BEEN INITIATED TO EVALUATE THIS ISSUE AND DETERMINATION OF ANY APPROPRIATE CORRECTIVE ACTIONS. (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    ORIGINALLY NO PRODUCT WAS RECEIVED; HOWEVER THE SAMPLE WAS RECEIVED. SAMPLE WAS OBSERVED IN THE HOOP. PROXIMAL END OF THE HOOP HAD RUST LIKE COLOR AS DID THE PROXIMAL END. THIS MATCHED THE PHOTOGRAPH PROVIDED BY THE CUSTOMER. INSIDE THE HOOP SEVERAL DROPS OF LIQUID WERE OBSERVED. THE DISTAL TIP OF THE GUIDEWIRE APPEARED UNUSED. THE CORROSION ON THE HOOP AND GUIDE WIRE APPEARS TO BE CAUSED BY THE LIQUID IN THE HOOP. IT IS UNKNOWN HOW THE LIQUID GOT INTO THE HOOP AS THEY ARE RECEIVED DRY FROM THE MANUFACTURER IN DOUBLE BAGS AND THERE IS NO WATER IN THE AREA WHERE PACKAGING OCCURS. A DHR WAS PERFORMED AND FOUND NO NONCONFORMITIES WITHIN THE MANUFACTURING PROCESS. THE DEVICE WAS SENT TO FT-IR AND X-RAY ANALYSIS, IN ORDER TO IDENTIFY THE FOREIGN MATTER PRESENTED IN THE HOOP AND IN THE GUIDEWIRE, AND THE FINDINGS WERE THE FOLLOWING: FT-IR RESULTS: CONTAMINATION WAS CHARACTERIZED BY INFRARED SPECTROSCOPY; THIS ANALYSIS CONFIRMS PRESENCE OF (B)(4) THAT COULD BE FORMED DURING THE RUSTY REACTION. X-RAY RESULTS: THE DEPOSITED MATERIAL WAS COMPOSED OF (B)(4); THESE ARE THE MAIN ELEMENTAL COMPONENTS OF STAINLESS STEEL. IT IS POSSIBLE THAT SOME OF THE ELEMENTS FOUND (SODIUM, CHLORINE) COULD HAVE COME FROM SALINE SOLUTION. THE X-RAY ANALYSIS CONFIRMED THAT THE CONTAMINATION PROBABLY CAME FROM RUST OF THE WIRE WHICH IS MADE OF STAINLESS STEEL. IN ADDITION HIGH CONCENTRATION OF OXYGEN WAS ALSO FOUND WHICH SUPPOSE THE PRESENCE OF THE IRON OXIDES DUE THE OXIDATION. THE COMPLAINT REPORTED BY CUSTOMER LIKE "PACKAGING/POUCH/BOX- FOREIGN MATERIAL-IN STERILE PACKAGE" WAS CONFIRMED DURING ANALYSIS, ACCORDING WITH THE RESULTS OBTAINED FOR FT-IR AND X-RAY TESTS THE FOREIGN MATTER WAS IDENTIFY LIKE CORROSION, HOWEVER THUS FAR , THE SOURCE OF THE LIQUID THAT COULD BE THE CAUSE OF THIS CORROSION COULD NOT BE CONCLUSIVELY DETERMINED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION AND ANALYSIS WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RE-STERILIZED, AND SALINE WAS UTILIZED TO FLUSH THE PRODUCT PRIOR TO USE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    PRIOR TO USE, UPON OPENING THE INNER PACKAGE, A RUST-LIKE MATERIAL WAS FOUND ON THE DISPENSER TUBE AND THE PROXIMAL PART OF THE AGILITY 10 SOFT MICROWIRE. A PICTURE OF THE EVENT WAS PROVIDED. THE PRODUCT WAS NEW, AND WAS STORED PER LABELING INSTRUCTIONS. THE PRODUCT WAS NOT EXPOSED TO EXCESSIVE HEAT OR HUMIDITY. PRIOR TO OPENING AND REMOVING FROM THE STERILE PACKAGE, NO CONDENSATION WAS NOTICED IN THE INNER STERILE PACKAGE. THE INTENDED SITE WAS THE ACOM. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA 13471625

    Patients

    Seq Age Sex Outcome Treatment
    1