BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1961216 · Received January 14, 2011

    Report

    Report Number
    9616099-2011-00038
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15182885 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NONCONFORMANCES: NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. PROCESS MONITORING: NO EXCURSIONS WERE FOUND FOR LOT 15182885. CANNULA SUBASSEMBLY LOTS 15174222, 15176581 AND 15177977 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE WAS GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. BRAIDED CANNULA SUBASSEMBLY LOTS 15173384, 15172909, 15177978 AND 15176582 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. OUTER SHAFT SUBASSEMBLY LOTS 15177979, 15176583 AND 15174223 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE WAS GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NOSECONE SUBASSEMBLY LOTS 15177981, 15176585, 15174225, 15171601 AND 15171623 WERE REVIEWED. IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCES WERE GENERATED AND NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE OPERATOR QUALIFICATION RECORDS FOR FINAL TQC MODEL OTB42120, ACCORDING TO (B)(4) WERE REVIEWED. THE OPERATOR THAT PERFORMED THIS OPERATION WAS QUALIFIED ON THE APPROPRIATE MANUFACTURING WORK INSTRUCTION REVISION AT THE TIME OF THE LOT MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EVALUATED; THEREFORE, HAS BEEN UPDATED. THE COMPLAINT RECEIVED STATES THAT DURING PREP OF AN OUTBACK DEVICE THE NEEDLE WOULD NOT RETRACT. DURING AND AFTER FLUSHING WITH SALINE SOLUTION, THE NEEDLE COULD NOT BE WITHDRAWN ENTIRELY INTO THE SYSTEM. THE NEEDLE TIP REMAINED OUTSIDE. THE PRODUCT WAS EXCHANGED AND THE PROCEDURE WAS FINISHED WITHOUT FURTHER COMPLICATIONS. THE OUTER AND INNER PACKAGE WAS NOT DAMAGED AND NO VISIBLE DAMAGES WERE OBSERVED ON THE PRODUCT. THE PRODUCT WAS STORED ACCORDING TO THE LABELING INSTRUCTIONS. THE DEVICE WAS NOT USED ON THE PATIENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE CUSTOMER WAS UNWILLING TO PROVIDE FURTHER INFORMATION. THE PHYSICIAN HAD BEEN USING THE PRODUCT ON A REGULAR BASIS (MINIMUM 40 OUTBACKS). ONE NON STERILE OUTBACK WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. NO ANOMALIES WERE OBSERVED. PRESSURIZED WATER WAS APPLIED TO THE CATHETER THROUGH THE GUIDE WIRE PORT, AND EXITED THROUGH THE CANNULA PORT (AS EXPECTED), THEN THROUGH THE HEMOSTATIC ROTATING VALVE, AND EXITED THROUGH THE TIP (AS EXPECTED); NO ANOMALIES WERE DETECTED. A 0.014" GUIDE WIRE WAS INSERTED THROUGH THE TIP AND EXITED THROUGH THE GUIDE WIRE PORT (AS EXPECTED). THE GUIDE WIRE WAS THEN INSERTED THROUGH THE GUIDE WIRE PORT WITH THE CANNULA RETRACTED, AND EXITED THROUGH THE TIP (AS EXPECTED). FINALLY THE GUIDE WIRE WAS INSERTED THROUGH THE GUIDE WIRE PORT WITH THE CANNULA DEPLOYED, AND EXITED THROUGH THE CANNULA (AS EXPECTED). IN NONE OF THE CASES RESISTANCE WAS NOTICED. CANNULA WAS FULLY DEPLOYED AND RETRACTED WITH NO ANOMALIES. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN. THE REPORTED COMPLAINT WAS NOT CONFIRMED ON ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING AND AFTER FLUSHING WITH SALINE SOLUTION THE NEEDLE COULD NOT BE WITHDRAWN ENTIRELY INTO THE SYSTEM. THE NEEDLE TIP REMAINED OUTSIDE. THE PRODUCT WAS EXCHANGED AND THE PROCEDURE WAS FINISHED WITHOUT FURTHER COMPLICATIONS. THE OUTER AND INNER PACKAGE WAS NOT DAMAGED AND NO VISIBLE DAMAGES WERE OBSERVED ON THE PRODUCT. THE PRODUCT WAS STORED ACCORDING TO THE LABELING INSTRUCTIONS. THE DEVICE WAS NOT USED ON THE PATIENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE CUSTOMER WAS UNWILLING TO PROVIDE FURTHER INFORMATION. THE PHYSICIAN WAS USING THE PRODUCT ON A REGULAR BASIS (MINIMUM 40 OUTBACKS). THEREFORE, THE LOCAL SALES REPRESENTATIVE ASSUMED THE PHYSICIAN WAS FAMILIAR WITH THE PRODUCT AND ITS USAGE. FOR SAFETY REASONS, THE PRODUCT WAS NOT USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEMS (DQY) DQY CORDIS DE MEXICO NA 15182885

    Patients

    Seq Age Sex Outcome Treatment
    1