BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 2060656 · Received April 18, 2011

    Report

    Report Number
    9616099-2011-00256
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY SALES REP, THE TIP OF THE OUTBACK CATHETER FELL OFF DURING DEVICE PREPARATION RENDERING THE CATHETER UNUSABLE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE. ONE NON STERILE OUTBACK WAS RECEIVED COILED INSIDE TWO PLASTIC BAGS. THE DISTAL TIP WAS RECEIVED SEPARATELY INSIDE ONE PLASTIC BAG. NO OTHER ANOMALIES WERE OBSERVED. DURING THE MICROSCOPIC ANALYSIS RESIDUES OF THE SOFT TIP WERE OBSERVED IN THE NOSECONE. IT WAS ALSO NOTICED THAT THE TIP SEEMED TO BE TORN PRIOR THE SEPARATION. 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 WAS CONFIRMED. THE CAUSE OF THE FAILURE EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE FAILURE. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THIS FAILURE IS RELATED TO THE MANUFACTURING PROCESS; THEREFORE NO ACTION WAS TAKEN. WITH THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY SALES REP, THE TIP OF THE OUTBACK CATHETER FELL OFF DURING PREP RENDERING THE CATHETER UNUSABLE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PACKAGE.

    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 15049817

    Patients

    Seq Age Sex Outcome Treatment
    1