BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVOY 6F GUIDING CATHETERS

    MDR report key: 1833003 · Received September 14, 2010

    Report

    Report Number
    9616099-2010-00679
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 25, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 15048364 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE RECEIVING INSPECTION RECORDS FOR THE EXTRUDED MATERIAL USED WERE REVIEWED, AND THIS LOT WAS DEEMED ACCEPTABLE. BASED ON THE LACK OF INFORMATION REGARDING THE REPORTED FRACTURE OF THE DEVICE AND WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE EVENT. WITH REVIEW OF THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY RELATED MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENVOY GUIDING CATHETER PRESENTED WITH FRACTURES MAKING THE PRODUCT UNSUITABLE FOR USE. THERE IS NO FURTHER INFORMATION AVAILABLE. THERE IS NO INFORMATION REGARDING THE LOCATION OR EXTENT OF THE FRACTURES OR WHEN AS RELATED TO PROCEDURAL USE IT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENVOY 6F GUIDING CATHETERS CES GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15048364

    Patients

    Seq Age Sex Outcome Treatment
    1