BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INTRODUCER, 7F 11CM

    MDR report key: 1982180 · Received January 18, 2011

    Report

    Report Number
    2953189-2011-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 26, 2010
    Report Date
    January 5, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(6) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A MICRO INTRODUCER SHEATH KIT. THE CUSTOMER REPORTS THAT ON (B)(6) 2010 THE PATIENT UNDERWENT A RADIO FREQUENCY ABLATION OF THE LEFT SAPHENOUS VEIN FOR TREATMENT OF VARICOSE VEINS. A MICRO INTRODUCER SET WAS USED WITHOUT APPARENT COMPLICATION. THE PATIENT STARTED HAVING LEFT GROIN PAIN ON (B)(6) 2010 AND WENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2010. X-RAY INDICATED A LINEAR FOREIGN BODY IN THE AREA OF PUBIC RAMUS. THE PATIENT HAD A 6 SECTION OF GUIDEWIRE SUCCESSFULLY REMOVED UNDER ULTRASOUND AND FLUOROSCOPY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO INTRODUCER, 7F 11CM MICRO INTRODUCER SHEATH KIT DYB COVIDIEN MIS-7F11 99760187

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention