BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSER CTO RECANALIZATION CATHETER

    MDR report key: 2211286 · Received August 3, 2011

    Report

    Report Number
    2020394-2011-00177
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    May 17, 2011
    Report Date
    July 22, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091119
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY UNDERWAY. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS UNDERWAY. NOTE: THIS IS THE SAME EVENT AND SAME PATIENT AS MANUFACTURER REPORT NUMBERS 2020349-2011-00170 AND 2020349-2011-00176.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND A LEFT THIGH HEMATOMA ONE HOUR AFTER COMPLETION OF A CTO RECANALIZATION PROCEDURE IN THE LEFT SFA. VESSEL PERFORATION WITH EXTRAVASATION WAS IDENTIFIED, INTERVENTION WAS PERFORMED AND TREATMENT CONSISTED OF ANGIOPLASTY AND PLACEMENT OF THREE STENT GRAFTS IN THE SFA. POST INTERVENTION, THE PATIENT REQUIRED A BLOOD TRANSFUSION. MULTIPLE INTERVENTIONAL DEVICES WERE USED DURING THE INITIAL PROCEDURE AND IT IS UNKNOWN WHICH DEVICE CAUSED THE PERFORATION. THERE WAS NO REPORTED MALFUNCTION OF THE CTO DEVICE. THE PATIENT WAS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSER CTO RECANALIZATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. FCVA10027

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention ASPIRIN| INSULIN ASPART| CLOPIDOGREL| GLIMEPIRIDE