BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITESEER-5F BRACHIAL 4.5 NGD DX CATHETER

    MDR report key: 1547409 · Received November 13, 2009

    Report

    Report Number
    1220452-2009-00053
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    October 13, 2009
    Report Date
    November 9, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQO
    PMA / PMN Number
    K932092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE SUBJECT DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVAL. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CANNOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. DEVICE DISCARDED-NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE PT'S VESSEL SPASM WHILE THE DIAGNOSTIC CATHETER WAS IN PLACE. THE PHYSICIAN INSERTED A DIAGNOSTIC CATHETER USING A RADIAL APPROACH. WHILE THE DIAGNOSTIC CATHETER WAS IN PLACE, THE PT SUFFERED VESSEL SPASMS. THE PHYSICIAN CONTINUED THE CASE WITHOUT ANY INCIDENT. POST PROCEDURE, THE PT RETURNED TO THE HOSPITAL HAVING COMPLICATIONS FROM THE PROCEDURE PERFORMED ON (B) (6) 2009. A THROMBUS WAS REPORTED IN THE AREA OF THE PT'S VESSEL SPASMS. THE PT WAS TREATED WITH BLOOD THINNING MEDICATIONS. THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITESEER-5F BRACHIAL 4.5 NGD DX CATHETER DQO MEDTRONIC, INC. NA 20064644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA