BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOGA-STAR DIAGNOSTIC CATHETER

    MDR report key: 1166339 · Received September 19, 2008

    Report

    Report Number
    2029046-2008-00030
    Event Type
    Injury
    Date Received
    September 19, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 25, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO BIOSENSE WEBSTER FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT SHORTLY AFTER THEY CROSSED THE VALVE WITH THE NOGASTAR CATHETER. THE CASE CONTINUED THROUGH TO COMPLETION AFTER THIS EVENT AND THERE WERE NO ADDITIONAL EVENTS. SUBSEQUENT INFO GATHERED FROM CUSTOMER INDICATES THAT A MODERATE MYOCARDIAL INFARCTION OCCURRED SEVERAL HOURS AFTER THE PROCEDURE. THE EVENT IS RELATED TO A NOGA ASSISTED STEM CELL INJECTION PROCEDURE IN THE CYTORI SPONSORED PRECISE STUDY IN ANOTHER COUNTRY. THE PROCEDURE WAS EXTENDED BY ABOUT 3 HOURS DUE TO SOME DIFFICULTY IN ADVANCING THE NOGASTAR MAPPING CATHETER THROUGH THE VALVE. THIS WAS DUE TO A NON-SYMPTOMATIC MALFORMATION OF THE AORTIC VALVE (STENOSIS OR FIBROSIS), WHICH WAS NOT VISIBLE IN ANY PRE-PROCEDURE IMAGING/DIAGNOSTIC PROCEDURES. ALSO POSSIBLE ENTRY INTO THE LEFT MAIN CORONARY ARTERY WITH THE PROBE DID NOT OCCUR. THE PROCEDURE COULD BE SUCCESSFULLY COMPLETED AFTER HAVING DONE 14 INJECTIONS IN THE DESIGNATED AREAS. THE EVENT PROLONGED HOSPITALIZATION. THE PT WAS TREATED WITH MEDICATION AND WAS DISCHARGED FROM THE HOSPITAL AFTER 3 DAYS. THE OUTCOME OF THE EVENT WAS DESCRIBED AS "RESOLVED WITHOUT SEQUELAE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOGA-STAR DIAGNOSTIC CATHETER NONE DRF BIOSENSE WEBSTER, INC. (IRWINDALE) NOGASTAR UNK_NOGAST

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L