BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR DEFLECTABLE TIP CATHETER

    MDR report key: 107020 · Received July 22, 1997

    Report

    Report Number
    2020638-1997-00005
    Event Type
    Injury
    Date Received
    July 22, 1997
    Date of Event
    June 17, 1997
    Report Date
    July 22, 1997
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LEFT VENTRICULAR NOGA MAP WAS PERFORMED WITH A DIAGNOSTIC NAVI-STAR DEFLECTABLE TIP CATHETER FOLLOWED BY TWO PTCA PROCEDURES TO THE LEFT ANTERIOR CORONARY AND TO THE CIRCUMFLEX CORONARY ARTERY. (THIS PROCEDURE WAS PERFORMED UNDER A PROTOCOL APPROVED BY ISRAEL'S MINISTRY OF HLTH). THE LENGTH OF TIME FOR THE MAPPING PROCEDURE WAS 2-5 MINS AND IT WAS UNEVENTFUL. THERE WAS NO EVIDENCE THAT THE NAVI-STAR CATHETER CAUSED THE EVENT. THE PTCA PROCEDURE WAS COMPLICATED AND LASTED 50 MINS. THIRTY MINS FOLLOWING THE PTCA PROCEDURE, A TAMPONADE WAS DIAGNOSED. EMERGENCY PERICARDIOCENTESIS WAS FOLLOWED BY AN OPEN SURGICAL DRAINAGE AND HEMOSTASIS. FOLLOWING SURGERY, THE PT SPENT THREE DAYS IN THE INTENSIVE POSTOPERATIVE UNIT AND WAS LATER TRANSFERRED TO THE WARD. THE PT WAS DISCHARGED SEVEN DAYS AFTER THE PROCEDURE AND THE PROGNOSIS WAS "VERY GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR DEFLECTABLE TIP CATHETER ELECTROPHYSIOLOGY CATHETER DRF CORDIS WEBSTER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R