BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS WEBSTER DECAPOLAR CATHETER

    MDR report key: 69922 · Received February 20, 1997

    Report

    Report Number
    2020638-1997-00001
    Event Type
    Injury
    Date Received
    February 20, 1997
    Date of Event
    November 6, 1996
    Report Date
    February 18, 1997
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CORONARY SINUS CATHETER WAS UTILIZED IN AN ABLATION CATHETERIZATION PROCEDURE FOR DYSRRHYTHMIA. DUE TO THE PTS ABNORMAL VENOUS ANATOMY THE CORONARY SINUS CATHETER ENTERED AND PERFORATED THE RIGHT VENTRICLE INSTEAD OF PASSING INTO THE CORONARY SINUS. AN ECHOCARDIOGRAM DETECTED PERICARDIAL EFFUSION AND THE PT REQUIRED SURGICAL DRAINAGE AND A SUTURE OF THE PERFORATION SITE. THE PT'S POSTOPERATIVE COURSE OF TREATMENT WAS REPORTED AS UNCOMPLICATED AND THE PT'S PROGNOSIS WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS WEBSTER DECAPOLAR CATHETER FIXED CURVE DECAPOLAR 7 FRENCH CATHETER LPB CORDIS WEBSTER, INC. NA 607125

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention