BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II

    MDR report key: 513764 · Received March 1, 2004

    Report

    Report Number
    2939222-2004-00008
    Event Type
    Injury
    Date Received
    March 1, 2004
    Date of Event
    January 28, 2004
    Report Date
    January 30, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A WPW ABALTION, THE PT'S SYSTOLIC BLOOD PRESSURE DECREASED FROM 170 TO 140 TO 90 TO THE 70'S. AN EFFUSION WAS DOCUMENTED BY A 2-D ECHOCARDIOGRAM. THERE WERE TWO PERICARDIAL TAPS (PERICARDIALCENTESIS). THE FIRST TAP WITHDREW 15CC OF FLUID BUT THE GUIDEWIRE USED WAS TOO SHORT TO ADVANCE AN INDEWLLING CATHETER. THEREFORE, A SECOND PERICARDIALCENTESIS WAS PERFORMED THAT ULTIMATELY WITHDREW 100 CC OF FLUID. A LONGER GUIDEWIRE WAS USED AND AN INDEWLLING CATHETER WAS INSERTED FOR DRAINAGE. THERE WAS NO FLUOROSCOPIC CONFIRMATION ON THE SUSPECT DEVICE THAT CREATED THE PERFORATION; HOWEVER, IT IS THE PHYSICIAN'S OPINION THAT THE ABLATION CATHETER WAS THE CAUSE OF THE PERFORATION. THE ABLATION SITE FOR THE CONCEALED BYPASS TRACT WAS NEAR THE CORONARY SINUS OS. THE PT WAS TRANSFERRED FROM THE EP LAB TO ICU FOR OBSERVATION POST PERICARDIALCENTESIS. TRANSFERRED TO THE TELEMETRY UNIT. DISCHARGED FROM THE HOSP TO HOME TWO DAYS LATER WITH NO APPARENT CLINICAL SEQUELAE FROM TAMPONADE. REPORTED ADMITTED TO ANOTHER FACILITY 3 DAYS LATER FOR DVT. PLAN FOR CONTINUED HOSPITALIZATION UNTIL THE FOLLOWING WEEKEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II THERAPEUTIC ABLATION CATHETER LPB EP TECHNOLOGIES, INC. 5086TN4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R DIAGNOSTIC CATHETER (OTHER MFR, (UNK), 2004.