BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3200205 · Received July 1, 2013

    Report

    Report Number
    2029046-2013-00083
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: LASSO: MODEL# D-1220-38-S, LOT# 15254755L,C3 NAV VARIABLE LASSO: MODEL# D-1290-02-S, LOT#UNKNOWN,CARTO 3: MODEL# FG-5400-00J, SERIAL # (B)(4).(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB), AFTER ABLATION WAS PERFORMED USING THE NAVISTAR THERMOCOOL CATHETER, THE PATIENT BLOOD PRESSURE HAD DROPPED DOWN AND EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHIC. THE PROCEDURE WAS INTERRUPTED AND PERICARDIAL DRAINAGE WAS PERFORMED. ACCORDING TO THE PHYSICIAN, A CS CATHETER (NOT BWI PRODUCT) WAS INSERTED DEEPLY, IT WAS CAUSED PERFORATION. DURING THE PROCEDURE THERE WERE NO ANOMALIES ON BWI CATHETERS. ADDTIONAL INFORMATION REGARDING THE DETAILS OF THE EVENT HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299167 EZ STEER? THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1292-01-S UNKNOWN_D-1292-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R