BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2112191 · Received June 2, 2011

    Report

    Report Number
    9673241-2011-00057
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY INDICATED THAT THE PATIENT INJURY HAD NOTHING TO DO WITH ANY BWI PRODUCTS AND NO SERVICE IS REQUESTED AT THIS TIME. THE DISPOSABLE PRODUCTS HAVE BEEN DISCARDED. NO ADDITIONAL INFORMATION ABOUT THE PATIENT OR THE PROCEDURE HAS BEEN PROVIDED BY THE FACILITY. IF THE FACILITY REQUESTS SERVICE, RETURNS THE PRODUCTS, OR PROVIDES MORE INFORMATION, A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED. BWI CONCOMITANT PRODUCTS: CARTO XP SYSTEM, CATALOG # M470001, (B)(4); STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4); COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, (B)(4); WEBSTER ELECTROPHYSIOLOGY CATHETER, CATALOG # F6QA005RT, LOT # 15340332M; WEBSTER ELECTROPHYSIOLOGY CATHETER, CATALOG # D610DRP10RT, LOT # 15341422M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IDIOPATHIC VT PROCEDURE THE PATIENT SUFFERED PERICARDIAL EFFUSION AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THERE WAS NO INDICATION THAT ANY BWI EQUIPMENT WAS AT FAULT DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15323030M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R