BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3010420 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00074
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S12
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CONCOMITANT PRODUCTS: STOCKERT MODEL# M-5463-01, SERIAL # (B)(4). CARTO 3 MODEL# M-4800-01, SERIAL # (B)(4). MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

    IN WAS REPORTED THAT DURING AVRT/WPW PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND A STAT ECHO CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO THE ICU. IT WAS NOTED THAT THE PHYSICIAN DID NOT USE ULTRASOUND DURING THE TRANSSEPTAL BUT USED FLUORO. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114070 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1268-05-S 15596232M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R