BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    MDR report key: 2073351 · Received May 1, 2011

    Report

    Report Number
    9673241-2011-00040
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K892265
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL FOLLOW-UP WITH THE FACILITY CONTACT INDICATED THAT THE PATIENT RECOVERED AND WAS RELEASED SUBSEQUENTLY. NO ADDITIONAL DETAILS REGARDING THE PATIENT WERE PROVIDED BY THE FACILITY. THEY ALSO INDICATED THAT THIS EVENT WAS NOT CAUSED BY ANY OF THE BWI PRODUCTS AS THESE OCCURRENCES ARE EXPECTED DURING SUCH PROCEDURES AND THERE IS NO SERVICE REQUIRED FOR THE EQUIPMENT INVOLVED IN THIS PROCEDURE. IF THE PRODUCT IS RETURNED TO BWI IN THE FUTURE, AN ANALYSIS WILL BE PERFORMED AND A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # M480001, SERIAL # (B)(4). STOCKERT 70 RF GENERATOR, CATALOG # S7001, SERIAL # (B)(4). COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, SERIAL # (B)(4). EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER, CATALOG # BNI75TCDFH, LOT # 15337178M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS VISUALIZED WITH ULTRASOUND NEAR THE RIGHT VENTRICLE. THE PATIENT'S BLOOD PRESSURE WAS STABILIZED WITH MEDICATION. NO PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WILL BE ADMITTED FOR OBSERVATION. THE CALLER STATED THAT THE PHYSICIAN BELIEVED IT MAY HAVE BEEN THE RESULT OF PLACEMENT OF A DIAGNOSTIC CATHETER IN THE RIGHT VENTRICULAR APEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID CATHETER, ELECTRODE RECORDING, OR PROBE ELECTRODE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1079-261-S 15172595

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R