BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR DIAGNOSTIC/ ABLATION CATHETER

    MDR report key: 1893452 · Received November 8, 2010

    Report

    Report Number
    2029046-2010-00061
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: 1.CARTO 3 RMT SYSTEM; MODEL #: M-5830-01; (B)(4). 2. STOCKERT RF GENERATOR: MODEL #: M-5463-01; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PERFORMING AN ACCESSORY PATHWAY (WPW) ABLATION, THE PATIENT'S BLOOD PRESSURE HAD DROPPED. IT WAS DETERMINED THAT THE PATIENT HAD SUFFERED CARDIAC TAMPONADE. PERICARDIALCENTESIS WAS PERFORMED, HOWEVER IT WAS UNSUCCESSFUL. THEREFORE SURGERY WAS NEEDED. THE SURGEON PERFORMED 'PERICARDIAL WINDOW' SURGERY. PATIENT HAD RECOVERED. PROGNOSIS WAS EXCELLENT. ADVERSE EVENT WAS STATED TO BE PROCEDURE RELATED. THE COMPLICATION HAD BEEN RESOLVED; OUTCOME WAS GOOD. THE TRANSEPTAL PROCEDURE WAS PERFORMED USING AGILIS SHEATH AND EITHER A BRK OR BRK1 NEEDLE (ST. JUDE MEDICAL'S SHEATH AND NEEDLE). THERE WERE NO ERROR MESSAGES OR INDICATIONS THAT ANY OF THE BWI EQUIPMENT MALFUNCTIONED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR DIAGNOSTIC/ ABLATION CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1183-08-S UNKNOWN_D-1183-08-S

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| R