BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID

    MDR report key: 1802988 · Received August 17, 2010

    Report

    Report Number
    9673241-2010-00062
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K090898
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATHETER PASSED CARTO 3 AND ELECTRICAL TESTS. NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR (DEVICE HISTORY RECORD) REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4) COOL FLOW IRRIGATION PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4) STOCKERT RF GENERATOR: MODEL #:M-5463-01, SERIAL #: (B)(4). THE PATIENT ADVERSE EVENT OCCURRED WHILE THE BIOSENSE WEBSTER FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR CASE SUPPORT. THE FSE SPOKE TO FELLOW PHYSICIAN WHO STATED THAT THE ADVERSE EVENT WAS NOT CAUSED BY ANY OF BWI EQUIPMENTS/ SYSTEMS. THEREFORE, THE PHYSICIAN DECLINED SYSTEM SERVICE. BIOSENSE WEBSTER MANUFACTURER'S REF NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: HI (GREATER THEN 600 MG/DL) AND 120 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ATRIAL TACHYCARDIA RIGHT SIDE PROCEDURE WAS COMPLETED AND ALL THE CATHETERS HAD BEEN RETRIEVED, A DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THE ULTRASOUND CONFIRMED THE OCCURRENCE OF PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED. THE STATUS OF THE PATIENT WAS STABLE, PATIENT WAS SENT TO RECOVERY AND TO ICU. NO PATIENT'S UPDATED STATUS HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1263-07-S 15120077

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention