BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7F ES STEER DS BI-DIRECTIONAL NAV CATHETER

    MDR report key: 3070858 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00119
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE PRODUCT ANALYSIS IS COMPLETED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US, CATALOG #: FG540000, SERIAL #: (B)(4); STOCKERT 70 SYSTEM US, CATALOG #: S7001, SERIAL #: (B)(4); C3 EZ STEER CS WITH AUTO ID US, CATALOG #: BD710FJ282CT, LOT #: 15665834M; WEBSTER 4 POLE W/ AUTO ID US, CATALOG #: D1085413, LOT #: 15649216M; 2 WEBSTER 4 POLE US, CATALOG #: F5QA252RT, LOT #: 15775839M; ACUNAV 8FR. SIEMENS, US CATALOG #: 10135936, LOT #: UNKNOWN; MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN AVRT (ATRIOVENTRICULAR REENTRANT TACHYCARDIA) / WPW (WOLFF-PARKINSON-WHITE SYNDROME) THE PATIENT SUFFERED A PERICARDIAL EFFUSION THAT WAS CONFIRMED BY ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE PATIENT WAS REPORTED STABLE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. ALSO A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED ALL TESTS. THE CATHETER PASSED ALL SPECIFICATIONS. HOWEVER, THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. 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 IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AVRT (ATRIOVENTRICULAR REENTRANT TACHYCARDIA) / WPW (WOLFF-PARKINSON-WHITE SYNDROME) THE PATIENT SUFFERED A PERICARDIAL EFFUSION THAT WAS CONFIRMED BY ICE (INTRACARDIAC ECHOCARDIOGRAPHY). IT WAS NOTICED THAT THE STOCKERT IMPEDANCE WAS 230 OHMS AFTER 5 SECONDS OF ABLATING A LATERAL ACCESSORY PATHWAY IN THE LEFT ATRIUM. THEY REMOVED THE CATHETER FROM THE PATIENT; THERE WAS NO CHAR OR COAGULATION OBSERVED. AT THAT POINT THE PATIENT WAS DIAPHORETIC AND A DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTICED. THE PHYSICIAN WITHDREW THE CATHETER BACK INTO THE LEFT ATRIUM AND THE IMPEDANCE WAS STILL HIGH. THE PROCEDURE WAS ABORTED AND A PERICARDIOCENTESIS WAS IMMEDIATELY PERFORMED. THE PATIENT WAS REPORTED STABLE. THREE ATTEMPTS TO OBTAIN DETAILED INFORMATION REGARDING THE EVENT WERE PERFORMED WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172484 7F ES STEER DS BI-DIRECTIONAL NAV CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1268-04-S 15606999M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R