BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE

    MDR report key: 3171244 · Received June 14, 2013

    Report

    Report Number
    2029046-2013-00072
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DYB
    PMA / PMN Number
    K982740
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: FG-5400-00M, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4). COOL FLOW PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4). CORONARY SINUS CATHETER: MODEL #: UNK, LOT#: UNK. SOUNDSTAR CATHETER: MODEL #: M-5723-05, LOT#: UNK. LASSO CATHETER: MODEL #: D-1343-01-S, LOT#: 15485592A. EZ STEER THERMOCOOL SF CATHETER: MODEL #: D-1313-05-S, LOT#: 15556649L. THIS EVENT IS ALSO REPORTED UNDER THIS PRODUCT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. IT WAS STATED BY THE CUSTOMER THAT THE PRODUCT HAD BEEN DISCARDED. THUS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES (B)(4).

    Description of Event or Problem · 1

    DURING AN AFIB ¿ PAROXYSMAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING ABLATION. A BLOOD PRESSURE DROP WAS NOTICED WHILE ABLATING THE RIGHT-SIDED PULMONARY VEINS AND THE EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHO. THE ABLATION WAS ABORTED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT BLOOD PRESSURE WAS STABLE AND WAS TRANSFERRED TO INTENSIVE-CARE UNIT. THE PHYSICIAN BELIEVED THAT THE PERFORATION RESULTING IN EFFUSION OCCURRED DURING THE TRANSSEPTAL PORTION OF THE PROCEDURE. THIS EVENT IS ALSO REPORTED UNDER THE EZ STEER THERMOCOOL SF CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272165 PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER, INC (IRWINDALE) 301803M OEM_301803M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R