BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3519744 · Received December 13, 2013

    Report

    Report Number
    9673241-2013-00443
    Event Type
    Injury
    Date Received
    December 13, 2013
    Date of Event
    December 10, 2013
    Report Date
    December 11, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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). PENTARAY NAV CATHETER; MODEL #: D128204; LOT #: 15836396L. WEBSTER CS CATHETER; MODEL #: D135303; LOT #: 15759439MA. MOBICATH SHEATH MODEL #: D140011 LOT #: W2566667. (B)(4).

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE PHYSICIAN NOTICED A SLIGHT PATIENT BLOOD PRESSURE DROP AND CONFIRMED THE EFFUSION ON INTRACARDIAC ECHO. THE ABLATION PROCEDURE WAS ABORTED AND A PERICARDIOCENTESIS WAS IMMEDIATELY PERFORMED. THE PATIENT'S BLOOD PRESSURE WAS STABILIZED AND PATIENT WAS TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652677 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 15919363L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R