BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3010637 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00077
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 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 Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL # M-4800-01, SERIAL # (B)(4). STOCKERT MODEL # M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP MODEL # M-5491-02, SERIAL # (B)(4). LASSO VARIABLE MODEL # UNKNOWN, LOT # UNKNOWN (DISPOSED OF). MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT THE LEFT HEART BORDER WAS NOT MOVING. THE ANESTHESIOLOGIST CONFIRMED THAT THE PATIENT'S BLOOD PRESSURE HAD DROPPED. ICE CONFIRMED A PERICARDIAL EFFUSION. A TAMPONADE FOLLOWED THE EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS TRANSFERRED TO CCU FOR OBSERVATION. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE EVENT WAS THAT IT PROBABLY HAPPENED DURING THE TRANSSEPTAL PUNCTURE AND PATIENT HAD A VERY THICK SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113749 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-00 UNKNOWN_TCOOL SF C3

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R