BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3163485 · Received June 11, 2013

    Report

    Report Number
    9673241-2013-00190
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 6, 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
    PA, US
    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 #: UNK; COOL FLOW PUMP MODEL #: M-5491-02 SERIAL #: UNK; (B)(4).

    Description of Event or Problem · 1

    DURING AN IDIOPATHIC VT PROCEDURE, IT WAS REPORTED DURING ABLATION THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHY IDENTIFIED A PERICARDIAL EFFUSION AND PERICARDIOCENTESIS WAS PERFORMED. FLUID WAS REMOVED FROM THE PERICARDIAL SPACE AND THE PATIENT WAS STABILIZED. THE PATIENT WAS ADMITTED FOR OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THIS EVENT AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264726 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-05-S 15832232L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R