BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3010425 · Received March 19, 2013

    Report

    Report Number
    2029046-2013-00033
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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). MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN IDIOPATHIC VT ABLATION, APPROXIMATELY 3-4 HOURS INTO THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL WINDOW WAS NEEDED IN SURGERY. THE CATHETER WAS DISPOSED OF. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114846 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1317-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R