BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER? NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3955108 · Received July 24, 2014

    Report

    Report Number
    2029046-2014-00208
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S12
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. DEVICE HISTORY REPORT (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCT: CARTO 3 SYSTEM; MODEL #:M-4800-01; SERIAL #: (B)(4). STOCKERT GENERATOR; MODEL #: UNKNOWN; SERIAL #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6) MALE, UNDERWENT A IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH AN EZ STEER NAVIGATIONAL 4MM CATHETER, WHICH SUFFERED A HEART BLOCK AV THIRD DEGREE. THE PATIENT¿S BASELINE BEFORE THE PROCEDURE WAS CONDUCTION DISEASE (BUNDLEBRANCH PLUS BLOCK). AFTER ABLATING THE PATIENTS¿ FASCICULAR VT, THE PATIENT WAS IN COMPLETE HEART BLOCK. PACING WAS NOT NEEDED. THE PROGNOSIS FOR THE PATIENT WAS THAT HE MIGHT REQUIRE A PACEMAKER. THE PATIENT POSSIBLY REQUIRED HOSPITALIZATION. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434025 EZ STEER? NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1268-05-S UNKNOWN_D-1268-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization