BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER THERMOCOOL NAVIGATIONAL BI-DIRECTIONAL CATHETER

    MDR report key: 2122148 · Received June 13, 2011

    Report

    Report Number
    2029046-2011-00047
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 15, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR INVESTIGATION. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER: MODEL #:D-1220-38-S; LOT # 15219882L. LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER: MODEL #:D-1220-39-S; LOT # 15254782L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PVI PROCEDURE THE PATIENT'S BLOOD PRESSURE DECREASED. A PERICARDIAL EFFUSION WAS OBSERVED WHILE MERGING WAS PERFORMED NOTED BY ECHOCARDIOGRAPH. AFTER DRAINAGE WAS PERFORMED THE BLOOD PRESSURE RETURNED TO NORMAL CONDITION. THE PHYSICIAN COMMENTED THE EVENT MIGHT HAVE OCCURRED WHILE THE CATHETER INSERTION TO THE AURICLE DURING ACCESS TO LIPV. THE PATIENT'S CONDITION HAD IMPROVED. PROGNOSIS WAS SATISFACTORY. THE PHYSICIAN ALSO CONSIDERED THAT THERE WAS NO CAUSALITY BETWEEN THE EVENT AND THE PRODUCTS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER THERMOCOOL NAVIGATIONAL BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1292-05-S UNKNOWN_D-1292-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R