BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2740883 · Received September 12, 2012

    Report

    Report Number
    2029046-2012-00125
    Event Type
    Injury
    Date Received
    September 12, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 27, 2012
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: LASSO: MODEL # D-1220-39-S, LOT # UNKNOWN. CARTO 3: MODEL # M-4800-01, SERIAL # (B)(4). COOLFLOW PUMP: MODEL # M-5491-02, SERIAL # (B)(4). STOCKERT: MODEL # M-5463-01, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITION. THE CATHETER WAS EVALUATED FOR DEFLECTION AND PATENCY FLOW CHARACTERISTICS, ALSO TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKER COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS.THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE COMPLAINT CONDITION CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN AFIB PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-17-S UNKNOWN_D-1197-17-S_IRW

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R