BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2080231 · Received May 6, 2011

    Report

    Report Number
    2029046-2011-00035
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED, THEREFORE NO EVALUATION WILL BE PERFORMED. BWI CONCOMITANT PRODUCTS: LASSO 2515 NAV VARIABLE CATHETER; US CAT NUM: LN122515CT; LOT NUMBER: UNKNOWN. MOBICATH, BI-DIRECTIONAL GUIDING SHEATH US CAT NUM: D140011; LOT NUMBER: R1701247; (PRODUCT NOT DISTRIBUTED IN THE US). OTHER CONCOMITANT PRODUCT: ST. JUDE MEDICAL'S SWATRZ SLO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, A PERICARDIAL EFFUSION WAS DISCOVERED WHEN THE PHYSICIAN REMOVED THE SHEATHS (MOBICATH, BI-DIRECTIONAL GUIDING SHEATH AND ST. JUDE MEDICAL'S SWATRZ SLO) FROM THE PATIENT'S BODY. PATIENT WAS STABLE AND FINE AFTER PERICARDIAL EFFUSION HAS BEEN DRAINED. PATIENT DID NOT REQUIRE HOSPITALIZATION AND HAS FULLY RECOVERED. PATIENT'S PROGNOSIS WAS EXCELLENT. THE PHYSICIAN STATED THAT THE INCIDENT WAS NOT PRODUCT-RELATED, BUT A MISLOCATED TRANSEPTAL PUNCTURE ON FOSSA OVALIS. FACILITY IS UNWILLING TO PROVIDE PATIENT INFORMATION.

    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) NAVISTAR THERMO TC UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R