BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2250477 · Received September 15, 2011

    Report

    Report Number
    9673241-2011-00097
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 26, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FOLLOW-UP WITH THE CUSTOMER FACILITY, THE CUSTOMER FACILITY CONFIRMED THAT THEY DO NOT CONSIDER THE BWI EQUIPMENT OR PRODUCTS TO BE THE CAUSE OF THE PATIENT INCIDENT. CUSTOMER DECLINED TO HAVE THE BWI EQUIPMENT FUNCTIONAL TESTED. CUSTOMER WILL CONTINUE TO USE THE BWI EQUIPMENT. THE CUSTOMER FACILITY DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT, PRODUCT, OR THE PROCEDURE. IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE CUSTOMER FACILITY DURING THE COMPLAINT INVESTIGATION, A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT DEVICES: CARTO 3 SYSTEM, CATALOG # FG540000, (B)(4); STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4); COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, (B)(4); LASSO ELECTROPHYSIOLOGY CATHETER, CATALOG # D7L1012RT, LOT # 15176628. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED DURING AN AFIB ABLATION PROCEDURE AND ICE CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM WITH A DISSECTED ATRIAL APPENDAGE. THE PATIENT REMAINED IN THE HOSPITAL.

    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. (JUAREZ) D-1197-16-S 15393081M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R