BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2132080 · Received June 16, 2011

    Report

    Report Number
    2029046-2011-00051
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN: NO RF ABLATION WAS PERFORMED. THE PERFORATION IN THE (B)(4) WAS PINPOINT AT THE TIME OF THE SURGERY AND DID NOT REQUIRE STITCHING. ADDITIONAL CAUSATION OF THIS EVENT: THERE WAS AN ATTEMPT AT ADDITIONAL RIJ CANNULATION DURING RESUSCITATION THAT SEEMED TO RESULT IN AN SVC TEAR. NO POST MORTEM WAS PERFORMED IN THIS CASE. NO MALFUNCTION OF THE (B)(4) PRODUCTS USED IN PROCEDURE WAS NOTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS DISCARDED IN THE OPERATING ROOM AND WILL NOT BE RETURNED FOR ANALYSIS. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01; SERIAL #: (B)(4). COOL FLOW IRRIGATION PUMP; MODEL #: M-5491-02. SERIAL #: UNK. STOCKERT RF GENERATOR: MODEL #: M-5463-01; SERIAL #: (B)(4). LASSO 2515 NAV VARIABLE CATHETER (PRODUCT DISCARDED. NOT RETURNED FOR ANALYSIS): MODEL #: D-1290-01-S; LOT #.: UNKNOWN. THE CUSTOMER WAS CONTACTED BY BIOSENSE WEBSTER FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS EVENT WAS NOT CAUSED BY BWI EQUIPMENT AND SERVICE WILL NOT BE REQUIRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE MAPPING PHASE OF AN A-FIB PROCEDURE, AN INJURY OCCURRED TO THE PATIENT THAT WITH FURTHER MEDICAL INTERVENTION RESULTED IN THE PATIENT'S DEATH. THE CASE BEGAN WITH THE PHYSICIAN INSERTING A THERMOCOOL CATHETER AND CREATED A FAM MAP FOR APPROXIMATELY 10 MINUTES. THE PHYSICIAN WAS BELIEVED TO BE IN THE LSPV AND ACCIDENTALLY PERFORATED THE LEFT ATRIAL APPENDAGE. THE ANESTHESIOLOGIST NOTED A DROP IN BLOOD PRESSURE AND NOTIFIED THE EP LAB TEAM THE PROBLEM. THE PHYSICIAN ATTEMPTED A PERICARDIOCENTESIS, BUT DID NOT YIELD MUCH FLUID/BLOOD RETURN. IT WAS BELIEVED THAT THE PERICARDIOCENTESIS WAS NOT PERFORMED IN THE CORRECT LOCATION. THE SECOND PERICARDIOCENTESIS WAS PERFORMED BY ANOTHER PHYSICIAN, RESULTING IN SUBSTANTIAL BLOOD RETURN. THE PATIENT'S STATUS CONTINUED TO DECLINE. AFTER RUSHING THE PATIENT TO OR WITH CATHETERS STILL IN PLACE AND UPON VISUAL INSPECTION, A LACERATION TO THE RIGHT VENTRICLE WAS NOTED. IT WAS NOTED AT THAT TIME THAT THE SECOND PERICARDIOCENTESIS RESULTED IN PUNCTURE OF THE RIGHT VENTRICLE WITH SUBSEQUENT EXSANGUINATION. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE PHYSICIAN FURTHER INDICATED THIS ISSUE WAS NOT CAUSED BY BWI EQUIPMENT AND SERVICE WILL NOT BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV 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 65 YR Death| O