BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2212729 · Received August 16, 2011

    Report

    Report Number
    2029046-2011-00075
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFORMATION WAS RECEIVED FROM CUSTOMER (AFFILIATE): THE EVENT WAS NOT LIFE THREATENING. MD USED 2 ST JUDE AGLLIS HEATHS AND A ST JUDE TRANSSEPTAL NEEDLE, AND SOUNDSTAR TO PERFORM THE TRANSSEPTAL PROCEDURE. TOWARDS THE END OF THE CASE HE SAW A PERICARDIAL EFFUSION BY USING THE SOUNDSTAR CATHETER (ICE). HE THEN DID A PERICARDIOCENTESIS PROCEDURE ON THE PATIENT, AND REMOVED 450 CC OF FLUID. THE CASE WAS COMPLETED. THE EVENT REQUIRED HOSPITALIZATION FOR 2 DAYS. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PROGNOSIS FOR THE PATIENT IS EXCELLENT. THE CAUSALITY OF ADVERSE EVENT WAS PROCEDURE RELATED AND MD WASN'T SURE WHAT CAUSED THE CARDIAC EFFUSION. THE CONCOMITANT DEVICES: CARTO 3 SYSTEM, US CATALOG #: FG540000, (B)(4). STOCKERT 70 SYSTEM, US CATALOG #: S7001, (B)(4). COOL FLOW PUMP, US CATALOG #: CFP002, (B)(4). SOUNDSTAR, US CATALOG #: SNDSTR10, LOT # S1046082. C3 NAV VARIABLE LASSO, US CATALOG #: LN222515CT, LOT # 15409182L. C3 EZ STEER CS WITH AUTO ID, US CATALOG #: BD710DF282CT, LOT # UNKNOWN (REPROCESSED). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER WAS EVALUATED AND IT PASSED ALL DEFLECTION TESTS, PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. VISUALLY THE CATHETER IS IN GOOD CONDITION. THE DEVICE HISTORY RECORD WAS REVIEWED, IT WAS IDENTIFIED THAT ONE PIECE WAS SCRAPED; HOWEVER DHR SHOWS THE PIECE WAS IDENTIFIED DURING THE PROCESS PRIOR THE FINAL INSPECTION STAGE AND DOCUMENTATION SHOWS THE SCRAP OF THIS PIECE EXISTS. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE THE PATIENT SUFFERED A PERICARDIAL EFFUSION. DOCTORS PERFORMED A PERICARDIOCENTESIS, 250 CC OF BLOOD WERE DRAWN OUT. THE PATIENT IS STATED TO BE IN STABLE CONDITION BUT WILL REMAIN IN THE HOSPITAL FOR TWO DAYS. THERE WAS NO KNOWN MALFUNCTION WITH ANY BWI EQUIPMENT. THE FOLLOWING ITEMS WERE IN USE: CARTO3, STOCKERT LOANER, COOL FLOW PUMP AND CATHETERS.

    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 57 YR Hospitalization| O| R