BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF BI-DIRECTIONAL CATHETER

    MDR report key: 3036220 · Received April 4, 2013

    Report

    Report Number
    2029046-2013-00047
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REPORTED WAS A C3 EZ STEER THERMOCOOL SF NON-NAV CATHETER/ MODEL #: D-1314-04-S / LOT #: UNKNOWN_D-1314-04-S, BUT THE PRODUCT RECEIVED WAS DIFFERENT. RECEIVED WAS AN EZ STEER THERMOCOOL SF NAV CATHETER/ MODEL #: D-1317-04-S / LOT #: 15626283L. WE REQUESTED CLARIFICATION ON THIS DISCREPANCY AND THE BWI FIELD REPRESENTATIVE WAS ABLE TO CONFIRM ON (B)(4) 2013 THAT THE PRODUCT RECEIVED WAS THE CORRECT PRODUCT FOR THIS COMPLAINT. THIS EVENT WAS ALSO REPORTED UNDER THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER MANUFACTURER'S REF.(B)(4). (B)(4). IT WAS REPORTED THAT WHILE MAPPING DURING A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER AND C3 EZ STEER THERMOCOOL SF NON-NAVIGATIONAL CATHETER WERE IN THE LEFT ATRIUM. AFTER THE PHYSICIAN PERFORMED A DOUBLE TRANSSEPTAL PROCEDURE WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND FAST ANATOMICAL MAPPING (FAM) WAS IN PROGRESS, THE ANESTHESIOLOGIST NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE. THE ANESTHESIOLOGIST NOTIFIED THE PHYSICIAN OF THE DROP IN BLOOD PRESSURE AFTER ADMINISTERING NEOSYNEPHRINE. THE PHYSICIAN THEN CONFIRMED THE PERICARDIAL EFFUSION USING ICE. THE PROCEDURE WAS ABORTED. HEPARIN REVERSING AGENTS WERE GIVEN AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. ALSO THE DEFLECTION AND IRRIGATION TEST WERE PERFORMED AND THE CATHETER PASSED ALL TESTS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). COOLFLOW PUMP: MODEL #: M-5491-02, SERIAL #: UNKNOWN. DISTRIBUTED PRODUCT - ACUNAV: MODEL #: M-5723-09, LOT #: OEM_M-5723-09. STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4). LASSO NAVIGATIONAL VARIABLE ECO CATHETER: MODEL #: D-1343-01-S, LOT #: UNKNOWN_D-1343-01-S. NON BWI - SL1 SHEATH - QUANTITY 2. NON BWI - AGILIS SHEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE MAPPING DURING A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. AFTER THE PHYSICIAN PERFORMED A DOUBLE TRANSSEPTAL PROCEDURE WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND FAST ANATOMICAL MAPPING (FAM) WAS IN PROGRESS, THE ANESTHESIOLOGIST NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE. THE ANESTHESIOLOGIST NOTIFIED THE PHYSICIAN OF THE DROP IN BLOOD PRESSURE AFTER ADMINISTERING NEOSYNEPHRINE. THE PHYSICIAN THEN CONFIRMED THE PERICARDIAL EFFUSION USING ICE. THE PROCEDURE WAS ABORTED. HEPARIN REVERSING AGENTS WERE GIVEN AND A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE PHYSICIAN USED ICE, WHICH WAS SUPPORTED BY OUR ULTRASOUND BWI FIELD REPRESENTATIVE, TO PERFORM DOUBLE TRANSSEPTAL PUNCTURES. THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER AND C3 EZ STEER THERMOCOOL SF NON-NAVIGATIONAL CATHETER WERE IN THE LEFT ATRIUM AND THE PHYSICIAN WAS USING FAM TO MAKE THE GEOMETRY. THE ANESTHESIOLOGIST INFORMED THE PHYSICIAN THAT THE PATIENT'S BLOOD PRESSURE WAS LOW. THE PHYSICIAN ASKED HOW LOW AND ONCE MADE AWARE OF THE LEVEL ASKED IF THE ANESTHESIOLOGIST HAD GIVEN THE PATIENT ANYTHING. THE ANESTHESIOLOGIST TOLD THE PHYSICIAN HE HAD ALREADY GIVEN NEOSYNEPHRINE. THE PHYSICIAN USED ICE AND CONFIRMED THE PERICARDIAL EFFUSION. THE PHYSICIAN THEN PERFORMED A PERICARDIOCENTESIS, WHICH STABILIZED THE PATIENT'S BLOOD PRESSURE. THE PHYSICIAN ALSO ASKED THE STAFF TO ORDER THREE UNITS PACKED RBC'S. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETERS. RF ENERGY HAD NOT BEEN USED DURING THE PROCEDURE. THE RF GENERATOR WAS SET TO TEMPERATURE CONTROL MODE. THE COOL FLOW PUMP WAS RUNNING AT 2ML/MIN WHILE MAPPING. SHEATHS USED WERE TWO SL1 AND ONE AGILIS. THE AGILIS REPLACED ONE OF THE SL1 SHEATHS. THE ACT MAINTAINED DURING THE PROCEDURE WAS >350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137985 THERMOCOOL® SF BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1314-04-S UNKNOWN_D-1314-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R