BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3024170 · Received March 27, 2013

    Report

    Report Number
    9673241-2013-00095
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT WHILE PERFORMING AN IDIOPATHIC VENTRICULAR TACHYCARDIA - RIGHT (R-IDVT) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE PATIENT'S BLOOD PRESSURE WAS LOW, 90MMHG SYSTOLIC, EVEN BEFORE THE CASE STARTED. VASOPRESSOR AGENTS WERE GIVEN TO RAISE IT TO 150MMHG SYSTOLIC AND THE CASE PROCEEDED. THE CASE WAS COMPLETED, A TRANSTHORACIC ECHO WAS THEN PERFORMED REVEALING THE PERICARDIAL EFFUSION. THE PHYSICIAN STATED THERE WAS ONE ABLATION THAT A SIGNIFICANT IMPEDANCE JUMP WAS NOTED. A PERICARDIOCENTESIS WAS IN PROGRESS AND THE PATIENT WAS FAIRLY STABLE. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THERE WERE ABOUT 15 ABLATIONS PRIOR TO THE EVENT. THE RF GENERATOR WAS SET TO "POWER CONTROL" MODE AT 35 WATTS. THE FLOW SETTING WAS 15ML/MIN. A LONG SHEATH WAS NOT USED. THE PATIENT DID NOT USE ANY ANTICOAGULATION DURING THE PROCEDURE. THE PATIENTS UPDATED HEALTH STATUS WAS RECOVERED AND DISCHARGED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY THE CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. 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 CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #: (B)(4). WEBSTER CS WITH AUTO ID, MODEL #: D-1353-04-S, LOT #: UNKNOWN_D-1353-04-S. COOLFLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). REPROCESSED - BWI - QUAD CATHETERS - QUANTITY 2 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN IDIOPATHIC VENTRICULAR TACHYCARDIA - RIGHT (R-IDVT) PROCEDURE, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THE PATIENT'S BLOOD PRESSURE WAS LOW, 90MMHG SYSTOLIC, EVEN BEFORE THE CASE STARTED. VASOPRESSOR AGENTS WERE GIVEN TO RAISE IT TO 150MMHG SYSTOLIC AND THE CASE PROCEEDED. THE CASE WAS COMPLETED, A TRANSTHORACIC ECHO WAS THEN PERFORMED REVEALING THE PERICARDIAL EFFUSION. THE PHYSICIAN STATED THERE WAS ONE ABLATION THAT A SIGNIFICANT IMPEDANCE JUMP WAS NOTED. A PERICARDIOCENTESIS IS NOW IN PROGRESS AND THE PATIENT IS FAIRLY STABLE. AFTERWARD, THE PATIENT WILL BE TRANSFERRED TO THE CICU. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THERE WERE ABOUT 15 ABLATIONS PRIOR TO THE EVENT. THE RF GENERATOR WAS SET TO "POWER CONTROL" MODE AT 35 WATTS. THE FLOW SETTING WAS 15ML/MIN. A LONG SHEATH WAS NOT USED. THE PATIENT DID NOT USE ANY ANTICOAGULATION DURING THE PROCEDURE. THE PATIENTS UPDATED HEATH STATUS IS RECOVERED AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126901 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15765340L

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R