BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3225077 · Received July 12, 2013

    Report

    Report Number
    2029046-2013-00087
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY, THE LOT NUMBER WAS REPORTED AS UNKNOWN_D-1313-04-S. PER THE BWI FAILURE ANALYSIS LAB, THE LOT NUMBER WAS RETRIEVED FROM THE EEPROM AS 15823521L. THEREFORE, THE LOT NUMBER WAS UPDATED FROM UNKNOWN_D-1313-04-S TO 15823521L. (B)(4). IT WAS REPORTED THAT DURING THE END OF THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND INTRACARDIAC ECHOCARDIOGRAPHY CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED AND WAS SENT TO OBSERVATION. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THAT HE WAS NOT SURE WHEN IT OCCURRED OR WHAT CAUSED IT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THE RF GENERATOR WAS SET TO POWER-CONTROL MODE. THE EVENT DID NOT OCCUR DURING ABLATION. POWER WAS TYPICALLY BETWEEN 30 AND 35 WATTS. THE TEMPERATURE CUT-OFF SETTING WAS 40 DEGREES. THE FLOW SETTING WAS SET TO 8 AND 15ML/MIN. IT WAS UNKNOWN WHICH SHEATH WAS USED. THE ANTICOAGULATION WAS SET BETWEEN 300-350. 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 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). COOLFLOW PUMP; MODEL #: M-5491-02; SERIAL #: (B)(4). LASSO NAV VARIABLE ECO CATHETER; MODEL #: D-1343-01-S; LOT #: UNKNOWN_D-1343-01-S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE END OF THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND INTRACARDIAC ECHOCARDIOGRAPHY CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED AND WAS SENT TO OBSERVATION. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION/TAMPONADE WAS THAT HE WAS NOT SURE WHEN IT OCCURRED OR WHAT CAUSED IT. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THE RF GENERATOR WAS SET TO POWER-CONTROL MODE. THE EVENT DID NOT OCCUR DURING ABLATION. POWER WAS TYPICALLY BETWEEN 30 AND 35 WATTS. THE TEMPERATURE CUT-OFF SETTING WAS 40 DEGREES. THE FLOW SETTING WAS SET TO 8 AND 15ML/MIN. IT WAS UNKNOWN WHICH SHEATH WAS USED. THE ANTICOAGULATION WAS SET BETWEEN 300-350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322263 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1313-04-S UNKNOWN_D-1313-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R