BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3092023 · Received May 3, 2013

    Report

    Report Number
    9673241-2013-00143
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, AFTER THE FOURTH LESION, A STEAM POP OCCURRED, THE PATIENT BECAME BRADYCARDIC AND THE BLOOD PRESSURE DROPPED. ECHO CONFIRMED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO RECOVERY FOR OBSERVATION. 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, A COOL FLOW PUMP TEST WAS PERFORMED AS WELL AND THE CATHETER PASSED SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, 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 TAMPONADE 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

    THE CONCOMITANTS PRODUCTS: CARTO 3: MODEL# M-4800-01, SERIAL # (B)(4). TOCKERT: MODEL# M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP: MODEL# M-5491-02, SERIAL # (B)(4). LASSO NAV VARIABLE ECO: MODEL# D-1343-01-S, LOT # 15797582L. CUSTOMER DISPOSED OF PI1-D4UJK0, WEBSTER CS WITH AUTO ID: MODEL# D-1353-03-S, LOT # 15712965M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, AFTER THE FOURTH LESION, A STEAM POP OCCURRED, THE PATIENT BECAME BRADYCARDIC AND THE BLOOD PRESSURE DROPPED. ECHO CONFIRMED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO RECOVERY FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194168 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-04-S 15712888L

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R