BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 4112816 · Received September 24, 2014

    Report

    Report Number
    9673241-2014-00362
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI # (B)(4) THE FOLLOWING BWI DEVICES WERE IN USE: CARTO 3 (11233), STOCKERT (ST-3379), COOL FLOW PUMP (03484), DECANAV CATHETER (R7F282CT, 15956892M), WEBSTER CS CATHETER (D135303, 17034128M) AND A LASSO CATHETER (D134301, 16074879). (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4). IT WAS REPORTED THAT DURING A LEFT SIDED ATRIAL FLUTTER, A STEAM POP WAS NOTED IN THE RIGHT ATRIUM. CALLER REPORTED THAT A PERICARDIAL EFFUSION WAS ALSO NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY A TRANSTHORACIC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 225 ML OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. 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. THE CATHETER WAS ALSO EVALUATED FOR CARTO 3 AND COIL DISCONNECTION TESTER. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. THE SENSOR COILS RESISTANCE WAS FOUND WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SIDED ATRIAL FLUTTER PROCEDURE, A STEAM POP WAS NOTED IN THE RIGHT ATRIUM. THE CUSTOMER REPORTED THAT A PERICARDIAL EFFUSION WAS ALSO NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY A TRANSTHORACIC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 225 ML OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. MULTIPLE ATTEMPTS WERE DONE TO REQUEST FOR FURTHER DETAILS OF THIS EVENT. HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596097 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17019215M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R