BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5917508 · Received August 31, 2016

    Report

    Report Number
    9673241-2016-00536
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 5, 2016
    Report Date
    August 5, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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. CONCOMITANT PRODUCTS: SMART TOUCH BIDIRECTIONAL CATHETER, MODEL # D-1327-05-S, LOT # 17495484M, LASSO NAV ECO CATHETER, MODEL AND LOT NUMBERS UNKNOWN, ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE, MODEL AND LOT NUMBERS UNKNOWN, ST. JUDE MEDICAL SL1 SHEATH, MODEL AND LOT NUMBERS UNKNOWN. (B)(4). EVENT DESCRIPTION CONTINUATION: SPI VALUE IS UNKNOWN. SMARTTOUCH CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST-CONNECTION TO THE CARTO 3 PIU, POST-PERFORATION. THE CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. WITH THE EXCEPTION OF THE HIGH TEMPERATURE ISSUE WITH SMARTTOUCH # 1, THERE WERE NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER FAST ANATOMICAL MAPPING (FAM) OF THE LEFT ATRIUM, ABNORMALLY HIGH BLOOD POOL TEMPERATURES (46-47 DEGREES CELSIUS) DISPLAYED ON THE GENERATOR. CABLES WERE REPLACED WITHOUT RESOLUTION. SMARTTOUCH CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. IN ORDER TO AVOID AN EEPROM ERROR, THE STAFF HAD THE CABLE UNPLUGGED. THE PHYSICIAN WAS UNDER THE IMPRESSION THAT IT WAS PLUGGED INTO THE PIU AND EXPECTED TO VISUALIZE THE CATHETER ADVANCING INTO THE LEFT ATRIUM. WHEN THE STAFF PLUGGED THE CABLE INTO THE PIU AND THE NEW CATHETER LOADED, THE CATHETER WAS OUTSIDE OF THE FAM SHELL AND IN THE AREA OF THE LEFT ATRIAL APPENDAGE (LAA). AFTER ABLATING THE LEFT COMMON PULMONARY VEIN, THE PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 800CC. PATIENT WAS REPORTED TO BE IN STABLE CONDITION IN THE CORONARY CARE UNIT. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK-1 NEEDLE. SHEATH USED WAS A ST. JUDE MEDICAL SL1. GENERATOR PARAMETERS AND ABLATION TIMES WERE NOT PROVIDED, AS THE ADVERSE EVENT WAS REPORTEDLY NOT RELATED TO ABLATION. IRRIGATED CATHETER FLOW WAS NOT REPORTED. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIMES MAINTAINED BETWEEN 300-350 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569592 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17488597M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R