BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6215567 · Received December 30, 2016

    Report

    Report Number
    9673241-2016-00922
    Event Type
    Death
    Date Received
    December 30, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 8, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL SF AND SUFFERED A CARDIAC TAMPONADE AND DECEASED. DURING THE ABLATION PHASE, A CARDIAC TAMPONADE WAS CONFIRMED ON THE ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS FOLLOW UP BY PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). AT A LATER DATE, OPEN CHEST SURGERY WAS PERFORMED AND CONFIRMED THE PERFORATION TOWARD THE LEFT ATRIAL APPENDAGE. AFTER THE OPEN CHEST SURGERY, THE PATIENT EXPIRED A WEEK LATER. THE CAUSE OF DEATH IS MULTIPLE ORGAN FAILURE DUE TO HEMOLYSIS OCCURRENCE DURING PCPS BEFORE THE THORACOTOMY. THE EXACT DATE OF DEATH IS UNKNOWN; HOWEVER IT IS BETWEEN (B)(6) 2016. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE CARDIAC TAMPONADE WAS PROCEDURE RELATED, IT WAS NOT RELATED TO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTION. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THE GENERATOR WAS IN POWER CONTROL MODE, HOWEVER OTHER SETTINGS ARE PERIMETERS ARE UNKNOWN. THE CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT. THERE WERE NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866518 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-01-S 17446178L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Death