BEUDAMED
    FDA Adverse Event Death Summary report: N

    THMCL SMTCH SF BID, TC, D-F

    MDR report key: 7062409 · Received November 27, 2017

    Report

    Report Number
    2029046-2017-01178
    Event Type
    Death
    Date Received
    November 27, 2017
    Date of Event
    November 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17701825L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: 1.NON BIOSENSE WEBSTER INC. - CRYOBALLOON ABLATION CATHETER; 2.CARTO 3 SYSTEM, US CATALOG #: M-4800-01, SERIAL #: (B)(4); 3. C3 EZ STEER CS WITH AUTO ID, US CATALOG #: BD710FJ282CT, LOT# 17722141M; 4. SOUNDSTAR CATHETER, US CATALOG #: 10439236, LOT#: G9047909. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A CRYOBALLOON ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BIDIRECTIONAL SF CATHETER AND SUFFERED A CARDIAC ARREST (REQUIRING FULL CODE PROTOCOL) AND DEATH. DURING THE PROCEDURE, THE PATIENT SUFFERED A CARDIAC ARREST. FULL CODE PROTOCOL EFFORTS WERE UNSUCCESSFUL. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS A REACTION TO ANESTHESIA. NO RADIOFREQUENCY ENERGY WAS APPLIED, AS THIS WAS A CRYOBALLOON ABLATION PROCEDURE. SINCE THIS ADVERSE EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841576 THMCL SMTCH SF BID, TC, D-F CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 17701825L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R