BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7336814 · Received March 13, 2018

    Report

    Report Number
    2029046-2018-01312
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 7, 2018
    Report Date
    February 14, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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) FOR THE LOT NUMBER 17743175L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCT: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #:(B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT, IN HIS MID-60S, UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CEREBROVASCULAR ACCIDENT (CVA) REQUIRING THROMBOLYTIC THERAPY. POST-PROCEDURE, THE PATIENT HAD DIFFICULTIES WAKING UP AND EXHIBITED SIGNS OF A STROKE. THROMBOLYTIC THERAPY WAS INITIATED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AND REMAINS HOSPITALIZED AS A RESULT OF THE ADVERSE EVENT FOR THROMBOLYTIC THERAPY. PATIENT OUTCOME IS IMPROVED. MEDICAL HISTORY INCLUDES SCARRING SECONDARY TO AMYLOIDOSIS AND A PREVIOUS CONFIRMED STROKE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION (HISTORY OF STROKE AND AMYLOIDOSIS) AND THE LIMITATIONS OF THE PROCEDURE (DIFFICULTIES ISOLATING PULMONARY VEINS, REQUIRING ADDITIONAL ABLATION). THERE WERE NO ISSUES OR ERRORS REPORTED WITH ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176173 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17743175L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R