BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3821297 · Received May 20, 2014

    Report

    Report Number
    9673241-2014-00195
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 7, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISPOSED BY THE CUSTOMER. SINCE THE LOT # 16072533M WAS PROVIDED, THE DEVICE HISTORY RECORDS 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 BWI PRODUCTS: PRODUCT: LASSO NAV ECO CATHETER: US CATALOG # D134901, LOT # UNKNOWN. PRODUCT: LASSO NAV ECO CATHETER: US CATALOG # D134904, LOT # UNKNOWN. PRODUCT: CARTO 3 SYSTEM: US CATALOG # FG540000M, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN (PV) ISOLATION IN AN ATRIAL FIBRILLATION PROCEDURE, THE CONTACT FORCE VALUE BECAME OVER 70 G. AND DISPLAYED ¿HI¿ WHEN THE ABLATION WAS CONDUCTED FOR THE LEFT ROOF BY 30 WATTS FOR 30 SECONDS WITH AROUND 20 G. AFTER THAT, AS MOVING OF THE PATIENT¿S HEART GOT SLOW, THE PV ISOLATION WAS CONDUCTED WITH CHECKING THE EFFUSION BY THE ECHOCARDIOGRAPHIC AND ELECTROCARDIOGRAM AND X-RAY. THE BLOOD PRESSURE STARTED TO DROP WITH INCREASING THE AMOUNT OF THE EFFUSION, THEREFORE, THE DRAINAGE WAS CONDUCTED AND THE PROCEDURE WAS FINISHED. THE PATIENT STATUS IS UNKNOWN. THE PHYSICIAN COMMENTED THAT PUNCTURING OCCURRED AT THE MOMENT OF HIGH CONTACT FORCE VALUE (> 50 G.) OR WHEN THE ABLATION WAS CONDUCTED DUE TO THE FTI. ON (B)(6), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT THE OUTCOME OF THE PATIENT WAS A FULL RECOVERY. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THIS ADVERSE EVENT IS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300137 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R