BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3512506 · Received December 10, 2013

    Report

    Report Number
    2029046-2013-00196
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    November 21, 2013
    Report Date
    November 22, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    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 AS PER THE REPORTED EVENT, BWI HAS NOTIFIED SIEMENS AG AND MEDICAL SERVICE GMBH THROUGH A MAIL NOTIFICATION IN REGARDS OF EACH OF THEIR INVOLVED PRODUCTS IN THIS EVENT. C) CONCOMITANT BWI PRODUCTS: JJKK CARTO 3 SYSTEM: US CATALOG # FG540000J, SERIAL # UNKNOWN. SOUNDSTAR CATHETER: US CATALOG # M-5723-00, LOT # UNKNOWN. LASSO NAV ECO: US CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE LOT # 15972353L 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. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    AN ATRIAL FIBRILLATION PROCEDURE WAS PERFORMED, CARTO 3 AND A COMPETITOR'S ULTRASOUND MACHINE (X300PE) WERE PREPARED WITHOUT A PROBLEM AND THE COMMUNICATION WAS ESTABLISHED NORMALLY. SOUNDSTAR WAS USED AS USUAL FOR MERGE. THE LASSO NAV ECO CATHETER WAS PLACED IN LEFT SUPERIOR PULMONARY VEIN (LSPV) AND A COMPETITOR¿S CATHETER (LIBERO) WAS PLACED IN LEFT INFERIOR PULMONARY VEIN (LIPV). LPV ISOLATION WAS SUCCESSFULLY COMPLETED. THEN THE LASSO NAV ECO CATHETER WAS PLACED IN RIGHT SUPERIOR PULMONARY VENTRICLE (RSPV) AND A COMPETITOR¿S CATHETER (LIBERO) WAS PLACED IN RIGHT INFERIOR PULMONARY VENTRICLE (RIPV). RPV ISOLATION WAS ALSO SUCCESSFULLY COMPLETED. ROOF LINE WAS CREATED AND THE ABLATION WAS DELIVERED TO MA ISTHMUS AND CORONARY SINUS. BLOCK LINE WAS ALSO CREATED AT TV-IVC ISTHMUS. THE END OF THE PROCEDURE, THE SLIGHT EFFUSION WAS CONFIRMED WHEN CHECKING LV BY THE SOUNDSTAR CATHETER. THE BLOOD PRESSURE REDUCTION WAS NOT CONFIRMED. THE PHYSICIAN INFUSED PROTAMINE 3 CC AND OBSERVED FOR 30 MINUTES. AFTER THAT WHEN CHECKING THE LV BY THE SOUNDSTAR CATHETER, THE INCREASED OF THE EFFUSION WAS NOT OBSERVED. THE BLOOD PRESSURE AND BEAT WERE STABLE, SO THE PROCEDURE WAS CONCLUDED. ON (B)(6), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT THE OUTCOME OF THIS ADVERSE EVENT WAS A FULL RECOVERY, THE PROGNOSIS FOR THE PATIENT IS STABLE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THIS EVENT IS UNCLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643020 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-01-S UNKNOWN_D-1317-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening