BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3070883 · Received April 22, 2013

    Report

    Report Number
    9673241-2013-00120
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    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

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. 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. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: FG-5400-00J, SERIAL #: (B)(4). C3 NAV VARIABLE LASSO, MODEL #: D-1290-01-S, LOT #15740115L. NON BWI - CORONARY SINUS CATHETER (BY JLL). MANUFACTURER'S REF. NO.: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN ATRIAL FIBRILLATION (AFIB) - PERSISTENT PROCEDURE, A NON-BWI CORONARY SINUS CATHETER MADE BY JLL WAS PLACED INSIDE THE RIGHT ATRIUM. BROCKENBROUGH WAS CONDUCTED OBSERVED BY ULTRASOUND FINDINGS. THEN PULMONARY VEIN ISOLATION (PVI) OF BOTH SIDES WERE CONDUCTED. AFTER COMPLETION OF BOTH PVI AND DURING CREATING A BLOCK LINE OF CTI, AN AFIB OCCURRED. THE PHYSICIAN DELIVERED ABLATION TARGETING CFAE (COMPLEX FRACTIONATED ATRIAL ELECTROGRAM) FROM RIGHT ATRIUM, CORONARY SINUS, AND THE LEFT ATRIUM. BUT DURING ABLATION AT THE LEFT ATRIUM, THE BLOOD PRESSURE REDUCTION WAS OBSERVED. A TAMPONADE WAS CONFIRMED BY ULTRASOUND FINDINGS. THE PATIENT'S CONDITION AND BLOOD PRESSURE RECOVERED AFTER DRAINAGE, AND THE PROCEDURE WAS CONCLUDED. UPON REQUEST FROM THE BWI FIELD REPRESENTATIVE, NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172105 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15783189L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R