BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3102324 · Received May 9, 2013

    Report

    Report Number
    9673241-2013-00147
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01 SERIAL # 11416; STOCKERT MODEL# M-5463-01, SERIAL # (B)(4); COOLFLOW PUMP MODEL# M-5491-02, SERIAL # (B)(4); SOUNDSTAR MODEL# M-5723-05, LOT # UNKNOWN; LASSO NAV VARIABLE ECO MODEL# D-1343-01-S, LOT # 15797590L. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED . THE DEVICE HISTORY RECORD 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR ANY CATHETER INSERTION IN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT HAD A PERICARDIAL EFFUSION. THE EFFUSION WAS FIRST SEEN WITH INTRACARDIAC ULTRASOUND. THE PHYSICIAN ELECTED TO CONTINUE THE PROCEDURE AND LEFT ATRIAL MAPPING WAS PERFORMED. THE EFFUSION WAS NOTED TO HAVE GOTTEN LARGER AND THE PROCEDURE WAS STOPPED. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202767 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15829126L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R