BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3010448 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00075
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: STOCKERT MODEL# M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP MODEL# M-5491-02, SERIAL # (B)(4). WEBSTER 10 POLE W/ AUTO MODEL# D-1079-258-S, LOT# 15116481. LASSO NAV VARIABLE ECO MODEL# D-1343-01-S, LOT# 15770986L. CARTO 3 MODEL# M-4800-01, SERIAL # (B)(4). MANUFACTURER REF # (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF # (B)(4). IT WAS REPORTED THAT DURING THE AFIB PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ICE CONFIRMED A SMALL PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO ICU FOR OBSERVATION. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. ALSO A DEFLECTION TEST AND AN IRRIGATION TEST WERE PERFORMED AND THE CATHETER PASSED ALL TESTS. 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. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE AFIB PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED AND ICE CONFIRMED A SMALL PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TAKEN TO ICU FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113888 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1313-02-S 15782677L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R