BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2750662 · Received September 19, 2012

    Report

    Report Number
    9673241-2012-00260
    Event Type
    Injury
    Date Received
    September 19, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, GENERATOR AND DEFLECTION TESTS. ALSO AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED. 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. SINCE THE CATHETER PASSED SPECIFICATIONS, THE ROOT CAUSE OF THE EFFUSION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3, MODEL # M-4800-01, SERIAL # (B)(4); STOCKERT, MODEL # M-5463-01, SERIAL #(B)(4); COOLFLOW PUMP, MODEL # M-5491-02, SERIAL # (B)(4); LASSO, MODEL # D-1220-39-S, LOT # UNKNOWN; WEBSTER 20 POLE, MODEL # D-1171-35-S, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIALCENTESIS. THE PHYSICIAN DROWNED OFF 500 CC FROM THE PERICARDIAL SPACE. THE PHYSICIAN DID NOT BELIEVE IT WAS CAUSED BY ANY OF THE BWI EQUIPMENT. HE BELIEVED THAT IT OCCURRED WHEN HE TRIED TO RE-CROSS THE SEPTUM. HE FELT THAT DURING THE TIME HE WAS ATTEMPTING TO GET BACK ACROSS TO THE LEFT ATRIUM THROUGH HIS ORIGINAL TRANSSEPTAL THAT THE PERFORATION HAPPENED THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-04-S 15570661L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R