BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 4686364 · Received April 13, 2015

    Report

    Report Number
    9673241-2015-00207
    Event Type
    Injury
    Date Received
    April 13, 2015
    Date of Event
    March 2, 2015
    Report Date
    March 31, 2015
    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)(6). BWI EQUIPMENT INVOLVED: CARTO3: SERIAL: (B)(4), STOCKERT: SERIAL: (B)(4), COOLFLOW PUMP: SERIAL: (B)(4), THERMOCOOL SF, F-CURVE CATHETER: CAT#: D131503, UNKNOWN LOT, CATHETER DISPOSED OF LASSONAV 10 POLE, 20MM CATHETER: CAT#: D134903, UNKNOWN LOT, CATHETER DISPOSED OF DUODECA CATHETER: CAT#: D728260RT, UNKNOWN LOT, CATHETER DISPOSED OF MANUFACTURER REF #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN AFIB ¿ PAROXYSMAL PROCEDURE ON (B)(6) 2015 WITH A THERMOCOOL SF NAV, IT WAS NOTICED THAT THE PATIENT SUFFERED CORONARY SINUS ESOPHAGUS FISTULA, WHICH REQUIRED AN ESOPHAGEAL STENT INSERTION. IT WAS STATED THAT THE PATIENT HAS ESOPHAGEAL FISTULA HISTORY PRIOR THIS EVENT. THE PATIENT WAS STABLE CONDITION AT THE TIME OF REPORTING THIS EVENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS COMBINATION OF BIOSENSE PRODUCT, PROCEDURE, AND PATIENT CONDITION, HOWEVER THERE IS NO DETAIL AVAILABLE. THERE WAS NO MALFUNCTION ON BWI PRODUCTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245965 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1315-03-S UNKNOWN_D-1315-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R