BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF UNI-DIRECTIONAL CATHETER

    MDR report key: 3977363 · Received August 4, 2014

    Report

    Report Number
    2029046-2014-00222
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A NOTIFICATION HAS BEEN SENT TO THE MANUFACTURER'S OF THE INVOLVED PRODUCTS THAT ARE NOT BWI (ST. JUDE MEDICAL AND BARD MEDICAL DIVISION). CONCOMITANT BWI PRODUCTS: PRODUCT: STOCKERT 70 RF GENERATOR, US CATALOG # S7001, SERIAL # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6)., MALE, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF UNI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. AT THE END OF THE PROCEDURE, THE PATIENT¿S PRESSURE DROPPED FROM 130 TO 70. A PERICARDIOCENTESIS (TWICE) WAS PERFORMED EXTRACTING 1200 ML OF FLUID. THE PATIENT DID REQUIRE SURGICAL INTERVENTION AND HOSPITALIZATION. THE PATIENT OUTCOME WAS IMPROVEMENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS POSSIBLE PROCEDURE RELATED. THE SETTINGS DURING THE EVENT INCLUDE: POWER CONTROL SET TO 25 WATTS, THE TEMPERATURE CUT OFF WAS AT 40 DEGREE, IRRIGATION FLOW WAS SET AT 2ML FOR MAPPING AND 8ML DURING ABLATION, NON-BWI SHEATH (AGILIS SHEAT & SL0) AND NON-BWI CATHETER (OPTIMA CIRCULAR) WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452905 THERMOCOOL® SF UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1316-03-S UNK_D-1316-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R