BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 9236743 · Received October 25, 2019

    Report

    Report Number
    2029046-2019-03813
    Event Type
    Death
    Date Received
    October 25, 2019
    Date of Event
    September 27, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009279
    PMA / PMN Number
    P030031/S034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. WE ARE WORKING ON THE MANUFACTURE RECORD EVALUATION (MRE), ONCE WE GET MORE INFORMATION IT WILL BE SUBMITTED IN THE SUPPLEMENTAL. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD PATIENT UNDERWENT AN ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) PROCEDURE WITH A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE AND DEATH. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK NEEDLE. ABLATION WAS PERFORMED BEFORE THE EFFUSION WAS DISCOVERED. PERICARDIOCENTESIS WAS PERFORMED. PATIENT SUFFERED OUTCOME OF DEATH LATER THAT EVENING. THE PHYSICIAN¿S OPINION IS THAT THE OUTCOME IS RELATED TO THE PATIENT CONDITION AND PROCEDURE. NO STEAM POP WAS REPORTED. NO ERROR MESSAGES ON AND BIOSENSE WEBSTER INC. (BWI) EQUIPMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031178 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835009279

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R ST. JUDE MEDICAL BRK NEEDLE