BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY

    MDR report key: 8903891 · Received August 16, 2019

    Report

    Report Number
    2029046-2019-03555
    Event Type
    Death
    Date Received
    August 16, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 23, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002430
    PMA / PMN Number
    K090898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON WHICH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY WAS USED AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND DEATH. UPON PROCEDURE COMPLETION BEFORE THE CATHETERS WERE REMOVED, THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION, THIS WAS CONFIRMED BY ULTRASOUND. 4 HOURS POST-PROCEDURE WHILE THE PATIENT WAS IN THE RECOVERY ROOM, THERE WAS A DROP-IN BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED, AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. ULTRASOUND CONFIRMED BLEEDING HAD STOPPED. THE PATIENT WAS STABLE OVERNIGHT; HOWEVER, EXPIRED THE NEXT DAY ((B)(6) 2019). THE PHYSICIAN COULD NOT CONFIRM FOR SURE THAT THE DEATH WAS RELATED TO THE PROCEDURE, CARDIAC TAMPONADE OR OTHER COMORBIDITIES. IT WAS CONFIRMED THAT NO BIOSENSE WEBSTER, INC. REPRESENTATIVE WAS PRESENT FOR THE CASE. THERE¿S NO INFORMATION THAT A THERAPEUTIC BIOSENSE WEBSTER, INC. CATHETER WAS USED DURING THE PROCEDURE. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694848 WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC 10846835002430

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R