BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID

    MDR report key: 9724523 · Received February 19, 2020

    Report

    Report Number
    2029046-2020-00262
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 23, 2020
    Report Date
    January 23, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835002409
    PMA / PMN Number
    K090898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION WITH WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ATRIAL FIBRILLATION ABLATION WHILE IN THE RIGHT SUPERIOR VEIN WITH LASER BALLOON TECHNOLOGY, THE PATIENT¿S BLOOD PRESSURE DROPPED. THE ULTRASOUND CONFIRMED THE PATIENT HAD A PERICARDIAL EFFUSION. THE PATIENT HAD A PERICARDIOCENTESIS AND MORE THAN ONE LITER OF FLUID REMOVED FROM THE PATIENT. THE PATIENT REMAINED STABLE DURING THE PROCEDURE. THE CASE WAS CANCELED. THE WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID WAS IN THE BODY AT THE TIME OF THE ADVERSE EVENT. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND HAS FULLY RECOVERED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL SL SHEATH AND A BAYLIS TRANSSEPTAL NEEDLE. THE EVENT OCCURRED DURING THE ABLATION PHASE. NO ERRORS MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. NO IRRIGATED CATHETER WAS USED. NO BIOSENSE WEBSTER, INC. ABLATION CATHETER WAS USED. THE EVENT WILL BE CONSERVATIVELY REPORTED UNDER THE WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID SINCE IT WAS IN THE HEART DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190288 WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER INC BD710DF282CT 10846835002409

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R