BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 8672344 · Received June 5, 2019

    Report

    Report Number
    2029046-2019-03233
    Event Type
    Death
    Date Received
    June 5, 2019
    Date of Event
    May 13, 2019
    Report Date
    May 13, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DRF
    UDI-DI
    10846835009972
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/5/2019, AFTER SUBMISSION OF THE 3500A INITIAL MDR, IT WAS NOTICED THAT THE CONCOMITANT DEVICES WERE INADVERTENTLY OMITTED FROM THE 3500A INITIAL MDR. THEY HAVE NOW BEEN ADDED TO SECTION D11. CONCOMITANT MEDICAL PRODUCTS. MANUFACTURER'S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30126551M NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION) AND DEATH. AFTER FEMORAL VEIN PUNCTURE, THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER WAS INSERTED INTO THE PATIENT¿S BODY AND SEVERAL CONTOURS OF THE LEFT ATRIUM AND RIGHT ATRIUM WERE ACQUIRED. AFTER THAT, TRANSSEPTAL PUNCTURE WAS PERFORMED, AND THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS INSERTED. AT THAT TIME DURING THE ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE, AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF ARTERIAL BLOOD FROM THE PERICARDIAL SPACE; HOWEVER, THE BLEEDING COULD NOT BE STOPPED, AND THORACOTOMY WAS PERFORMED. THE PATIENT APPEARED TO BE IN STABLE CONDITION; HOWEVER, THE PATIENT DIED AFTER THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE DEATH IS THAT IT OCCURRED DUE TO THE CARDIAC TAMPONADE THAT OCCURRED BY INJURY TO THE LEFT ATRIUM DURING TRANSSEPTAL PUNCTURE AND THAT THERE¿S NO RELATIONSHIP BETWEEN THE DEATH AND THE BWI PRODUCTS. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE CASE. DESPITE THE PHYSICIAN ATTRIBUTING THE CAUSALITY OF THE ADVERSE EVENT TO AN INJURY TO THE LEFT ATRIUM DURING THE TRANSSEPTAL PUNCTURE, IT CANNOT BE CONFIRMED THE INJURY WAS NOT CAUSED BY THE BIOSENSE WEBSTER INC. CATHETER; THEREFORE, THIS EVENT IT IS TO BE ATTRIBUTABLE TO THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463286 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC. 30126551M 10846835009972

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R CARTO3 EXTERNAL REFPATCH 6PACK| COOLFLOW TUBING SET,SINGLE PK| SOUNDSTAR ECO SMS 8F CATHETER