BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 3071266 · Received April 22, 2013

    Report

    Report Number
    3008203003-2013-00048
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED ON THE EVENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR APPROXIMATELY 2 HOURS. THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM. THERE WAS NO PRODUCT ISSUE. THE PHYSICIAN DID NOT CONSIDER CANCELLING THE PROCEDURE CAUSED A POTENTIAL RISK TO THE PATIENT. INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT APPROXIMATELY 2 HOURS INTO A PVI ATRIAL FIBRILLATION (AFIB) PROCEDURE, A TAMPONADE WAS SEEN ON THE ULTRASOUND SCREEN. ALL EQUIPMENT FUNCTIONED NORMALLY AND THERE WERE NO PROBLEMS WITH ANY OF THE PRODUCTS. THE PHYSICIAN REMOVED HALF A LITER OF BLOOD FROM THE PATIENT. A DRAIN WAS PLACED TO REMOVE ANY EXCESS. THE PATIENT WAS STABLE AND IN RECOVERY. PROCEDURE WAS ABORTED AND WILL BE RESCHEDULED IN APPROXIMATELY 1 WEEK. ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR APPROXIMATELY 2 HOURS. THE PROCEDURE WAS BEING PERFORMED IN THE LEFT ATRIUM. THE PHYSICIAN DID NOT CONSIDER CANCELLING THE PROCEDURE CAUSED A POTENTIAL RISK TO THE PATIENT. LATER INFORMATION WAS GIVEN THAT THERE WAS NO FAULT IN REGARDS TO THE CARTO 3 SYSTEM INVOLVED IN THIS PROCEDURE. THERE WAS NO SERVICE ON CARTO 3 SYSTEM AS THE ISSUE WAS NOT RELATED TO THIS SYSTEM. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 HOURS INTO A PVI ATRIAL FIBRILLATION (AFIB) PROCEDURE, A TAMPONADE WAS SEEN ON THE ULTRASOUND SCREEN. ALL EQUIPMENT FUNCTIONED NORMALLY AND THERE WERE NO PROBLEMS WITH ANY OF THE PRODUCTS. THE PHYSICIAN REMOVED HALF A LITER OF BLOOD FROM THE PATIENT. A DRAIN WAS PLACED TO REMOVE ANY EXCESS. THE PATIENT WAS STABLE AND IN RECOVERY. PROCEDURE WAS ABORTED AND WILL BE RESCHEDULED IN APPROXIMATELY 1 WEEK. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171869 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) FG-5400-00J

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R