BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARTO¿ XP SYSTEM

    MDR report key: 3143204 · Received June 3, 2013

    Report

    Report Number
    3008203003-2013-00069
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    June 4, 2010
    Report Date
    May 10, 2013
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K042999
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. THE BWI LEGAL DEPARTMENT PROVIDED ADDITIONAL INFORMATION ON THE EVENT ON (B)(4) 2013. THE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR HIS ATRIAL FIBRILLATION ON (B)(6) 2010, AND DEVELOPED ESOPHAGEAL FISTULA AND INFECTION. THE PATIENT SOUGHT TREATMENT ON (B)(6) 2010. DESPITE TREATMENT, THE INFECTION SPREAD THROUGHOUT THE PATIENT¿S BODY AND HE DIED OF FAILURE OF HIS ORGANS ON (B)(6) 2010. THE PHYSICIAN WHO PERFORMED THE PROCEDURE ON THIS PATIENT WAS ALLEGED PERFORATING THE PATIENT¿S PERICARDIUM AND THE WALL OF ESOPHAGUS DURING THE ABLATION PROCEDURE. THE ALLEGATIONS TO THE PHYSICIAN WERE FAILING TO ADEQUATELY MONITOR THE PLACEMENT OF ELECTRODES DURING ABLATION, ADMINISTERING EXCESSIVE ABLATION AND USING TOO MUCH POWER TO PATIENT¿S HEART IN THE AREA NEAR THE ESOPHAGUS, AND FAILING TO PERFORM TESTING AFTER THE PROCEDURE TO DETECT THE PERFORATION OF PERICARDIUM AND ESOPHAGUS. THE BWI LEGAL DEPARTMENT ALSO PROVIDED INFORMATION STATING IT WAS NOT THOUGHT THAT THERE WAS AN ISSUE WITH THE CARTO XP SYSTEM. (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

    ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT ON OCTOBER 9, 2013. IT WAS THOUGHT THAT THERE WAS AN ESOPHAGUS PROBE/TEMPERATURE MONITOR USED WITH THE CARTO XP SYSTEM IN THIS PROCEDURE. INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT HE IS INVOLVED IN A LAWSUIT REGARDING AN ABLATION PROCEDURE. THE ALLEGATION IS THAT HIS CLIENTS ESOPHAGUS WAS PERFORATED WHICH SUBSEQUENTLY LED TO HIS CLIENT¿S DEATH. HIS UNDERSTANDING IS THAT THERE WAS A 3D MAPPING OF THE PROCEDURE IN WHICH IT WOULD PROVIDE LOCATIONS AND AMOUNT OF ELECTRICITY APPLIED. THE HOSPITAL IS TELLING HIM THAT THEY CAN NOT RETRIEVE THE INFORMATION. THE ATTORNEY IS TRYING TO EDUCATE HIMSELF ON HOW THAT MIGHT BE RETRIEVED. THE USER DID NOT BACKUP THE PATIENT FILES AS IT IS RECOMMENDED IN THE USER MANUAL. IN ADDITION, THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH THIS SPECIFIC SYSTEM WAS REVIEWED AND THERE WAS NOT ANY COMPLAINT THAT MAY BE RELATED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT HE IS INVOLVED IN A LAWSUIT REGARDING AN ABLATION PROCEDURE. THE ALLEGATION IS THAT HIS CLIENTS ESOPHAGUS WAS PERFORATED WHICH SUBSEQUENTLY LED TO HIS CLIENT¿S DEATH. ADDITIONAL INFORMATION ON THE EVENT WAS REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244312 CARTO¿ XP SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4700-01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death