BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEVEEN COACCESS ELECTRODE SYSTEM

    MDR report key: 1359457 · Received April 7, 2009

    Report

    Report Number
    3005099803-2009-01588
    Event Type
    Death
    Date Received
    April 7, 2009
    Report Date
    March 10, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH - UNKNOWN. OTHER, BOWEL INJURY, ORGAN FAILURE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RENAL RFA PROCEDURE PERFORMED IN 2007. ACCORDING TO THE COMPLAINANT, THE DEVICE, IN CONJUNCTION WITH THE APPROPRIATE TREATMENT ALGORITHM, WAS USED TO SUCCESSFULLY ABLATE THE APPROX 3.5 CENTIMETER RENAL CARCINOMA. DUE TO THE CLOSE PROXIMITY OF THE SURROUNDING BOWEL, A 22-GAUGE FINE NEEDLE WAS INSERTED PRIOR TO ABLATION TO INFUSE SOLUTION IN ORDER TO 'HYDRO DISSECT' THE BOWEL AWAY FROM THE POTENTIAL ABLATION ZONE. AFTER LESS THAN A WEEK, THE PT WAS RE-ADMITTED, COMPLAINING OF FEELING UNWELL. AN ABDOMINAL CT WAS PERFORMED TO DETERMINE IF A THERMAL INJURY TO THE BOWEL HAD OCCURRED. HOWEVER, THE TEST WAS INCONCLUSIVE. FURTHER INVESTIGATIONS, INCLUDING ENDOSCOPY AND FLEXIBLE SIGMOIDOSCOPY, WERE CARRIED OUT TO IDENTIFY CAUSE OF WORSENING PT CONDITION. AS HIS CONDITION DETERIORATED, THE PT WAS ADMITTED TO INTENSIVE CARE AND PLACED ON VENTILATION TO HELP WITH A SEPTICEMIA SECONDARY TO MRSA INFECTION. A BARIUM SWALLOW PROCEDURE WAS CARRIED OUT WHICH CONFIRMED A BOWEL INJURY AND HE LATER DIED OF MULTI ORGAN FAILURE. THE PHYSICIAN IS CONFIDENT THAT THE ORIGINAL RFA CASE WAS UNEVENTFUL AND THE CIRCUMSTANCES THAT FOLLOWED WERE A SERIES OF UNFORTUNATE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEEN COACCESS ELECTRODE SYSTEM JOS BOSTON SCIENTIFIC CORPORATION M001262240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death