BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEEN COACCESS ELECTRODE SYSTEM

    MDR report key: 1013885 · Received March 14, 2008

    Report

    Report Number
    3005099803-2008-00273
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JOS
    PMA / PMN Number
    K012315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT IS UNDETERMINED. THE USER FACILITY DID NOT PROVIDE A LOT NUMBER; THEREFORE, A SHIPMENT HISTORY SEARCH WAS PERFORMED WHICH IDENTIFIED THREE LOTS (11017437, 11053584, AND 11076382) THAT WERE SHIPPED TO THE USER FACILITY PRIOR TO THE EVENT DATE. THE DEVICE HISTORY RECORD OF EACH LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADD'L COMPLAINTS FOR LOT 11076382. AN UNRELATED COMPLAINT WAS FOUND FOR LOT 11017437 (DAMAGED INSULATION) AND FOR LOT 11053584 (BENT NEEDLE). THE JAN 2008 15-MONTH RF PROBE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED IN A RADIO FREQUENCY ABLATION PROCEDURE IN A MALE PT (WEIGHT UNK) IN 2008. ACCORDING TO THE COMPLAINANT, THE "LESION WAS VERY DIFFICULT TO VIEW... UNDER ECHO... BECAUSE OF SOME PAIN THE PT MOVED AROUND A LOT, THE PHYSICIAN CONTINUED THE PROCEDURE BY GIVING HIM SEDATIVE [UNK]. THE ABLATION WAS PERFORMED... ON THE CANCER WHICH WAS APPROX 3CM AT THE BORDER OF S5 AND S6." THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON THREE DAYS LATER, THE PHYSICIAN "...FOUND SOME DAMAGE IN [THE] BOWEL AND A HOLE IN BOWEL DURING [A] CT TEST... THE PHYSICIAN EXPLAINED THAT THE HOLE WAS LOCATED... FAR FROM THE... ABLATION [SITE] UNDER CT (APPROX 1CM)." THE PT WAS SENT FOR "...AN URGENT ABDOMINAL OPERATION" ON TWO DAYS LATER. THE COMPLAINANT REPORTED THAT "AT THIS POINT, THE PROGRESS OF THE PT [IS BEING MONITORED] AT [THE] ICU." DESPITE SEVERAL ATTEMPTS, THERE IS NO FURTHER INFO AVAILABLE.

    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 75 YR Required Intervention