BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 729801 · Received June 26, 2006

    Report

    Report Number
    1317056-2006-00041
    Event Type
    Death
    Date Received
    June 26, 2006
    Report Date
    June 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON CONTACTING THE CATH LAB MANAGER, NO ADD'L DETAILS ARE ABLE TO BE OBTAIEND, INCLUDING DATE OF THE EVENT, AND LOT NUMBER OF THE REPORTED DEVICE. THE LAB MANAGER HAS INDICATED THAT THE BOSTON SCIENTIFIC PRODUCT IS NOT BEING CONSIDERED AS THE CAUSE OF THE EVENT. WE ARE UNABLE TO CONDUCT A FAILURE ANALYSIS AS NO PRODUCT IS BEING RETURNED FOR EVAL. THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. SHOULD ADD'L DETAILS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED BY SALES REP, A PT (VERY LARGE ADULT FEMALE WITH MEDICAL CONDITIONS PRIOR TO THIS PROCEDURE) DEATH OCCURRED, BECAUSE OF A HEMORRHAGE OF THE RIGHT FEMORAL ARTERY. THIS OCCURRED FOLLOWING A PROCEDURE IN WHICH A BOSTON SCIENTIFIC CONVENIENCE KIT WAS UTILIZED. THE DATE OF THE PROCEDURE WAS NOT KNOWN. WHEN CONTACTED FOR ADDITIONAL DETAILS, THE HOSP INDICATED THAT THE PT DEVELOPED DIC (DISSEMINATED INTRAVASCULAR COAGULATION), WHICH WAS "UNEXPECTED AND QUITE RARE." THE HOSP DID NOT FEEL THAT THE BOSTON SCIENTIFIC PRODUCTS WERE RESPONSIBLE FOR THE EVENT. THEY DECLINED TO PROVIDE ADD'L INFO INCLUDING THE DATE OF THE EVENT. NO DEVICE SAMPLES ARE BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CONVENIENCE KIT DTL BOSTON SCIENTIFIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death
    2