BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER PREFACE SHEATH

    MDR report key: 759382 · Received September 11, 2006

    Report

    Report Number
    2029046-2006-00077
    Event Type
    Injury
    Date Received
    September 11, 2006
    Date of Event
    November 21, 2005
    Report Date
    September 11, 2006
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS PART OF A EPISO-D STUDY BASED IN EUROPE, WHICH INITIALLY WAS THOUGHT OF AS A CLINICAL TRIAL (PRE CE MARK OR IDE). THE EVENT OCCURRED IN 2005 AND WAS NOT ENTERED AS A COMPLAINT UNTIL 08/11/2006 AT WHICH POINT IT WAS DETERMINED A REPORTABLE COMPLAINT.

    Description of Event or Problem · 1

    CUSTOMER STATES TRANSIENT ST ELEVATION WAS OBSERVED JUST AFTER PLACEMENT OF THE INTRODUCER IN THE LEFT ATRIUM. AIR EBOLISM WAS DISCOVERED AND MEDICAL INTERVENTION WAS ADMINISTERED (NITROGLYCERIN). PROGNOSIS OF THE PATIENT WAS REPORTED AS EXCELLENT. CUSTOMER STATES THAT THE EVENT WAS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER PREFACE SHEATH GUIDING SHEATH DYB BIOSENSE WEBSTER, INC. D-1215-01-S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening