BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADIAL JAW 3

    MDR report key: 417459 · Received September 18, 2002

    Report

    Report Number
    417459
    Event Type
    Death
    Date Received
    September 18, 2002
    Date of Event
    September 16, 2002
    Report Date
    September 17, 2002
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    KNW
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/12/02: THE SUBJECT DEVICE HAS BEEN RETAINED BY THE USER FACILITY. ALTHOUGH REQUESTED, MFR HAS NOT BEEN PERMITTED TO EXAMINE THE DEVICE ON-SITE AT HOSPITAL, NOR HAVE THEY BEEN PROVIDED WITH ANY ADD'L INFO RELATIVE TO THE CASE. THEREFORE, MFR HAS BEEN UNABLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE DEVICE AND THE CAUSE OF THE EVENT. A REVIEW OF THE COMPLAINT HISTORY FOR THE PULMONARY RADIAL JAW 3 BIOPSY FORCEP DEVICE REVEALED THAT BOSTON SCIENTIFIC CORPORATION HAS RECEIVED ONLY ONE OTHER REPORT ALLEGING EXCESSIVE BLEEDING DURING A PROCEDURE UTILIZING THIS DEVICE. UNFORTUNATELY, THE SUBJECT DEVICE WAS NOT RETURNED FOR EVALUATION AND TESTING AND NO FINAL DETERMINATION RELATIVE TO CAUSE OF THE EVENT COULD BE MADE.

    Description of Event or Problem · 1

    DURING A BRONCHOSCOPY, THE BIOPSY FORCEPS CAUGHT THE TIP OF THE SCOPE AND COULD NOT BE WITHDRAWN WITHOUT DISLODGING THE TIP FROM THE BRONCHUS. BLEEDING OCCURRED. THE BRONCHUS COULD NOT SUCCESSFULLY BE RE-ENTERED BLINDLY OR WITH FLUOROSCOPY. THE BLOOD COAGULATED IN THE AIRWAY LEADING TO ASPHYXIATION, BRADYCARDIA, HYPOXEMIA AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS (PULMONARY) KNW BOSTON SCIENTIFIC CORP * 4781859

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death