BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERWIRE RADIOFREQUENCY GUIDEWIRE

    MDR report key: 855597 · Received May 25, 2007

    Report

    Report Number
    9710452-2007-00002
    Event Type
    Death
    Date Received
    May 25, 2007
    Date of Event
    April 24, 2007
    Report Date
    May 25, 2007
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DQX
    PMA / PMN Number
    K051670
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. INFORMATION IS INSUFFICIENT TO DETERMINE THE EXACT REASON OF THIS INCIDENT. THE MANUFACTURER WILL CONTINUE TO MONITOR THESE KINDS OF INCIDENTS FOR TREND ANALYSIS.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AN OCCLUDED RIGHT BRACHIOCEPHALIC VEIN. THE OCCLUSION WAS 5-6 CM LONG AND THE PHYSICIAN COMMENTED THAT IT MUST BE ABOUT 2 YEARS OLD. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO RECANALIZE THE OCCLUSION USING CONVENTIONAL GUIDEWIRES WITH MECHANICAL FORCE. THESE ATTEMPTS WERE NOT SUCCESSFUL. THE PHYSICIAN THEN USED A POWERWIRE TO ATTEMPT TO RECANALIZE THE OCCLUSION. THESE ATTEMPTS WITH THE POWERWIRE WERE ALSO NOT SUCCESSFUL. THE PHYSICIAN COMMENTED THAT THE LENGTH AND THE AGE OF THE OCCLUSION MAY BE FACTORS INVOLVED WITH THE DIFFICULTY IN CROSSING THE OCCLUSION. THE PATIENT WAS DISCHARGED AND LEFT THE HOSPITAL. THE FOLLOWING DAY AFTER DISCHARGE, THE PATIENT RETURNED TO THE HOSPITAL WITH CHEST PAIN. THE PATIENT HAD INTERNAL BLEEDING. A SURGICAL PROCEDURE WAS PERFORMED TO CORRECT THIS. THE EXACT CAUSE OF THIS INTERNAL BLEEDING IS NOT KNOWN, HOWEVER, IT WAS SPECULATED THAT THIS MAY HAVE BEEN DUE TO THE ATTEMPTS TO RECANALIZE THE OCCLUSION. THE PATIENT WAS STABILIZED. A FEW DAYS LATER, THE PATIENT EXPIRED OF A HEART ATTACK. THE DEATH WAS REPORTED TO THE MANUFACTURER IN MAY, 2007. THE DOCTOR ATTRIBUTED THE DEATH TO THE PATIENT OVERALL DISEASE PROCESS AND ANATOMY. NO MALFUNCTION OF THE POWERWIRE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERWIRE RADIOFREQUENCY GUIDEWIRE TUNNELER WIRE DQX BAYLIS MEDICAL CO., INC. TUN 35-250-5A TNFA 181105

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening