BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERWIRE RADIOFREQUENCY GUIDEWIRE

    MDR report key: 2629670 · Received May 10, 2012

    Report

    Report Number
    9710452-2012-00002
    Event Type
    Injury
    Date Received
    May 10, 2012
    Date of Event
    April 13, 2012
    Report Date
    May 10, 2012
    Manufacturer
    BAYLIS MEDICAL CO., INC.
    Product Code
    DQX
    PMA / PMN Number
    K101615
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION OF THE CARDIAC TAMPONADE IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A RECANALIZATION PROCEDURE THAT THE PT DEVELOPED A TAMPONADE FOLLOWED BY CARDIAC ARREST. THE PHYSICIAN HAD USED A STRAIGHT POWERWIRE RF GUIDEWIRE TO RECANALIZE THE SUPERIOR VENA CAVA. ONCE THE GUIDEWIRE WAS BELIEVED TO HAVE PASSED THE OCCLUSION, AN ANGIOPLASTY BALLOON WAS INSERTED OVER THE GUIDEWIRE AND INFLATED. AFTER BALLOON INFLATION, THE PT'S BLOOD PRESSURE DROPPED AND PERICARDIAL TAMPONADE OCCURRED. THE PT SUFFERED CARDIAC ARREST AND INTERVENTIONAL SURGERY WAS REQUIRED. TWO PUNCTURES WERE OBSERVED; ONE IN THE BRACHIOCEPHALIC VEIN AND ONE IN THE PERICARDIUM. THE SURGERY TO CORRECT THE PROBLEM WAS COMPLETED WITHOUT FURTHER COMPLICATION AND THE PT WAS REPORTED IN STABLE CONDITION AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERWIRE RADIOFREQUENCY GUIDEWIRE GUIDEWIRE DQX BAYLIS MEDICAL CO., INC. EVW35-250-12-6S EWFA250511

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention