BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVAS

    MDR report key: 230857 · Received July 8, 1999

    Report

    Report Number
    1721520-1999-00006
    Event Type
    Injury
    Date Received
    July 8, 1999
    Date of Event
    June 26, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    901080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON TUESDAY, 6 JULY 1999, INFO WAS RECEIVED BY THE INNERDYNE, INC REGULATORY AFFAIRS DEPT FROM DEVELOPMENT/MARKETING REP, REGARDING ONE (1) INCIDENT INVOLVING A REVAS PRODUCT. THE EPISODE OCCURRED AT USER FACILITY DURING A DIAGNOSTIC CORONARY CATHERIZATION PROCEDURE. THE PT WAS AN OBSESE WHITE MALE, WEIGHING APPROXIMATELY 370, ANTICIPATED FOR CABG SURGERY IN THE ENSUING DAYS. ARTERIAL ACCESS WAS ACHIEVED WITH STANDARD TECHNIQUE, FOLLOWED SUCCESSFUL INTRODUCER WIRE PLACEMENT IN THE RIGHT GROIN/FEMORAL REGION. THE REVAS RADIALLY EXPANDING SLEEVE WAS ADVANCED OVER THE WIRE, AND SUCCESSFULLY INTO THE TARGET VESSEL. THE CATHETERIZATION PROCEDURE WAS SATISFACTORILY ACCOMPLISHED AND ROUTINE POST-PROCEDURE CARE WAS ADMINISTERED, WITH THE PT AMBULATING APPROXIMATELY 2 HRS POST PROCEDURE. UPON HOURLY ENTRY WOUND ASSESSMENTS FOR THE NEXT SIX HRS, THE PT WAS DISCHARGED. APPROXIMATELY 1 1/2 HRS POST DISCHARGE, THE PT RETURNED TO THE HOSP PRESENTING SWELLING OF THE RIGHT GROIN. THE PT WAS TAKEN TO SURGERY FOR EXPLORATION OF THE RIGHT GROIN REGION AND UNDERWENT SURGICAL REPAIR OF THE FEMORAL ARTERY, FOLLOWED BY ADMINISTRATION OF FOUR (4) UNITS OF BLOOD. THE PROCEDURE WAS BROUGHT TO CONCLUSION AND THE PT WAS CLOSED, TAKEN TO RECOVERY, AND IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE FROM THIS EPISODE. THEREFORE, THE EVENT IS REPORTED AS A SERIOUS INJURY, REQUIRING SECONDARY SURGICAL INTERVENTION FOR CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVAS RADIALLY EXPANDING SLEEVE GCJ INNERDYNE, INC. RV00400 UNREPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention