BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEP

    MDR report key: 107899 · Received July 25, 1997

    Report

    Report Number
    1721520-1997-00003
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Date of Event
    July 2, 1997
    Report Date
    July 25, 1997
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON WEDNESDAY, 23 JULY 1997, INFO WAS RECEIVED BY THE INNERDYNE, INC. REGULATORY AFFAIRS DEPT GENERAL MGR, REGARDING ONE (1) INCIDENT. THE EPISODE OCCURRED AT MEDICAL CENTER, DURING A SURGICAL PROCEDURE UNDER THE DIRECTION OF DR. ON 2 JULY 1997. DURING THE PROCEDURE, A REPOSABLE STEP RADIALLY EXPANDING DILATION ACCESS WAS PLACED WITHOUT INCIDENT. AN INCORRECT SIZE DILATOR WAS PLACED WITHIN THE CANNULA, FOR INTRODUCTION THROUGH THE SLEEVE. THE DISTAL OF THE CANNULA BARREL FRACTURED AND SHATTERED. SUCCESSFUL RETRIEVAL OF THE FRAGMENTS WAS ACCOMPLISHED BY THE ATTENDING SURGEON, AND NO PT INJURY IS REPORTED. THE PT IS BELIEVED TO HAVE RECOVERED FROM THE SCHEDULED PROCEDURE AND IS DOING FINE. THE REPORTED EVENT IS DESCRIBED AS A USER AND PROCEDURAL RELATED EPISODE. THE DAMAGED CANNULA BARREL WAS RETURNED TO INNERDYNE, INC., FOR EVAL WHICH HAS BEEN COMPLETED. THE RETRIEVED BARREL FRAGMENTS WERE RETAINED BY THE MEDICAL INSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP PERCUTANEOUS SHEATH WITH DILATOR GCJ INNERDYNE, INC. NA 9701051

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention