BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVAS

    MDR report key: 226721 · Received June 2, 1999

    Report

    Report Number
    1721520-1999-00005
    Event Type
    Other
    Date Received
    June 2, 1999
    Date of Event
    May 27, 1999
    Report Date
    June 2, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON MONDAY, 1 JUNE 1999, INFORMATION WAS RECEIVED BY THE INNERDYNE, INC QUALITY COMPLIANCE DEPARTMENT FROM PROJECT MARKETING REPRESENTATIVE, REGARDING ONE (1) INCIDENT INVOLVING A REVAS PRODUCT. THE EPISODE OCCURRED AT HOSPITAL, DURING A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE UNDER THE HAND OF A DR. ARTERIAL ACCESS WAS ACHIEVED WITH AN 18G NEEDLE USING STANDARD TECHNIQUE, WITH SUCCESSFUL INTRODUCER WIRE PLACEMENT IN THEFEMORAL REGION. THE REVAS RADIALLY EXPANDING SLEEVE WAS ADVANCED OVER THE WIRE, TO THE SKIN. UPON VESSEL ENTRY, RESISTANCE WAS NOTED AND AN ATTEMPT WAS MADE TO BACKUP THE SLEEVE. DURING THIS TECHNIQUE, APPOSITION WAS LOST BETWEEN THE INNER-DILATOR TIP AND THE SLEEVE, WHICH WAS CONFIRMED VIA FLUOROSCOPY. WITH SEVERAL UNSUCCESSFUL ATTEMPTS TO REGAIN APPOSITION, THE ENTIRE DELIVERY SYSTEM WAS WITHDRAWN UNDER SUBSTANTIAL FORCE FROM THE PATIENT. UPON RETRIEVAL, IT WAS NOTED THAT THE DISTAL TIP OF THE INNER-DILATOR WAS MISSING. THE ATTENDING PHYSICIAN WAS BROUGHT IN, AND THE CASE PARTICULARS WERE REVIEWED WHEREIN IT WAS DISCOVERED THAT THE REVAS ACCESS SYSTEM WAS BEING PLACED THROUGH A DACRON FEMORAL GRAFT IN ORDER TO ESTABLISH FEMORAL ACCESS. THE LOCATION OF THE DISLODGED TIP WAS OBSERVED USING FLUOROSCOPY. ATTEMPTS TO RETRIEVE THE TIP VIA SOFT TISSUE DISSECTION WERE UNSUCCESSFUL, AND IT WAS DETERMINED THAT THE TIP WAS UNRETRIEVABLE. THE WIRE WAS REMOVED, HEMOSTASIS ACHIEVED, AND THE PROCEDURE CONTINUED WITH A SECOND ARTERIAL ACCESS AT THE SAME SITE. THE PROCEDURE WAS BROUGHT TO CONCLUSION AND THE PATIENT WAS CLOSED, TAKEN TO RECOVERY, AND IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE. THEREFORE, THE EVENT IS REPORTED FOR THE LEAVING OF A FOREIGN MATERIAL IN THE ABDOMINAL REGION. SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE, WAS UNDERTAKEN FOR RETRIEVAL OF THE DISLODGED PIECE, WHICH WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVAS RADIALLY EXPANDING SLEEVE GCJ INNERDYNE, INC. RV00400 ETR-0359

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R