BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTUSSUSCEPTION AIR REDUCTION KIT WITH PINK TIP

    MDR report key: 537760 · Received August 6, 2004

    Report

    Report Number
    537760
    Event Type
    Death
    Date Received
    August 6, 2004
    Date of Event
    July 26, 2004
    Report Date
    August 3, 2004
    Manufacturer
    GRI MEDICAL PRODUCTS, INC
    Product Code
    KDH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/31/2004: GRI DOES NOT MANUFACTURE DEVICE #3. A COPY OF THE REPORT HAS BEEN FORWARDED TO THAT COMPANY. THE IARK-2 USED IN THIS CASE WAS FROM A LOT #081001. IT WAS MANUFACTURED BY COMPANY'S PREVIOUS MA LOCATION, AND WAS NOT SOLD TO THE REPORTING FACILITY. THE DEVICE WAS DISPOSED. NO EVALUATION OF THE ACTUAL DEVICE IS POSSIBLE. THE AUTOPSY REPORT IS NOT YET AVAILABLE. IT CANNOT BE RELIABLY DETERMINED IF THE DEVICE CONTRIBUTED TO THE DEATH AS NO ALLEGATIONS OR DATA EXIST OF THE DEVICE MALFUNCITONING. BOWEL PERFORATION IS A CONSEQUENCE OF THIS PROCEDURE THAT IS FULLY DOCUMENTED IN THE LITERATURE AND INSTRUCTIONS FOR USE. NO OTHER INCIDENCES HAVE BEEN REPORTED TO DATE. MFR WILL CONTINUE TO MONITOR AND INVESTIGATE THIS INCIDENT AS INFO BECOMES AVAILABLE. THE CATHETER / TIP USED IN THESE PROCEDURES IS DETERMINED BY THE RADIOLOGIST BASED ON THE SIZE OF THE PT. WE ARE AWARE OF OTHER INSTITUTIONS USING FOLEY TYPE CATHETERS FOR SMALLER PTS. THE PT PRIOR TO THE PROCEDURE HAD A 3 DAY HISTORY OF SYMPTOMS AND COMPLAINTS BEFORE PRESENTING TO THE REPORTING FACILITY.

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED FOR AN INTUSSUSCEPTION IN THE RADIOLOGY SUITE. THE PHYSICIAN USED AIR REDUCTION KIT AND 22 INCH FRENCH FOLEY CATHETER INSTEAD OF CATHETER THAT CAME WITH AIR REDUCTION KIT FOR PROCEDURE DUE TO AGE OF PT. THE PT HAD FOLEY CATHETER INSERTED INTO RECTUM AND 8CC OF AIR INSTILLED INTO THE FOLEY BALLOON. UNDER FLUOROSCOPIC CONTROL, AN ATTEMPT AT AIR REDUCTION WAS MADE USING 120 MMHG OF PRESSURE. THE INTUSSUSCEPTION WAS SLOWLY REDUCED. SUDDENLY, PT ARRESTED. PERFORATION NOTED AND HEART STOPPED. PT CODED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTUSSUSCEPTION AIR REDUCTION KIT WITH PINK TIP AIR REDUCTION KDH GRI MEDICAL PRODUCTS, INC * *
    2 BARDEX IC 22 INCH FRENCH 5 CC RIBBED BALLOON KOD C. R. BARD, INC * *
    3 IARB BULB WITH GAUGE PRESSURE UNIT KQT GRI MEDICAL PRODUCTS, INC. * *
    4 KENDALL ARGYLE 5 IN 1 CONNECTOR CONNECTOR FOR TUBING BZA KENDALL, A DIV OF TYCO HEALTHCARE GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death THE AIR REDUCTION KIT WAS USED WITH A BARDEX I.C.| 22 INCH FRENCH FOLEY CATHETER AND A KENDALL ARGYLE| 5 IN 1 CONNECTOR.