BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREPERITONEAL DISTENTION BALLOON

    MDR report key: 137647 · Received December 12, 1997

    Report

    Report Number
    2939738-1997-00035
    Event Type
    Death
    Date Received
    December 12, 1997
    Date of Event
    November 1, 1996
    Report Date
    December 11, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FGY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DR PERFORMING SURGERY REPORTED COMPLICATIONS WITH A PT. THE DR ALLEGEDLY INSERTED THE UNIT INTO THE PT AND ATTEMPTED TO INFLATE THE PRODUCT WITH ITS ACCOMPANYING BULB. HE PUMPED UP THE UNIT ABOUT 8-9 TIMES. HE FELT THAT THE UNIT INFLATED TO LESS THAN 50% OF THE AVERAGE INFLATED SIZE. HE COULDN'T PENETRATE THROUGH THE PT'S BODY, THEREFORE PROCEEDED TO MAKE AN EXTRA INCISION ABOUT 1" LONG TO ASSIST WITH THE INTRODUCTION OF THE UNIT INTO THE PT. AFTER INSERTING THE UNIT, HE CONFRONTED SOME ADHESIONS INSIDE THE PT. HE RETRACTED THE UNIT AND NOTICED THE BOWEL HAD BEEN TORN. ANOTHER SURGEON WAS THEN CALLED TO REPAIR THE BOWEL. THE TEAR WAS CONSIDERED REPAIRED AT THE TIME. THE PT THEN RETURNED A MONTH LATER AND WAS DIAGNOSED WITH PERITONITIS. THE PT WAS HOSPITALIZED AND PASSED AWAY ABOUT 15 DAYS LATER. THE DR THAT INITIALLY PERFORMED THE SURGERY SPECULATES THAT THE ADHESIONS WERE DUE TO PREVIOUS SURGERIES AND/OR TREATMENTS. BASED ON THE DR'S STATEMENTS, THE UNIT DIDN'T MALFUNCTION DURING THE PROCEDURE. HE HAD PREVIOUSLY PERFORMED 40-50 CASES USING THE PRODUCT LINE AND BELIEVES THE INCIDENT WAS DUE TO THE ADHESIONS IN THE PT. THE UNIT WAS DISPOSED BY THE FACILITY DUE TO THE FACT THAT THE EVENT OCCURRED SEVERAL MONTHS AGO, AND THE DR BELIEVED THAT THE PT WOULD HAVE NO SERIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPERITONEAL DISTENTION BALLOON PREPERITONEAL DISTENTION BALLOON FGY ORIGIN MEDSYSTEMS, INC. OMS-PDB1000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| R