BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELPORT BALLOON TROCAR SYSTEM

    MDR report key: 1070703 · Received July 2, 2008

    Report

    Report Number
    2027111-2008-00027
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 2, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE FIRST RETURNED SAMPLE WOULD NOT HOLD PRESSURE DUE TO A SLIT IN THE BALLOON. BALLOON RUPTURE CAN OCCUR FROM OVER-INFLATION. THE PRODUCT INFO DATA SHEET STIPULATES THAT CARE MUST BE TAKEN DURING INFLATION OR WHEN INFLATING BALLOON BEFORE IT HAS REACHED THE CORRECT LOCATION IN THE PERITONEUM. SLITS CAN OCCUR WHEN THE BALLOON CONTACTS SHARP INSTRUMENTS DURING USAGE. THE CAUSE OF THE SLIT IN THIS PARTICULAR BALLOON COULD NOT BE DETERMINED DUE TO A LACK OF DEFINITIVE INFO SURROUNDING THE USAGE OF THE TROCAR. THE SECOND SAMPLE WAS CONFIRMED TO HAVE A BALLOON THAT WAS OFF-SET AFTER INFLATION. BALLOONS ARE CHECKED FOR CONCENTRICITY PRIOR TO PACKAGING. HOWEVER, BALLOONS HAVE BEEN KNOWN TO INFLATE ASYMMETRICALLY AFTER PROLONGED PERIODS OF STORAGE. APPLIED HAS SINCE CHANGED THE BALLOON MATERIAL TO A DIFFERENT FORMULATION.

    Description of Event or Problem · 1

    "ONE BALLOON TROCAR DEFLATED AFTER INSERTION INTO THE ABDOMEN AND WOULD NOT RE-INFLATE. THE OTHER BALLOON WOULD NOT INFLATE ENOUGH TO GIVE A PROPER SEAL AND ANCHOR THE TROCAR AGAINST THE PERITONEUM (THE BALLOON WAS OFFSET/OBLONG ON THE CANNULA SHAFT). PT WAS OK, BUT THIS PROLONGED THE PROCEDURE BECAUSE NEED TO GOT GET A 2ND GELPORT BALLOON WHICH FAILED AND THEN TO GO GET A COMPETITIVE TAUT BALLOON TROCAR FOR THE SURGEON TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT BALLOON TROCAR SYSTEM NONE GCJ APPLIED MEDICAL RESOURCES CORP. C0747 1041072

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization