BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 4902430 · Received July 9, 2015

    Report

    Report Number
    2647580-2015-00485
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    April 20, 2015
    Report Date
    September 30, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF COMPLAINT DATA REVEALS NO TREND FOR A DEVICE RELATED FAILURE FOR THIS CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. THE REPORTED CONDITION FOR THIS INCIDENT WAS THAT THE BALLOON HAD A PUNCTURE AND DID NOT INFLATE AT ALL IN THE PATIENT DURING AN INGUINAL HERNIA REPAIR PROCEDURE. THE OBTURATOR WAS RECEIVED. THE INFLATION BULB WAS RECEIVED. VISUAL INSPECTION NOTED THAT THE VALVE SEAL WAS INTACT. A CUT WAS OBSERVED TO PENETRATE THE BALLOON. THE BALLOON WAS UNABLE TO BE INFLATED DUE TO THE OBSERVED CUT. THE FLAPPER VALVE FUNCTIONED PROPERLY. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITION DUE TO THE CUT IN THE BALLOON AND THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS. SUBSEQUENTLY, THE COMPLAINT DATA DID NOT DISPLAY AN INCREASED TREND. REPLICATION OF THE REPORTED CONDITION MAY OCCUR AS A RESULT OF EITHER AN INFLATED OR DEFLATED BALLOON MAKING CONTACT WITH A SHARP OBJECT DURING USE. THEREFORE, NO CORRECTIVE ACTION WAS GENERATED FOR THE REPORTED CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON 07/09/2015.

    Description of Event or Problem · 1

    PROCEDURE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER, THE BALLOON HAD A PUNCTURE AND DID NOT INFLATE INSIDE THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445636 SPACEMAKER PREPERITONEAL DIST BALLOON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMSPDB1000 P4H0003X

    Patients

    Seq Age Sex Outcome Treatment
    1