BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 4173965 · Received October 15, 2014

    Report

    Report Number
    2647580-2014-00870
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K946002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: KIDNEY SHAPE BALLOON INSERTED INTO PATIENT TO CREATE SPACE FOR INGUINAL HERNIA REPAIR. BULB INSERTED INTO PORT AND PUMPED BY SURGEON, HOWEVER BALLOON DID NOT INFLATE. THIS WAS THEN REPEATED WITH A SECOND BALLOON WHICH ALSO DID NOT INFLATE. THE THIRD ATTEMPT WORKED. ADDITIONAL INFORMATION RECEIVED VIA EMAIL WAS THERE ANY UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM: NO. WAS THERE ANY TISSUE DAMAGE AS A RESULT OF THIS PROBLEM: NO. IF YES, DESCRIBE THE DAMAGE AND PROVIDE DETAILS ON HOW THE DAMAGE WAS TREATED/CORRECTED. WAS THE DAMAGE IRREVERSIBLE? WAS THERE BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM: NO. DID ANY ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM REQUIRE A BLOOD TRANSFUSION: NO. WAS SURGICAL TIME EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM: NO. WAS ANY ADVERSE EVENT REPORTED AS A RESULT OF ANY DELAY IN SURGERY? (I.E. AN EXTENSION OF THE HOSPITAL STAY, INFECTION, ETC.): NO. HOW IS THE PATIENT CURRENTLY: NO ADVERSE EFFECTS TO THE PATIENT. THE BALLOONS THAT DID NOT INFLATE WERE SIMPLY REMOVED UNTIL A BALLOON THAT WORKED WAS INFLATED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655458 SPACEMAKER PREPERITONEAL DIST BALLOON SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMSPDBS2 P4C0129X

    Patients

    Seq Age Sex Outcome Treatment
    1