BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 4008200 · Received July 31, 2014

    Report

    Report Number
    2647580-2014-00600
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: INGUINAL HERNIA REPAIR. ACCORDING TO THE REPORTER: THE BLADDER WAS TORN, EXPOSING THE FOLEY CATHETER. PROBLEM WAS NOTICED AFTER REMOVAL OF DISSECTION BALLOON FROM THE SPACEMAKER DEVICE. DID NOT ENCOUNTER ANY OTHER DIFFICULTY, AND PT HAD NO OTHER INDICATIONS OF BEING A DIFFICULT CASE. UROLOGIST WAS CALLED TO CLOSE BLADDER. COMMENTED THAT BLADDER WALL WAS THINNER THAN MOST. LAPAROTOMY WAS MADE TO REPAIR BLADDER. BLADDER REPAIRED AS ABOVE. HERNIA REPAIR ABORTED. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS UNANTICIPATED TISSUE DAMAGE. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 250CC. THERE WAS DELAY OVER 30 MINUTES. I LISTED THE DATE OF NOTIFICATION AS THE DATE OF THE CASE BECAUSE THEY CALLED ME FROM THE ROOM THAT DAY TO ASK ABOUT MESH, AND THE USE OF MESH IN THE PRESENCE OF URINE. OUR ENTIRE DISCUSSION THAT DAY WAS ABOUT THE MESH. NOT THE SPACEMAKER. I DID NOT GET INTO THE SPACEMAKER DISCUSSION IN ANY DETAIL UNTIL I SAW THE SURGEON AGAIN ON (B)(6). THAT IS WHEN I FOUND OUT THAT THEY CONVERTED TO OPEN, AND WE HAD THE DISCUSSION ABOUT THE SPACEMAKER AND WHAT THEY THOUGHT MAY HAVE HAPPENED. WE DISCUSSED COMPLETION THE FORM, WHICH I DID, AND SENT IT TO THE DR TO REVIEW AND COMPLETE. WHEN I GOT IT BACK I SENT IT IN. AGAIN, I LISTED THE DATE OF NOTIFICATION AS THE DATE OF THE CASE, BECAUSE THEY DID CALL ME THAT DAY TO TALK ABOUT THE MESH. IN HINDSIGHT, I PROBABLY SHOULD HAVE GOTTEN MORE DETAIL AT THE TIME AND SUBMITTED THE REPORT, BUT HONESTLY I GOT BUSY WITH OTHER THINGS AND DID NOT THINK ABOUT IT. I DO NOT HAVE THE LOT NUMBER OR THE PRODUCT, AS I WAS NOT PRESENT DURING THE CASE AND I GOT THESE DETAILS AT A LATER DATE. NOBODY KNOWNS FOR SURE WHAT THE RELATIONSHIP IS BETWEEN THE SPACEMAKER AND CATHETER. THEY ARE VERY UNCLEAR WHAT EXACTLY HAPPENED OR IN WHAT SEQUENCE EVENTS HAPPENED. AS I UNDERSTAND IT, THEY COULD SEE THE CATHETER THROUGH OUR DISSECTION BALLOON ONCE THE SCOPE WAS IN IT FOR THE DISSECTION, BUT THEY DO NOT KNOW IF THE CATHETER WENT THROUGH THE BLADDER, OR IF THERE WAS SOME INTERFERENCE WITH THE SPACEMAKER OR ITS INSERTION. EVERYTHING NOTED WAS ON THE SAME PROCEDURE. I AM NOT AWARE OF ANY OTHER SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447322 SM PLUS SBT/OVAL BALLOON DISSECTOR NONE GCJ COVIDIEN, FORMERLY USSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other