BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS SBT/OVAL BALLOON DISSECTOR

    MDR report key: 3683491 · Received March 4, 2014

    Report

    Report Number
    2647580-2014-00149
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    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 TYPE: TEP HERNIA REPAIR. ACCORDING TO THE REPORTER: DR (B)(6) WAS ASSISTED BY MR (B)(6). DR (B)(6) PLACED THE KIDNEY SHAPED SPACEMAKER INTO THE PT'S BODY AND INFLATED THE DISSECTION BALLOON WHEN HE THOUGHT HE HAD FELT THE PUBIC BONE. AFTER HE REMOVED THE DISSECTION BALLOON FROM THE SPACEMAKER, HE INFLATED THE STRUCTURAL PART OF THE SPACEMAKER. HE ALSO INSERTED TWO PEDIPORTS. WHEN THE CAMERA VIEW WAS ESTABLISHED, THERE WAS SUBSTANTIAL AMOUNT OF BLOOD IN VIEW ON THE SCREEN. WHEN THE BLOOD WAS CLEARED BY THE IRRIGATOR, THE URINARY CATHETER WAS IN VIEW THROUGH DAMAGE TO THE BLADDER NECK. AFTER DISCUSSIONS WITH AN UROLOGIST AT (B)(4) HOSPITAL AND (B)(6) HOSPITAL'S SENIOR CONSULTANT (DR (B)(6)), DR (B)(6) PROCEEDED TO DRAIN AND CLOSE. AFTER SOME DIFFICULTIES, THE STRUCTURAL BALLOON WAS REMOVED. COVIDIEN EMPLOYEE, (B)(4) WAS PRESENT DURING THE INITIAL PART OF THE PROCEDURE AND ALSO WHEN THE SURGEON WAS CLOSING UP THE PT. CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PT: PT WAS TRANSFERRED TO (B)(6) HEALTH UNDER THE CARE OF THE UROLOGY DEPT. PT OUTCOME. NOT ADVISED BY HOSPITAL...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130546 SM PLUS SBT/OVAL BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3H0330X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other