BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATOR KIT 18INFKIT BALLOON

    MDR report key: 4011953 · Received August 15, 2014

    Report

    Report Number
    1045254-2014-00188
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LRC
    PMA / PMN Number
    K132297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: BALLOON SEEKER 1830617FRT EM FRNT 6X17MM, 510K: K132297, LOT # 0208412034, MANUFACTURED DATE: 2014-06-03, USE-BY/EXPIRATION DATE: 2015-11-30; BALLOON SEEKER 1830717SPH EM SPHN 7X17MM, 510K: K132297, LOT #: 0208433140, MANUFACTURED DATE: 2014-06-10, USE-BY DATE/ EXPIRATION: 2015-12-07; ENT INSTRUMENT 9735016 (MALLEABLE SUCTION TUBE), LOT #: 140530J PUMP 1991005 ENDO-SCRUB 2, 510K: K982594 MICRODEBRIDER 1898200T IGS M4, 510K: K041413 ENT ENDO P/N UNKNOWN (TRICUT BLADE). (B)(4). THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    AN MDT SALES REP REPORTED THE FOLLOWING: DURING A BALLOON SINUS CASE USING THE NUVENT BALLOON AND MALLEABLE SUCTION, THE SURGEON NOTICED THAT THE EYE ON THE SIDE THAT THEY WERE PERFORMING THE SURGERY ON (RIGHT) STARTED TO SWELL. THE SURGEON WAS USING THE MALLEABLE SUCTION TUBE ATTACHED TO A 60ML SYRINGE OF SALINE TO IRRIGATE THE SINUSES. EACH SINUS (FRONTAL AND SPHENOID) HAD BEEN BALLOONED AND WAS IRRIGATED APPROXIMATELY 4 TIMES WITH THIS METHOD. AFTER IRRIGATION, THE SURGEON BEGAN TO WORK ON PENETRATION OF THE POSTERIOR ETHMOID BONE/CELL WITH THE M4 AND TRACKABLE TRICUT BLADE. PER THE SALES REP, THE SURGEON WORKED ON THIS FOR ABOUT 45 MINUTES, AND MORE THAN ONCE COMMENTED ABOUT THE DIFFICULTY SHE WAS HAVING WITH PENETRATING THE BONE, AND HAD TO "REALLY LEAN ON IT." AT ABOUT 45 MINUTES OF WORK, EYE SWELLING WAS NOTICED. THE PROCEDURE WAS IMMEDIATELY STOPPED, AND THE SURGEON PERFORMED AN EMERGENCY LATERAL CANTHOTOMY. AFTER THE LATERAL CANTHOTOMY, THE REP NOTED THAT THERE WAS ONE DROP/STREAK OF BLOOD, PRESUMABLY FROM THE CUT MADE, AND THE ORBIT APPEARED "WATERY" AS IF THE PATIENT HAD TEARS. IT IS UNKNOWN IF THIS WAS IRRIGATION FLUID OR TEARS FROM EYE MANIPULATION. AN OPHTHALMOLOGIST WAS CALLED IN. THE SURGEON LATER REPORTED THAT THE PATIENT COULD SEE AND EYE PRESSURE WAS NORMAL. IT WAS ALSO NOTED THAT THE SURGEON WAS USING A DIFFERENT MANUFACTURER¿S SCOPE IRRIGATOR, AND SHE FELT IT PUT OUT AN EXCESSIVE AMOUNT OF SALINE (500 CC¿S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490959 INFLATOR KIT 18INFKIT BALLOON INSTRUMENT, ENT MANUAL SURGICAL LRC MEDTRONIC XOMED INC. 18INFKIT 0208433059

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Required Intervention