BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEL (MOMETOSONE FUROATE IMPLANT, 370 UG)

    MDR report key: 3979430 · Received July 18, 2014

    Report

    Report Number
    3010101669-2014-00002
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    March 2, 2014
    Report Date
    July 18, 2014
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE COMPANY'S COMPLAINT INVESTIGATION, THE DEVICE MET ITS SPECIFICATIONS. IN AN ABUNDANCE OF CAUTION, INTERSECT ENT IS REPORTING THIS EVENT IS A MALFUNCTION BASED ON THE INFO IT RECEIVED THE REMOTE POSSIBILITY OF SERIOUS INJURY SHOULD A SIMILAR EVENT OCCUR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A MALE PT HAD FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) AND WAS TREATED WITH PROPEL SINUS STENTS BILATERALLY IN THE ETHMOID SINUSES. THE PHYSICIAN PERFORMED AN ANTERIOR ETHMOIDECTOMY, USED BALLOON THERAPY IN THE MAXILLARY AND FRONTAL SINUSES AND HAD UNCAPPED THE BULLA. THE PHYSICIAN USED EVICEL FIBRIN SEALANT FOR HEMOSTASIS. ON (B)(6) 2014, 4 DAYS POST SURGERY, THE IMPLANT MIGRATED FROM THE LEFT SINUS TO THE THROAT. THE PHYSICIAN INITIALLY REPORTED THAT THE PT WAS CHOKING AND THAT THE AIRWAY WAS OBSTRUCTED, AND LATER CLARIFIED THAT THE PT DESCRIBED FEELING SOMETHING IN HIS THROAT, FELT A CHOCKING SENSATION AND COUGHED UP THE IMPLANT. IT WAS CONFIRMED THE PT DID NOT RECEIVE ASSISTANCE FROM A THIRD PARTY AT THE TIME OF THE EVENT. THE PT BROUGHT THE IMPLANT TO THE PHYSICIAN THE FOLLOWING DAY AND IT WAS DISCARDED. THERE WERE NO ISSUES REPORTED WITH RIGHT IMPLANT. THE PT WAS REPORTED TO HAVE TO SUBSEQUENT TISSUES POST EVENT AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423502 PROPEL (MOMETOSONE FUROATE IMPLANT, 370 UG) DRUG-ELUTING SINUS STENT OWO INTERSECT ENT 70011 31018001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK