BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 2926202 · Received January 15, 2013

    Report

    Report Number
    3005172759-2013-00002
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADD'L INFO. THE SURGEON REPORTED THAT THE ACCLARENT DEVICE PERFORMED AS EXPECTED. THE SURGEON STATED THAT THEY ARE UNCERTAIN AS TO THE CAUSE OF THE ABSCESS. ONE OF THE POSSIBILITIES COULD BE A UNRECOGNIZED BONY DEFECT FROM THE CHRONIC SINUSITIS OR BALLOON SINUPLASTY. VP OF MEDICAL AFFAIRS STATED THAT AT THIS TIME THERE IS NOT ENOUGH INFO AVAILABLE TO DETERMINE IF THE ACCLARENT DEVICE WAS RELATED IN ANY WAY TO THE ABSCESS. ACCLARENT WILL CONTINUE TO UPDATE THE FILE IF ADD'L INFO PROVIDED BY THE SURGEON. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVAL, AND IT'S WHEREABOUTS ARE UNK. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2012 OF AN EVENT OCCURRED ON (B)(6) 2012 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WERE USED. THE SURGEON PERFORMED AN UNREMARKABLE BILATERAL ANTERIOR ETHMOIDECTOMY USING AN MICRO-SHAVER AND A BILATERAL FRONTAL AND MAXILLARY BALLOON SINUPLASTY USING THE ACCLARENT SPIN DEVICE. THE BALLOON WAS EASILY USED TO DILATE THE SINUS OUTFLOW. THERE WAS SOME BLEEDING, SO A BILATERAL MEROCEL NON-ABSORBABLE SPONGE WAS PLACED IN THE NOSE AND SINUS CAVITY. THE FOLLOWING DAY THE SURGEON SAW THE PT AND REMOVED THE FIRST SPONGE. THE PT RETURNED TO SURGEON 4 DAYS LATER AND THE SECOND PACK WAS REMOVED. NO PROBLEMS WERE NOTED. THE FOLLOWING DAY THE PT WAS FOUND UNCONSCIOUS BY HIS PARTNER AND WAS TAKEN TO EMERGENCY DEPT. A MRI SCAN REVEALED A FRONTAL LOBE ABSCESS. A CRANIOTOMY WAS PERFORMED BY A NEUROSURGEON TO DRAIN THE ABSCESS. THE PT REMAINS HOSPITALIZED. HE IS CONSCIOUS AND ALL HIS LIMBS ARE MOVING. CULTURES REVEALED A STAPHYLOCOCCUS SPECIES ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22933 RELIEVA SPIN SINUPLASTY SYSTEM SPIN SINUS BALLOON CATHETER LRC ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R BILATERAL MEROCEL NON-ABSORBABLE SPONGE