BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK

    MDR report key: 7097595 · Received December 7, 2017

    Report

    Report Number
    3005172759-2017-00056
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 16, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K143541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S GENDER IS NOT KNOWN. THE PATIENT'S WEIGHT IS NOT KNOWN. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNAVAILABLE. THE LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER FOR THE ACCLARENT RELIEVA SPINPLUS DEVICE WAS UNAVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED ON (B)(4) 2017, FOR AN EVENT THAT OCCURRED ON (B)(6) 2017 INVOLVING A RELIEVA SPINPLUS KIT, 3 GUIDES, 6 MM, 5PK (LOT# NOT AVAILABLE). DURING A PRIMARY BALLOON SINUPLASTY PROCEDURE, THE TIP OF THE BALLOON CATHETER FULLY SEPARATED AND DETACHED FROM THE BALLOON. IT WAS RETRIEVED WHILE IT WAS STILL ON THE GUIDEWIRE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS RESUMED AND SUBSEQUENTLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875185 RELIEVA SPIN PLUS KIT, 3 GUIDES, 6MM, 5PK INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1