BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA SPIN SINUPLASTY SYSTEM

    MDR report key: 6168053 · Received December 12, 2016

    Report

    Report Number
    3005172759-2016-00022
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    October 7, 2016
    Report Date
    December 6, 2016
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    K111875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT RECEIVED THE COMPLAINT PACKAGE ON 11/22/2016, WHICH INCLUDED THE FOLLOWING: A.A SPIN SINUPLASTY BALLOON. B.BALLOON SLIDER. C.WIRE SLIDER. BEFORE DECONTAMINATION, VISUAL INSPECTION WAS PERFORMED. THE FOLLOWING OBSERVATIONS WERE NOTED: THE BALLOON AND THE SMALL PORTION OF THE SHAFT WERE COMPLETELY SEPARATED; THESE PARTS DID NOT GET SENT BACK. FURTHER INSPECTION OF THE SHAFT INDICATED THAT THERE WAS NO EVIDENCE OF THE SHAFT BEING CUT WITH A SHARP OBJECT. THE RECEIVED BALLOON CATHETER IS NOT FUNCTIONAL. THE INTEGRITY OF THE BALLOON PORTION OF THE BALLOON CATHETER CANNOT BE DETERMINED DUE TO THE MISSING BALLOON SECTION ON THE RETURNED DEVICE. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. A REVIEW OF THE LOT HISTORY RECORD FOR THE SUBJECT DEVICE DID NOT NOTE ANY ANOMALIES.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED ON (B)(6) 2016, FOR AN EVENT THAT OCCURRED ON (B)(6) 2016, INVOLVING A RELIEVA SPIN 6X16 SINUPLASTY SYSTEM, 3 GUIDE KIT (LOT# 160406A-PC). THE REPORTED ISSUE WAS THAT THE PLASTIC SHEATH HAS BEEN DETACHED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817921 RELIEVA SPIN SINUPLASTY SYSTEM INSTRUMENT, ENT MANUAL SURGICAL LRC ACCLARENT, INC. NA 160406A-PC

    Patients

    Seq Age Sex Outcome Treatment
    1