BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA FLEX SINUS GUIDE CATHETER

    MDR report key: 5006400 · Received August 15, 2015

    Report

    Report Number
    3005172759-2015-00011
    Event Type
    Malfunction
    Date Received
    August 15, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K043445
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT RECEIVED THE SUBJECT DEVICE, THE RELIEVA FLEX® SINUS GUIDE CATHETER. EVALUATION OF THE RETURNED PRODUCT WAS COMPLETED ON JULY 16, 2015 AND REVEALED THAT THE DISTAL TIP WAS SEPARATED FROM THE NYLON SHAFT OF THE GUIDE CATHETER. THE EVALUATION FOUND THE NYLON SHAFT MATERIAL BETWEEN THE LINEAR AND NYLON SECTIONS WAS PEELED OFF FROM THE PEBAX, AND THE NYLON MATERIALS WERE EXPOSED ON THE LUMEN OF THE GUIDE CATHETER. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. CONCOMITANT MEDICAL PRODUCTS: RELIEVA SINUS INFLATION DEVICE (LOT# 96427016), RELIEVA SOLO PRO SINUS BALLOON CATHETER 5X16MM (LOT# 130823F), RELIEVA SIDEKICK LP (LOT# 120710H), AND STEEL INSTRUMENTS OF UNKNOWN TYPE.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED OF AN EVENT THAT WAS SAID TO HAVE OCCURRED DURING A PROCEDURE IN WHICH A RELIEVA FLEX SINUS GUIDE CATHETER WAS SAID TO HAVE BEEN USED. THE USER FACILITY REPORTED THAT DURING A BALLOON SINUPLASTY OF THE RIGHT MAXILLARY SINUS OF A PEDIATRIC PATIENT, THERE WAS TIGHT SPACE WITH TISSUE EDEMA THAT WAS SAID TO MAKE IT VERY DIFFICULT TO POSITION THE GUIDE CATHETER TIP. WHEN ATTEMPTING TO RETRACT THE GUIDE CATHETER MEDIALLY AND SUPERIORLY THE SURGEON NOTED THAT THE BLUE TIP OF THE GUIDE CATHETER HAD SLIGHTLY CRACKED. THE BALLOON WAS SUCCESSFULLY INFLATED, AND THE DEVICE WAS REMOVED FROM THE NOSE. OUTSIDE OF THE PATIENT'S ANATOMY, THE SURGEON PROCEEDED TO WITHDRAW THE BALLOON CATHETER FROM THE FLEX GUIDE CATHETER, AND THE BLUE MARKER MATERIAL TORE OFF FROM THE DISTAL TIP. THE SURGEON CHECKED THOROUGHLY IN THE NOSE AND CONFIRMED THAT NO BLUE MARKER MATERIAL REMAINED IN THE PATIENT'S ANATOMY. NO PATIENT INJURY WAS REPORTED AND THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A REPLACEMENT GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541097 RELIEVA FLEX SINUS GUIDE CATHETER CANNULA, SINUS KAM ACCLARENT, INC. M-110 130823F-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR