BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM

    MDR report key: 7132354 · Received December 19, 2017

    Report

    Report Number
    3005172759-2017-00059
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    UDI-DI
    10705031147744
    PMA / PMN Number
    K110218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE IS NOT KNOWN. THE PATIENT¿S GENDER IS NOT KNOWN. THE PATIENT'S WEIGHT IS NOT KNOWN. A REVIEW OF THE LOT HISTORY RECORD THE SUBJECT DEVICE (LOT# 160518A-PC) DID NOT PRESENT ANY ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED ON (B)(6) 2017, OF AN EVENT THAT OCCURRED ON (B)(6) 2017, INVOLVING AN INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM (LOT#: 160518A-PC). IT WAS REPORTED THAT DURING THE BRONCHIAL DILATION PROCEDURE, THE INSPIRA BALLOON WOULD NOT DEFLATE. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907739 INSPIRA AIR BALLOON DILATION SYSTEM, 16X40MM BRONCHOSCOPE ACCESSORY LRC ACCLARENT, INC. BC1640A 160518A-PC 10705031147744

    Patients

    Seq Age Sex Outcome Treatment
    1