BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPHIRION DEEP BALLOON CATHETER OTW 0.014"

    MDR report key: 1932787 · Received December 1, 2010

    Report

    Report Number
    3004066202-2010-00015
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 15, 2010
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES, SPA.
    Product Code
    DQY
    PMA / PMN Number
    K083919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THE BALLOON DEFLATED DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE BALLOON CATHETER INTO THE PATIENT. THE PHYSICIAN INFLATED THE BALLOON TO DILATE THE LESION AND THE BALLOON BURST. NO PATIENT ISSUES. THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPHIRION DEEP BALLOON CATHETER OTW 0.014" DQY INVATEC INNOVATIVE TECHNOLOGIES, SPA. NA OPI05648101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA