BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REEF HP PTA BALLOON CATHETER OTW 0.035"

    MDR report key: 1983331 · Received February 4, 2011

    Report

    Report Number
    3004066202-2011-00005
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    INVATEC INNOVATIVE TECHNOLOGIES SPA.
    Product Code
    DQY
    PMA / PMN Number
    K092361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS INDICATED THAT THE SUBJECTED DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MANUFACTURING PROCESS. DEVICE DISCARDED-NOT RETURNED FOR EVALUATION. THE EVENT HAS NOT BEEN CONFIRMED; NO PRODUCT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE BALLOON RUPTURED. PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REEF HP PTA BALLOON CATHETER OTW 0.035" DQY INVATEC INNOVATIVE TECHNOLOGIES SPA. NA 1B003501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA