BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERCROSS 035

    MDR report key: 6101510 · Received November 15, 2016

    Report

    Report Number
    2183870-2016-00662
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 17, 2016
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K110319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE THE EVERCROSS PTA BALLOON CATHETER. IT WAS REPORTED THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON DUE TO A BLOCKAGE. THE BALLOON WAS DEFLATED USING A PRESSURE PUMP AND REMOVED FROM THE PATIENT. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752780 EVERCROSS 035 CATHETER, PERCUTANEOUS DQY COVIDIEN AB35W06120135 A212693

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR