BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 1852184 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01849
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: OTHER - ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A 2.0MM DIAMETER X 12MM LENGTH SPRINTER LEGEND RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER IN TO A PATIENT TO PRE-DILATE A LESION WITH STENOSIS GREATER THAT 70%. HOWEVER, IT WAS REPORTED THAT WHEN THE DEVICE WAS INSERTED IN THE PATIENT AND NEGATIVE PRESSURE WAS APPLIED, BLOOD STARTED LEAKING IN THE INFLATION DEVICE. THE PATIENT IS REPORTED TO BE STABLE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: A LARGE HOLE HAD A RAISED FLAP OF BALLOON MATERIAL WERE EVIDENT OVER THE PROXIMAL INNER SHAFT MARKER BAND. THE FLAP OF MATERIAL WAS LOCATED ON THE DISTAL SIDE OF THE HOLE. THE BALLOON FOLDS WERE EVIDENT AND INTACT ALONG THE WORKING LENGTH OF THE BALLOON INDICATING THAT THE BALLOON HAD NOT BEEN INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 11026312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK