BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC SPRINTER RX BALLOON DILATATION CATHETER

    MDR report key: 1915306 · Received November 2, 2010

    Report

    Report Number
    2953200-2010-02116
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: OTHER (NO ROOT CAUSE OF THE EVENT CAN BE DETERMINED BASED ON INFO AVAILABLE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO USE A 3.5MM DIAMETER X 15MM LENGTH NC SPRINTER RAPID EXCHANGE (RX) TO POST DILATE A NEWLY DEPLOYED STENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED; HOWEVER, IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO INFLATE THE BALLOON OF THE RELEVANT DEVICE, IT DID NOT INFLATE. ON REMOVAL FROM THE PT, THE BALLOON CATHETER RUPTURED. THE PT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC SPRINTER RX BALLOON DILATATION CATHETER LOX MEDTRONIC CARDIOVASCULAR GALWAY NA 10708551

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK