BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2093346 · Received April 19, 2011

    Report

    Report Number
    9612164-2011-00264
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS, CONCLUSION: (HEAVY CALCIFICATION).

    Description of Event or Problem · 1

    A 1.25 MM DIAMETER X 20 MM LENGTH SPRINTER LEGEND RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER WAS USED IN A PT TO CROSS A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING INFLATION, THE DEVICE WOULD NOT HOLD PRESSURE. THE ACCOUNT CONFIRMS THAT NO ABNORMALITIES WERE NOTED DURING PREPARATION OF THE DEVICE PRIOR TO INITIAL USE. THE LESION WAS HEAVILY CALCIFIED. A SECOND ATTEMPT WAS MADE USING A 2.0 MM DIAMETER X 20 MM LENGTH SPRINTER LEGEND RAPID EXCHANGE (RX) BALLOON DILATATION CATHETER WITH THE SAME RESULT. NO OTHER CLINICAL SEQUELAE WERE REPORTED. (REF MFR# 9612164-2011-00263).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC IRELAND NA 10921221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK