BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC SPRINTER RX BALLOON DILATATION CATHETER

    MDR report key: 2192819 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00767
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS/CONCLUSIONS: GUIDEWIRE. EVAL SUMMARY: THE DEVICE WAS RETURNED FOR EVAL. A 0.014" MANDREL WOULD NOT PASS THROUGH INNER MOST LIKELY DUE TO HARDENED BLOOD OR CONTRAST. THE BALLOON HAD BEEN INFLATED. THERE WAS A HOLE LOCATED JUST DISTAL TO THE BALLOON BOND. BLOOD AND CONTRAST WERE PRESENT INSIDE THE BALLOON AND INFLATION LUMEN. THE DEVICE WAS PLACED IN A WATER BATH TO SOFTEN THE HARDENED BLOOD AND CONTRAST. THE DISTAL SHAFT WAS CUT JUST DISTAL TO THE EXCHANGE JOINT AND ATTACHED TO AN INFLATION DEVICE. NEGATIVE PREP WAS PERFORMED AND A CONTINUOUS FLOW OF BUBBLES WAS NOTED. THE BALLOON COULD NOT BE INFLATED DUE TO THE HOLE LOCATED JUST DISTAL TO THE BALLOON BOND. THE INNER WAS REMOVED FROM THE OUTER. A PROTRUDING HOLE WAS LOCATED ON THE INNER SHAFT APPROX 2MM PROXIMAL TO THE PROXIMAL MARKER BAND.

    Description of Event or Problem · 1

    A NC SPRINTER BALLOON DILATATION CATHETER DIAMETER 3MM LENGTH 12MM WAS BEING USED TO PRE-DILATE A LESION IN THE LEFT MAIN TRUNK. PRIOR TO USE THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. THE DEVICE WAS ADVANCED OVER THE LESION AND SUCCESSFULLY INFLATED AND DEFLATED. THE DEVICE WAS WITHDRAWN FROM THE VESSEL AND RE-LOADED BACK INTO THE GUIDEWIRE. DURING THIS ATTEMPT THE PHYSICIAN NOTED THAT THE WIRE CAME THROUGH THE BALLOON. THE PHYSICIAN STOPPED USING THE PRODUCT AND USED A NON-MEDTRONIC DEVICE AS A REPLACEMENT. THE PHYSICIAN CONFIRMED THERE WAS A HOLE ON THE BALLOON BUT COULD NOT CONFIRM THE HOLE ON THE WIRE LUMEN. NO HEALTH HAZARD WAS CAUSED TO THE PT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC SPRINTER RX BALLOON DILATATION CATHETER LOX MEDTRONIC IRELAND NA 11205815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK