BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2211118 · Received August 5, 2011

    Report

    Report Number
    9612164-2011-00883
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    K103095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION BY MEDTRONIC. THE PRESENCE OF A LEAK WAS CONFIRMED. THE DEVICE WOULD NOT HOLD PRESSURE WHEN AN ATTEMPT WAS MADE TO INFLATE IT USING AN INDEFLATOR. A SHORT RADIAL TEAR WAS LOCATED ON THE BODY OF THE BALLOON OVER THE PROXIMAL END OF THE INNER SHAFT MARKER. VISUAL INSPECTION CONFIRMED NO DAMAGE EVIDENT TO THE INNER SHAFT MARKER. (B)(4). RESULTS - (THE NATURE OF THE TEAR ON THE BALLOON CONSISTENT WITH THE BALLOON MATERIAL BEING PRESSED AGAINST STENOSIS OR CALCIUM AS THE BALLOON DURING DELIVERY AND/OR INFLATION), (DEVICE INFLATION EXCEEDED RATED BURST PRESSURE). CONCLUSIONS - (THE NATURE OF THE TEAR ON THE BALLOON CONSISTENT WITH THE BALLOON MATERIAL BEING PRESSED AGAINST STENOSIS OR CALCIUM AS THE BALLOON DURING DELIVERY AND/OR INFLATION), (DEVICE INFLATION EXCEEDED RATED BURST PRESSURE).

    Description of Event or Problem · 1

    A SPRINTER LEGEND RX BALLOON DILATATION CATHETER, LENGTH 20 MM, DIAMETER 1.25MM, WAS USED TO TREAT A LESION IN A PATIENT. IT WAS REPORTED THAT THE BALLOON WAS INFLATED FOR THE 3RD TIME TO 14ATMS AND IT BURST. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC IRELAND NA 0004537604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK