BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 2160951 · Received June 16, 2011

    Report

    Report Number
    9612164-2011-00584
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC TIJUANA
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(46). EVAL RESULTS: (ROOT CAUSE CANNOT BE DETERMINED). EVAL SUMMARY: THE HYPOTUBE WAS BENT AND WAVY. THERE WAS A HARDENED CRYSTALLIZED SUBSTANCE PRESENT INSIDE THE INFLATION LUMEN. THE DISTAL TIP WAS DAMAGED. THE BALLOON BOND WAS STRETCHED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION IN THE LAD. THE LESION WAS 90% STENOSED. A SPRINTER LEGEND RAPID EXCHANGE (RX) BALLOON CATHETER HAS BEEN USED TO PRE-DILATE THE LESION. THE DEVICE WAS INFLATED TO EIGHT ATMOSPHERES BUT THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON. MANUAL ASPIRATION AND INDEFLATOR WERE USED IN AN ATTEMPT TO DEFLATE THE BALLOON. THIS WAS UNSUCCESSFULLY AND THE PHYSICIAN WITHDREW THE BALLOON MANUALLY WITHOUT ANY FURTHER ISSUES. THE DEVICE WAS PREPPED AND INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THERE WAS NO PT INJURY AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINTER LEGEND RX BALLOON DILATATION CATHETER LOX MEDTRONIC TIJUANA NA 11403431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK