BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX BALLOON DILATATION CATHETER

    MDR report key: 1963850 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02616
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 25, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: NO ROOT CAUSE OF THE EVENT CAN BE DETERMINED BASED ON INFO AVAILABLE. EVAL SUMMARY: THERE WAS NO EVIDENCE OF DAMAGE TO THE HOOP AND NO RESISTANCE FELT UPON REMOVAL OF THE DEVICE. THE DEVICE WAS SLIGHTLY WAVY MOST LIKELY AS A RESULT OF HANDLING. A CLEAR RESIDUE WAS PRESENT INSIDE THE INFLATION LUMEN. THE BALLOON BOND WAS STRETCHED. THE BALLOON WAS PARTIALLY INFLATED. NO FURTHER DAMAGE NOTED.

    Description of Event or Problem · 1

    A 2.0MM DIAMETER X 15MM SPRINTER LEGEND RAPID EXCHANGE (RX) WAS INFLATED IN THE LCX EXHIBITING 100% STENOSIS. NO ISSUES WERE NOTED DURING PREPARATION AND INSPECTION OF THE RELEVANT DEVICE PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT IT TOOK LONGER THAN USUAL TO INFLATE THE BALLOON. ALSO, THE BALLOON DID NOT FULLY DEFLATE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY FROM THE PT AND A COMPETITOR'S PRODUCT WAS USED INSTEAD. NO HEALTH HAZARD WAS CAUSED TO THE PT 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 CARDIOVASCULAR GALWAY NA 10473460

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR