BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3931281 · Received July 14, 2014

    Report

    Report Number
    9612164-2014-00915
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    K103095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (DEVICE NOT RETURNED FOR EVALUATION). EVALUATION CONCLUSIONS: (ROOT CAUSE COULD NOT BE DETERMINED). (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, DEFORMATION PROBLEM. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO USE ONE (1) SPRINTER LEGEND BALLOON (1.25MM X 10MM) TO PRE-DILATE AN OCCLUDED LESION IN THE LCX BUT WHEN THE BALLOON WAS INFLATED TO 12ATM IT WAS REPORTED THAT THE BALLOON BURST. THE PHYSICIAN CHANGED TO A NEW DEVICE TO COMPLETE THE SURGERY. NO CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED. THE HYPOTUBE BOND HAD PULLED OUT FROM THE HYPOTUBE SHAFT. 3.5MM OF THE BOND WAS INTACT; THE DISTAL SECTION OF THE BOND AND TRANSITION SHAFT WAS STRETCHED. THE BALLOON WAS INFLATED TO 12 ATMS (RATED BURST PRESSURE) AND SUCCESSFULLY MAINTAINED PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410474 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 207791628

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR