BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 4781149 · Received May 19, 2015

    Report

    Report Number
    9612164-2015-00712
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 20, 2015
    Report Date
    June 19, 2015
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT (NO ISSUES WITH THE DEVICE PRIOR TO USE, THEREFORE THE ISSUE MOST LIKELY OCCURRED DURING THE PROCEDURE). EVALUATION CONCLUSIONS: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (NO ISSUES WITH THE DEVICE PRIOR TO USE, THEREFORE, THE ISSUE MOST LIKELY OCCURRED DURING THE PROCEDURE).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE UNDETERMINED); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE NOT RETURNED). EVALUATION CONCLUSIONS: UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RETURNED); (ROOT CAUSE UNDETERMINED). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A SPRINTER LEGEND RX BALLOON TO PRE-DILATE A LESION IN THE LAD. NO ISSUES WAS NOTED WITH THE DEVICE BEFORE USE. NEGATIVE PREP WAS PERFORMED ON THE DEVICE WITH NO ISSUES IDENTIFIED. IT IS REPORTED THAT THE BALLOON RUPTURED DURING POSITIONING. THE DEVICE DID NOT EXCEED RATED BURST PRESSURE. THE PHYSICIAN USED ANOTHER SPRINTER BALLOON OF SAME SIZE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327215 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 208614041

    Patients

    Seq Age Sex Outcome Treatment
    1