BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3831638 · Received May 26, 2014

    Report

    Report Number
    9612164-2014-00539
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (IFU CONTRAVENED - KINKED DEVICE USED IN PATIENT). USED IN PATIENT). (B)(4)

    Description of Event or Problem · 1

    IT WAS INTENDED TO USE A SPRINTER LEGEND 2.50 X 12 MM BALLOON TO TREAT A 10 MM LESION IN THE PDA WHICH HAD MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 95% STENOSIS. THE DEVICE WAS REMOVED FROM THE PACKAGING WITH NO ISSUES NOTED, BUT DURING INSPECTION IT WAS NOTED THAT THE DISTAL SHAFT WAS KINKED. NEGATIVE PREP WAS THEN PERFORMED. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. THE BALLOON WAS THEN INFLATED AT THE LESION BUT COULD NOT BE DEFLATED. THE INFLATED BALLOON WAS REMOVED WITHOUT INCIDENCE. AN UNKNOWN STENT WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309896 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 208119552

    Patients

    Seq Age Sex Outcome Treatment
    1