BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3151270 · Received June 7, 2013

    Report

    Report Number
    9612164-2013-00608
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    January 15, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    K103095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED). CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (ROOT CAUSE OF REPORTED EVENT WAS MOST LIKELY PROCEDURAL RELATED).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A SPRINTER LEGEND BALLOON TO TREAT A LESION IN THE RCA WITH 70-100% STENOSIS, MODERATE TORTUOSITY AND MODERATE TO SEVERE CALCIFICATION. IT WAS REPORTED THAT THE DEVICE BECAME CAUGHT ON THE GUIDEWIRE AND WAS DAMAGED. THE GUIDEWIRE AND BALLOON WERE REMOVED. AN ATTEMPT WAS MADE TO USE ANOTHER SPRINTER LEGEND BALLOON, HOWEVER THIS ALSO BECAME CAUGHT ON THE GUIDEWIRE AND WAS DAMAGED. PATIENT STATUS POST PROCEDURE WAS OK AND NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE PROCEDURAL GUIDEWIRE WAS LOCKED IN THE INNER LUMEN OF THE DEVICE WITH 2.2CM OF THE GUIDEWIRE EXITING THE DISTAL TIP. THERE WAS BUNCHING VISIBLE ALONG THE DISTAL SHAFTS. THE BALLOON MATERIAL WAS BUNCHED WITH A TEAR VISIBLE IN THE MID TO DISTAL SECTION OF THE BALLOON. THE TRANSITION SHAFT AND COREWIRE WERE KINKED DISTAL TO THE GUIDEWIRE ENTRY PORT. THE DISTAL TIP WAS BUNCHED AND DAMAGED. NUMEROUS COILS ALONG THE GUIDEWIRE WERE RAISED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252070 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC IRELAND 0005836118

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR PLAVIX, ASPIRIN