BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3151271 · Received June 7, 2013

    Report

    Report Number
    9612164-2013-00609
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    January 15, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    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. PRIOR TO THIS, 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 2.6CM OF THE GUIDEWIRE EXITING THE DISTAL TIP. THERE WAS BUNCHING VISIBLE ALONG THE DISTAL SHAFT. THE BALLOON, DISTAL TIP AND A SECTION OF THE INNER SHAFT HAD DETACHED PROXIMAL TO THE BALLOON BOND. THE DETACHMENT SITE WAS JAGGED. THE GUIDEWIRE ENTRY PORT WAS PARTIALLY RIPPED. THE COREWIRE WAS KINKED DISTAL TO THE GUIDEWIRE ENTRY PORT. NUMEROUS COILS ALONG THE GUIDEWIRE WERE RAISED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252875 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 206130008

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR PLAVIX, ASPIRIN