BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXCIMER LASER ATHERECTOMY CATHETERS

    MDR report key: 1198945 · Received September 26, 2008

    Report

    Report Number
    1721279-2008-00030
    Event Type
    Other
    Date Received
    September 26, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 24, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT. IS (B) (6) MALE PATIENT WITH A HISTORY OF CAD AND DIABETES. THIS PT HAS HAD A PREVIOUS CORONARY PROCEDURE FOR CAD IN THE PAST (DATE UNKNOWN). PROCEDURE: (B) (6) WAS UTILIZING AN ELCA .9MM AND 1.4MM CATHETERS FOR THE ATHERECTOMY PROCEDURE, WHEN HE NOTED A DECREASE IN THE PT'S BLOOD PRESSURE AND DECREASED WALL MOVEMENT VIA FLUORO. IT WAS DETERMINED PERICARDIAL EFFUSION HAD OCCURRED, A COVERED STENT WAS APPLIED TO THE ARTERIAL PERFORATION AND THE BLEEDING WAS CONTROLLED. PATIENT OUTCOME: PROCEEDING PATIENT STABILIZATION AND TRANSFER TO THE ICU, THE PATIENT WAS DISCHARGED SEVERAL DAYS LATER. FAILURE ANALYSIS: THERE WERE NO DEVICES RETURNED FOR FAILURE ANALYSIS. HOWEVER, THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPECTRANETICS DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCIMER LASER ATHERECTOMY CATHETERS ELCA LPC SPECTRANETICS CORP. 110-004 / 114-009 UNK/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SPECTRANETICS CVX-300 LASER