BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELCA LASER SHEATH

    MDR report key: 3140758 · Received May 31, 2013

    Report

    Report Number
    1721279-2013-00080
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT INFORMATION WAS ANNOUNCED IN THE KANTO KOSHINNETSU AREA MEETING OF CVIT(JAPANESE ASSOCIATION OF CARDIO VASCULAR INTERVENTION AND THERAPEUTICS) ON 11MAY2013. AN ADVERSE EVENT OCCURRED DURING PCI, THE INJURY WAS PERFORATION OF LAD. THIS PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS STARTED WITH INTRA-AORTIC BALLOON PUMP (IABP). THE PHYSICIAN NOTICED A GIANT THROMBUS AT THE LEFT MAIN TRUNK (LMT); HE TRIED TO ASPIRATE IT WITH AN ASPIRATION CATHETER; HOWEVER, HE WAS NOT ABLE TO ASPIRATE IT. THE PHYSICIAN BEGAN USING A 1.4MM ELCA RX CATHETER. HE COMPLETED A GIANT THROMBUS REMOVAL. AFTER USING A 1.4MM ELCA RX CATHETER, HE NOTICED PERFORATION AT THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THIS INJURY WAS TREATED WITH A PERFUSION BALLOON CATHETER AND GRAFT MASTER STENT (ABBOTT). THE PATIENT RECOVERED, AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242192 ELCA LASER SHEATH ELCA RX LPC SPECTRANETICS CORPORATION 114-009 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R CVX-300 EXCIMER LASER (SN (B)(4))