BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS ELCA LASER SHEATH

    MDR report key: 3272644 · Received August 8, 2013

    Report

    Report Number
    1721279-2013-00119
    Event Type
    Injury
    Date Received
    August 8, 2013
    Date of Event
    July 26, 2013
    Report Date
    August 7, 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 ADVERSE EVENT OCCURRED DURING PCI PROCEDURE USING 2.0 MM ELCA CATHETER. A CORONARY ARTERY PERFORATION OCCURRED. THE PROCEDURE APPROACHED FROM FEMORAL ARTERY. THE PHYSICIAN APPLIED A PERFUSION BALLOON CATHETER TO TREAT BLEEDING BECAUSE OF PERFORATION OF RCA SEG. 1. PATIENT RECOVERED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373263 SPECTRANETICS ELCA LASER SHEATH ELCA LPC SPECTRANETICS CORPORATION 120-009 FLL12J05G

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R CVX-300 EXCIMER LASER ((B)(4))