BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELCA LASER SHEATH

    MDR report key: 1991103 · Received February 11, 2011

    Report

    Report Number
    1721279-2011-00006
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    LPC
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE PERFORMED IN THE CARDIAC CATHETER LAB. THE MD BEGAN LASING WITH THE 0.9 ELCA, WITH INTENT TO LASE A LESION IN THE RCA. THE WIRE HAD INADVERTENTLY GONE INTO A BRANCH OF THE RCA AND A SMALL PERFORATION OF THE VESSEL WALL WAS NOTED. THE MD PULLED BACK THE CATHETER AND WIRE AND REINSERTED THEM, LASED THE RCA, BALLOON AND STENTED BOTH THE DISSECTION AND THE RCA. AN ECHO WAS PERFORMED AND THE PERFORATION WAS CONTAINED SUCCESSFULLY. THE PT RECOVERED AND WAS DISCHARGED HOME WITH NO REPORTED DEFICITS. THE DEVICE WAS NOT RETAINED FOR RETURN ANALYSIS BY THE HOSPITAL. SEVERAL, UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN FURTHER DEVICE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELCA LASER SHEATH ELCA 0.9 LPC SPECTRANETICS CORP. 110-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening CVX-300 EXCIMER LASER (B)(4)