BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 6140227 · Received December 1, 2016

    Report

    Report Number
    1721279-2016-00183
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS WAS A PROCEDURE TO EXTRACT THREE CARDIAC LEADS DUE TO A SYSTEM/CIED POCKET INFECTION. A SPECTRANETICS CORP GLIDELIGHT LASER SHEATH WAS SELECTED TO REMOVE THE LEADS. UPON EXTRACTION OF THE FINAL RV LEAD, THE PATIENT EXPERIENCED HEMODYNAMIC CHANGES. THE SURGEON IMMEDIATELY PERFORMED A PERICARDIAL WINDOW AND DRAINED THE PERICARDIUM OF BLOOD. A STERNOTOMY WAS THEN PERFORMED WHICH REVEALED A LACERATION AT THE SVC RA JUNCTION. THE INJURY WAS REPAIRED AND THE PATIENT SURVIVED THE PROCEDURES. THIS REPORT IS BEING MADE AGAINST THE GLIDELIGHT AS A POTENTIAL MECHANISM OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788344 SPECTRANETICS GLIDELIGHT LASER SHEATH GLIDELIGHT MFA SPECTRANETICS 500-303 FGC16H22A

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R CARDIAC LEAD, MDT 6947 (IMPL.48MOS.)| CARDIAC LEAD, SJM 1688 (IMPL.48MOS.)| CARDIAC LEAD, SJM 1688(IMPL.48MOS.)| SPECTRANETICS GLIDELIGHT LASER SYSTEM