BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 5958706 · Received September 17, 2016

    Report

    Report Number
    1721279-2016-00129
    Event Type
    Injury
    Date Received
    September 17, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PROCEDURE WAS TO REMOVE A NON-FUNCTIONING ICD LEAD, GUIDANT 0140 FROM THE RIGHT VENTRICLE. SPORADIC CALCIFICATION WAS NOTED IN THE DEVICE POCKET. A 14 FR GLIDELIGHT LASER SHEATH WAS ADVANCED TO THE MID INNOMINATE VEIN THEN PROGRESS STALLED. A VISISHEALTH WAS USED FOR SLIGHT ADVANCEMENT. THE GLIDELIGHT WAS UPSIZED TO 16 FR AND LASED THROUGH BINDING SITES NEAR THE SVC/RA JXN. ONCE THE BINDING SITE WAS LASED THE PATIENT EXPERIENCED HYPOTENSIVE VITAL SIGNS. INTERVENTION BEGAN TO REPAIR A SMALL HOLE IN THE SVC-RA JXN. PATIENT SURVIVED THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609926 SPECTRANETICS GLIDELIGHT LASER SHEATH GLIDELIGHT MFA SPECTRANETICS 500-303 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R CARDIAC LEAD GUIDANT 0140 (IMPL. 74 MOS.)| SPECTRANETICS 14 FR. GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE| SPECTRANETICS VISISHEATH DILATOR SHEATH