BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 4251848 · Received November 14, 2014

    Report

    Report Number
    1721279-2014-00201
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    SPECTRANETICS CORPORTATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUCTIONS FOR USE STATE: THE SAFETY AND EFFECTIVENESS OF THE LASER SHEATH HAS NOT BEEN ESTABLISHED FOR THE FOLLOWING: LASER SHEATH ADVANCEMENT INTO THE CORONARY SINUS.

    Description of Event or Problem · 1

    LEAD MANAGEMENT CASE TO EXTRACT TWO LEADS DUE TO LOW THRESHOLD AND ELECTRICAL ABNORMALITIES. THE PHYSICIAN PREPPED BOTH LEADS WITH LLD EZS. THE RA LEAD (4549) WAS EXTRACTED SUCCESSFULLY USING THE 12F GLIDELIGHT AND VISISHEATH. THE 12F GLIDELIGHT HAD REACHED THE CORONARY SINUS ON THE LV LEAD (4470) WHEN THE BLOOD PRESSURE DROPPED. A PERICARDIAL WINDOW WAS PERFORMED; HOWEVER WAS UNSUCCESSFUL AS AN INTERVENTION SO A STERNOTOMY WAS ALSO PERFORMED DISCOVERING A VESSEL INJURY AT THE CORONARY SINUS. THE INJURY WAS REPAIRED BUT A PART OF THE LV LEAD WAS ABANDONED (THE LLD WAS NOT ABANDONED WITH THE REMAINDER OF THE LEAD). THE PATIENT SURVIVED THE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736304 SPECTRANETICS GLIDELIGHT LASER SHEATH 12F GLIDELIGHT MFA SPECTRANETICS CORPORTATION 500-301 FGA14D17A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R BSC 4549 CARDIAC LEAD (IMPL 96MO)| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE EZ X2| SPECTRANETICS VISISHEATH SMALL| BSC 4470 CARDIAC LEAD (IMPL 96MO)