BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 3013599 · Received March 20, 2013

    Report

    Report Number
    1721279-2013-00033
    Event Type
    Death
    Date Received
    March 20, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE OR TO REMOVE ONE RV LEAD. THE LEAD WAS PREPPED WITH AN LLD-EZ. USING A 16F GLIDELIGHT, PHYSICIAN BEGAN TO EXTRACT THE RV LEAD (ST JUDE RIATA MODEL 1570, IMPLANT DATE: (B)(6) 2003. THE LEAD WAS SUCCESSFULLY EXTRACTED. THE ARTERIAL LINE SHOWED A DROP IN BP 3-4 MINUTES AFTER LASER WAS REMOVED FROM THE BODY. PHYSICIAN ATTEMPTED SUBXIPHOID WINDOW AS TREATMENT, BUT RECOGNIZED SVC TEAR. THE TEAR WAS REPAIRED BY STERNOTOMY BY SURGEON. PATIENT WAS PLACED ON A PUMP DUE TO THE EF BEING 10%. THE PHYSICIAN LATER STATED THAT THE EXTRACTION WAS PERFECT TECHNIQUE, BUT THE ANATOMY WAS ISSUE. PATIENT WAS TAKEN TO RECOVERY, BUT PASSED AWAY ABOUT 4 DAYS LATER DUE TO CARDIAC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115651 SPECTRANETICS GLIDELIGHT LASER SHEATH 16 F GLIDELIGHT MFA SPECTRANETICS CORPORATION 500-303 FGC13A18A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death CVX-300 EXCIMER LASER (SN (B)(4))| ST. JUDE MEDICAL 1570 LEAD| LLD-EZ