BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 5778722 · Received July 8, 2016

    Report

    Report Number
    1721279-2016-00083
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    June 14, 2016
    Report Date
    June 14, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PRESENTED FOR EXTRACTION OF 16 YEAR OLD PACING LEADS DUE TO MALFUNCTION AND OCCLUSION. THE PATIENT HAS A HISTORY OF CVA, AFIB, HTN AND SICK SINUS SYNDROME. A TEMPORARY PACEMAKER WAS INSERTED PRIOR TO THE EXTRACTION PROCEDURE. THE ATRIAL LEAD WAS REMOVED. DURING EXTRACTION OF THE VENTRICLE LEAD THERE WAS SNOWPLOWING AT THE RA/SVC JXN, THE PHYSICIAN UPSIZED TO A 14 FR GLIDELIGHT LASER SHEATH THAT WAS ADVANCED TO THE CARDIAC APEX, LEAD RELEASED AFTER LASING. PT. EXPERIENCED A DROP IN BP. A PERICARDIAL TAP WAS DONE WHICH FOUND BLOOD. THERE WAS A TEAR AT THE APEX. A REPAIR WAS DONE, PATIENT WAS RE-IMPLANTED WITH NEW LEADS. PT. SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433846 SPECTRANETICS GLIDELIGHT LASER SHEATH GLIDELIGHT MFA SPECTRANETICS 500-302 FGB15K14A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R