BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 6114439 · Received November 18, 2016

    Report

    Report Number
    1721279-2016-10172
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED TO INCLUDE DEVICE AND PATIENT CODES.

    Description of Event or Problem · 1

    THIS (B)(6) FEMALE PRESENTED FOR EXTRACTION OF A DUAL-COIL MDT SPRINT FIDELIS (6949) LEAD. THE LEAD WAS PREPARED FOR EXTRACTION BY ATTEMPTING TO RETRACT THE HELIX, THIS WAS UNSUCCESSFUL. A SPECTRANETICS LEAD LOCKING DEVICE WAS INSERTED INTO THE MDT (6949) LEAD. A 14FR. GLIDELIGHT WAS USED FOR THE PROCEDURE. THE PATIENT EXPERIENCED HEMODYNAMIC CHANGES WHEN THE LASER REACHED THE RA. A SPECTRANETICS BRIDGE BALLOON WAS PLACED ON THE BACK TABLE AND THREADED UP THE FEMORAL WIRE THAT WAS PLACED PRE-OPERATIVELY. ONCE ADVANCED INTO THE SVC, THE BRIDGE GUIDEWIRE WAS INADVERTENTLY REMOVED, WHICH MAY CAUSE INSTABILITY OF THE BALLOON. THE BALLOON WAS INFLATED AND UNDER FLUOROSCOPY, CONFORMED TO THE SVC, HOWEVER PATIENT STATUS REMAINED UNCHANGED. CPR WAS BEGUN AS THE CARDIAC SURGEON ARRIVED. THE INJURY WAS DESCRIBED AS A TEAR OF THE SVC. DURING THE INTERVENTION, THE MDT 6949 LEAD WAS CUT AND REMAINS IN THE PATIENT. THE PATIENT DID NOT SURVIVE THE PROCEDURE. THE REPORT IS BEING MADE AGAINST THE GLIDELIGHT LASER SHEATH AS A POTENTIAL MECHANISM OF INJURY. ADDITIONAL REPORTS FOR THIS CASE; LEAD LOCKING DEVICE: 1721279-2016-00171 AND BRIDGE OCCLUSION BALLOON: 1721279-2016-00173.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763412 SPECTRANETICS GLIDELIGHT LASER SHEATH GLIDELIGHT MFA SPECTRANETICS 500-302 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death CARDIAC LEAD: LV UNKNOWN MFR. (IMPL.252 MOS)| CARDIAC LEAD: MDT 4524 (IMPL. 252 MOS.)| CARDIAC LEAD:MDT 6949 (IMPL.127 MOS.)| SPECTRANETICS CVX-300 LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICE