BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12207797 · Received July 21, 2021

    Report

    Report Number
    1721279-2021-00133
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020330
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LABORATORY DATA UNAVAILABLE FROM FACILITY. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO OCCLUSION AND NON FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED IN THE RV LEAD TO ACT AS A TRACTION PLATFORM TO AID IN THE LEAD'S EXTRACTION. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ALONG WITH A SPECTRANETICS VISISHEATH DILATOR SHEATH TO ATTEMPT EXTRACTION. HOWEVER, THE REPORT STATED THAT THERE WAS NOT AN ADEQUATE RAIL (STRAIGHTENING OF THE LEAD TO PROVIDE A PATH ON WHICH TO ADVANCE THE GLIDELIGHT AND VISISHEATH). DURING THIS TIME, IT WAS REPORTED THAT THE SUBCLAVIAN VEIN WAS DAMAGED AND BLOOD WAS GETTING INTO THE LUNGS. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PRESSURE TO THE INJURY. THE SURGEON WAS CALLED AND QUICKLY PUT IN A CHEST TUBE TO DRAIN. IT WAS REPORTED THAT THE BLEED IN THE SUBCLAVIAN VEIN WAS STOPPED BY PRESSURE. THE RV LEAD WAS ABANDONED WITHIN THE PATIENT. THE PATIENT WAS SENT TO ICU AND FROM THE REPORT, WAS DOING WELL. IT WAS REPORTED THAT THE LLD WAS REMOVED FROM THE RV LEAD PRIOR TO ABANDONING THE RV LEAD IN THE PATIENT. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE GLIDELIGHT DEVICE WHICH USED WHEN THE SUBCLAVIAN PERFORATION WAS DISCOVERED REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103274 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 FGB21E05A 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention