BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12174138 · Received July 15, 2021

    Report

    Report Number
    1721279-2021-00128
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    June 17, 2021
    Report Date
    June 17, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE THREE LEADS: A LEFT VENTRICULAR (LV), RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. THE PHYSICIAN CHOSE A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO AID IN LEAD EXTRACTION. ACCORDING TO THE REPORT, THE RA LEAD WAS REMOVED FIRST WITH NO ISSUE. NEXT, THE LV LEAD WAS REMOVED. IT WAS REPORTED AT THAT TIME THAT THE PATIENT'S BLOOD PRESSURE WAS SLOWLY DROPPING AND ANESTHESIA BEGAN TREATING THE PATIENT. APPROXIMATELY 8 MINUTES FROM THE TIME THE LV LEAD WAS REMOVED, FLUID WAS NOTICED IN THE RIGHT PLEURAL SPACE VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), WITH NO PERICARDIAL EFFUSION PRESENT. THE TEAM ASSUMED A HIGH SUPERIOR VENA CAVA (SVC) TEAR HAD OCCURRED. A TEMPORARY PACING WIRE WAS PLACED, AND THE CARDIOTHORACIC (CT) SURGEON JOINED THE PROCEDURE. THE DECISION WAS MADE TO REMOVE THE REMAINING RV LEAD DUE TO THE PATIENT'S SYSTEMIC INFECTION, WHICH WAS SUCCESSFULLY REMOVED. USING CONTRAST, THERE WAS NO EVIDENCE OF TEAR FROM THE MID SVC AND BELOW, SO CONTRAST WAS USED AGAIN, SHOWING A SMALL TEAR IN THE INNOMINATE/SVC JUNCTION. RESCUE EFFORTS BEGAN, INCLUDING PAGING VASCULAR SURGERY TO PUT IN A COVERED STENT, AND USING A RESCUE BALLOON. A HEMOTHORAX AND COLLAPSED RIGHT LUNG WERE EVIDENT ON FLUOROSCOPY, AND A WALL STENT WAS PLACED, WITH APPROXIMATELY 90% OF THE TEAR BEING COVERED. HOWEVER, THERE WAS NO UPWARD TREND IN THE PATENT'S' BLOOD PRESSURE. VASCULAR SURGERY THEN BALLOONED THE STENT FOR BETTER RESULTS, AND THE CT SURGEON SCRUBBED IN, DRAINED THE FLUID IN THE LUNGS. WITH THE FLUID DRAINED AND LUNGS EXPANDING, THE PATIENT'S BLOOD PRESSURE REBOUNDED. A COVERED STENT WAS THEN PLACED AND THE TEAR WAS COMPLETELY CLOSED OFF. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE GLIDELIGHT DEVICE WHICH WAS BEING USED IN THE AREA IN WHICH AN SVC TEAR OCCURRED, REQUIRING MEDICAL INTERVENTION. THERE IS NO REPORTED MALFUNCTION OF THE GLIDELIGHT DEVICE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069693 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 FGB20L30A 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R MEDTRONIC 4076 RA PACING LEAD| MEDTRONIC 6935M RV ICD LEAD| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICES| SPECTRANETICS VISISHEATH DILATOR SHEATH| ST. JUDE MEDICAL 1458Q LV PACING LEAD