BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12217250 · Received July 23, 2021

    Report

    Report Number
    1721279-2021-00138
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    June 25, 2021
    Report Date
    June 25, 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
    AS
    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 COMMENCED TO REMOVE ONE RIGHT VENTRICULAR (RV) ICD LEAD DUE TO NON FUNCTION AND THE NEED FOR A NEW SYSTEM UPGRADE. A RIGHT ATRIAL (RA) AND SECOND RV PACING LEAD WERE PRESENT IN THE PATIENT AS WELL BUT WERE NOT TARGETED FOR EXTRACTION UNLESS THE PHYSICIAN DEEMED IT NECESSARY. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE THE TRACTION PLATFORM TO AID IN THE LEAD''S EXTRACTION. THE PHYSICIAN BEGAN BY CHOOSING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH PER SIZING RECOMMENDATIONS. THE GLIDELIGHT DEVICE WAS ABLE TO ADVANCE THROUGH FIBROUS TISSUE ON THE PROXIMAL COIL OF THE LEAD, THEN TRACKED DOWN TO THE PROXIMAL SUPERIOR VENA CAVA (SVC) REGION. AT THIS POINT, THE DEVICE JUMPED FORWARD SLIGHTLY. THE GLIDELIGHT LASED EASILY TO THE DISTAL COIL OF THE RV LEAD AND WAS ABLE TO GET THROUGH SOME FIBROUS TISSUE ON THE RV LEAD''S DISTAL COIL. AT THIS TIME, THE RV LEAD WAS SUCCESSFULLY REMOVED. IMMEDIATELY POST PROCEDURE, THERE WERE NO COMPLICATIONS NOTED. THE RE-IMPLANTATION OF A NEW SYSTEM TOOK PLACE WITH ALL LEADS FUNCTIONING WELL. HOWEVER, TEN MINUTES POST PROCEDURE, THE PATIENT''S BLOOD PRESSURE DROPPED AND CONTINUED TO FALL. PLEURAL EFFUSION WAS CONFIRMED, ALONG WITH CARDIAC TAMPONADE. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING A RESCUE BALLOON, BYPASS AND STERNOTOMY. THE SURGEON DISCOVERED A TEAR IN THE SVC. A BOVINE PATCH WAS USED TO REPAIR THE TEAR SUCCESSFULLY AND THE PATIENT SURVIVED THE PROCEDURE. IT WAS REPORTED THAT DURING FURTHER INSPECTION OF THE RV LEAD WHICH WAS REMOVED, SMALL FRAGMENTS OF TISSUE WERE PRESENT WITHIN THE COILS OF THE RV LEAD. ACCORDING TO REPORTS, THE PATIENT HAS REMAINED STABLE AND OFF VENTILATION. THE PHYSICIAN BELIEVES THE CAUSE OF THE SVC TEAR WAS MULTIFACTORIAL: THE PATIENT HAD REPORTEDLY BEEN SET UP FOR A FEMORAL BYPASS PRE SURGERY, LENGTH OF DWELL TIME OF THE RV ICD LEAD (96 MONTHS), NUMBER OF LEADS IMPLANTED, POSSIBLE STENOSIS IN THE SVC, AND FRAGILITY OF TISSUES AND OTHER MORBIDITY FACTORS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE GLIDELIGHT WHICH WAS IN USE WITHIN THE SVC DURING THE LEAD EXTRACTION AND A LIFE THREATENING SVC TEAR WAS DISCOVERED POST PROCEDURE, REQUIRING INTERVENTION. THERE IS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117329 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 FGB20G15A 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R