BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 25193600 · Received May 15, 2026

    Report

    Report Number
    3007284006-2026-00235
    Event Type
    Injury
    Date Received
    May 15, 2026
    Date of Event
    November 30, 2016
    Report Date
    January 15, 2026
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE - MEAN AGE 66.2 ± 14.4 YEARS (N=151 PATIENTS) A3A) PATIENT SEX - 111/151 MALE, 40 FEMALES. A3B-A6) SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. B4) DATE LISTED IS THE DATE THE MANUFACTURER BECAME AWARE. B6) PATIENT INFORMATION REGARDING RELEVANT TESTS/LABORATORY - SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED. D4/H4) THE LOT NUMBER WAS NOT PROVIDED; THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL/CATALOG NUMBER, DEVICE SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. E) ALTHOUGH THE JOURNAL ARTICLE ORIGINATED FROM GERMANY, PHYSICIAN AND FACILITY INFORMATION ARE UNKNOWN; THEREFORE, THE INFORMATION LISTED IS THE CORRESPONDING AUTHOR OF THE JOURNAL ARTICLE. G3) THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW FOR LITERATURE MDR PER CAPA 207. H3) THE DEVICE WAS DISCARDED; THUS, NO PRODUCT INVESTIGATION WAS PERFORMED. H6) PER IFU, PERFORATION IS LISTED AS A POTENTIAL ADVERSE EVENT WITH USE OF THE GLIDELIGHT DEVICES. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE (PUBLISHED ONLINE 30NOV2016) ¿LEAD EXTRACTION WITH HIGH FREQUENCY LASER SHEATHS: A SINGLE-CENTRE EXPERIENCE¿. THE STUDY RETROSPECTIVELY AIMED TO REPORT ON CLINICAL EXPERIENCE WITH THE SPECTRANETICS GLIDELIGHT LASER SHEATHS. A TOTAL OF 151 PATIENTS WHO UNDERWENT TLE OF 292 LEADS WERE ENROLLED IN THE STUDY BETWEEN JANUARY 2012 AND AUGUST 2016. ALL EXTRACTIONS WERE SEQUENTIALLY TREATED WITH SPECTRANETICS GLIDELIGHT LASER SHEATHS. PROCEDURAL COMPLICATIONS INCLUDED 1 PERFORATION OF THE RIGHT ATRIAL APPENDAGE REQUIRING STERNOTOMY AND 1 POCKET HEMATOMA REQUIRING SURGICAL REVISION. ADDITIONALLY, A 75-YEAR-OLD MALE PATIENT WITH TWO ACTIVE FIXATION PACEMAKER LEADS, IMPLANTED FOR 154 MONTHS EXPERIENCED A SUPERIOR VENA CAVA (SVC) PERFORATION. AFTER AN EMERGENT STERNOTOMY, THE PATIENT WAS SUCCESSFULLY SUTURED WITHOUT CARDIOPULMONARY BYPASS OR FURTHER COMPLICATIONS (MDR #3007284006-2026-00234). ALTHOUGH GENERALIZED PATIENT INFORMATION/MEDICAL HISTORY WAS LISTED WITHIN THE JOURNAL ARTICLE, SPECIFIC PATIENT/CASE DETAIL WAS NOT PROVIDED FOR THE ADVERSE EVENTS INVOLVING THE SPECTRANETICS DEVICES. ADDITIONALLY, THE DATE OF PROCEDURE WAS NOT LISTED FOR THESE EVENTS; THEREFORE, 30NOV2016 HAS BEEN USED, THE DATE OF PUBLICATION. PECHA S, LINDER M, GOSAU N, CASTRO L, VOGLER J, WILLEMS S ET AL. LEAD EXTRACTION WITH HIGH FREQUENCY LASER SHEATHS: A SINGLE-CENTRE EXPERIENCE. EUR J CARDIOTHORAC SURG 2017;51:902¿5. HTTPS://ACADEMIC.OUP.COM/EJCTS/ARTICLE/51/5/902/2962997. THIS REPORT CAPTURES THE SERIOUS INJURIES THAT OCCURRED AFTER USE OF THE GLIDELIGHT DEVICE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518299 GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening LV LEADS (MANUFACTURER, MODEL, TYPE UNK)| RA LEADS (MANUFACTURER, MODEL, TYPE UNK)| RV LEADS (MANUFACTURER, MODEL, TYPE UNK)| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM