BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 16325876 · Received February 8, 2023

    Report

    Report Number
    1721279-2023-00020
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 1, 2013
    Report Date
    February 8, 2023
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT''S DOB, AGE UNK. PATIENT''S GENDER UNK. PATIENT''S WEIGHT UNK. PATIENT''S ETHNICITY/RACE UNK. RELEVANT TESTS/LABORATORY DATA UNK. OTHER RELEVANT HISTORY UNK. SPECIFIC PHYSICIAN INFORMATION UNK. HOWEVER, JOURNAL ARTICLE WAS AUTHORED BY A PHYSICIAN. THIS EVENT WAS CAPTURED FROM INFORMATION CONTAINED WITHIN A JOURNAL ARTICLE WITH LIMITED PRODUCT AND CASE DETAIL AVAILABLE. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. DEVICE MANUFACTURE DATE UNK BECAUSE LOT NUMBER UNK. PERFORATION OF VESSELS IS A KNOWN RISK OF COMPLICATION WITH USE OF THE LASER (GLIDELIGHT) DEVICE. 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 ON 12JAN2023, ACCEPTED AFTER REVISION ON 22AUG2022 (ELSEVIER, JOURNAL OF CARDIOLOGY, (2023) 111-116), TITLED "SURGICAL EXTRACTION OF CARDIAC IMPLANTABLE ELECTRONIC DEVICE LEADS BASED ON A HEART TEAM APPROACH". THE AIM OF THIS STUDY WAS TO INVESTIGATE OUTCOMES OF SURGICAL LEAD EXTRACTION (SLE), AND TO CLARIFY THE ESSENTIAL POINTS OF A HEART TEAM APPROACH IN PROVIDING THE OPTIMAL TREATMENT, AND MAINTAINING MEDICAL SAFETY POLICIES. THE ARTICLE IDENTIFIED 384 CONSECUTIVE PATIENTS BETWEEN 2013-2021 AT A SINGLE INSTITUTION UNDERGOING TRANSVENOUS LEAD EXTRACTIONS (TVLE). THE SPECTRANETICS EXCIMER LASER SYSTEM AND OTHER LEAD EXTRACTION DEVICES (SUCH AS COOK MEDICAL EVOLUTION RL ROTATION) WERE USED IN THE EXTRACTION PROCEDURES; THEREFORE, SPECIFIC DEVICES USED DURING THE PROCEDURE COULD NOT BE DETERMINED. SLE WAS PROPOSED AS THE PRIMARY PROCEDURE FOR 21 PATIENTS. FOR THE 363 REMAINING PATIENTS, BLEEDING COMPLICATIONS WERE OBSERVED IN 5 EVENTS. IN 4 OF THE ADVERSE EVENTS, THERE WAS INADEQUATE CASE DETAIL TO IMPLICATE A SPECIFIC DEVICE AS CAUSING OR CONTRIBUTING TO THE INJURY. HOWEVER, IN 1 EVENT, THE STUDY REPORTED A LARGE PSEUDOANEURYSM WAS OBSERVED IN THE LEFT SHOULDER AFTER TVLE BECAUSE THE LEFT SUBCLAVIAN VEIN AND ARTERY WERE PERFORATED BY THE LASER SHEATH DURING THE PROCEDURE. SURGICAL REPAIR OF THE PERFORATIONS WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. IT COULD NOT BE DETERMINED WHICH LASER SHEATH WAS USED DURING THE PROCEDURE, BUT THE SPECTRANETICS EXCIMER LASER SYSTEM WAS IN USE. THIS REPORT IS CAPTURING THE SPECTRANETICS GLIDELIGHT LASER SHEATH (ONE OF TWO TYPES OF LASER DEVICES COMPATIBLE WITH THE EXCIMER LASER SYSTEM), WHICH WAS IN USE WHEN THE PERFORATIONS OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE LASER DEVICE IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2223664 SPECTRANETICS GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention LEAD(S) MANUFACTURER/TYPE UNK| OTHER DEVICES MANUFACTURER/TYPE UNK| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM