BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 12555035 · Received September 30, 2021

    Report

    Report Number
    1721279-2021-00183
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    January 1, 2012
    Report Date
    September 8, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S DATE OF BIRTH UNK. PATIENT'S WEIGHT UNK. PATIENT'S ETHNICITY/RACE UNK. RELEVANT TESTS/LABORATORY DATA UNK. OTHER RELEVANT HISTORY UNK. DEVICE MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE AND UDI UNK. PHYSICIAN AND FACILITY INFORMATION UNK. THIS EVENT WAS CAPTURED FROM INFORMATION CONTAINED WITHIN A JOURNAL ARTICLE, WITH LIMITED PRODUCT AND CASE DETAIL AVAILABLE. THE DEVICE WAS NOT RETURNED TO MANUFACTURER, THEREFORE NO INVESTIGATION COULD BE COMPLETED. DEVICE MANUFACTURE DATE UNK BECAUSE LOT NUMBER UNK.

    Description of Event or Problem · 0

    A PHILIPS EMPLOYEE BECAME AWARE OF A JOURNAL ARTICLE ON 08 SEPTEMBER 2021, PUBLISHED 30 SEPTEMBER 2013 TITLED, "INITIAL EXPERIENCE OF PACEMAKER AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD EXTRACTION WITH THE NEW GLIDELIGHT 80 HZ LASER SHEATHS". THIS ARTICLE IDENTIFIED PATIENTS UNDERGOING LEAD EXTRACTION BETWEEN JANUARY 2012 AND APRIL 2013; THEREFORE THE PROCEDURE DATE WAS IDENTIFIED AS (B)(6) 2012. THE EXTRACTION INDICATION AND LOCATION OF THE LEADS IS UNK. THE ARTICLE DESCRIBED AN ADVERSE EVENT IN WHICH AN SVC TEAR OCCURRED DURING USE OF A SPECTRANETICS GLIDELIGHT LASER SHEATH. THE ARTICLE STATED, "THE MAJOR COMPLICATION WAS A LATERAL PERFORATION OF THE SUPERIOR VENA CAVA (SVC) DURING THE LEAD EXTRACTION PROCEDURE IN A (B)(6) MALE PATIENT WITH TWO ACTIVE-FIXATION PM LEADS WHICH HAD BEEN IMPLANTED FOR 154 MONTHS. THE REASON FOR THE PERFORATION HAS PROBABLY BEEN A STRONG ADHESION OF ONE LEAD TO THE LATERAL PART OF THE SVC. AFTER STERNOTOMY, THE SVC WAS SUCCESSFULLY SUTURED WITHOUT CARDIOPULMONARY BYPASS AND WITHOUT FURTHER COMPLICATIONS." THIS REPORT CAPTURES THE GLIDELIGHT DEVICE IN USE WHEN THE SVC PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454448 SPECTRANETICS GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 2 PM LEADS MANUFACTURER MODEL AND LOCATION UNK| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM