BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS GLIDELIGHT LASER SHEATH

    MDR report key: 12513265 · Received September 22, 2021

    Report

    Report Number
    1721279-2021-00177
    Event Type
    Injury
    Date Received
    September 22, 2021
    Date of Event
    May 1, 2010
    Report Date
    August 25, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION UNK. RELEVANT TESTS/LABORATORY DATA UNK. OTHER RELEVANT HISTORY UNK. DEVICE MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE AND UDI UNK. PHYSICIAN INFORMATION UNK. THE DEVICE WAS DISCARDED, THEREFORE NO INVESTIGATION COULD BE PERFORMED. DEVICE MANUFACTURE DATE UNK BECAUSE LOT NUMBER UNK.

    Description of Event or Problem · 1

    A PHILIPS EMPLOYEE BECAME AWARE ON 25 AUG 2021 OF AN ARTICLE PRESENT IN PLOS ONE, A PEER-REVIEW JOURNAL FROM THE DEPARTMENT OF CARDIAC SURGERY, HEIDELBERG UNIVERSITY HOSPITAL, GERMANY (ARTICLE ACCEPTED 04 MAY 2021; PUBLISHED 14 MAY 2021). THE JOURNAL ARTICLE, TITLED "THE USE OF LASER LEAD EXTRACTION SHEATH IN THE PRESENCE OF SUPRA-CARDIAC OCCLUSION OF THE CENTRAL VEINS FOR CARDIAC IMPLANTABLE ELECTRONIC DEVICE LEAD UPGRADE OR REVISION", INVOLVES A STUDY OF 106 PATIENTS THAT UNDERWENT PERCUTANEOUS LASER LEAD EXTRACTION (LLE) WITH LEAD REVISION AND/OR UPGRADE. THE STUDY TOOK PLACE FROM MAY 1, 2010 TO JANUARY 1, 2020, SO THE PROCEDURE DATE USED FOR THIS REPORT IS 01 MAY 2010. IT IS UNKNOWN THE INDICATION FOR EXTRACTION OR HOW MANY LEADS WERE BEING EXTRACTED. THE ARTICLE STATED THAT SPECTRANETICS 14F AND 16F GLIDELIGHT LASER SHEATHS WERE IN USE, ALONG WITH SPECTRANETICS LEAD LOCKING DEVICES (LLDS). ONE OF THE PATIENTS EXPERIENCED AN INTRAOPERATIVE SUPERIOR VENA CAVA (SVC) TEAR AND WAS TREATED BY IMMEDIATE THORACOTOMY AND SURGICAL REPAIR. THIS REPORT CAPTURES THE GLIDELIGHT DEVICE (MODEL UNK) IN USE WHEN THE SVC TEAR OCCURRED, REQUIRING INTERVENTION. 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
    1412600 SPECTRANETICS GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention