BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 14F GLIDELIGHT LASER SHEATH

    MDR report key: 12368705 · Received August 25, 2021

    Report

    Report Number
    1721279-2021-00160
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    August 9, 2021
    Report Date
    August 9, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT UNK. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO EXTRACT A RIGHT VENTRICULAR (RV) ICD LEAD DUE TO NON-FUNCTION. THE LEAD WAS PREPPED WITH A SPECTRANETICS LEAD LOCKING DEVICE (LLD) TO MAINTAIN TRACTION DURING THE PROCEDURE. THE PHYSICIAN THEN USED A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ALONG WITH A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH. HE PROCEEDED DOWN INTO THE SUBCLAVIAN VEIN AND INTO THE LEFT INNOMINATE VEIN. AS THE GLIDELIGHT DEVICE REACHED THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION, THE PATIENT'S BLOOD PRESSURE DROPPED. A HEMOTHORAX WAS NOTICED ON IMAGING AND A RESCUE BALLOON WAS DEPLOYED IMMEDIATELY. THE CARDIOTHORACIC (CT) SURGEON WAS CALLED IN AND A STERNOTOMY WAS PERFORMED. TWO SVC TEARS APPROXIMATELY 4-5 MM LONG WERE DISCOVERED AND WERE SUCCESSFULLY REPAIRED. THE PHYSICIAN ATTEMPTED TO UNLOCK THE LLD FROM THE RV LEAD AND WAS UNSUCCESSFUL; THE RV LEAD, ALONG WITH THE LLD, WERE CUT AND CAPPED AND LEFT IN THE PATIENT (REFERENCE MDR #1721279-2021-00162). THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE GLIDELIGHT DEVICE WHICH WAS IN USE AND SVC PERFORATIONS OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265196 SPECTRANETICS 14F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-302 FGB21D24A 00813132020330

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R