BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS 16F GLIDELIGHT LASER SHEATH

    MDR report key: 12554837 · Received September 30, 2021

    Report

    Report Number
    1721279-2021-00180
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 2, 2021
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    MFA
    UDI-DI
    00813132020347
    PMA / PMN Number
    P960042 S069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S DATE OF BIRTH :UNK PATIENT'S WEIGHT: UNK. THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO INFECTION (BOTH LEADS WERE IMPLANTED (B)(6) 2009). SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION: AN LLD #2 WAS USED IN THE RA LEAD AND AN LLD EZ WAS USED IN THE RV LEAD. THE RA LEAD WAS SUCCESSFULLY REMOVED USING A COOK MEDICAL EVOLUTION DILATOR SHEATH AND A SPECTRANETICS GLIDELIGHT LASER SHEATH. THE PHYSICIAN THEN ATTEMPTED EXTRACTION OF THE RV LEAD. THE COOK MEDICAL EVOLUTION AND THE SPECTRANETICS GLIDELIGHT DEVICE WERE USED TO ADVANCE TO THE TIP OF THE RV LEAD. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED AN ACCUMULATION OF PERICARDIAL FLUID. IMMEDIATELY, A PERICARDIAL PUNCTURE WAS PERFORMED, BUT THE BLOOD PRESSURE DID NOT RETURN. A THORACOTOMY WAS PERFORMED AND A MYOCARDIAL PERFORATION WAS DISCOVERED, SPECIFIC LOCATION UNK. THE REPAIR TO THE INJURY WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. THE DOCTORS BELIEVE THE INJURY WAS DUE TO LASING. MANUFACTURER ATTEMPTED TO OBTAIN MORE SPECIFIC CASE DETAIL, BUT UNAVAILABLE FROM THE ACCOUNT DUE TO COVID-19. THIS REPORT CAPTURES THE GLIDELIGHT DEVICE IN USE WHEN THE MYOCARDIAL PERFORATION 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
    1453637 SPECTRANETICS 16F GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA THE SPECTRANETICS CORPORATION 500-303 FGC20B20A 00813132020347

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R BOSTON SCIENTIFIC 0185 RV ICD LEAD| BOSTON SCIENTIFIC 4470 RA PACING LEAD| COOK MEDICAL 11F EVOLUTION DILATOR SHEATH| COOK MEDICAL 9F EVOLUTION DILATOR SHEATH| SPECTRANETICS 12F GLIDELIGHT LASER SHEATH| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM| SPECTRANETICS LEAD LOCKING DEVICES