BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDELIGHT LASER SHEATH

    MDR report key: 18761684 · Received February 22, 2024

    Report

    Report Number
    3007284006-2024-00040
    Event Type
    Death
    Date Received
    February 22, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 28, 2024
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2): PATIENT''S DATE OF BIRTH, AGE UNK. A3): PATIENT''S GENDER UNK. A4): PATIENT''S WEIGHT UNK. A5A./5B.): PATIENT''S ETHNICITY/RACE UNK. B6): RELEVANT TESTS/LABORATORY DATA UNK. B7): OTHER RELEVANT HISTORY UNK. D4): DEVICE MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE, SERIAL NUMBER, AND UDI UNK. H3): THE DEVICE WAS DISCARDED, THUS NO INVESTIGATION COULD BE COMPLETED. H4): DEVICE MANUFACTURE DATE UNK BECAUSE LOT NUMBER UNK. H6): GREAT VESSEL PERFORATION AND DEATH ARE KNOWN RISKS OF COMPLICATION WITH USE OF THE 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.

    Additional Manufacturer Narrative · 0

    A2): PATIENT'S AGE POPULATED. A3): PATIENT'S GENDER POPULATED. A5B.): PATIENT'S RACE POPULATED. B5): EDITED TO POPULATE ADDITIONAL/CORRECTED INFORMATION. ADDITIONAL INFORMATION: CASE DETAIL, DEVICES IN USE. CORRECTED INFORMATION: NO RV AVULSION OCCURRED, AS REPORTED IN THE INITIAL MDR. B6): RELEVANT TESTS/LABORATORY DATA POPULATED. B7): OTHER RELEVANT HISTORY POPULATED. D10): TRACTION PLATFORMS, LEAD INFORMATION POPULATED. G3): ADDITIONAL/CORRECTED INFORMATION RECEIVED 23FEB2024. H6): ADDITION OF HECC CODE 3271. ADDITION OF HEIC CODES 4641 AND 4624. ALL OTHER CODES REMAIN APPLICABLE AS SUBMITTED WITHIN THE INITIAL MDR. 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.

    Additional Manufacturer Narrative · 0

    D4/H4): THE LOT NUMBER WAS NOT PROVIDED, THUS THE FOLLOWING INFORMATION IS UNKNOWN: MODEL NUMBER, CATALOG NUMBER, SERIAL NUMBER, UNIQUE ID, EXPIRATION DATE, AND MANUFACTURE DATE. 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 LEAD EXTRACTION PROCEDURE COMMENCED. LEAD LOCATION, EXTRACTION INDICATION, AND TRACTION PLATFORM UNK. A SPECTRANETICS GLIDELIGHT LASER SHEATH WAS USED TO TREAT THE PATIENT. DURING USE, A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. A RIGHT VENTRICULAR (RV) AVULSION WAS DISCOVERED AS WELL, BUT INFORMATION PROVIDED DID NOT IMPLICATE ANY DEVICE AS THE CAUSE FOR THE AVULSION. INTERVENTION TO REPAIR THE SVC PERFORATION UNK; HOWEVER, THE EVENT RESULTED IN THE PATIENT''S DEATH. THIS REPORT CAPTURES THE GLIDELIGHT IN USE WHEN THE SVC PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE DURING THE PROCEDURE.

    Description of Event or Problem · 0

    A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FRACTURE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. A SPECTRANETICS GLIDELIGHT LASER SHEATH WAS USED TO TREAT THE PATIENT. THE RA WAS ABLE TO BE REMOVED WITHOUT ISSUES. THE RV LEAD WAS REMOVED AS WELL; HOWEVER, AFTER REMOVAL OF THE LEAD, A LARGE PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND THORACOTOMY. A LARGE SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. REPAIR WAS ATTEMPTED, BUT UNFORTUNATELY THE PATIENT DID NOT SURVIVE. THIS REPORT CAPTURES THE GLIDELIGHT IN USE WHEN THE SVC PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. 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
    116044 GLIDELIGHT LASER SHEATH DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS MFA SPECTRANETICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| L| D LEAD(S) MANUFACTURER/MODEL/TYPE UNK.| RA LEAD MANUFACTURER/MODEL/TYPE UNK.| SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.| SPECTRANETICS LEAD LOCKING DEVICES.| ST. JUDE MEDICAL DURATA RV ICD LEAD.| TRACTION PLATFORM MANUFACTURER/MODEL/TYPE UNK.