GlideLight Laser Sheath 500-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 00813132020330), received between Apr 30, 2018 and Sep 17, 2026 — classified as 39 deaths, 96 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Material Separation” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 180 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 50809413 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 50329261 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON BOTH LEADS, MODERATE CALCIFICATIONS WERE CLEARED. NEXT, UTILIZING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RV LEAD, ADVANCEMENT WAS MADE TO THE DISTAL COIL WHEN TISSUE PLOWING OCCURRED, AND UPSIZED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, CLEARING THE DISTAL COIL, BUT NOT FURTHER BEYOND. THEREFORE, TARGETING THE RA LEAD, THE 14F GLIDELIGHT WAS USED AND PROGRESS WAS MADE TO THE RA DISTAL TIP, AND THE COIL WAS FREED FROM THE HEART. STILL EXPERIENCING SOME RESISTANCE, LASING CONTINUED, AND WITH FURTHER TRACTION, THE LEAD PULLED BACK IN THE 14F GLIDELIGHT AND WAS EXTRACTED. HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND AN RA PERFORATION WAS DISCOVERED AND REPAIRED. THE RV LEAD WAS REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25734827 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS VISISHEATH DILATOR SHEATH ON THE RA LEAD, PROGRESS WAS MADE TO THE SUPERIOR VENA CAVA (SVC) WHEN BINDING WAS ENCOUNTERED. WHEN TRYING TO PUSH THROUGH THE CALCIFICATION, THE PATIENT¿S BLOOD PRESSURE DROPPED AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE LEADS WERE REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24783762 ↗
• MalfunctionMar 24, 2026Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE LEADS WERE HEAVILY ADHERED, AND DURING REPEATED ADVANCEMENT AND RETRACTION, LASER LIGHT WAS OBSERVED EXITING LATERALLY FROM THE CATHETER TIP (MDR #3007284006-2026-00028). THEREFORE, A SECOND GLIDELIGHT LASER SHEATH WAS UTILIZED TO REMOVE THE LEADS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE SECOND GLIDELIGHT WAS NOT REPORTED BY THE FACILITY, BUT WAS RETURNED FOR EVALUATION ON 17MAR2026. VISUAL INSPECTION FOUND A BREACH TO THE OUTER JACKET JUST DISTAL TO THE BIFURCATE HANDLE WITH BROKEN FIBERS AND MELTING OBSERVED (MDR #). ADDITIONALLY, HEAVY BIOLOGICS WERE PRESENT AT THE DISTAL TIP . THIS EVENT IS BEING REPORTED FOR THE SECOND GLIDELIGHT DUE TO UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24680536 ↗
• MalfunctionFeb 24, 2026Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. DURING PREPARATION FOR USE OF A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, DAMAGE WAS NOTED ON THE BIFURCATE COVER, EXPOSING THE FIBER; THEREFORE, USE OF THE GLIDELIGHT WAS DISCONTINUED. A NEW GLIDELIGHT WAS USED TO REMOVE THE LEADS, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE GLIDELIGHT DEVICE WAS RETURNED FOR EVALUATION ON 04FEB2026. VISUAL INSPECTION FOUND THE DEVICE APPEARED TO BE USED IN THE PATIENT, AND THE BIFURCATE COVER WAS MISSING, WITH EXPOSED AND BROKEN FIBERS. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 24428538 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE TO THE MIDDLE OF THE SUPERIOR VENA CAVA (SVC). HOWEVER, WHEN SWITCHING TO ANOTHER TOOL, THE PATIENT'S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE DECISION WAS MADE TO CUT/CAP THE RA LEAD, ALONG WITH THE LLD EZ (MDR #3007284006-2026-00042), AND REMAINED IN THE PATIENT. THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 24308543 ↗
• MalfunctionFeb 3, 2026Positioning Failure

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION, OCCLUSION, REDUNDANCY, AND FRACTURE. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RA LEAD, EXAMINATION UNDER FLUOROSCOPY NOTED THE TIP BEVEL ORIENTATION WAS NOT ALIGNED WITH THE HANDLE. THE GLIDELIGHT DEVICE WAS REMOVED, AND VISUAL INSPECTION FOUND THE BEVEL ORIENTATION WAS ROTATED 45 DEGREES. UPSIZING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, BOTH THE RA AND RV LEADS WERE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 14F GLIDELIGHT WITH A MISALIGNED BEVEL TIP; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247163 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEAD DUE TO FRACTURE. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE RA AND LV LEAD WERE SUCCESSFULLY REMOVED. HOWEVER, WHEN REMOVING THE RV LEAD, A PERICARDIAL EFFUSION WAS DETECTED AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24210899 ↗
• MalfunctionJan 26, 2026Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE LEADS WERE HEAVILY ADHERED, AND DURING REPEATED ADVANCEMENT AND RETRACTION, LASER LIGHT WAS OBSERVED EXITING LATERALLY FROM THE CATHETER TIP. THEREFORE, ANOTHER GLIDELIGHT LASER SHEATH WAS UTILIZED USED TO REMOVE THE LEADS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 24180669 ↗
• MalfunctionJan 5, 2026Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RV LEAD, PROGRESS STALLED AND SWITCHED TO THE RA LEAD; HOWEVER, ENCOUNTERED THE SAME OBSTRUCTION. TARGETING THE RV LEAD AGAIN, FURTHER ADVANCEMENT WAS MADE BUT STALLED ONCE MORE. AFTER ATTEMPTS TO CLEAR, AND SALINE FLUSHING PROVED INEFFECTIVE, A NEW 14F GLIDELIGHT WAS USED. THE RV AND RA LEAD WERE REMOVED SUCCESSFULLY. THE PATIENT SURVIVED THE PROCEDURE. UPON DEVICE EVALUATION ON 11DEC2025, VISUAL INSPECTION FOUND A KINK ON THE TAIL TUBE WITH SCRAPING ON THE OUTER JACKET NEAR THE DISTAL TIP. ADDITIONALLY, THERE WERE CRACKED FIBERS AND MISSING EPOXY OBSERVED. USING A BORESCOPE TO IMAGE THE INNER LUMEN OF THE GLIDELIGHT, A LARGE PIECE OF LEAD INSULATION WAS PRESENT, BLOCKING THE INNER LUMEN APPROXIMATELY 50 MM FROM THE DISTAL TIP. THIS REPORT CAPTURES THE GLIDELIGHT WITH MISSING MATERIAL, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970234 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A CAPPED AND ACTIVE RIGHT VENTRICULAR (RV) LEADS DUE TO NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE CAPPED RV LEAD, STEADY PROGRESS WAS MADE DOWN THE INNOMINATE, INTO THE SUPERIOR VENA CAVA (SVC), AND DOWN THE RA. ONCE PAST THE SVC, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN; INCLUDING RECUSE BALLOON AND STERNOTOMY. A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT STABILIZED. THE EXTRACTION PROCEDURE CONTINUED, AND UTILIZING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, BOTH LEADS WERE REMOVED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 23767796 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD, DUE TO BI-VENTRICULAR UPGRADE. THERE WAS A RIGHT ATRIAL (RA) LEAD PRESENT WITHIN THE PATIENT BUT WAS NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT DEVICE ON THE RV LEAD, LEAD ON LEAD BINDING WITH THE RA LEAD WAS ENCOUNTERED, AND THE RA LEAD STARTED PULLING BACK. AT THAT TIME, THE RV LEAD BROKE, AND THE REMAINING PORTION OF THE LEAD AND LLD WERE REMOVED FROM THE PATIENT. THE RA LEAD WAS THEN PULLED OUT WITH MANUAL TRACTION, AND THE GLIDELIGHT WAS REMOVED FROM THE BODY. HOWEVER, UPON REMOVAL, A KINK AND RED LASER LIGHT EMITTING WAS OBSERVED. CONTINUING THE PROCEDURE, FEMORAL SNARE WAS ATTEMPTED TO REMOVE THE REMAINING PORTION OF THE RV LEAD BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABANDON THE RV LEAD; THEREFORE, THE LEAD WAS CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23621891 ↗
• MalfunctionNov 4, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHILE LASING THROUGH CALCIFIED LESIONS, THE SPECTRANETICS 14F GLIDELIGHT LASER SHEATH OUTER JACKET SEPARATED, AND FIBERS WERE EXPOSED. A NEW GLIDELIGHT WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23472874 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. COOK MEDICAL LIBERATOR TIP LOCKING STYLETS WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED BACK AND FORTH ON THE RA AND RV LEAD DUE TO SEVERE LEAD ADHESION. AT THAT TIME, A PERICARDIAL EFFUSION WAS DETECTED, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING THORACOTOMY. A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED; HOWEVER, THE RV AND RA LEADS REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22983627 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RA LEAD, HEAVY CALCIUM WAS ENCOUNTERED. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, PROGRESS COULD NOT BE MADE THROUGH THE SUBCLAVIAN; THEREFORE, THE LV LEAD WAS TARGETED AND REMOVED. NEXT, UTILIZING THE 14F GLIDELIGHT ON THE RA LEAD, ADVANCEMENT WAS MADE THROUGH THE SUBCLAVIAN AND INTO THE SUPERIOR VENA CAVA (SVC). THEN, WHEN IN THE RIGHT ATRIUM, THE RA LEAD CAME FREE, BUT THE PATIENT¿S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 22679571 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. DURING PREPARATION, THE SPECTRANETICS 14F GLIDELIGHT LASER WAS PLUGGED INTO THE SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM AND CALIBRATED. WHILE REMOVING THE RV LEAD, OUTER JACKET DAMAGE WAS OBSERVED. A NEW GLIDELIGHT WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22383387 ↗
• DeathJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT ATRIAL (RA) AND TWO LEFT VENTRICULAR (LV) LEADS DUE TO FRACTURE. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHILE OPENING OF THE POCKET, ONE OF THE RA LEADS STARTED TO COME APART, BUT DID NOT CUT TO MAINTAIN ITS STRUCTURE. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE TWO LV LEADS, AND ONE RA LEAD WERE REMOVED SUCCESSFULLY. DURING EXTRACTION OF THE LAST RA LEAD, WHEN THE GLIDELIGHT WAS BEING USED AS A MECHANICAL SHEATH, IT WAS NOTICED THAT THE TIP WAS BENT. HOWEVER, EXTRACTION CONTINUED BUT THE LEAD BROKE, AND THE LLD, ALONG WITH A PORTION OF THE LEAD WERE REMOVED. THE GLIDELIGHT WAS REMOVED FROM THE BODY, AND THE BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, STERNOTOMY, AND CELL SAVER. AFTER SOME TIME, A PERFORATION IN THE SUBCLAVIAN VEIN WAS DISCOVERED, WHICH WAS ORIGINALLY THOUGHT TO HAVE BEEN IN THE SUPERIOR VENA CAVA (SVC). THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM, REPAIR WAS COMPLETED, AND THE PATIENT STABILIZED; UNFORTUNATELY, DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE GLIDELIGHT IN USE WHEN THE SUBCL

  Patient problems: Perforation of Vessels

  MAUDE report 22171544 ↗
• MalfunctionApr 17, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED, AND A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH WERE BEING USED TO TREAT THE PATIENT. UPON LOADING THE GLIDELIGHT DEVICE ONTO A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD), DAMAGED WAS NOTED NEAR THE HANDLE OF THE DEVICE. A NEW GLIDELIGHT WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON COMPLETION OF THE GLIDELIGHT DEVICE EVALUATION ON 10APR2025, VISUAL INSPECTION FOUND A KINK ON THE WORKING LENGTH OF THE DEVICE, JUST DISTAL TO THE BIFURCATE HANDLE. AT THE AREA OF THE KINK, A BREACH WAS DETECTED ON THE OUTER JACKET, WITH MELTING AND BROKEN FIBERS. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21861568 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RA LEAD, PROGRESS WAS ACHIEVED TO ABOUT AN INCH FROM THE TIP OF THE LEAD, WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS DETECTED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED. THE RA LEAD WAS REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 21858519 ↗
• DeathApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RV LEAD, THE LEAD WAS REMOVED. THEN, SWITCHING TO THE RA LEAD, THE LEAD WAS REMOVED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND THORACOTOMY. A SUPERIOR VENA CAVA PERFORATION (SVC) WAS DISCOVERED AND REPAIRED. THE PATIENT WAS TRANSFERRED TO ICU, BUT PASSED AWAY THE FOLLOWING DAY. THIS REPORT CAPTURES THE 14F GLIDELIGHT DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade; Great Vessel Perforation

  MAUDE report 21856777 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO NEEDING A TRICUSPID VALVE REPLACEMENT. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RA LEAD, PROGRESS WAS MADE TO THE SUBCLAVIAN AND STALLED. SWITCHING TO THE RV LEAD WITH THE SAME GLIDELIGHT, ADVANCEMENT WAS MADE TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION AND PROGRESS STALLED. AS THE GLIDELIGHT WAS BEING REMOVED TO TARGET THE RA LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS DETECTED, AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. THE LEADS WERE REMOVED POST-STERNOTOMY, AND THE TRICUSPID VALVE WAS REPLACED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 21774088 ↗
• MalfunctionApr 2, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. DURING PREPARATION, THE SPECTRANETICS 14F GLIDELIGHT LASER WAS PLUGGED INTO THE PHILIPS LASER SYSTEM AND CALIBRATED. UPON INSPECTION, A KINK AND OUTER JACKET DAMAGE WAS OBSERVED. A NEW GLIDELIGHT WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21756447 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEAD DUE TO CHRONIC PAIN. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION. FIRST, A NON-PHILIPS SHOCKWAVE DEVICE WAS USED IN THE INNOMINATE AND SUPERIOR VENA CAVA (SVC) AREA. THEN, USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH ON THE RA LEAD, ADVANCEMENT WAS MADE TO THE SVC WITH SOME DIFFICULTY. THE GLIDELIGHT WAS REMOVED, AND THE LV LEAD WAS BEING PREPPED WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. AN EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND RESCUE EFFORTS BEGAN, INCLUDING BYPASS AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED. THE RV, RA, AND LV LEADS WERE REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 21721819 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO THE LEAD PERFORATING THE RV AND WAS ADHERED TO THE LATERAL WALL OF THE SVC. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION FROM THE POCKET, ALONG WITH A COOK MEDICAL ENSNARE TO PULL TRACTION FROM BELOW. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, PROGRESS WAS ACHIEVED THROUGH THE INNOMINATE VEIN AND SUPERIOR VENA CAVA (SVC), WHEN THE LEAD FREED. THE ENSNARE WAS RELEASED, AND THE LEAD AND TOOLS WERE REMOVED FROM THE BODY. HOWEVER, APPROXIMATELY TWO TO THREE MINUTES AFTER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, BYPASS, AND STERNOTOMY. A LARGE SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. THE PATIENT¿S VASCULATURE WAS VERY FRAIL, AND RV FUNCTION WAS LOW; THEREFORE, THE PATIENT WAS PUT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TO RECOVER. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 14F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 21669042 ↗