GlideLight Laser Sheath 500-303Recalls & reported problems

Summary

The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 00813132020347), received between Apr 13, 2018 and Sep 29, 2026 — classified as 63 deaths, 140 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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 221 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 50938355 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove two right ventricular (RV) (left and right side) and two right atrial (RA) leads (left and right side) due to bacteremia. Spectranetics LLD Lead Locking Devices (LLDs) was inserted into each lead to provide traction. Beginning with a Spectranetics 14F GlideLight Laser Sheath on the left RV lead, adhesions in the vasculature were removed. Switching to a Spectranetics 13F TightRail Sub-C Rotating Dilator Sheath, the left RV and left RA lead were removed successfully. Next, a Spectranetics 16F GlideLight Laser Sheath was used on both the right RV and right RA. When lasing on the right RV lead, the patient's blood pressure dropped and a pericardial effusion was detected via transesophageal echocardiogram (TEE). Rescue efforts began, including rescue balloon, CPR, and sternotomy. A perforation at the inferior vena cava (IVC)/RA junction into the RA was discovered and repaired; however the patient did not survive procedure, and the right RA and RV lead remained in the patient.This report captures the 16F GlideLight in use when the perforation occurred, requiring intervention, but resulting death. There was no alleged malfunction of any Spec

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

  MAUDE report 50803939 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50796787 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right ventricular (RV) and right atrial (RA) 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 both leads, significant adhesions were encountered. Switching to a Spectranetics 13F TightRail Sub-C Rotating Dilator Sheath, advancement was made through the subclavian region. Next, utilizing the 14F GlideLight, progress remained challenging due to the extensive adhesions and lead on lead binding. Upsizing to a Spectranetics 16F GlideLight Laser Sheath, gradual advancement was made to the distal coil of the RV lead. With traction from the LLD EZ, the RV lead was removed; however, the patient's blood pressure dropped and rescue efforts began, inlcuding CPR, pericardiocentisis, and sternotomy. An RV perforation was discovered, and repaired, and the RA lead was removed post-sternotomy. The patient survived the procedure. This report captures the GlideLight in use when the perforation occurred, requiring intervention. There was no alleged malfunction of any Spectranetics devices in use during the proced

  Patient problems: Cardiac Perforation

  MAUDE report 50221178 ↗
• InjuryJun 22, 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 12F GLIDELIGHT LASER SHEATH, THE RA LEAD WAS REMOVED SUCCESSFULLY. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH ON THE RV LEAD, PROGRESS WAS MADE THROUGH THE INNNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION WHEN RESISTANCE WAS ENCOUNTERED AT THE SVC/RA JUNCTION AND ADVANCEMENT STALLED. THE PATIENT'S BLOOD PRESSURE DROPPED AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE RV LEAD WAS REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F 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 25588217 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. THE RV LEAD WAS AN ADVISORY RIATA LEAD THAT SHOWED OBVIOUS CABLE EXTERNALIZATION UNDER PRE-CASE X-RAY AND FLUORO. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. TARGETING THE RV LEAD WITH THE SAME TIGHTRAIL, IT PROGRESSED THROUGH THE SUBCLAVIAN; HOWEVER, STOPPED AT THE INNOMINATE/SUPERIOR VENA CEVA (SVC) JUNCTION. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, PROGRESS WAS MADE THROUGH THE SVC AND IN TO THE HEART, BUT STALLED AT THE POINT WHERE THE CABLE EXTERNALIZATION OCCURRED BETWEEN THE TWO SHOCKING COILS. ATTEMPTING TO PULL THE GLIDELIGHT OFF TO POSSIBLY UTILIZE A SPECTRANETICS VISISHEATH DILATOR SHEATH, IT WAS NOTED THAT THE RV LEAD WAS FREE FROM THE VENTRICLE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED THE LEAD WAS FREE FROM THE APEX. HIGH VOLTAGE CABLES WERE PULLED DIRECTLY FROM THE POCKET INTO THE LEAD BODY, WHILE THE GLIDELIGHT WAS OFF THE LEAD AND OUTSIDE THE BODY. BECAUSE THE

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24811248 ↗
• InjuryApr 3, 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 NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS SUCCESSFULLY REMOVED. WHEN REMOVING THE RA LEAD, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE WHEN THE PERFORATIONS OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 24781294 ↗
• DeathMar 25, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO RIGHT VENTRICULAR (RV) LEADS, AND A LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALL THE LEADS WERE REMOVED. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. A SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION PERFORATION WAS DISCOVERED, BUT REPAIR ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT USED IN THE PROCEDURE WHEN A PERFORATION OCCURRED, REQUIRING INTERVENTION, BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 24690347 ↗
• InjuryMar 13, 2026Adverse 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 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 RA LEAD, PROGRESSION WAS SLOW, SO ATTENTION SHIFTED TO THE RV LEAD. HOWEVER, ADVANCEMENT REMAINED CHALLENGING; THEREFORE, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS UTILIZED, AND REACHED THE UPPER SUPERIOR VENA CAVA (SVC). CONCERN FOR AN OBSTRUCTION IN THE SVC, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS DEPLOYED THROUGH THE SUSPECTED OCCLUSION, WITH MINIMAL PROGRESS, DUE TO THE LEAD FIRMLY EMBEDDED IN THE VESSEL WALL AND SURROUNDED BY EXTENSIVE CALCIFICATION. DURING FURTHER ADVANCEMENT, THE PATIENT¿S BLOOD PRESSURE DROPPED, CARDIAC TAMPONADE WAS DETECTED VIA TRANSOESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED, AND THE LEADS WERE REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENT

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Great Vessel Perforation

  MAUDE report 24595963 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV), A RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LV LEAD, AND COOK MEDICAL LIBERATOR BEACON TIP LOCKING STYLETS WERE INSERTED INTO BOTH RV LEADS TO PROVIDE TRACTION. BEGINNING ON THE RA LEAD, THE LEAD WAS SUCCESSFULLY REMOVED WITH MANUAL TRACTION. NEXT, UTILIZING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, COOK MEDICAL 11F EVOLUTION SHORTIE, AND COOK MEDICAL 11F BYRD DILATOR SHEATH, ONE OF THE RV LEADS AND LV LEAD WERE REMOVED. TARGETING THE REMAINING RV LEAD WITH THE 16F GLIDELIGHT, PROGRESS WAS MADE TO THE SUBCLAVIAN VEIN BUT STALLED. SWITCHING TO THE 11F EVOLUTION SHORTIE AND 11F BYRD DILATOR SHEATH, ADVANCEMENT WAS MADE INTO THE SVC AND STALLED AGAIN. THEN, USING THE 16F GLIDELIGHT, PROGRESS WAS MADE TOWARDS THE DISTAL TIP OF THE LEAD; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, HEART MASSAGE, EXTRACORPOREAL MEMBRANE OXYGE

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

  MAUDE report 24252465 ↗
• InjuryJan 26, 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 CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO THE RV AND LV LEAD, AND A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) IN THE RA LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS REMOVED SUCCESSFULLY. SWITCHING TO THE LV LEAD, PROGRESS WAS MADE TO THE OSTIUM OF THE CORONARY SINUS (CS), BUT THE LEAD WOULD NOT RETRACT, SUGGESTING THERE WAS BINDING AT THE DISTAL ELECTRODES. HOWEVER, ONCE THE LASER PASSED THE PROXIMAL ELECTRODES, THE LV LEAD RELEASED, BUT THE PATIENT¿S BLOOD PRESSURE DROPPED, AND LATER STABILIZED. THE EXTRACTION PROCEEDED ON THE RA LEAD WITH LITTLE RESISTANCE, EXCEPT THE BLOOD PRESSURE DROPPED AGAIN, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING BYPASS AND STERNOTOMY. PERFORATIONS TO THE CS AND RA WERE DISCOVERED AND REPAIRED, AND THE RA LEAD WAS REMOVED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED

  Patient problems: Cardiac Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24184299 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, DAMAGE WAS NOTED ON THE OUTER SHEATH; THEREFORE, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS UTILIZED BUT WAS ALSO DAMAGED. USE OF THE GLIDELIGHT WAS DISCONTINUED, AND ANOTHER 16F GLIDELIGHT WAS USED TO REMOVE THE LEADS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE GLIDELIGHT DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND KINKS IN THE WORKING LENGTH. AT THE AREA OF THE KINKS, THERE WAS MELTING AND BREACHES OF THE OUTER JACKET, WITH EXPOSED AND BROKEN FIBERS PRESENT. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23820786 ↗
• DeathDec 12, 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 NON-FUNCTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH ON THE RA LEAD, ADVANCEMENT WAS MADE TO THE DISTAL TIP OF THE LEAD; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, STERNOTOMY, AND BYPASS. A PERFORATION IN THE INNOMINATE VEIN WAS DISCOVERED, BUT REPAIR WAS UNSUCCESSFUL, AND THE PATIENT DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION, RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 23796506 ↗
• InjuryNov 26, 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 FRACTURE. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH ON THE RV LEAD, PROGRESS WAS MADE THROUGH THE SUBCLAVIAN VEIN INTO THE SUPERIOR VENA CAVA (SVC). RESISTANCE WAS ENCOUNTERED IN THE UPPER TO MID SVC, WITH LEAD-ON-LEAD BINDING, AND PROGRESS STALLED. A LARGE DROP IN THE PATIENT¿S BLOOD PRESSURE WAS NOTED, GLIDELIGHT WAS REMOVED FROM THE PATIENT, AND THE BLOOD PRESSURE NORMALIZED. THEN, THE GLIDELIGHT WAS LOADED ON TO THE RA LEAD, ADVANCING THROUGH THE SUBCLAVIAN VEIN AND UPPER SVC UNTIL RESISTANCE WAS MET AGAIN. LASING RESUMED, AND THE RA LEAD WAS REMOVED. TARGETING THE RV LEAD, FORWARD MOVEMENT WAS MADE; HOWEVER, RESISTANCE WAS ENCOUNTERED IN THE UPPER TO MID SVC ONCE MORE, BUT MANUAL ADVANCEMENT CONTINUED AND REACHED THE DISTAL TIP OF THE LEAD. REMOVING THE GLIDELIGHT, THE OUTER SHEATH WAS INSERTED ONTO THE DEVICE AND LOADED ON TO THE RV LEAD. PROGRESS WAS MADE TO THE DISTAL TIP OF THE LEAD, WITH LITTLE RESISTANCE THROUGH THE SUBCLAVIAN VEIN AND SVC, AND THE RV LEA

  Patient problems: Great Vessel Perforation

  MAUDE report 23657377 ↗
• InjuryNov 14, 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 NON-FUNCTION AND FRACTURE. A RIGHT ATRIAL (RA) 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 LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, MINIMAL PROGRESS WAS MADE, AND A SPECTRANETICS VISISHEATH DILATOR SHEATH WAS ADDED TO OBTAIN MORE PROGRESS INTO THE SUBCLAVIAN. ADVANCEMENT STALLED ABOUT MIDWAY, SO SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH. MOVING TOWARDS THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION, IT STALLED AGAIN, AND DECIDED TO SWITCH BACK TO THE GLIDELIGHT AND VISISHEATH, BUT COULD ONLY ADVANCE JUST BEFORE THE SVC. THE PATIENT¿S BLOOD PRESSURE DROPPED SLIGHTLY, AND UPON REMOVAL OF THE GLIDELIGHT, THE PRESSURE DROPPED RAPIDLY. RESCUE EFFORTS BEGAN, INCLUDING CPR AND STERNOTOMY. PERFORATIONS IN THE INNOMINATE VEIN AND THE SVC WERE DISCOVERED AND REPAIRED (MDR # 3007284006-2025-00234). THE DECISION WAS MADE TO ABANDON THE EXTRACTION DEEMING IT TOO RISKY TO CONTINUE; THEREFORE, THE RV LEAD, ALONG WITH THE LLD EZ, WERE CUT AND CAP

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 23560740 ↗
• InjurySep 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) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A 16F GLIDELIGHT LASER SHEATH, PROGRESS WAS MADE DOWN THE INNOMINATE TO THE SUPERIOR VENA CAVA (SVC). ADVANCEMENT WAS ACHIEVED TO THE DISTAL TIP OF THE LEAD, AND WAS FREED. UPON REMOVAL OF THE GLIDELIGHT, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F 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

  MAUDE report 23080608 ↗
• InjurySep 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), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND SPECTRANETICS VISISHEATH DILATOR SHEATH, THE LV LEAD WAS REMOVED SUCCESSFULLY. NEXT, UPSIZING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS REMOVED WITHOUT ISSUE. THEN, ATTEMPTING REMOVAL OF THE RA LEAD, THE LEAD STARTED TO UNRAVEL; THEREFORE, THE DECISION WAS MADE TO SNARE FROM THE GROIN. USING MULTIPLE NON-PHILIPS DEVICES (AGILIS NXT STEERABLE INTRODUCER, BOSTON SCIENTIFIC BARD EP CATHETER, AND MEDTRONIC SPIDERFX WIRE) AND THE 16F GLIDELIGHT ALONG WITH THE VISISHEATH, ALL WERE ADVANCED WITH SOME RESISTANCE, BUT ABLE TO REACH THE TIP OF THE LEAD. WITH TRACTION FROM THE SNARE, THE LEAD RELEASED; HOWEVER, THE BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS NOT INITIALLY EVIDENT VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), BUT BECAME APPARENT FROM A DIFFERENT VIEW. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, WHICH WAS UNSUCCESSFUL, AND STERNOTOMY WAS PERFO

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

  MAUDE report 23080549 ↗
• InjurySep 9, 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 FRACTURE. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED ON THE RA LEAD, AND A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) AND A COOK MEDICAL BULLDOG LEAD EXTENDER ON THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH ON THE RA LEAD, ATTEMPTS WERE MADE TO EXTRACT THE LEAD, BUT RESISTANCE WAS ENCOUNTERED IN THE SUBCLAVIAN AREA. SWITCHING TO THE RV LEAD WITH A 14F GLIDELIGHT, LITTLE ADVANCEMENT WAS MADE. UTILIZING A COOK MEDICAL 11F EVOLUTION, PROGRESS WAS MADE FROM THE SUBCLAVIAN DOWN TO THE SUPERIOR VENA CAVA (SVC), BUT STALLED DUE TO THE SEVERE ADHESION OF THE RA AND RV LEAD. ALTERNATING ON THE RA AND RV LEAD, ADVANCEMENT WAS STILL NOT POSSIBLE. UPSIZING TO A 16F GLIDELIGHT, THE PROCEDURE CONTINUED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND AN AORTOGRAPHY WAS PERFORMED. AS A RESULT, RESCUE EFFORTS BEGAN, INCLUDING STERNONTOMY. A PERFORATION TO THE SUBCLAVIAN VEIN AND INNOMINATE WAS DISCOVERED AND REPAIRED. THE RV AND RA LEAD WERE REMOVED POST-STERNOTOMY WITH A COOK MEDICAL 13F EVOLUTION AND COOK MEDICAL

  Patient problems: Perforation of Vessels

  MAUDE report 23006452 ↗
• 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 VENTRICULAR (RV) LEAD DUE TO FRACTURE. 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, PROGRESS WAS MADE TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION, WHEN SIGNIFICANT BINDING WAS ENCOUNTERED. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE TO THE SVC/RA JUNCTION AGAIN, BUT THE PATIENT¿S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS DETECTED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED (MDR #3007284006-2025-00149). THE DECISION WAS MADE TO ABANDON THE EXTRACTION; THEREFORE, THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #3007284006-2025-00150). THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F 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 22681253 ↗
• DeathJul 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), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEADS DUE TO CIED SYSTEM/POCKET INFECTION. DUE TO SIGNIFICANT COMORBIDITIES, THE PATIENT WAS DEEMED UNFIT FOR SURGICAL INTERVENTION OR SURGICAL BACKUP. PRE-PROCEDURAL VENOGRAPHY SHOWED THAT THE LEADS WERE BORDERING THE LATERAL WALL OF THE SUPERIOR VENA CAVA (SVC), CAUSING CONCERN FOR VESSEL EXTERNALIZATION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS), ALONG WITH SUTURE TIES, WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH ON THE RV LEAD, THE LEAD WAS SUCCESSFULLY REMOVED. NEXT, SWITCHING TO THE RA LEAD, USING THE SAME TECHNIQUE, ADVANCEMENT WAS MADE TO THE INNOMINATE, WHEN THE LEAD DETACHED AND WAS REMOVED. THEN, TARGETING THE LV LEAD, THE LLD EZ BROKE AT THE POCKET (MDR #3007284006-2025-00141), AND THE SUTURE TIES WERE USED TO MAINTAIN TRACTION. WHEN PROGRESS WAS MADE TO THE SVC/RA JUNCTION, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RELEASING THE TRACTION, THE PATIENT STABILIZED, BUT THEN DECLINED AGAIN. THERE WAS NO PERICARDIAL EFFUSION DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE); HOWEVER,

  Patient problems: Great Vessel Perforation

  MAUDE report 22555906 ↗
• InjuryJul 16, 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 OCCLUSION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. SWITCHING BACK AND FORTH BETWEEN A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH AND SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS REMOVED. UPON REMOVING THE LEAD AND LASER SHEATH, THERE WAS NO SIGNIFICANT CHANGE IN BLOOD PRESSURE. WHEN PREPARING FOR IMPLANTATION OF A NEW RV LEAD, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F 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

  MAUDE report 22518256 ↗
• InjuryJul 9, 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 FRACTURE. COOK MEDICAL LIBERATOR LOCKING STYLETS WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RA LEAD, ADHESION TO THE RV LEAD AT THE SUBCLAVIAN VEIN WAS ENCOUNTERED. SWITCHING TO THE RV LEAD, THE ADHESION RELEASED; HOWEVER, PULLING THE LEAD WITH TRACTION WAS UNSUCCESSFUL. THEREFORE, THE RV LEAD WAS SNARED FEMORALLY FROM THE GROIN. LASING FROM THE POCKET CONTINUED, AND THE GLIDELIGHT REACHED THE SNARE, BUT THE LEAD WOULD NOT RETRACT INTO THE LASER SHEATH. MORE ADHESIONS WERE PRESENT NEAR THE SUPERIOR VENA CAVA (SVC), THUS, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS UTILIZED, BUT THE LEAD WOULD STILL NOT RETRACT INTO THE LASER SHEATH. THEN, THE 14F GLIDELIGHT WAS USED AGAIN, AND THE ADHESIONS NEAR THE SVC STILL PREVENTED ANY PROGRESSION. SWITCHING BACK TO THE 16F GLIDELIGHT ON THE RA LEAD, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING PERCUTANEOUS CARDIOPULMONARY SUPPORT, CPR, AND THORACOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCED

  Patient problems: Great Vessel Perforation

  MAUDE report 22463082 ↗
• DeathJun 27, 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 VENTRICULAR (RV), A RIGHT ATRIAL (RA), AND A LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION, REDUNDANT LEAD, AND OCCLUSION. SPECTRANETICS LLD LEAD LOCKING DEVICE (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RA, LV, AND ONE RV LEAD WERE REMOVED. DURING EXTRACTION OF THE LAST RV LEAD, THE GLIDELIGHT DEVICE PERFORATED THE SUPERIOR VENA CAVA (SVC) AND RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. THE PERFORATION WAS REPAIRED; HOWEVER, THE SVC WALL HAD BECOME VERY THIN, AND THERE WAS DIFFICULTY IN REPAIRING. THE PATIENT WAS TRANSFERRED TO ICU, BUT UNFORTUNATELY DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE 16F 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: Great Vessel Perforation

  MAUDE report 22345996 ↗
• DeathMay 22, 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 BACTEREMIA. 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, ADVANCEMENT WAS MADE THROUGH THE SUBCLAVIAN VEIN TO THE SUPERIOR VENA CAVA (SVC). SWITCHING TO A COOK MEDICAL 11F EVOLUTION, ATTEMPTS TO GO THROUGH THE SVC WERE UNSUCCESSFUL, SO THE RA LEAD WAS TARGETED, AND SUCCESSFULLY EXTRACTED. MOVING BACK TO THE RV LEAD, A 16F GLIDELIGHT WAS UTILIZED AND PROGRESSED FROM THE SVC TO THE RA. THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE RV LEAD WAS REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F 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

  MAUDE report 22073713 ↗
• InjuryMay 19, 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 (WITH ONE RA AND TWO RV ELECTRODES) DUE TO NON-FUNCTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RA ELECTRODE, AND COOK MEDICAL BULLDOG LEAD EXTENDERS ON THE RV ELECTRODES TO PROVIDE TRACTION FROM THE GROIN. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND COOK MEDICAL 11F EVOLUTION SHORTIE, PROGRESS WAS MADE TOWARDS THE INNOMINATE. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE LEAD TIP WAS FREED FROM THE HEART. ADVANCEMENT WAS SUCCESSFUL TO THE RA ELECTRODE, WHEN THE LLD AND LEAD INSULATION CAME OFF. USING THE 16F GLIDELIGHT, NO FURTHER PROGRESS COULD BE MADE; THEREFORE, SWITCHED TO A COOK MEDICAL 13F EVOLUTION, AND THE LEAD WAS REMOVED. AFTER EXTRACTION, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS DETECTED, AND SUSPECTED AN RA PERFORATION. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, WHICH STABILIZED THE PATIENT, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 16F GLIDELIGHT DEVICE IN THE AREA WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DE

  Patient problems: Cardiac Perforation

  MAUDE report 22048457 ↗