GlideLight Laser Sheath 500-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00813132020323), received between May 25, 2018 and Jun 22, 2026 — classified as 3 deaths, 17 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 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 FRACTURE. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING MULTIPLE SPECTRANETICS DEVICES (12F GLIDELIGHT LASER SHEATH, 14F GLIDELIGHT LASER SHEATH, 16F GLIDELIGHT LASER SHEATH, 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH) THE RV AND RA LEADS WERE REMOVED. POST-EXTRACTION, THE INITIAL TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS NEGATIVE FOR AN EFFUSION; HOWEVER, SEVERAL MINUTES LATER AFTER A REPEAT TEE, A SMALL PERICARDIAL EFFUSION WAS DETECTED. UNDER CONTINUED MONITORING, IT WAS NOTED THAT THE PERICARDIAL EFFUSION HAD GROWN, AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 12F GLIDELIGHT IN USE WHEN A PERICARDIAL EFFUSION OCCURRED POST-PROCEDURE, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE GLIDELIGHT DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Pericardial Effusion

  MAUDE report 25588088 ↗
• InjuryMar 30, 2026Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT WITHIN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. A COOK MEDICAL LIBERATOR LOCKING STYLET WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE TO THE PROXIMAL COIL OF THE LEAD, AND STALLED. HOWEVER, WHEN ATTEMPTING TO RETRACT THE DEVICE, IT BECAME STUCK AND WITH TRACTION APPLIED TO THE GLIDELIGHT, THE PATIENT¿S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS NOTED. UTILIZING A SNARE, ATTEMPTS TO REMOVE THE GLIDELIGHT WERE UNSUCCESSFUL, AND THE PERICARDIAL EFFUSION WAS GROWING. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND AN RV PERFORATION WAS DISCOVERED AND REPAIRED. THE GLIDELIGHT WAS REMOVED, AND THE RV LEAD WAS EXTRACTED USING A COOK MEDICAL BYRD DILATOR SHEATH POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 12F GLIDELIGHT IN USE IN THE AREA WHEN THE ENTRAPMENT AND PERFORATION OCCURRED, REQUIRING INTERVENTION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24735858 ↗
• InjuryJun 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), 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 EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ATTEMPTS WERE MADE TO EXTRACT THE RA AND RV LEAD, BUT THE GLIDELIGHT WOULD NOT ADVANCE PAST THE CLAVICLE. SWITCHING TO A SPECTRANETICS 12F GLIDELIGHT ON THE LV LEAD, PROGRESS WAS MADE TO THE SVC; HOWEVER, THE ATRIAL LINE PRESSURE WAS NOT DETECTED. RESCUE EFFORTS BEGAN, INCLUDING CPR AND STERNOTOMY. A GROWING PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND A TOTAL OF 400 CCS OF BLOOD WAS DRAINED. THE PATIENT¿S BLOOD PRESSURE STABILIZED, BUT A PERFORATION WAS DISCOVERED AND REPAIRED IN THE INNOMINATE VEIN. EXTRACTION CONTINUED WITH THE 12F GLIDELIGHT, AND THE LV LEAD WAS REMOVED. THE REMAINING RV (MDR #3007284006-2025-00109) AND RA (MDR #3007284006-2025-00110) LEADS WERE CUT/CAPPED AND REMAINED IN THE PATIENT. THERE WERE NO ATTEMPTS MADE TO UNLOCK THE LLD EZS. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 12F GLIDELIGHT

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 22155378 ↗
• MalfunctionDec 30, 2024Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FRACTURE (IMPLANTED OVER 12 YEARS). A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL BUT WAS NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS SMALL VISISHEATH DILATOR SHEATH, ADVANCEMENT WAS ACHIEVED TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. SIGNIFICANT LEAD ON LEAD BINDING WAS NOTED IN THE SUBCLAVIAN, INNOMINATE, AND TOP OF SVC, SO THE DECISION WAS MADE TO ALSO EXTRACT THE RA LEAD. LLD #2 AND LLD EZ DEVICES WERE ALTERNATED, BEING INSERTED INTO THE RA LEAD, IN AN ATTEMPT TO REACH THE DISTAL TIP OF THE LEAD. HOWEVER, DUE TO LEAD FRACTURE AND BINDING, THE LLDS COULD ONLY REACH TO THE TOP OF THE SVC, SO THE LLD #2 WAS LOCKED WITHIN THE RA LEAD IN THAT AREA. USING THE SAME GLIDELIGHT AND VISISHEATH ON THE RA LEAD, PROGRESS COULD ONLY BE MADE TO THE INNOMINATE/SVC REGION. SWITCHING BACK TO THE RV LEAD, ADVANCEMENT WAS REACHED TO THE MID-SVC AREA; HOWEVER, THE RV LEAD BEGAN TO BREAK, WITH EXTRUDING WIRES OBSERVED. AT

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21042845 ↗
• InjuryJul 5, 2024Adverse 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 INFECTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE THROUGH THE INNOMINATE REGION AND INTO THE SUPERIOR VENA CAVA (SVC) WHEN THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND THORACOTOMY. AN ANTERIOR, 6 CM PERFORATION EXTENDING FROM THE INNOMINATE, THROUGH THE SVC, AND INTO THE RA WAS DISCOVERED AND REPAIRED. POST-THORACOTOMY, THE RA LEAD WAS REMOVED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE 12F 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; Perforation of Vessels; Pericardial Effusion

  MAUDE report 19680381 ↗
• MalfunctionMay 15, 2024Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO OCCLUSION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, HEAVY CALCIFICATION AND OCCLUSION WAS PRESENT IN THE INNOMINATE VEIN. WITH TRACTION, THE RV LEAD FRACTURED AND WAS PULLED BACK INTO THE INNOMINATE REGION, LEAVING A 3-4 CM REMNANT (RV DISTAL TIP AND OUTER INSULATION) IN THE AREA. THE LEAD CONDUCTORS AND LLD WERE REMOVED FROM THE PATIENT, WITH NO FURTHER ATTEMPTS MADE TO RETRIEVE THE LEAD REMNANT. UPON EXAMINATION OF THE GLIDELIGHT, THE OUTER SHEATH WAS FRACTURED, WITH THE DAMAGE BELIEVED TO BE AS A RESULT OF THE HEAVY CALCIFICATION ENCOUNTERED IN THE VASCULATURE. AFTER THE PROCEDURE, NO ACCESS COULD BE ATTAINED TO RE-IMPLANT NEW LEADS, SO PLANS WERE MADE TO FOLLOW UP WITH A RIGHT SIDED IMPLANTATION AT A LATER DATE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19325862 ↗
• MalfunctionApr 24, 2024Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH ON THE RV LEAD, THE LEAD WAS SUCCESSFULLY EXTRACTED. NEXT, WHILE WORKING TO EXTRACT THE LV LEAD, THE BLUE CORD (TAIL TUBE) SEPARATED AT THE BIFURCATE HANDLE, AND SMOKE EMITTED FROM THE AREA OF SEPARATION. USE OF THE GLIDELIGHT WAS DISCONTINUED, AND THE BLUE CORD WAS IMMEDIATELY CUT MIDWAY BETWEEN THE COUPLER AND HANDLE. THEN, THE GLIDELIGHT WAS REMOVED FROM THE BODY, AND THE LV LEAD WAS EXTRACTED AT THE SAME TIME WITH NO REPORTED PATIENT HARM. THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19176546 ↗
• InjuryDec 20, 2022Adverse 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 UPGRADED TO A CRT-D DEVICE. THE PATIENT''S LEFT SUBCLAVIAN VEIN WAS OCCLUDED AND IT WAS DECIDED TO EXTRACT THE RV LEAD IN ORDER TO GAIN ACCESS THROUGH THE OCCLUSION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. SIMPLE TRACTION WAS APPLIED TO THE RV LEAD, CAUSING THE LEAD TO DISLODGE BUT NOT COMPLETELY FREED DUE TO BINDING WITHIN THE VASCULATURE. A MEDTRONIC 15 MM AMPLATZ GOOSENECK SNARE WAS INSERTED INTO THE RIGHT GROIN TO GRASP THE RV LEAD AND APPLY TRACTION, WHILE A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WAS USED FROM THE POCKET IN ORDER TO FREE THE LEAD. ADVANCEMENT WAS MADE TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION WITH LASING OCCURRING THROUGH THE BINDING PRESENT IN THE AREA, WHEN THE PATIENT''S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, MEDICATIONS, AND BLOOD ADMINISTRATION. APPROXIMATELY 1,100 CC OF BLOOD WAS DRAINED VIA PERICARDIOCENTESIS. THE PATIENT WAS MONITORED AND NO ADDITIONA

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

  MAUDE report 16014400 ↗
• InjuryDec 15, 2022Adverse 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), A RIGHT VENTRICULAR (RV), AND A LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE RV AND LV LEADS TO PROVIDE TRACTION. A STANDARD MEDTRONIC STYLET BECAME STUCK IN THE RA LEAD DURING ATTEMPTS TO RETRACT THE SCREW AT THE RA LEAD TIP, SO IT WAS NOT INITIALLY PREPPED FOR REMOVAL. THE PHYSICIAN USED MULTIPLE SPECTRANETICS DEVICES (14F GLIDELIGHT LASER SHEATH, 16F GLIDELIGHT LASER SHEATH, 13F TIGHTRAIL ROTATING DILATOR SHEATH), SWITCHING BACK AND FORTH BETWEEN THE RV AND LV LEADS. DENSE FIBROSIS WAS NOTED NEAR THE CLAVICLE AND THE PHYSICIAN ENCOUNTERED STALLED PROGRESSION, WITH NONE OF THE DEVICES ABLE TO ADVANCE PAST THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. THE PHYSICIAN SWITCHED TO A 12F GLIDELIGHT TO ATTEMPT REMOVAL OF THE LV LEAD. THE LEAD WOULD NOT RELEASE, SO THE PHYSICIAN LASED WITHIN THE CORONARY SINUS, THE LV LEAD FREED AND WAS REMOVED. THE PHYSICIAN ATTEMPTED RV LEAD REMOVAL AGAIN USING THE 16F GLIDELIGHT; HOWEVER, DURING THIS TIME THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, AND A

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 15987988 ↗
• InjuryAug 31, 2022Adverse 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 A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. THE PATIENT'S BLOOD PRESSURE DROPPED RAPIDLY, AND A PERICARDIAL EFFUSION WAS DETECTED BY TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PATIENT'S BLOOD PRESSURE DROPPED TO ZERO CAUSED BY CARDIAC TAMPONADE. A STERNOTOMY WAS IMMEDIATELY PERFORMED AND A 1.5 CM SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. A RESCUE BALLOON WAS INFLATED TO CONTROL BLEEDING, AND THE PATIENT WAS PLACED ON BYPASS. THE REPAIR OF THE SVC PERFORATION WAS SUCCESSFUL. THE RV LEAD WAS ALSO REMOVED DURING THE PROCEDURE, AND THE PATIENT SURVIVED. THIS REPORT CAPTURES THE 12F GLIDELIGHT IN USE WHEN THE SVC PERFORATION OCCURRED, REQUIRING INTERVENTION.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 15332051 ↗
• MalfunctionAug 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH TO ASSIST WITH EXTRACTION ATTEMPT. WHEN THE GLIDELIGHT WAS REMOVED FROM THE PATIENT, A SPLIT IN THE CATHETER WAS NOTED. A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED TO SUCCESSFULLY REMOVE THE RV LEAD WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 15303063 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE FOUR LEADS. TWO LEADS WERE FROM A LEFT ACCESS (RIGHT ATRIAL (RA) LEAD (SIELLO S) AND A NON FUNCTIONAL RIGHT VENTRICULAR (RV) LEAD (LINOX SMART S), AND TWO WERE FROM A RIGHT ACCESS (RA LEAD (SOLIA S) AND RV LEAD (PROTEGO S), DUE TO NON FUNCTION AND A REDUNDANT LEAD. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE RIGHT SIDED RA (SOLIA) LEAD WAS SUCCESSFULLY REMOVED USING A COOK MEDICAL 11F EVOLUTION SHORTIE AND COOK MEDICAL EVOLUTION 11F RL DEVICES. ATTEMPTING TO REMOVE THE RIGHT SIDED RV (PROTEGO S) LEAD, THE PHYSICIAN USED THE EVOLUTION 11F SHORTIE, BUT MET STALLED PROGRESSION, SO SWITCHED DEVICES TO A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH. THE GLIDELIGHT WAS ADVANCING NEAR THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION, BUT MET STALLED PROGRESS AGAIN. HE REMOVED THE GLIDELIGHT DEVICE FROM THE PATIENT IN ORDER TO CHANGE DEVICES, BUT THE PATIENT''S BLOOD PRESSURE DROPPED RAPIDLY. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS), STERNOTOMY AND BYPASS. A PERFORATION IN THE SVC WAS DISCOVERED (MDR #1721279-2022-00052). THE REPAIR TO THE

  Patient problems: Great Vessel Perforation

  MAUDE report 13739049 ↗
• MalfunctionFeb 17, 2022Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH TO ATTEMPT EXTRACTION. DURING THE CASE, THE PHYSICIAN WAS AT AN ODD ANGLE, PUSHING AND BENDING THE GLIDELIGHT DEVICE WHEN FIBERS BROKE THROUGH. ANOTHER GLIDELIGHT DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO THE DEVICE''S SEPARATION AND UNINTENDED RADIATION EXPOSURE FROM THE 12F GLIDELIGHT DEVICE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13552844 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS EMPLOYEES BECAME AWARE OF AN ADVERSE EVENT THAT OCCURRED ON 02 JUNE 2021 WHERE A SUPERIOR VENA CAVA (SVC)/INNOMINATE TEAR OCCURRED. FURTHER INFORMATION WAS OBTAINED ON 29 SEPTEMBER 2021 FROM THE PHYSICIAN¿S OPERATION NOTE. A LEAD EXTRACTION PROCEDURE COMMENCED FOR REMOVAL AND REIMPLANTATION OF PACEMAKER DEVICE DUE TO THE DEVICE ERODING THROUGH THE SKIN OF THE PATIENT. A RIGHT VENTRICULAR (RV), A RIGHT ATRIAL (RA), AND A LEFT VENTRICULAR (LV) LEAD WERE TO BE REMOVED TO REPLACE THE DEVICE. THE PHYSICIAN MADE AN INCISION OVER THE DEVICE ON THE LEFT SIDE OF THE CHEST. THE DEVICE WAS SHOWING THROUGH THE SKIN AND THE LEADS WERE VISIBLE. THE LV LEAD, WITH A DWELL TIME OF ONLY TWO YEARS, WAS TARGETED FIRST AND WAS SUCCESSFULLY EXTRACTED. SPECTRANETICS LEAD LOCKING DEVICES (LLD) WERE THEN PLACED ON THE RV AND RA LEAD TO AID IN EXTRACTION. PHYSICIAN UTILIZED 12F SPECTRANETICS GLIDELIGHT LASER SHEATH ON THE RA LEAD AND BEGAN LASING FROM THE SUBCLAVIAN VEIN THROUGH THE INNOMINATE VEIN. THERE WERE MULTIPLE LEAD-ON-LEAD BINDING SITES, SO THE PHYSICIAN SWITCHED TO THE RV LEAD AND ADVANCED FURTHER DOWN THE SVC. ONCE PROGRESS WAS MADE JUST PAST THE SVC AND THE RA, BOTH LEADS APPEARED TO B

  Patient problems: Great Vessel Perforation

  MAUDE report 12572633 ↗
• MalfunctionMay 24, 2021Break; Break

  DURING PREPARATION FOR A LEAD EXTRACTION PROCEDURE, A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WAS CALIBRATED FOR USE. HOWEVER, THE PHYSICIAN THEN REALIZED THAT A PORTION OF THE DEVICE'S SHEATH NEAR THE TIP WAS COMPROMISED, AS IT WAS REPORTED THAT LASER LIGHT WAS SHOWING THROUGH. IT WAS REPORTED THAT THE DEVICE WAS NEVER USED IN THE PATIENT AND WAS NOT KINKED. THE PHILIPS REPRESENTATIVE PRESENT IN THE PROCEDURE PLACED THE GLIDELIGHT DEVICE IN A BIOHAZARD BAG FOR RETURN TO THE MANUFACTURER FOR EVALUATION. ANOTHER 12F GLIDELIGHT DEVICE WAS OPENED AND THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE MANUFACTURER IS ANTICIPATING RETURN OF THE DEVICE FOR EVALUATION, BUT HAS NOT RECEIVED IT AT THIS TIME.

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

  MAUDE report 11869216 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE WAS INFORMED THAT A LEAD EXTRACTION PROCEDURE COMMENCED TO EXTRACT A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) AND A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WERE IN USE TO AID IN LEAD EXTRACTIONS. ACCORDING TO THE REPORT, IMAGING PRIOR TO THE PROCEDURE SHOWED NO CONCERNS. THE EXTRACTIONS WENT SMOOTHLY AND THE PHYSICIANS BEGAN WORKING ON REPLACING THE SYSTEM AND IMPLANTING NEW LEADS. WHILE SUTURING THE POCKET CLOSED AFTER THE PROCEDURE, THE PATIENT REPORTEDLY COUGHED REALLY HARD AND THE BLOOD PRESSURE THEN DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING STERNOTOMY. WHEN THE SURGEON OPENED THE CHEST, THEY NOTICED THAT THE PATIENT'S SUPERIOR VENA CAVA (SVC) WAS SHREDDED. ATTEMPT TO REPAIR THE SVC WAS MADE BUT WAS NOT SUCCESSFUL AND THE PATIENT EXPIRED. THE PHYSICIANS BELIEVE THAT THE SVC TEAR MAY HAVE OCCURRED WHILE CUTTING OPEN THE PATIENT'S CHEST, AS THERE WERE NO HEMODYNAMIC CHANGES NOTED DURING THE PROCEDURE. IT COULD NOT BE CONFIRMED WHAT CAUSED THE INITIAL BLOOD PRESSURE DROP AFTER THE PATIENT COUGHED REALLY HARD; IT WAS THOUGHT THAT IT MAY HAVE BEEN DUE TO A SMALL PUNCTURE

  Patient problems: Iatrogenic Source; Low Blood Pressure/ Hypotension

  MAUDE report 11132005 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SUMMARY WAS COMPILED FROM PROCEDURE NOTES PROVIDED BY THE FACILITY: A PHILIPS REPRESENTATIVE WAS PRESENT IN A LEAD EXTRACTION PROCEDURE WHICH COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) DUE TO BACTEREMIA. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION TO AID IN EXTRACTION. IN ADDITION, MULTIPLE SPECTRANETICS TOOLS WERE IN USE DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A PRE-EXISTING PLEURAL EFFUSION NOTED AT THE START OF THE CASE, AND A RIGHT SIDED CHEST TUBE WAS PLACED OUT OF PRECAUTION. IT WAS CONFIRMED THAT NO SPECTRANETICS DEVICES WERE IN USE AT THE TIME THE EFFUSION WAS NOTICED. THE PHYSICIAN BEGAN BY USING A 14F GLIDELIGHT LASER SHEATH, THEN SWITCHED TO A TIGHTRAIL 13F SUB-C ROTATING DILATOR SHEATH. THE PHYSICIAN THEN UPSIZED TO A 16F GLIDELIGHT DEVICE. A BYRD DILATOR SHEATH 11.5F WAS INSERTED INTO THE SUBCLAVIAN VEIN OVER THE RA LEAD. THE PHYSICIAN THEN ALTERNATED TOOLS BETWEEN THE TIGHTRAIL SUB-C DEVICE AND THE 16F GLIDELIGHT DEVICE. WHILE THE 16F GLIDELIGHT WAS IN USE, THE RA LEAD WAS ULTIMATELY REMOVED. THE 16F GLIDELIGHT DEVICE WAS REINSERTED THEN REMOVED, AND

  Patient problems: Cardiac Perforation; Iatrogenic Source

  MAUDE report 11041249 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, AMONG OTHER DEVICES, WAS IN USE. WHILE USING THE GLIDELIGHT DEVICE TO EXTRACT THE RV LEAD, HEMODYNAMIC CHANGES IN THE PATIENT WAS NOTED BY THE PHYSICIAN. RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING RESCUE DEVICE, CPR AND STERNOTOMY. A SUPERIOR VENA CAVA (SVC) TEAR WAS DISCOVERED. REPAIR WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE. IT WAS REPORTED THAT BOTH LEADS WERE REMOVED SUCCESSFULLY DURING THE PROCEDURE. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Iatrogenic Source

  MAUDE report 9941482 ↗
• DeathJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION COMMENCED TO EXTRACT A RIGHT VENTRICULAR (RV) LEAD DUE TO THE PATIENT BEING OCCLUDED. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, AND WAS NOT INITIALLY SCHEDULED FOR EXTRACTION. THE PATIENT ALSO NEEDED AN UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE. THE OCCLUSION WAS DISCOVERED AT ANOTHER HOSPITAL WHERE THE PATIENT WAS INITIALLY SCHEDULED TO HAVE THE CRT UPGRADE. THE INITIAL PROCEDURE PLAN WAS TO EXTRACT THE RV LEAD AND THEN USE THE CONDUIT FOR ACCESS FOR THE UPGRADE. THE RV LEAD WAS REMOVED EASILY. HOWEVER, THE TEAM WAS NOT ABLE TO PASS A WIRE AFTER THE RV LEAD WAS REMOVED, SO THEY DECIDED TO TAKE OUT THE RA LEAD AS WELL. AFTER REMOVING THE RA LEAD, THEY WERE ABLE TO PASS A WIRE THROUGH THE OCCLUDED AREA, AND PROCEEDED WITH RE-IMPLANT OF A NEW RA, RV & CORONARY SINUS (CS) LEAD. THE CASE WAS COMPLETED, AND THEY BEGAN TO PREPARE THE PATIENT AS NORMALLY, POST PROCEDURE, REMOVING GROIN LINES, ETC. IT WAS AT THIS TIME ANESTHESIA NOTED THAT THE PATIENT'S HEART RATE HAD INCREASED. AT THAT POINT THEY USED FLUOROSCOPY TO LOOK AT THE CARDIAC SILHOUETTE, AND NOTED NO MOVEMENT. CHEST COMPRESSIONS WERE STARTED, A TRANSTHORACIC ECHOCARDIOGRAM (

  Patient problems: Death; Great Vessel Perforation; Iatrogenic Source; Perforation of Vessels

  MAUDE report 9644688 ↗
• InjuryDec 19, 2019Break; Temperature Problem; Break; Temperature Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED. WHILE THE PHYSICIAN WAS USING A SPECTRANETICS GLIDELIGHT LASER SHEATH, HE WAS HOLDING THE LASER SHEATH BY THE HANDLE AND HIS RIGHT LITTLE FINGER WAS AGAINST THE JOINT (JUNCTION) BETWEEN THE DEVICE BIFURCATE HANDLE AND THE WORKING LENGTH OF THE LASER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN FELT A POPPING SENSATION AGAINST HIS HAND, AND HE STOPPED LASING AT THAT TIME. IT WAS REPORTED THAT A SMALL HOLE HAD BEEN CREATED THROUGH BOTH LAYERS OF THE PHYSICIAN'S GLOVES, AS THE HANDLE HEATED UP AND THE PHYSICIAN REALIZED THE DEVICE HAD STARTED TO BREAK AT THE JUNCTION BETWEEN THE BIFURCATE HANDLE AND THE DEVICE. A 1MM AREA OF SKIN WAS AFFECTED ON THE PHYSICIAN'S FINGER; THIS AREA REQUIRED NO TREATMENT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE MANUFACTURER IS ANTICIPATING THE RETURN OF THE DEVICE FOR EVALUATION BUT IT HAS NOT BEEN RETURNED AT THIS TIME.

  Patient problems: Burn(s); Burning Sensation; Radiation Exposure, Unintended; Superficial (First Degree) Burn

  MAUDE report 9492531 ↗
• MalfunctionNov 22, 2019Fracture; Fracture

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 2 LEADS: A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FAILURE. THE PROCEDURE BEGAN BY USING A SPECTRANETICS 12F GLIDELIGHT DEVICE ALONG WITH A LEAD LOCKING DEVICE (LLD) AND THE RA LEAD WAS TARGETED FOR REMOVAL FIRST. THE 12F GLIDELIGHT WAS UNABLE TO PROGRESS IN THE VASCULATURE, AND THE PHYSICIAN OPTED TO UPSIZE TO A 14F GLIDELIGHT. THEY ENCOUNTERED ADHESION OF THE RA LEAD SO THEY CHANGED THEIR TARGET TO ATTEMPT REMOVAL OF THE RV LEAD. THE PHYSICIAN CHOSE TO USE A 12F GLIDELIGHT DEVICE; THE DEVICE COULD NOT CALIBRATE. A SECOND 12F GLIDELIGHT DEVICE WAS USED TO ATTEMPT REMOVAL OF THE RV LEAD BUT COULD NOT PROGRESS DUE TO ADHESION. DURING THE PROCEDURE, THE SECOND 12F GLIDELIGHT DEVICE WAS REPORTED TO BE KINKED AND TO HAVE RED LIGHT BEING EMITTED FROM THE SIDE OF THE DEVICE'S OUTER JACKET. THE LOCATION WHERE THE EMISSION OF THE RED LIGHT WAS OBSERVED, WAS OUT OF THE PATIENT'S BODY, NEAR THE BIFURCATE HANDLE OF THE DEVICE. THIS IS CLOSE TO WHERE THE PHYSICIAN PLACES HIS HAND WHILE USING THE DEVICE. THEY ATTEMPTED TO REMOVE THE RA LEAD AGAIN, NOW USING A 14F GLIDELIGHT DEVICE. HOWEVER, DURING THE PROCEDURE, A SIMI

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9365876 ↗
• DeathJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT A CARDIAC LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A MALFUNCTIONING RIGHT ATRIAL (RA) LEAD. THE RA LEAD WAS SUCCESSFULLY REMOVED WITH A SPECTRANETICS LEAD LOCKING DEVICE AND A SPECTRANETICS 12FR GLIDELIGHT LASER SHEATH. NO HEMODYNAMIC CHANGES WERE NOTED. AFTER LEAD EXTRACTION 6F LONG SHEATH WAS INSERTED INTO THE ANATOMY VIA THE OPEN POCKET. AN ABBOTT RA LEAD WAS INSERTED TO THE LEVEL OF THE RA. THE PHYSICIAN NOTED INCORRECT POSITIONING, REMOVED THE LEAD, AND CONDUCTED A VENOGRAM. VISIBLE STAINING WAS NOTED IN THE SUPERIOR VENA CAVA (SVC) AREA. HEMODYNAMIC CHANGES WERE NOTED. RESCUE INTERVENTIONS COMMENCED. THE SURGEON INTERVENED WITH STERNOTOMY. A 2 INCH BRACHIOCEPHALIC TO SVC TEAR WAS REPAIRED. PATIENT DID NOT SURVIVE PROCEDURE. THE GLIDELIGHT FUNCTIONED PER DESIGN WITH NO MALFUNCTION. THE CHANGES IN HEMODYNAMICS AND VISIBLE CONTRAST STAINING IN THE EPICARDIAL SPACE WERE NOTED AFTER THE ATTEMPTED IMPLANT OF THE NEW RA LEAD.

  Patient problems: Death; Great Vessel Perforation; Iatrogenic Source

  MAUDE report 8741266 ↗
• DeathJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT A CARDIAC LEAD MANAGEMENT PROCEDURE COMMENCED TO REMOVE 2 PACING LEADS, ONE RIGHT ATRIAL (RA) AND ONE RIGHT VENTRICULAR (RV). A SPECTRANETICS GLIDELIGHT LASER SHEATH 500-301 WAS UTILIZED TO FACILITATE LEAD EXTRACTION. HEAVY SCARRING STALLED PROGRESS TOWARDS THE ENTRANCE OF THE SUPERIOR VENA CAVA (SVC). AS THE GLIDELIGHT PROGRESSED PAST THE SVC, THERE WAS A DECREASE IN THE PATIENT'S BLOOD PRESSURE AND RESCUE INTERVENTIONS BEGAN. SURGEON NOTICED A ¿5CM TEAR¿ OF THE SVC. THE TEAR WAS REPAIRED OVER THE COURSE OF 2 HOURS. PATIENT WAS STABILIZED. BRAIN DAMAGE WAS OBSERVED POST CASE. PATIENT EXPIRED 3 DAYS LATER.

  Patient problems: Death; Great Vessel Perforation; Iatrogenic Source

  MAUDE report 8732768 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT VENTRICULAR (RV) LEAD AND A LEFT VENTRICULAR (LV) LEAD, DUE TO NON-FUNCTION. THE SPECTRANETICS DEVICES IN USE WERE A 12F AND 14F GLIDELIGHT, AN 11F TIGHTRAIL, AND LEAD LOCKING DEVICES (LLD'S). THE RV WAS SUCCESSFULLY REMOVED FIRST, WITH A 14F LASER AND 11F TIGHTRAIL. THEN ATTEMPT WAS MADE TO EXTRACT THE LV LEAD USING THE 12F GLIDELIGHT DEVICE, AND THE DESIRE WAS TO UTILIZE AN LLD WITHIN THE LV LEAD. HOWEVER, THE LLD COULD NOT BE ADVANCED DOWN THE LEAD NEAR THE POCKET, DUE TO LEAD FRACTURE. IT WAS REPORTED THE PHYSICIAN WAS MANIPULATING THE GLIDELIGHT WITHIN THE CORONARY SINUS (CS), AND ALSO LASED WITH THE GLIDELIGHT WHILE IN THE CS. THE PATIENT'S BLOOD PRESSURE DROPPED AFTER LV LEAD WAS EXTRACTED. RESCUE EFFORTS COMMENCED IMMEDIATELY. AN INJURY WAS DISCOVERED AT THE ENTRY OF THE OSTIUM OF THE CS AND APPROXIMATELY 2 CM INTO THE CS. REPAIR WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Cardiac Perforation; Iatrogenic Source; Perforation of Vessels

  MAUDE report 8670340 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PROCEDURE COMMENCED TO EXTRACT THREE LEADS: RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) DUE TO INFECTION. THIS WAS A VERY HIGH RISK EXTRACTION CASE. THE RA LEAD WAS SUCCESSFULLY REMOVED FIRST, WITH USE OF A GLIDELIGHT 500-301 DEVICE AND A LEAD LOCKING DEVICE (LLD). ONCE THE RA LEAD WAS REMOVED, DR THEN ATTEMPTED REMOVAL OF THE LV LEAD. WHILE LASING DOWN THE LV LEAD, THERE WERE SIGNIFICANT ADHESIONS NOTED IN THE INNOMINATE AREA. THE GLIDELIGHT WAS SLOWLY ADVANCED INTO THE SUPERIOR VENA CAVA (SVC). THERE APPEARED TO BE ADHESIONS BETWEEN THE RV AND LV LEADS IN THE SVC ULTIMATELY, THE LV LEAD WAS EXTRACTED. THEN, AS THE RV LEAD WAS BEING PREPARED FOR EXTRACTION, THE PATIENT'S BLOOD PRESSURE DROPPED SHARPLY. RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING CHEST COMPRESSIONS, STERNOTOMY AND BYPASS. A TEAR WAS CONFIRMED IN THE INNOMINATE AND SVC REGIONS. A DIFFICULT REPAIR WAS SUCCESSFUL; THE RV LEAD WAS REMOVED AT THIS TIME AND THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Iatrogenic Source; Perforation of Vessels

  MAUDE report 7708359 ↗