LLD EZ Lead Locking Device 518-067Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00813132023065), received between Apr 9, 2018 and Sep 29, 2026 — classified as 1 death, 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Entrapment of Device

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50937874 ↗
• MalfunctionJul 14, 2025Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ), ALONG WITH A COOK MEDICAL ONE-TIE COMPRESSION COIL, WERE INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 9F TIGHTRAIL ROTATING DILATOR SHEATH, THE OUTER SHEATH WOULD NOT ENTER THE ACCESS SITE AT THE SUBCLAVIAN VEIN, THUS UNABLE TO ADVANCE TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. DURING REMOVAL, THE TIGHTRAIL (MDR #3007284006-2025-00136) GOT STUCK ON THE LLD EZ (MDR #.), AND BOTH WERE REMOVED TOGETHER, ALONG WITH THE ONE-TIE. UPON REMOVAL, THE LLD EZ AND ONE-TIE COULD NOT BE REMOVED FROM THE TIGHTRAIL; THEREFORE, THE TIGHTRAIL WAS CUT TO PRESERVE THE LEAD AND LLD EZ LENGTH. A COOK MEDICAL NEEDLE¿S EYE SNARE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE LLD EZ THAT GOT STUCK ON THE CONCOMITANT DEVICES THAT HAD TO BE REMOVED AS A SYSTEM, POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493187 ↗
• InjuryJan 29, 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 AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA AND CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED TO ATTEMPT REMOVAL OF THE LEADS; HOWEVER, THE DEVICE FAILED TO ACTUATE AFTER MINIMAL USE IN THE INNOMINATE AREA. SWITCHING TO ANOTHER TIGHTRAIL DEVICE, COOK MEDICAL EVOLUTION DILATOR SHEATH, AND A COOK MEDICAL BULLDOG LEAD EXTENDER FROM A FEMORAL APPROACH, THE LEADS WERE STILL UNABLE TO BE REMOVED FROM THE BODY. AT THAT POINT, THE DECISION WAS MADE TO STOP THE EXTRACTION. THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLDS FROM THE RV (MDR #3007284006-2025-00020) AND THE RA (MDR # 3007284006-2025-00019) LEAD; THEREFORE, THE LEADS WERE CUT/CAPPED, ALONG WITH THE LLDS, AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ WITHIN THE RA LEAD, WHICH WAS CUT/CAPPED AND REMAINED IN THE PATIENT. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21265787 ↗
• InjuryJan 29, 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 AND A RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA AND CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED TO ATTEMPT REMOVAL OF THE LEADS; HOWEVER, THE DEVICE FAILED TO ACTUATE AFTER MINIMAL USE IN THE INNOMINATE AREA. SWITCHING TO ANOTHER TIGHTRAIL DEVICE, COOK MEDICAL EVOLUTION DILATOR SHEATH, AND A COOK MEDICAL BULLDOG LEAD EXTENDER FROM A FEMORAL APPROACH, THE LEADS WERE STILL UNABLE TO BE REMOVED FROM THE BODY. AT THAT POINT, THE DECISION WAS MADE TO STOP THE EXTRACTION. THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLDS FROM THE RV AND THE RA (MDR #3007284006-2025-00019) LEAD; THEREFORE, THE RA LEAD WAS CUT AND CAPPED, ALONG WITH THE LLD, AND REMAINED IN THE PATIENT. THE RV LEAD WAS UNABLE TO BE CAPPED, AND WAS JUST CUT, ALONG WITH THE LLD, AND REMAINED IN THE INFERIOR VENA CAVA (IVC) IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ WITHIN THE RV LEAD, WHICH WAS CUT AND REMAINED IN THE PATIENT. THERE WAS NO ALLEGED MALFUNCTION OF ANY

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21265760 ↗
• InjurySep 8, 2023Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV), A RIGHT ATRIAL (RA), AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA AND CIED SYSTEM/POCKET INFECTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD, AND AN LLD (MODEL UNK) WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION. THE LV LEAD WAS REMOVED BY SIMPLE TRACTION, WITHOUT USE OF A TRACTION PLATFORM. HOWEVER, PRIOR TO USE OF ANY EXTRACTION TOOLS, THE PATIENT''S HEART STOPPED BEATING. AFTERWARDS, IT WAS REPORTED THAT A SPECTRANETICS GLIDELIGHT LASER SHEATH WAS USED TO AID IN LEAD EXTRACTION. WHILE ATTEMPTING TO REMOVE THE RV LEAD, THE RV LEAD AND LLD BROKE (CAUSE UNK), IN THE AREA UNDER THE PROXIMAL BUCKLE, AND BOTH WERE CAPPED AND REMAINED IN THE PATIENT (MDR 3007284006-2023-00023). THE PATIENT''S HEMODYNAMICS WERE TOO UNSTABLE TO CONTINUE THE PROCEDURE. THEREFORE, THE RA LEAD WAS NOT REMOVED; THE PHYSICIAN DID NOT ATTEMPT TO UNLOCK THE LLD FROM THE RA LEAD PRIOR TO CUTTING AND CAPPING BOTH, WHICH REMAINED IN THE PATIENT (MDR #3007284006-2023-00027). THIS REPORT CAPTURES THE PORTION OF THE LLD WHICH WAS CAPPED WITHIN THE RV LEAD, AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712489 ↗
• InjuryAug 4, 2023Adverse 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 TWO RIGHT VENTRICULAR (RV) LEADS (ONE ACTIVE, ONE ABANDONED) DUE TO CIED SYSTEM/POCKET INFECTION. INSERTION OF SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE ATTEMPTED IN THE ABANDONED AND THE ACTIVE RV LEADS TO PROVIDE TRACTION, BUT COULD NOT BE ADVANCED FARTHER THAN THE MIDDLE OF THE LEADS, AND WERE REMOVED. AN LLD WAS SUCCESSFULLY PLACED IN THE RA LEAD, AND A SPECTRANETICS 9F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS USED TO REMOVE ADHESIONS IN THE SUBCLAVIAN REGION. A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WAS USED NEXT; HOWEVER, PROGRESS STALLED NEAR THE SUPERIOR VENA CAVA (SVC) REGION DUE TO CALCIUM. AN LLD WAS THEN INSERTED IN THE ACTIVE RV LEAD, WHICH COULD ONLY BE ADVANCED TO THE MIDDLE OF THE LEAD, AND WAS LOCKED IN PLACE. USING THE SAME TIGHTRAIL SUB-C AND GLIDELIGHT DEVICES, PROGRESS STALLED IN THE SVC REGION, SAME AREA WHERE PROGRESS STALLED ON THE RA LEAD. DUE TO HEAVY FIBROSIS/CALCIFICATIONS, THE PATIENT''S ADVANCED AGE, AND THAT THE EXTRACTION ATTEMPTS CONTINUED FOR NEARLY 4 HOURS, IT WAS DETERMINED THERE WAS NO WAY TO EXTRACT THESE LEADS. THE PHYSICIAN DID NOT ATTEMPT TO UNLOCK THE LLDS FR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17461322 ↗
• InjuryDec 7, 2022Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD, EXTRACTION INDICATION UNK. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO ATTEMPT REMOVAL OF THE RV LEAD. PROGRESS STALLED AROUND THE SUBCLAVIAN VEIN, AND THE PHYSICIAN PUSHED THE 14F GLIDELIGHT TO ASSESS IF IT WAS ADVANCING; HOWEVER, NO PROGRESS WAS NOTED. AT THAT TIME, THE LLD WITHIN THE RV LEAD BROKE OUTSIDE THE PATIENT''S BODY AT THE FRONT SIDE OF THE LOCKING MECHANISM (MDR #1721279-2022-00219). THE 14F GLIDELIGHT WAS STUCK ON THE RV LEAD, SO THE PHYSICIAN INSERTED A COOK NEEDLE''S EYE SNARE FROM A RIGHT FEMORAL APPROACH, CAPTURING THE RV LEAD WHILE HE SUCCESSFULLY PULLED THE 14F GLIDELIGHT FROM THE PATIENT (MDR #1721279-2022-00220). HOWEVER, WHEN THE 14F GLIDELIGHT WAS EXAMINED OUTSIDE THE PATIENT''S BODY, IT WAS NOTED THAT IT WAS BROKEN ON THE WORKING LENGTH, JUST DISTAL TO THE BIFURCATE HANDLE (MDR #1721279-2022-00220). THE PHYSICIAN SWITCHED EFFORTS TO ATTEMPT REMOVAL OF THE RA LEAD. A COOK 11F EVOLUTION MECHANICAL DILATOR SHEATH AND A GREEN COOK BYRD DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936132 ↗
• InjuryDec 7, 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, EXTRACTION INDICATION UNK. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO ATTEMPT REMOVAL OF THE RV LEAD. PROGRESS STALLED AROUND THE SUBCLAVIAN VEIN, AND THE PHYSICIAN PUSHED THE 14F GLIDELIGHT TO ASSESS IF IT WAS ADVANCING; HOWEVER, NO PROGRESS WAS NOTED. AT THAT TIME, THE LLD WITHIN THE RV LEAD BROKE OUTSIDE THE PATIENT''S BODY AT THE FRONT SIDE OF THE LOCKING MECHANISM (MDR #1721279-2022-00219). THE 14F GLIDELIGHT WAS STUCK ON THE RV LEAD, SO THE PHYSICIAN INSERTED A COOK NEEDLE''S EYE SNARE FROM A RIGHT FEMORAL APPROACH, CAPTURING THE RV LEAD WHILE HE SUCCESSFULLY PULLED THE 14F GLIDELIGHT FROM THE PATIENT (MDR #1721279-2022-00220). HOWEVER, WHEN THE 14F GLIDELIGHT WAS EXAMINED OUTSIDE THE PATIENT''S BODY, IT WAS NOTED THAT IT WAS BROKEN ON THE WORKING LENGTH, JUST DISTAL TO THE BIFURCATE HANDLE (MDR #1721279-2022-00220). THE PHYSICIAN SWITCHED EFFORTS TO ATTEMPT REMOVAL OF THE RA LEAD. A COOK 11F EVOLUTION MECHANICAL DILATOR SHEATH AND A GREEN COOK BYRD DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15935119 ↗
• InjuryMar 11, 2022Break; Break

  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 P

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13739128 ↗
• InjuryMar 11, 2022Break; Break

  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 P

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13739123 ↗
• InjuryMar 11, 2022Break; Break

  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: Device Embedded In Tissue or Plaque

  MAUDE report 13739082 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 5 LEADS: A RIGHT ATRIAL (RA), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD (ALL ACTIVE), AND A TWO INACTIVE RV LEADS DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION ALONG WITH COOK MEDICAL BULLDOG LEAD EXTENDERS ON EACH OF THE THREE RV LEADS. THE ACTIVE RV AND RA LEADS WERE REMOVED SUCCESSFULLY BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND LASTLY A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE INACTIVE RV LEAD WHEN THE REMAINING LEADS BEGAN TO "BUNCH UP" DUE TO A SIGNIFICANT AMOUNT OF CALCIUM PRESENT IN THE VASCULATURE. THE PHYSICIAN ALTERNATED BETWEEN A SPECTRANETICS 13F TIGHTRAIL DEVICE AND A SPECTRANETICS 16F GLIDELIGHT DEVICE TO ATTEMPT LEAD EXTRACTION. AT SOME POINT DURING ATTEMPTED REMOVAL OF THIS INACTIVE RV LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING USE OF A RESCUE BALLOON, CPR, PERICARDIOCENTESIS, BYPASS AND STERNOTOMY. THE SURGEON WAS DELAYED IN ARRIVING AT CASE. SIGNIFICANT PLAQUE WA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13359445 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 5 LEADS: A RIGHT ATRIAL (RA), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD (ALL ACTIVE), AND A TWO INACTIVE RV LEADS DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION ALONG WITH COOK BULLDOG LEAD EXTENDERS ON EACH OF THE THREE RV LEADS. THE ACTIVE RV AND RA LEADS WERE REMOVED SUCCESSFULLY BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND LASTLY A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE INACTIVE RV LEAD WHEN THE REMAINING LEADS BEGAN TO "BUNCH UP" DUE TO A SIGNIFICANT AMOUNT OF CALCIUM PRESENT IN THE VASCULATURE. THE PHYSICIAN ALTERNATED BETWEEN A SPECTRANETICS 13F TIGHTRAIL DEVICE AND A SPECTRANETICS 16F GLIDELIGHT DEVICE TO ATTEMPT LEAD EXTRACTION. AT SOME POINT DURING ATTEMPTED REMOVAL OF THIS INACTIVE RV LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING USE OF A RESCUE BALLOON, CPR, PERICARDIOCENTESIS, BYPASS AND STERNOTOMY. THE SURGEON WAS DELAYED IN ARRIVING AT CASE. SIGNIFICANT PLAQUE WAS SEEN P

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13359434 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 5 LEADS: A RIGHT ATRIAL (RA), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD (ALL ACTIVE), AND A TWO INACTIVE RV LEADS DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION ALONG WITH COOK MEDICAL BULLDOG LEAD EXTENDERS ON EACH OF THE THREE RV LEADS. THE ACTIVE RV AND RA LEADS WERE REMOVED SUCCESSFULLY BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND LASTLY A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE INACTIVE RV LEAD WHEN THE REMAINING LEADS BEGAN TO "BUNCH UP" DUE TO A SIGNIFICANT AMOUNT OF CALCIUM PRESENT IN THE VASCULATURE. THE PHYSICIAN ALTERNATED BETWEEN A SPECTRANETICS 13F TIGHTRAIL DEVICE AND A SPECTRANETICS 16F GLIDELIGHT DEVICE TO ATTEMPT LEAD EXTRACTION. AT SOME POINT DURING ATTEMPTED REMOVAL OF THIS INACTIVE RV LEAD, THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING USE OF A RESCUE BALLOON, CPR, PERICARDIOCENTESIS, BYPASS AND STERNOTOMY. THE SURGEON WAS DELAYED IN ARRIVING AT CASE. SIGNIFICANT PLAQUE W

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13359428 ↗
• InjuryJan 10, 2022Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION AND THE RV LEAD DELIVERING INAPPROPRIATE SHOCKS. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN THE EXTRACTION ATTEMPT OF THE RV LEAD USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, WITH PROGRESS STALLING AT THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION WITH OBVIOUS LEAD INTERACTION WITH THE RA LEAD. THE PHYSICIAN THEN SWITCHED TO THE RA LEAD, PROGRESS STALLING IN THE SAME AREA. THE PHYSICIAN UPSIZED TO A 16F GLIDELIGHT DEVICE AND THE EXTRACTION OF THE RA LEAD WAS SUCCESSFUL SHORTLY AFTERWARD. AFTER APPROXIMATELY 2 MINUTES POST EXTRACTION, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, ADMINISTRATION OF BLOOD PRODUCTS, AND STERNOTOMY. THE SURGICAL TEAM WORKED FOR 13 MINUTES TO STABILIZE THE PATIENT. NO OBVIOUS TEAR WAS NOTED IN EITHER THE SVC OR IN THE HEART, BUT LARGE CLOTTING WAS NOTED, AND THE TEAR WAS PRESUMED CLOSED. AFTER CONSULTATION WITH COLLEAGUES, IT WAS DECIDED TO ATTEMPT REMOVAL OF THE RV LEAD, SINCE THE PATIENT'S CHEST WAS OPEN A

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13212211 ↗
• DeathOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE THREE LEADS: A RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) DUE TO CIED SYSTEM/POCKET INFECTION. A SPECTRANETICS LEAD LOCKING DEVICES (LLD) WERE USED WITHIN EACH LEAD TO ACT AS A TRACTION PLATFORM TO AID IN EXTRACTION. AFTER SUCCESSFUL EXTRACTION OF THE RA LEAD AND A PARTIAL LV EXTRACTION (DETAILS OF THE PARTIAL LV LEAD EXTRACTION UNKNOWN, BUT REPORTEDLY DID NOT RESULT IN AN ADVERSE EVENT), THE SURGEON BEGAN ATTEMPTS TO EXTRACT THE RV ICD LEAD USING A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH IN ADDITION TO THE LLD. IT WAS REPORTED THAT NO EXTERNALIZATION OF THE BLUE HIGH VOLTAGE WIRE WAS SEEN ON CT SCAN PRIOR TO THE EXTRACTION. DURING ATTEMPTED EXTRACTION OF THE RV LEAD, THE PATIENT''S BLOOD PRESSURE DROPPED WHEN THE COIL OF THE RV LEAD REPORTEDLY CAME OFF THE VENTRICULAR WALL AND THE LEAD RETRACTED INTO THE TIGHTRAIL SHEATH. AT THE TIME, THE TIGHTRAIL DEVICE WAS 3 CENTIMETERS UP THE COIL OF THE RV LEAD WHEN THE LEAD BECAME FREE. THE PHILIPS REPRESENTATIVE, PRESENT AT THE PROCEDURE, OBSERVED THE TWO ELECTRODES (PACING AND SENSING) STILL PRESENT IN THE APEX WALL. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING

  Patient problems: Cardiac Perforation; Death; Iatrogenic Source

  MAUDE report 10678394 ↗
• MalfunctionOct 6, 2020Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION AND OCCLUSION. THE PHYSICIAN INSERTED A SPECTRANETICS LEAD LOCKING DEVICE (LLD) INTO THE RV LEAD TO ACT AS THE TRACTION PLATFORM TO AID IN LEAD EXTRACTION. TRACTION WAS BEING APPLIED TO THE LEAD WITH USE OF THE LLD AND REPORTEDLY A HEMOSTAT CLAMPED ONTO THE LLD WHEN THE LLD BROKE, OUTSIDE THE LEAD. THE PHYSICIAN KNOTTED THE BROKEN LLD TOGETHER, AND A SPECTRANETICS TIGHT RAIL SUB-C ROTATING DILATOR SHEATH WAS USED TO EFFECTIVELY REMOVE THE RV LEAD. PER REPORT, THE RA LEAD WAS ALSO REMOVED SUCCESSFULLY, THE PROCEDURE WAS COMPLETED AND THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE EVENT WERE TO RECUR. THE MANUFACTURER IS ANTICIPATING RETURN OF THE DEVICE, BUT IT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10635134 ↗
• InjuryAug 27, 2020Adverse 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 RIGHT VENTRICULAR (RV) LEAD DUE TO INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE PLACED IN EACH LEAD TO ACT AS TRACTION PLATFORMS TO AID IN EXTRACTION. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON BOTH THE RA AND RV LEADS, SUCCESSFULLY PASSING THE FIBROSIS LOCATED IN THE SUBCLAVIAN VEIN. HE THEN CHOSE A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH ON THE RA LEAD; THE PHYSICIAN PASSED THROUGH SIGNIFICANT FIBROTIC TISSUE IN THE SUPERIOR VENA CAVA (SVC). AT THAT TIME THE RA LEAD FREED AND WAS SUCCESSFULLY REMOVED. ATTENTION WAS THEN TURNED TO REMOVAL OF THE RV LEAD. USING THE 11F TIGHTRAIL DEVICE, WITH ADVANCEMENT TO THE SVC/ATRIAL JUNCTION. THE TIP OF THE RV LEAD UNHOOKED FROM THE WALL OF THE VENTRICLE AND MOVED UP INTO THE RIGHT ATRIUM, BUT THE RV LEAD WAS NOT FREE, WITH THE PHYSICIAN UNABLE TO PASS THROUGH THE FIBROSIS IN THE RIGHT ATRIUM WITH USE OF THE 11F TIGHTRAIL. THE PHYSICIAN DECIDED TO UPSIZE TO A 13F TIGHTRAIL DEVICE, AND WAS ABLE TO PASS OVER THE TIP OF THE RV LEAD, NOW LOCATED IN THE RIGHT ATRIUM. WHILE TRYING TO PUSH AND PULL AND APP

  Patient problems: Atrial Perforation; Iatrogenic Source

  MAUDE report 10463269 ↗
• MalfunctionFeb 21, 2020Crack; Crack

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICLE LEAD DUE TO INFECTION. DURING THE PROCEDURE, THE PHYSICIAN WAS USING A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH AND A SPECTRANETICS LEAD LOCKING DEVICE TO EXTRACT THE LEAD. WHILE THE PHYSICIAN WAS PULLING THE LEAD FROM THE LLD, IT CRACKED BETWEEN THE DISTAL LOOP AND THE PROXIMAL CONNECTOR. THE PHYSICIAN THEN USED A COOK MEDICAL NEEDLE'S EYE SNARE, BY FEMORAL ACCESS, TO GRAB THE LEAD FROM THE DISTAL END IN ORDER TO FREE THE LEAD AND THE TIGHTRAIL. THE TIGHTRAIL WAS FREED FROM THE SUBCLAVIAN ARTERY SUCCESSFULLY AND THE LEAD WAS SUCCESSFULLY EXTRACTED WITH THE NEEDLE'S EYE SNARE THROUGH THE FEMORAL ACCESS. THERE WAS NO INJURY TO THE PATIENT. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR SERIOUS INJURY WITH RECURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9742155 ↗
• InjuryAug 1, 2019Material Separation; Material Separation

  A PHILIPS REPRESENTATIVE REPORTED THAT A CARDIAC LEAD MANAGEMENT PROCEDURE COMMENCED TO REMOVE A NON-FUNCTIONAL/FRACTURED RIGHT VENTRICULAR (EV) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS UTILIZED AS THE TRACTION PLATFORM FOR THE EXTRACTION. THE LLD SNAPPED AT THE RV LEAD FRACTURE AREA, WHICH WAS AT THE PROXIMAL END OF THE COIL. THE PATIENT'S BLOOD PRESSURE DROPPED AT THAT TIME. RESCUE EFFORTS, INCLUDING CPR AND STERNOTOMY, REVEALED THAT THE SUPERIOR VENA CAVA (SVC) WAS TORN DURING THE EXTRACTION (PLEASE SEE MDR 1721279-2019-00136, AS THE SVC TEAR IS NOT ATTRIBUTED TO THE LLD DEVICE). RESCUE EFFORTS COMMENCED INCLUDING STERNOTOMY, AND THE LEAD WAS REMOVED DURING OPEN HEART. NOTE: 4076 RIGHT ATRIAL (RA) LEAD, REP BELIEVES, WAS TAKEN OUT DURING THE OPEN HEART ALONG WITH THE 0292 RIGHT VENTRICULAR (RV) LEAD, DUE TO BEING POTENTIALLY DISLODGED. ORIGINAL INTENTION WAS TO JUST TAKE OUT 0292 RV LEAD. THE PATIENT SURVIVED THE PROCEDURE.

  Patient problems: Iatrogenic Source; Low Blood Pressure/ Hypotension

  MAUDE report 8852076 ↗
• MalfunctionMar 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE REPORTED THAT A CARDIAC LEAD MANAGEMENT PROCEDURE COMMENCED. THE LEAD EXTRACTION WAS BEING PERFORMED DUE TO "NOISE" ON THE RIGHT VENTRICULAR (RV) LEAD. THE OPERATIVE PLAN WAS TO REMOVE THE CURRENT CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) AND IMPLANT A DIFFERENT DEVICE. THE PHYSICIAN OPENED THE POCKET AND DISSECTED OUT THE LEAD. WHEN HE TOOK AN XRAY IMAGE IT WAS SEEN THAT THE LEAD WAS ATTACHED FROM THE CLAVICLE. HE THEN USED A SPECTRANETICS LEAD LOCKING DEVICE (LLD) EZ 518-067 WHICH WAS DEPLOYED SUCCESSFULLY. THEN HE USED A 13FR SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH. THE TIGHTRAIL ADVANCED, BUT STOPPED AT THE CLAVICLE. FROM THIS POINT, THE SHEATH ADVANCED SLOWLY AND WITH DIFFICULTY. THE TIGHTRAIL SHEATH AND THE OUTER SHEATH WERE ADVANCED JUST PAST THE SUPERIOR VENA CAVA (SVC). AT THIS POINT, DESPITE PUTTING TENSION ON THE SPECTRANETICS LLD EZ, THE LEAD DID NOT APPEAR TO STRAIGHTEN. AT THIS POINT IT WAS THOUGHT THAT THE LLD HAD SLIPPED BACK FROM THE TIP OF THE LEAD. THE PHYSICIAN ATTEMPTED TO FURTHER MANIPULATE THE TIGHTRAIL SHEATH AND THE LLD SNAPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388565 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC LEAD MANAGEMENT CASE, A PERFORATION TO THE CORONARY SINUS (CS) OCCURRED. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) 518-067 WAS UTILIZED IN THE LEFT VENTRICULAR (LV) LEAD. IN THIS SCENARIO, THE TYPE OF LEAD USUALLY USED FOR RIGHT VENTRICULAR (RV) IMPLANTATION WAS PRESENT IN THE LV. REP STATED THAT THIS LEAD IS A LITTLE BIGGER THAN WHAT IS USUALLY USED FOR THE LV. BY APPLYING TRACTION/COUNTER TRACTION, THE LEAD EVENTUALLY CAME LOOSE AND WAS COMPLETELY REMOVED. APPROXIMATELY 1 MINUTE LATER, THE ANESTHESIOLOGIST NOTICED SOME BLOOD GATHERING VIA THE TRANS-ESOPHAGEAL ECHO-CARDIOGRAM (TEE). RESCUE EFFORTS WERE IMPLEMENTED. DURING THORACOTOMY THE SURGEON DISCOVERED A SMALL PERFORATION IN THE CS REGION AND WAS ABLE TO STITCH/REPAIR THE INJURY. THE SURGEON ELECTROPHYSIOLOGIST CLOSED THE PATIENT AND THE PROCEDURE WAS ABANDONED. PATIENT REMAINED STABLE THROUGHOUT. ALTHOUGH IT WAS REPORTED THAT THERE WERE 4 LEADS TO BE REMOVED, ONLY THE LV WAS REMOVED; THE OTHER LEADS REMAINED IN THE PATIENT. THERE WERE NO LLD'S PRESENT IN ANY OF THE LEADS LEFT IN THE PATIENT.

  Patient problems: Iatrogenic Source; Perforation of Vessels

  MAUDE report 8174237 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7408168 ↗