LLD EZ Lead Locking Device 518-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 00813132023072), received between Apr 5, 2018 and Sep 30, 2026 — classified as 18 deaths, 294 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 322 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2026Material Separation

  A lead extraction procedure commenced to remove a right ventricular (RV) lead due to fracture. A right atrial (RA) lead was present within the patient, but was not targeted for extraction. A Spectranetics LLD EZ Lead Locking Devices (LLD EZ) was inserted into the lead to provide traction. During extraction, utilizing multiple Spectranetics devices (GlideLight Laser Sheath, VisiSheath Dilator Sheath, TightRail Sub-C Rotating Dilator Sheath, and TightRail Rotating Dilator Sheath), the lead, along with the LLD broke in the subclavian. Switching to a Merit Medical Needle's Eye Snare, attempts were made to snare from the groin; however, the snare broke and a Abbott Agilis catheter was then used. After several attempts to dislodge the lead, a pericardial effusion was noted in the RV apex, and rescue efforts began, including pericardiocentesis and sternotomy. An RV perforation was discovered and repaired, and the RV lead was removed. The patient was transferred to the ICU in critical condition, and made no improvement in the following days. Care was withdrawn and the patient did not survive.This report captures the LLD that broke, and perforation occurred, requiring intervention, but resu

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50946464 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50938354 ↗
• InjurySep 17, 2026Material Separation

  Patient problems: Device Embedded In Tissue or Plaque; Hemodynamic instability; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50809096 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50805748 ↗
• InjurySep 17, 2026Adverse 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 EZ Lead Locking Device (LLD EZ) was inserted into the lead to provide traction. Beginning with a Spectranetics GlideLight Laser Sheath, progress stalled above the superior vena cava (SVC), and pulling with traction forces from the LLD EZ, the RV lead came free. However, a pericardial effusion was detected, and rescue efforts began, including sternotomy. An RV perforation was discovered and repaired, and the RV lead was removed post-sternotomy with a Spectranetics TightRail Rotating Dilator Sheath. The patient survived the procedure.This report captures the LLD EZ providing traction on the RV lead 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 50805522 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), 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, along with a Spectranetics VisiSheath Dilator Sheath, advancement was made through the subclavian down past the RA. With traction from the LLD EZ, the LV lead was extracted; however, a pericardial effusion was detected. Rescue efforts began, including bypass, pericardial window, and sternotomy. A perforation to the coronary sinus (CS) was discovered and repaired (MDR #3007284006-2026-00431). The decision was made to abandon the extraction; therefore, the LLD EZs, along with the RA and RV lead, were cut and capped and remained in the patient (MDR #3007284006-2026-00432). There was no attempt made to unlock the LLD EZs. 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 50498457 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50498454 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), 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, along with a Spectranetics VisiSheath Dilator Sheath, advancement was made through the subclavian down past the RA. With traction from the LLD EZ, the LV lead was extracted; however, a pericardial effusion was detected. Rescue efforts began, including bypass, pericardial window, and sternotomy. A perforation to the coronary sinus (CS) was discovered and repaired (MDR #3007284006-2026-00431). The decision was made to abandon the extraction; therefore, the LLD EZs, along with the RA and RV lead, were cut and capped and remained in the patient (MDR #3007284006-2026-00432, MDR #3007284006-2026-00433). There was no attempt made to unlock the LLD EZs. The patient survived the procedure.This report captures the LLD EZ providing traction when the perforation occurred, requiring intervention. There was no alleged malfunction of any Spectranetics devices in use during the procedure.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 50498450 ↗
• InjuryAug 19, 2026Material Separation

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50330333 ↗
• DeathJul 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 25908907 ↗
• InjuryJun 22, 2026Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A CAPPED RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. AN ACTIVE RV AND ACTIVE RIGHT ATRIAL (RA) LEAD WERE PRESENT WITHIN THE PATIENT, BUT WERE NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION; HOWEVER, DURING PREPARATION OF THE CAPPED RV LEAD, THE HIGH VOLTAGE CABLES BROKE AT THE CLAVICLE AND PULLED OUT OF THE LEAD. ATTEMPTS WERE MADE TO ADVANCE TO THE LLD EZ, ONLY MAKING IT TO THE TOP OF THE SUPERIOR VENA CAVA (SVC). THE LLD EZ WAS RETRACTED AND A SPECTRANETICS LLD #1 LEAD LOCKING DEVICE (LLD #1) WAS USED WITH THE SAME RESULT, SO THE LLD #1 WAS REMOVED AND THE LLD EZ WAS INSERTED ONTO THE LEAD AGAIN, LOCKED, AND SUTURE WAS APPLIED TO THE OUTER INSULATION OF THE LEAD. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, THE GLIDELIGHT WOULD NOT ADVANCE PAST THE CLAVICLE DUE TO SEVERE LEAD ON LEAD BINDING. THE DECISION WAS MADE TO ABANDON THE PROCEDURE FOR FEAR OF DAMAGING THE UNTARGETED LEADS. ATTEMPTS TO UNLOCK THE LLD EZ FROM THE CAPPED RV LEAD WERE UNSUCCESSFUL; THEREFORE, THE RV LEA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25587720 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE AND OCCLUSION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT WAS MADE DOWN TO THE ATRIUM. WHILE PULLING ON THE LLD, THE LEAD PULLED BACK; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA ECHO. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN INFERIOR VENA CAVA (IVC)/RA JUNCTION PERFORATION WAS DISCOVERED, AND BELIEVED TO HAVE BEEN CAUSED BY PULLING ON THE LEAD, WHICH WAS ADHERED IN THE AREA CREATING THE PERFORATION. THE INJURY WAS REPAIRED, AND THE DECISION WAS MADE TO ABANDON THE PROCEDURE. THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT AND CAPPED, AND REMAINED IN THE PATIENT. THERE WAS NO ATTEMPT TO UNLOCK THE LLD EZ, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION TO THE LEAD WHEN THE SUSPECTED PERFORATION OCCURRED, REQUIRING INTERVENTION, AND WAS CUT/CAPPED AND REMAINED IN THE PATIENT.

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

  MAUDE report 25535493 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A LEFT VENTRICULAR (LV) LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD WERE PRESENT WITHIN THE PATIENT BUT WERE 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 12F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS SMALL VISISHEATH DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE DISTAL PORTION OF THE INNOMINATE JUST PRIOR TO THE SUPERIOR VENA CAVA (SVC). WITH TRACTION FROM THE LLD EZ, THE LEAD RETRACTED TO THE MID SVC. UPSIZING TO A 14F GLIDELIGHT, THE LEAD WAS EXTRACTED; HOWEVER, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. AN RV PERFORATION WAS SUSPECTED, BUT THE PATIENT STABILIZED AND SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION TO THE LEAD 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 25504069 ↗
• MalfunctionJun 12, 2026Material Separation

  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 TIGHTRAIL ROTATING DILATOR SHEATH, THE RA AND LV LEADS WERE REMOVED SUCCESSFULLY. SWITCHING TO THE RV LEAD AND WHEN PULLING ON THE LLD EZ, THE LLD EZ BROKE PROXIMAL TO THE MANDREL. THE PHYSICIAN WAS STILL ABLE TO USE THE LLD EZ AND THE RV LEAD WAS REMOVED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES A PORTION OF THE LLD EZ THAT SEPARATED IN THE PATIENT; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490959 ↗
• InjuryMay 6, 2026Adverse 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) AND LEFT VENTRICULAR (LV) LEAD WERE PRESENT WITHIN THE PATIENT, BUT WERE 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, ADVANCEMENT WAS MADE TO THE TIP OF THE LEAD, AND THE LEAD WAS FREED. HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION AND RV PERFORATION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING A PERICARDIOCENTESIS. THE PATIENT STABILIZED WITH NO FURTHER INTERVENTION REQUIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION TO THE RV LEAD 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 25107371 ↗
• InjuryMar 20, 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 RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEAD WERE PRESENT WITHIN THE PATIENT, BUT 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, PROGRESS STALLED BECAUSE THE LEAD STARTED TO SNOWPLOW. THEREFORE, UPSIZED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH. ADVANCEMENT WAS MADE TO THE INNOMINATE VEIN, AND THE LEAD FREED FROM THE HEART. A NEW RA LEAD WAS IMPLANTED; HOWEVER, THE PATIENT'S BLOOD PRESSURE DECLINED AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. AN RA PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT STABILIZED AND SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ PROVIDING TRACTION TO THE RA LEAD 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 24656377 ↗
• InjuryMar 19, 2026Adverse 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 EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH, THE RV LEAD WAS REMOVED; HOWEVER, A PERICARDIAL EFFUSION AND RV PERFORATION WERE DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, AND THE PATIENT STABILIZED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ DEVICE PROVIDING TRACTION TO THE RV LEAD 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 24646135 ↗
• InjuryMar 5, 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 BACTEREMIA AND ENDOCARDITIS. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING MULTIPLE SPECTRANETICS DEVICES (11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 11F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), 14F GLIDELIGHT LASER SHEATH, 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), 12F GLIDELIGHT LASER SHEATH, 16F GLIDELIGHT LASER SHEATH, AND VISISHEATH (LARGE AND SMALL) DILATOR SHEATHS), THE RA LEAD WAS SUCCESSFULLY REMOVED. TARGETING THE RV LEAD WITH THE 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), IT WOULD NOT ADVANCE PAST THE MIDWAY POINT BETWEEN THE TWO COILS OF THE LEAD DUE TO EXTRUDING WIRES FROM THE LEAD. DURING THE ATTEMPT TO BEND THE EXTRUDING WIRES BACK TOWARD THE DISTAL TIP WHICH WOULD FREE ADVANCEMENT OF THE TIGHTRAIL, THE DISTAL TIP RELEASED FROM THE RV APEX FREEWALL. THE RV LEAD WAS REMOVED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING COMPRESSIONS, PERICARDIOCENTESIS, BYPASS, AND STERNOTOMY. A R

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24520736 ↗
• InjuryFeb 24, 2026Break

  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 ON THE RA LEAD, STEADY PROGRESSION WAS MADE DOWN THE INNOMINATE, THROUGH THE SUPERIOR VENA CAVA (SVC), AND DOWN TO THE RIGHT ATRIUM. THEN, TARGETING THE RV LEAD WITH THE 14F GLIDELIGHT, ADVANCEMENT WAS MADE TO THE INNOMINATE/SVC JUNCTION, BUT BINDING WAS ENCOUNTERED. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE PAST THE BINDING SITE, AND THE RA LEAD WAS REMOVED. WHEN REMOVING THE TIGHTRAIL FROM THE PATIENT, THE BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON. THE BLOOD PRESSURE STABILIZED; HOWEVER, THE ABDOMEN BECAME EXTENDED AND IT WAS UNCLEAR WHERE THE BLEEDING WAS COMING FROM. THEREFORE, A STERNOTOMY AND EXPLORATORY LAPAROTOMY WERE PERFORMED, BUT UNABLE TO FIND THE SOURCE OF THE BLEEDING. ANGIOGRAPHIC IMAGING WAS PERFORMED AND DETECTED A FISTULA BETWEEN THE AORTA AND INNOMINATE VEIN (MDR#: 3007284006-2026-00060). THE DECISION WAS MADE TO ABANDON TH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24428892 ↗
• InjuryFeb 4, 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 MRI AND NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. HOWEVER, WHEN REMOVING THE RV LEAD, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION EXTENDING FROM THE INNOMINATE TO THE SUPERIOR VENA CAVA (SVC) AND INTO THE RIGHT ATRIUM WAS DISCOVERED AND REPAIRED (MDR #3007284006-2026-00038). 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 #). THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ WITHIN THE RV 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 24264144 ↗
• InjuryJan 29, 2026Material Separation

  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), ALONG WITH COOK MEDICAL BULLDOG LEAD EXTENDER, WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG) WITH OUTER SHEATH, SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND COOK MEDICAL 11F EVOLUTION DILATOR SHEATH ON THE RA LEAD, THE LEAD WAS SUCCESSFULLY REMOVED. TARGETING THE RV LEAD WITH THE SAME DEVICES, THE HIGH VOLTAGE CABLES BEGAN TO EXTERNALIZE IN THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION. THE LEAD FREED FROM THE HEART UP TO THE RV COIL, AND A COOK MEDICAL NEEDLE¿S EYE SNARE WAS USED FOR MORE TRACTION. HOWEVER, THE LEAD, ALONG WITH THE LLD, BROKE IN THE RA. ATTEMPTS TO SNARE FROM THE GROIN WERE UNSUCCESSFUL; THEREFORE, THE DECISION WAS MADE TO ABANDON THE PROCEDURE. THE LEAD AND LLD EZ REMAINED IN THE PATIENT, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES A PORTION OF THE LLD EZ WITHIN THE RV LEAD THAT SEPARATED, ALONG WITH THE LEAD, AND RETAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24211555 ↗
• InjuryJan 15, 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 TRICUSPID REGURGITATION. ATTEMPTS WERE MADE TO INSERT SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) INTO EACH LEAD TO PROVIDE TRACTION, BUT WAS UNSUCCESSFUL, SO SWITCHED TO SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS). BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS SMALL VISISHEATH DILATOR SHEATH, PROGRESS WAS MADE TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION THROUGH THE SVC/RA JUNCTION, WHERE LEAD ON LEAD BINDING WAS ENCOUNTERED. WHILE ON THE RA LEAD, MECHANICAL ABLATION WAS PERFORMED WITH THE VISISHEATH, AND THE RA LEAD WAS REMOVED. UPSIZING TO A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, ALONG WITH THE VISISHEATH ON THE RV LEAD, ADVANCEMENT WAS MADE TO THE DISTAL TIP OF THE LEAD, AND WITH TRACTION, THE LEAD TIP FREED FROM THE HEART. HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. A RV PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. THI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24089845 ↗
• InjuryDec 15, 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 16F GLIDELIGHT LASER SHEATH ON BOTH LEADS, LEAD ON LEAD BINDING WAS ENCOUNTERED. SWITCHING TO A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH, THE RA LEAD WAS REMOVED SUCCESSFULLY. TARGETING THE RV LEAD, RESISTANCE WAS EXPERIENCED; THEREFORE, THE DECISION WAS MADE TO ABANDON THE EXTRACTION DUE TO PATIENT RISK. THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD EZ WITHIN THE RV 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 23803206 ↗
• InjuryDec 5, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO LEFT VENTRICULAR (LV), AND TWO RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, TIGHTRAIL ROTATING DILATOR SHEATH (LONG), AND VISISHEATH DILATOR SHEATH), ONE LV AND THE RA LEADS CAME FREE. HOWEVER, UPON REMOVING ONE OF THE RV LEADS, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN RV PERFORATION WAS DISCOVERED AND REPAIRED (MDR #3007284006-2025-00254), AND THE EXTRACTION CONTINUED. WHILE REMOVING THE SECOND RV AND SECOND LV, BOTH LEADS, ALONG WITH THE LLDS, SEPARATED. ATTEMPTS WERE MADE TO SNARE BUT WERE UNSUCCESSFUL. THEREFORE, THE LV AND RV (MDR #3007284006-2025-00256) LEADS AND LLD REMNANTS REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES A PORTION OF THE LLD EZ WITHIN THE LV LEAD THAT SEPARATED AND RETAINED IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23728944 ↗
• InjuryDec 5, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO LEFT VENTRICULAR (LV), AND TWO RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, TIGHTRAIL ROTATING DILATOR SHEATH (LONG), AND VISISHEATH DILATOR SHEATH), ONE LV AND THE RA LEADS CAME FREE. HOWEVER, UPON REMOVING ONE OF THE RV LEADS, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN RV PERFORATION WAS DISCOVERED AND REPAIRED (MDR #3007284006-2025-00254), AND THE EXTRACTION CONTINUED. WHILE REMOVING THE SECOND RV AND SECOND LV, BOTH LEADS, ALONG WITH THE LLDS, SEPARATED. ATTEMPTS WERE MADE TO SNARE BUT WERE UNSUCCESSFUL. THEREFORE, THE LV (MDR #3007284006-2025-00255) AND RV LEADS AND LLD REMNANTS REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES A PORTION OF THE LLD EZ WITHIN THE RV LEAD THAT SEPARATED AND RETAINED IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23728753 ↗