LLD #2 Lead Locking DeviceRecalls & reported problems across all models

We found 2 models of LLD #2 Lead Locking Device by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2018 and Oct 30, 2025 — classified as 2 deaths, 68 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LLD #2 Lead Locking Device problems

LLD #2 Lead Locking Device models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LLD #2 Lead Locking Device 518-019

  Stylet, Catheter
  2 deaths62 reports
• LLD #2 Lead Locking Device 518-022

  Stylet, Catheter
  10 reports

Recent LLD #2 Lead Locking Device adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD #2S LEAD LOCKING DEVICE (LLD #2S) WAS INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH MULTIPLE SPECTRANETICS DEVICES (14F GLIDELIGHT LASER SHEATH, 16F GLIDELIGHT LASER SHEATH, AND 11F TIGHTRAIL ROTATING DILATOR SHEATH) ON THE RA LEAD, THE LEAD WAS SUCCESSFULLY REMOVED. SWITCHING BACK TO THE 16F GLIDELIGHT ON THE RV LEAD, THE LLD #2, ALONG WITH THE LEAD SEPARATED. THE DECISION WAS MADE TO CONTINUE THE EXTRACTION USING A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH; HOWEVER, THE LEAD AND LLD #2 SEPARATED EVEN FURTHER. THEREFORE, THE EXTRACTION ATTEMPTS WERE ABORTED, AND THE DISTAL PORTION OF THE LEAD AND LLD #2 WERE CAPPED, AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES A PORTION OF THE LLD #2 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 23430737 ↗
• InjurySep 18, 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 NON-FUNCTION. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT AND SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, THE RV LEAD WAS SUCCESSFULLY REMOVED. TARGETING THE RA LEAD WITH THE GLIDELIGHT AND VISISHEATH, THE RA LEAD WAS REMOVED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS. WITH ADDITIONAL SUPPORT OF EPINEPHRINE, THE EFFUSION REDUCED IN SIZE AND THE BLOOD PRESSURE IMPROVED. RE-IMPLANT WAS COMPLETED, AND THE PATIENT WAS ADMITTED TO THE ICU WITH A DRAIN IN PLACE. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 DEVICE 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 23090319 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO CAPPED RIGHT VENTRICULAR (RV) LEADS (5068 AND 1088TC) DUE TO REDUNDANCY AND TO ADD A LEFT VENTRICULAR (LV) LEAD. ANOTHER RV LEAD AND AN RA LEAD WERE ALSO PRESENT WITHIN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE 5068 LEAD AND A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) INTO THE 1088TC LEAD, TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, ATTEMPTS WERE MADE TO FREE THE LEADS THROUGH THE INNOMINATE, BUT WERE UNSUCCESSFUL. SWITCHING TO MULTIPLE SPECTRANETICS DEVICES (11F TIGHTRAIL ROTATING DILATOR SHEATH (LONG) AND 14F GLIDELIGHT LASER SHEATH WITH A MEDIUM VISISHEATH DILATOR SHEATH), NO FURTHER PROGRESS WAS MADE PAST THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. THUS, THE DECISION WAS MADE TO ABANDON THE PROCEDURE, RECAP THE LEADS, AND IMPLANT THE LV LEAD. THE RV LEADS, ALONG WITH THE LLD #2 AND LLD EZ, WERE CUT/CAPPED AND REMAINED IN THE PATIENT. ATTEMPTS TO UNLOCK THE LLD EZ WAS UNSUCCESSFUL (MDR #3007284006-2025-00118); THEREFORE, NO ATTEMPT WAS MADE TO UNLOCK THE LLD #2. THE PATIENT SURVIVED TH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22386886 ↗
• InjuryMay 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 ATRIAL (RA) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. USING MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND TIGHTRAIL (LONG) ROTATING DILATOR SHEATH) ATTEMPTS WERE MADE TO REMOVE THE RA LEAD, BUT WERE UNSUCCESSFUL. THEREFORE, THE DECISION WAS MADE TO ABANDON THE PROCEDURE, AND THE REMAINING RA LEAD, ALONG WITH THE LLD #2, WERE CUT/CAPPED AND REMAINED IN THE PATIENT. THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD #2. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 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 22028128 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO REDUNDANCY. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH ON BOTH LEADS, LITTLE PROGRESS WAS MADE DUE TO HEAVY CALCIFICATION. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE RA LEAD, ADVANCEMENT WAS MADE THROUGH THE SUPERIOR VENA CAVA (SVC). A PLEURAL EFFUSION WAS DETECTED VIA VENOGRAM, AND A SUBCLAVIAN PERFORATION WAS NOTED (MDR #3007284006-2025-00077). RESCUE EFFORTS BEGAN, AND THE TIGHTRAIL DEVICE WAS USED TO STOP BLEEDING FROM THE PERFORATION. A RESCUE BALLOON WAS USED TO TAMPONADE THE INJURY, AND A CHEST DRAIN WAS PLACED TO REMOVE THE BLOOD. THE PATIENT STABILIZED, AND VENOGRAM SHOWED NO EFFUSION, BUT MINIMAL BLOOD LOSS WAS COMING FROM THE CHEST TUBE. AS A RESULT, THE DECISION WAS MADE TO STOP THE EXTRACTION. NO ATTEMPT WAS MADE TO UNLOCK THE LLDS FROM THE RV LEAD, THE RA LEAD (MDR #3007284006-2025-00079), SO THE LEADS, ALONG WITH THE LLDS, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21894257 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO REDUNDANCY. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH ON BOTH LEADS, LITTLE PROGRESS WAS MADE DUE TO HEAVY CALCIFICATION. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE RA LEAD, ADVANCEMENT WAS MADE THROUGH THE SUPERIOR VENA CAVA (SVC). A PLEURAL EFFUSION WAS DETECTED VIA VENOGRAM, AND A SUBCLAVIAN PERFORATION WAS NOTED (MDR #3007284006-2025-00077). RESCUE EFFORTS BEGAN, AND THE TIGHTRAIL DEVICE WAS USED TO STOP BLEEDING FROM THE PERFORATION. A RESCUE BALLOON WAS USED TO TAMPONADE THE INJURY, AND A CHEST DRAIN WAS PLACED TO REMOVE THE BLOOD. THE PATIENT STABILIZED, AND VENOGRAM SHOWED NO EFFUSION, BUT MINIMAL BLOOD LOSS WAS COMING FROM THE CHEST TUBE. AS A RESULT, THE DECISION WAS MADE TO STOP THE EXTRACTION. NO ATTEMPT WAS MADE TO UNLOCK THE LLDS FROM THE RV LEAD, (MDR #3007284006-2025-00078), OR THE RA LEAD (MDR #3007284006-2025-00079), SO THE LEADS, ALONG WITH THE LLDS, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SU

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21894251 ↗
• InjuryMar 25, 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 NON-FUNCTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND TRACTION WITH A NON-PHILIPS FIBER WIRE, THE RA LEAD WAS REMOVED. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS THEN INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. HOWEVER, THE LLD WAS UNABLE TO REACH THE TIP OF THE LEAD, AND THE LEAD STARTED TO FALL APART. THEREFORE, A COOK MEDICAL BULLDOG LEAD EXTENDER WAS ADDED TO AID IN TRACTION. THE 14F GLIDELIGHT WAS UNABLE TO GO OVER THE LEAD, SO UPSIZED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH. PROGRESS WAS MADE TO THE INNOMINATE VEIN, BUT SLOWLY ADVANCED TO THE TIP OF THE LEAD DUE TO RESISTANCE. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE UP TO THE SAME POINT, WHEN THE PATIENT¿S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON. NO EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), BUT THE BLOOD PRESSURE REMAINED LOW (CAUSE UNKNOWN), AND NO PERFORATION OR INJURY WAS IDENTIFIED. THE DECISION WAS MADE TO PUT THE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21692217 ↗
• InjuryFeb 20, 2025Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND THREE RIGHT VENTRICULAR (RV) LEADS DUE TO FRACTURE, NON-FUNCTION, AND REDUNDANCY. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2), SPECTRANETICS LLD E LEAD LOCKING DEVICES (LLD ES), AND SPECTRANETICS LLD #1 LEAD LOCKING DEVICES (LLD #1S), WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 13F TIGHTRAIL (LONG), AND 16F GLIDELIGHT LASER SHEATH) WERE USED DURING THE PROCEDURE. THE RV LEAD, IMPLANTED IN 2024, WAS REMOVED WITH NO ISSUES. HOWEVER, EFFORTS WERE MADE TO REMOVE THE OTHER 3 LEADS BUT WERE UNSUCCESSFUL. AS A RESULT, THE DECISION WAS MADE TO STOP THE EXTRACTION. FAILED ATTEMPTS WERE MADE TO UNLOCK THE LLDS FROM THE RV LEAD, IMPLANTED IN 2009. THE RA LEAD, IMPLANTED IN 2009 (MDR#: 3007284006-2025-00031), AND THE RV LEAD, IMPLANTED IN 2018 (MDR#: 3007284006-2025-00032), SO THE LEADS, ALONG WITH THE LLDS, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 WITHIN THE RV LEAD, IMPLANTED IN 2009, WHICH WAS CUT AND CAPPED AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21422502 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEADS DUE TO NON-FUNCTION AND FRACTURE. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH ON THE RA LEAD, PROGRESS WAS MADE TO THE TOP OF THE SUPERIOR VENA CAVA (SVC), WHERE LEAD ON LEAD BINDING WOULD NOT ALLOW FOR FURTHER ADVANCEMENT. NEXT, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED ON THE RA LEAD AND THE LEAD WAS REMOVED; HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN RA PERFORATION WAS DISCOVERED AND REPAIRED. ANOTHER PERFORATION IN THE INNOMINATE REGION WAS DISCOVERED AND REPAIRED, BUT THE PHYSICIAN BELIEVED THIS OCCURRED DURING THE STERNOTOMY. THE RV AND LV LEADS WERE NOT EXTRACTED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 PROVIDING TRACTION WITHIN THE RA LEAD, WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20903128 ↗
• InjuryNov 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), A LEFT VENTRICULAR (LV), AND TWO RIGHT VENTRICULAR (RV, ONE ACTIVE, ONE REDUNDANT) LEADS DUE TO NEEDING AN MRI COMPATIBLE SYSTEM, AND A REDUNDANT RV LEAD. PRIOR TO THE PROCEDURE, THE PATIENT'S VESSELS WERE HEAVILY CALCIFIED, WITH THE LEADS BOUND TOGETHER. SPECTRANETICS LEAD LOCKING DEVICES (AN LLD # 2 IN RA, LLD E IN LV, LLD EZ IN ACTIVE RV, LLD # 2 IN REDUNDANT RV) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE ACTIVE RV LEAD, THE PATIENT'S BLOOD PRESSURE SLOWLY DECLINED DUE TO TRACTION, BUT WAS REMOVED WITH NO EVIDENCE OF INJURY. NEXT, THE RA WAS TARGETED, USING THE SAME 13F TIGHTRAIL. THE RA LEAD WAS REMOVED; HOWEVER, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DECLINE, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, WITH 400 CC BLOOD DRAWN OFF THE HEART. OVER THE NEXT 90 MINUTES, MORE BLOOD WAS REMOVED; THEREFORE, A STERNOTOMY WAS PERFORMED. A SMALL PERFORATION IN THE INFERIOR RV WAS DISCOVERED (MDR # .); THE SURGEON PLUGGED THE HOLE WITH HIS FINGE

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20613253 ↗
• InjuryNov 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), A LEFT VENTRICULAR (LV), AND TWO RIGHT VENTRICULAR (RV, ONE ACTIVE, ONE REDUNDANT) LEADS DUE TO NEEDING AN MRI COMPATIBLE SYSTEM, AND A REDUNDANT RV LEAD. PRIOR TO THE PROCEDURE, THE PATIENT'S VESSELS WERE HEAVILY CALCIFIED, WITH THE LEADS BOUND TOGETHER. SPECTRANETICS LEAD LOCKING DEVICES (AN LLD #2 IN RA, LLD E IN LV, LLD EZ IN ACTIVE RV, LLD #2 IN REDUNDANT RV) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE ACTIVE RV LEAD, THE PATIENT'S BLOOD PRESSURE SLOWLY DECLINED DUE TO TRACTION, BUT WAS REMOVED WITH NO EVIDENCE OF INJURY. NEXT, THE RA WAS TARGETED, USING THE SAME 13F TIGHTRAIL. THE RA LEAD WAS REMOVED; HOWEVER, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DECLINE, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, WITH 400 CC BLOOD DRAWN OFF THE HEART. OVER THE NEXT 90 MINUTES, MORE BLOOD WAS REMOVED; THEREFORE, A STERNOTOMY WAS PERFORMED. A SMALL PERFORATION IN THE INFERIOR RV WAS DISCOVERED (MDR #3007284006-2024-00220); THE SURGEON PLUGGED THE HO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20612411 ↗
• InjurySep 17, 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), A RIGHT VENTRICULAR (RV), AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS (LLD #2 IN RA LEAD, LLD EZ IN RV LEAD, AND LLD E IN LV LEAD) TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RA LEAD, LEAD ON LEAD BINDING, CALCIUM, AND FIBROSIS WAS ENCOUNTERED, BUT ADVANCEMENT WAS MADE TO THE MID SUPERIOR VENA CAVA (SVC). SWITCHING TO THE RV LEAD WITH THE SAME 14F GLIDELIGHT, PROGRESS WAS ACHIEVED TO THE SAME AREA, AND IT APPEARED THAT THE RA LEAD WAS BOUND TO THE RV LEAD AT THE DISTAL PORTION OF THE RV LEAD PROXIMAL COIL. UPSIZING TO A 16F GLIDELIGHT ON THE RV LEAD, ADVANCEMENT COULD ONLY BE ACHIEVED TO THE SAME BINDING SITE, SO A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH WAS ADDED, AND THE DEVICES REACHED THE BEGINNING OF THE RV DISTAL COIL. THE VISISHEATH WAS USED TO ADVANCE TO THE RV DISTAL TIP, AND WITH TRACTION FROM THE LLD EZ, THE RV LEAD WAS EXTRACTED WITHOUT ISSUES. NEXT, THE 16F GLIDELIGHT (WITHOUT VISISHEATH) WAS USED ON THE RA LEAD, AND THE LEAD WAS EXTRACTED. HOWEVER, THE PATIENT'S BLOOD PRESSU

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20237909 ↗
• InjuryAug 21, 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) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA, CIED SYSTEM/POCKET INFECTION, AND LEAD FRACTURE. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD, TO PROVIDE TRACTION. IN ADDITION, MEDTRONIC POLYSORB SUTURE WAS TIED TO THE LEAD INSULATION, TO PROVIDE ADDITIONAL TRACTION. APPROXIMATELY 10 ATTEMPTS WERE MADE TO RETRACT THE RV LEAD DISTAL SCREW FROM THE HEART BUT WERE UNSUCCESSFUL. THERE WERE NO ATTEMPTS TO RETRACT THE RA LEAD DISTAL SCREW, BECAUSE OF NOTED LEAD FRACTURE. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, MINIMAL RESISTANCE WAS ENCOUNTERED, AND ADVANCEMENT WAS ACHIEVED TO THE RV LEAD DISTAL END. USING GENTLE TRACTION/COUNTERTRACTION, THE RV LEAD IMMEDIATELY CAME FREE, AND THE GLIDELIGHT, VISISHEATH, AND RV LEAD WERE REMOVED. WHILE THE RV LEAD WAS BEING REMOVED FROM THE GLIDELIGHT OUTSIDE THE PATIENT, A PERICARDIAL EFFUSION WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAPHY (TTE). THE EFFUSION RAPIDLY GREW, AND THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PERICARDIOCENTESIS

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20019631 ↗
• InjuryJul 5, 2024Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO OCCLUSION AND NON FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH FOLLOWED BY A 13F TIGHTRAIL (LONG), ATTEMPTS WERE MADE TO ADVANCE PAST THE OCCLUSION. DURING THE PROCEDURE, ACCESS WAS GAINED USING A WIRE, AND A NEW RV LEAD WAS IMPLANTED. AT THAT TIME, THE DECISION WAS MADE TO STOP ANY FURTHER EXTRACTION ATTEMPTS, LEAVING THE NON FUNCTIONAL RV LEAD IN PLACE. ATTEMPTS WERE MADE TO UNLOCK THE LLD #2 FROM THE RV LEAD, BUT WERE UNSUCCESSFUL; THEREFORE, THE RV LEAD/LLD WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 WITHIN THE RV LEAD WHICH WAS CUT AND CAPPED AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19680312 ↗
• DeathMay 8, 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) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE RV LEAD, PROGRESS STALLED NEAR THE TRICUSPID VALVE DUE TO LEAD ON LEAD BINDING. NEXT, COOK MEDICAL BYRD POLYPROPYLENE DILATOR SHEATHS WERE UTILIZED ON THE RV LEAD, BUT WERE UNSUCCESSFUL AT ADVANCEMENT. THEN, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED ON THE RV LEAD BUT STALLED IN THE SAME AREA, SO THE DECISION WAS MADE TO ATTEMPT EXTRACTION OF THE RA LEAD. AN LLD #2 WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION. USING THE GLIDELIGHT ON THE RA LEAD, PROGRESS STALLED AT THE SAME LEAD ON LEAD BINDING SITE NEAR THE TRICUSPID VALVE. UPSIZING TO A 16F GLIDELIGHT, AND FOCUSING ATTENTION AGAIN ON THE RV LEAD, PROGRESS WAS MADE THROUGH THE BINDING SITE TO 2-3 CM FROM THE LEAD TIP, AND THE LEAD RELEASED AND WAS REMOVED. THE 16F GLIDELIGHT WAS THEN USED ON THE RA LEAD, AND WAS ABLE TO ADVANCE SMOOTHLY TO THE LEAD TIP. STRONG TRACTION WAS APPLIED WITH USE OF THE LLD EZ, BUT THE LEAD STAYED ATT

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 19274578 ↗

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