LLD #2 Lead Locking Device 518-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00813132023010), received between Oct 9, 2018 and Oct 30, 2025 — classified as 2 deaths, 58 injuries, 2 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 25 most recent of 62 reports, 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 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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 A RIGHT ATRIAL (RA) LEAD WERE PRESENT IN THE PATIENT, BUT WERE NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LLD E LEAD LOCKING DEVICE (LLD E) WAS INSERTED INTO THE LV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE LEAD BEGAN TO BREAK AND PROGRESS STALLED. THE DECISION WAS THEN MADE TO ATTEMPT REMOVAL OF THE RV LEAD, AND AN LLD #2 WAS INSERTED INTO THE RV LEAD FOR TRACTION. THE TIGHTRAIL SUB-C AND A TIGHTRAIL (LONG) WERE USED TO ALTERNATE BETWEEN LEADS, ALONG WITH A COOK MEDICAL BULLDOG LEAD EXTENDER FOR ADDITIONAL TRACTION. STALLED PROGRESS OCCURRED AFTER SLIGHT ADVANCEMENT ON THE RV LEAD, AND EFFORTS SWITCHED BACK TO THE LV LEAD. ADVANCEMENT COULD NOT BE ACHIEVED DUE TO LEAD ON LEAD BINDING ON THE LV LEAD. THEREFORE, THE RA LEAD WAS TARGETED FOR EXTRACTION AS WELL. AN LLD #2 WAS INSERTED INTO THE RA LEAD FOR TRACTION, BUT LEAD REMOVAL WAS UNSUCCESSFUL. SLIGHT INCREASED BLEEDING WAS NOTED FROM THE POCKET (LIKELY FROM ENLARGEMENT OF THE SUBCLAVIAN VEIN ACCESS SITE WITH REPEATED INSERTIONS O

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19168624 ↗
• InjuryFeb 22, 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 TWO RIGHT VENTRICULAR LEADS (RV MODELS 4088 AND 4137) LEADS DUE TO NON-FUNCTION AND TOTAL SVC OCCLUSION. A SPECTRANETICS LLD #2 LEAD LOCKING DEVICE (LLD #2) WAS INSERTED INTO THE RV 4088 LEAD. MULTIPLE SPECTRANETICS DEVICES (14F GLIDELIGHT LASER SHEATH, 11F TIGHTRAIL ROTATING DILATOR SHEATH, 2-13F TIGHTRAIL ROTATING DILATOR SHEATHS) WERE USED TO ATTEMPT EXTRACTION. DURING USE OF THE SECOND 13F TIGHTRAIL ON THE RV 4088 LEAD AND WHILE SIGNIFICANT TRACTION WAS BEING APPLIED WITH THE LLD, A SMALL PERICARDIAL EFFUSION WAS DETECTED NEAR THE RV VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE PATIENT WAS MONITORED DUE TO A SUSPECTED RV PERFORATION. THE PATIENT'S BLOOD PRESSURE DID NOT CHANGE, THE EFFUSION RESOLVED, BUT THE RV 4088 LEAD WAS NOT EXTRACTED AT THAT TIME. EFFORTS SWITCHED TO REMOVE THE RV 4137 AND RA LEADS. HOWEVER, ATTEMPTING REMOVAL WITH USE OF A 14F GLIDELIGHT AND THE SAME 13F TIGHTRAIL (TRACTION PLATFORMS UNK), THE LEADS COULD NOT BE REMOVED FROM THE POCKET. THEREFORE, TWO ABBOTT AGILIS STEERABLE INTRODUCER-ASSISTED WIRE LOOP SNARES WERE USED TO SUCCESSFULLY EXTRACT THE RV 4137 AND THE RA LEADS. ATTEMPT

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18761008 ↗
• InjuryFeb 5, 2024Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND TWO RIGHT VENTRICULAR (RV) LEADS, ONE ACTIVE AND ONE CAPPED, DUE TO REDUNDANT LEAD. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, GLIDELIGHT LASER SHEATH) WERE USED IN THE PROCEDURE. DURING THE PROCEDURE, THE ACTIVE RV AND RA LEADS WERE SUCCESSFULLY REMOVED. THEN, USING THE TIGHTRAIL SUB-C ON THE CAPPED RV LEAD, THE LLD AND LEAD BROKE OUTSIDE THE PATIENT''S BODY; THEREFORE, THERE WAS NO LONGER A TRACTION PLATFORM. A SNARE WAS USED FROM THE GROIN, AND THE CAPPED RV LEAD AND LLD REMNANTS WERE SUCCESSFULLY REMOVED. THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED PATIENT INJURY. THIS REPORT CAPTURES THE LLD #2 PROVIDING TRACTION WITHIN THE CAPPED RV LEAD WHICH BROKE, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645159 ↗
• InjuryNov 15, 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 A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S), ALONG WITH SUTURE AND FEMORAL SNARES, WERE USED TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THEN SWITCHING TO AN 11F TIGHTRAIL (LONG), THE RV LEAD WAS REMOVED WITHOUT ISSUES. NEXT, THE 11F TIGHTRAIL SUB-C WAS USED ON THE RA LEAD, ENCOUNTERING SNOWPLOWING OF THE LEAD (LEAD INSULATION BUNCHING UP ON ITSELF) OCCURRED IN THE INNOMINATE REGION. A 13F TIGHTRAIL (LONG) WAS USED TO ADVANCE OVER THE SNOWPLOWED REGION, AND THE RA LEAD WAS REMOVED; HOWEVER, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). WHILE THE PHYSICIAN WAS EXAMINING THE RA LEAD, WHICH HAD SIGNIFICANT TISSUE ON THE TINES AT THE LEAD'S TIP, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION OF THE RIGHT ATRIAL APPENDAGE (RAA) WAS DISCOVERED AND REPAIRED. AN INNOMINATE PERFORATION WAS ALSO DISCOVERED DURING THE REPAIR; HOWEVER THE PHYSICIAN FELT THIS WAS RELATED TO THE SAW USED

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18145033 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS, ONE MALFUNCTIONING (IMPLANTED IN 2001), AND ONE CAPPED (FROM 1992). SPECTRANETICS LEAD LOCKING DEVICES (LLD #2) WERE INSERTED INTO EACH LEAD, ALONG WITH SUTURE, TO PROVIDE TRACTION. BEGINNING WITH THE MALFUNCTIONING RV LEAD, A SPECTRANETICS GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH WERE USED TO MAKE STEADY PROGRESS THROUGH THE VASCULATURE, DOWN TO THE RV. THERE WERE MOMENTS OF THE PATIENT'S BLOOD PRESSURE DROPPING, BUT THE BLOOD PRESSURE WOULD RECOVER AND NO EFFUSION WAS DETECTED. THE RV LEAD FINALLY RELEASED, AND THE BLOOD PRESSURE DROPPED AGAIN, PRECIPITOUSLY. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON. A PERICARDIAL EFFUSION IN THE RV REGION WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), AND A STERNOTOMY WAS PERFORMED. AN RV PERFORATION WAS DISCOVERED AND REPAIRED, AND THE CAPPED RV LEAD WAS REMOVED POST-STERNOTOMY. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 PROVIDING TRACTION TO THE MALFUNCTIONING RV LEAD WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DUR

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 17987076 ↗
• InjuryOct 23, 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 A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LEAD LOCKING DEVICES (LLD #2) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH THE RV LEAD, A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED, ADVANCING TO THE TIP OF THE LEAD, AND THE LEAD CAME FREE. APPROXIMATELY 2 MINUTES LATER, THE PATIENT''S BLOOD PRESSURE DROPPED, A PERICARDIAL EFFUSION WAS DETECTED IN THE REGION OF THE RV APEX, AND AN RV PERFORATION WAS SUSPECTED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, AND 250 CC OF BLOOD WAS DRAINED FROM THE AREA, STABILIZING THE PATIENT WITH NO FURTHER INTERVENTION REQUIRED. THE PROCEDURE CONTINUED, EXTRACTING THE RA LEAD SUCCESSFULLY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD #2 PROVIDING TRACTION TO THE RV LEAD WHEN A SUSPECTED 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 17986859 ↗
• InjuryAug 15, 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 A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA AND CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO BOTH LEADS TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 12F, 14F AND 16F GLIDELIGHT LASER SHEATHS, VISISHEATH DILATOR SHEATH, 13F TIGHTRAIL (LONG) ROTATING DILATOR SHEATH) WERE USED TO ADVANCE DOWN THE LEADS, DUE TO STALLED PROGRESSION. THE RV LEAD WAS EXTRACTED FIRST, THEN THE RA LEAD; AND IT WAS NOTED THAT NO EFFUSION WAS DETECTED BETWEEN REMOVAL OF THE RV AND RA LEADS. AFTER THE CASE WAS FINISHED, A SMALL EFFUSION WAS DETECTED, WHICH GREW OVER TIME, AND IT WAS SUSPECTED THAT THE SMALL EFFUSION MAY HAVE ORIGINATED IN THE RIGHT ATRIUM, AS CONSIDERABLE DIFFICULTY WAS ENCOUNTERED WHEN REMOVING THE RA LEAD. A SUBXIPHOID DRAIN WAS PLACED TO TREAT THE EFFUSION; HOWEVER, DURING INSERTION INTO THE INTRAPERICARDIAL SPACE, THE DRAIN CREATED AN RV PERFORATION, RESULTING IN A LARGE EFFUSION AND NEED FOR IMMEDIATE INTERVENTION. A STERNOTOMY WAS PERFORMED, THE RV REPAIR WAS COMPLETED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPOR

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 17552451 ↗
• InjuryMay 3, 2023Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, VISISHEATH DILATOR SHEATH, TIGHTRAIL ROTATING DILATOR SHEATH) WERE USED TO ATTEMPT EXTRACTION. THE RA AND RV LEADS HAD SIGNIFICANT CALCIFIED BINDING BETWEEN THEM, AND THE LEADS BEGAN TO SNOWPLOW (THE INSULATION BUNCHING UP ON ITSELF). THE LEADS COULD NOT BE SAFELY EXTRACTED, SO THEY WERE ABANDONED. THE LLD WITHIN THE RA LEAD WAS SUCCESSFULLY UNLOCKED AND REMOVED FROM THE LEAD''S INNER LUMEN. HOWEVER, THE LLD WITHIN THE RV LEAD COULD NOT BE UNLOCKED; THEREFORE, THE RV LEAD/LLD WERE CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD WITHIN THE RV LEAD WHICH WAS CUT AND CAPPED AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16864617 ↗
• InjuryMar 7, 2023Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO MALFUNCTION. FUNCTIONING RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE PRESENT IN THE PATIENT AS WELL, NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (13F TIGHTRAIL GUARDIAN MOTORIZED DILATOR SHEATH, 16F GLIDELIGHT LASER SHEATH, AND 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG)) WERE USED DURING THE PROCEDURE. WHILE THE 13F TIGHTRAIL LONG WAS BEING USED AND WHILE SIGNIFICANT TRACTION WAS BEING APPLIED, THE RV LEAD AND LLD SEPARATED. THE PHYSICIAN THEN REMOVED THE RV LEAD/LLD REMNANTS THROUGH THE FEMORAL VEIN USING A SNARE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT CAPTURES THE LLD WHICH SEPARATED ALONG WITH THE RV LEAD, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499811 ↗
• InjuryNov 21, 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) LEAD, LEAVING THE RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS IN PLACE WITHIN THE PATIENT. THE PHYSICIAN BEGAN EXTRACTION ATTEMPT OF THE RV LEAD. A SPECTRANETICS LEAD LOCKING DEVICE WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WITH ITS OUTER SHEATH, THE PHYSICIAN ENCOUNTERED IMMEDIATE LEAD TO LEAD BINDING IN THE SUBCLAVIAN REGION. THIS BINDING CAUSED THE PHYSICIAN TO REASSESS HIS PLAN AND ATTEMPT TO EXTRACT ALL LEADS AND RE-IMPLANT A NEW SYSTEM. PHYSICIAN THEN SWITCHED TO THE RA LEAD; INSERTING AN LLD FOR TRACTION AND USING THE SAME GLIDELIGHT AND OUTER SHEATH, THE RA LEAD WAS EXTRACTED SUCCESSFULLY. PHYSICIAN THEN SWITCHED BACK TO THE RV LEAD, TIP OF THE GLIDELIGHT LOCATED IN THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION, WHEN THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON. A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). CPR PERFORMED AND STERNOTOMY FOLLOWED. A PERICARDIOCENTESIS WAS PERFORMED THROUGH THE OPENING OF THE STERNOTOMY. THE PATIENT''S HEART WAS SHOCKED, A

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 15837541 ↗