LLD E Lead Locking Device 518-039Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00813132023058), received between May 29, 2019 and Jul 30, 2026 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 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 bacteremia. During preparation, the RV lead was removed successfully with manual traction. A Spectranetics LLD E Lead Locking Device (LLD E) was inserted into the RA lead to provide traction. Beginning with a Spectranetics 11F TightRail Sub-C Rotating Dilator Sheath, it was noted that the lead was heavily calcified and resistance was encountered. Advancement was made just before the superior vena cava (SVC), and upsized to a Spectranetics 13F TightRail Rotating Dilator Sheath. Resistance was observed on the entire length of the lead, but the RA lead was freed and extracted. However, the patient's blood pressure dropped, and rescue efforts began, including rescue balloon, CPR, blood product, medications, and sternotomy. An RA perforation was discovered and repaired, and the patient survived the procedure.This report captures the LLD E providing traction on 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

  MAUDE report 50091040 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD E LEAD LOCKING DEVICE (LLD E) WAS INSERTED INTO THE LV LEAD, AND A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE LV LEAD, HEAVY BINDING SITES WERE ENCOUNTERED. NEXT, TARGETING THE RV LEAD WITH THE 14F GLIDELIGHT, PROGRESS STALLED AND SWITCHED TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE LV AND RV LEAD. THEN, UTILIZING THE 14F GLIDELIGHT ON THE LV LEAD, ADVANCEMENT WAS MADE DOWN THE CORONARY SINUS (CS), PAST THE SUPERIOR VENA CAVA (SVC), WHEN PROGRESS STALLED AGAIN. SWITCHING TO THE RV LEAD WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT STALLED IN THE SVC; THEREFORE, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED, AND MADE IT PAST THE SVC WHEN THE RV LEAD BROKE. THE INTACT LLD EZ, ALONG WITH A PORTION OF THE RV LEAD WERE REMOVED FROM THE PATIENT. MOVING BACK THE LV LEAD WITH THE 14F GLIDELIGHT, PROGRESS WAS MADE PAST THE SVC DOWN TO THE CS, AND WHILE PULLING TRACTION

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 25669794 ↗
• InjuryMar 12, 2026Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE UPGRADE. A SPECTRANETICS LLD E LEAD LOCKING DEVICE (LLD E) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE SUBCLAVIAN AND SLIGHT CALCIFICATION WAS ENCOUNTERED. HOWEVER, ONCE PAST THE POINT OF THE OCCLUSION, THE DECISION WAS MADE TO ABANDON THE PROCEDURE AS IT WAS TOO RISKY TO CONTINUE. ATTEMPTS TO UNLOCK THE LLD E WERE UNSUCCESSFUL; THEREFORE, THE RV LEAD, ALONG WITH THE LLD E, WERE CUT/CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD E WITHIN THE RV LEAD, WHICH WAS CUT/CAPPED AND REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24585986 ↗
• InjuryOct 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 LEFT VENTRICULAR (LV), RIGHT ATRIAL (RA), AND RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD E LEAD LOCKING DEVICES (LLD ES) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RA AND RV LEAD WERE REMOVED SUCCESSFULLY. THEN, SWITCHING TO THE LV LEAD WITH THE 14F GLIDELIGHT, PROGRESS WAS MADE DOWN TO THE CORONARY SINUS (CS). WHILE PULLING TRACTION WITH THE LLD E, THE LEAD BROKE AT THE INNOMINATE VEIN, AND THE LLD E AND PROXIMAL END OF THE LEAD WERE REMOVED. AN ATTEMPT WAS MADE TO SNARE; HOWEVER, DURING SET UP, A PERICARDIAL EFFUSION WAS DETECTED. THE PATIENT¿S BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, STERNOTOMY, AND BYPASS. A CS PERFORATION WAS DISCOVERED AND REPAIRED, AND THE DECISION WAS MADE TO ABANDON THE DISTAL TIP LV LEAD. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE LLD E PROVIDING TRACTION ON THE LV LEAD WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDU

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 23416125 ↗
• 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 20614210 ↗
• 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: Perforation of Vessels

  MAUDE report 20237918 ↗
• InjuryJun 20, 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 VENTRICULAR (RV), A RIGHT ATRIAL (RA), AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. PRIOR TO THE PROCEDURE, THE PATIENT HAD A SMALL VEGETATION SUSPECTED ON THE RV LEAD NEAR THE TRICUSPID VALVE. A TEMPORARY PACEMAKER WAS PLACED, AND SPECTRANETICS LEAD LOCKING DEVICES (LLD E IN LV LEAD, LLD #2S IN RV AND RA LEADS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH ON THE LV LEAD, ADVANCEMENT WAS MADE TO JUST PROXIMAL OF THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. TRACTION WAS APPLIED TO THE LV LEAD, THE LEAD WAS PULLED INTO THE GLIDELIGHT, AND BOTH WERE REMOVED, BUT THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DETECTED NO EFFUSION IN THE SVC OR INNOMINATE REGIONS. HOWEVER, AN EFFUSION WAS NOTED, SUSPECTING A SMALL PERFORATION OF A LATERAL BRANCH OF THE CORONARY SINUS. A SUBXIPHOID WINDOW WAS PERFORMED, SUCTION WAS APPLIED, AND A BLAKE DRAIN WAS PLACED, WITHDRAWING 300 ML OF BLOOD. THE PATIENT STABILIZED AND THE EXTRACTION CONTINUED. A 16F GLIDELIGHT WAS USED ON THE RV LEAD, AN

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 19575698 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A CAPPED SINGLE LUMEN RIGHT VENTRICULAR (RV) LEAD, AND A TRIPLE LUMEN RV LEAD, DUE TO NON-FUNCTION. TO PROVIDE TRACTION, A SPECTRANETICS LLD E LEAD LOCKING DEVICE (LLD E) WAS INSERTED INTO THE SINGLE LUMEN LEAD, AND THREE SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO THE TRIPLE LUMEN LEAD. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE SINGLE LUMEN LEAD, ADVANCEMENT WAS MADE TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. NEXT, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS USED, PROGRESSING INTO THE HEART, THEN ADVANCING WITHOUT LASING TO THE LEAD''S TIP. LIGHT TRACTION WAS APPLIED BY THE LLD E, AND THE LEAD TIP CAME FREE. THE GLIDELIGHT WAS PULLED BACK NEAR THE INFERIOR VENA CAVA (IVC) REGION, THE LEAD WAS REMOVED, AND A GUIDE WIRE WAS PLACED TO PREPARE FOR RE-IMPLANTATION OF A NEW LEAD. THE PATIENT''S BLOOD PRESSURE SLOWLY DROPPED, BUT NO INJURY WAS EVIDENT. THE GLIDELIGHT WAS REMOVED, AND AT THAT TIME, A PERICARDIAL EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A SMALL, ANTERIOR WALL RV

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18518487 ↗
• InjuryAug 30, 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), A RIGHT VENTRICULAR (RV), AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. PRIOR TO THE PROCEDURE, A SMALL EFFUSION WAS NOTED, AND EXISTING LEAD VEGETATION WAS REMOVED. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE RA AND RV LEADS WERE EXTRACTED SUCCESSFULLY. USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH TO REMOVE THE LV LEAD, ADVANCEMENT WAS MADE TO JUST UNDER THE CLAVICLE. THE LV LEAD PULLED FREE AND THE EXISTING EFFUSION WAS NOTED TO HAVE GROWN; HOWEVER, THE PATIENT REMAINED STABLE. DUE TO THE INCREASED EFFUSION THAT WAS DETECTED AFTER LV LEAD REMOVAL, A CORONARY SINUS (CS) PERFORATION WAS SUSPECTED WITH NO INTERVENTION PERFORMED AT THAT TIME. THE PROCEDURE WAS COMPLETED AND THE PATIENT SURVIVED. LATER THAT EVENING A PERICARDIOCENTESIS WAS PERFORMED TO DRAW OFF BLOOD THAT HAD ACCUMULATED IN THE PERICARDIAL SAC, AND THE PATIENT RESPONDED WELL TO THE INTERVENTION. HOWEVER, IT CANNOT BE CONFIRMED WHETHER THE LLD WITHIN THE LV LEAD CAUSED OR CONTRIBUTED TO THE SUSPECTED CS PERFORATION. THIS REPORT IS BEING SUBMITTED CONSERVATIVELY FOR THE LLD PRESENT WITHIN T

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 17652335 ↗
• MalfunctionMar 9, 2023Material Separation; Material Separation

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. THE PHYSICIAN USED A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH AND DURING THE PROCEDURE, THE LLD SEPARATED OUTSIDE THE PATIENT, IN THE INTERMEDIATE-DISTAL SECTION (UNKNOWN IF WITHIN THE WORKING LENGTH). THE PROXIMAL AND DISTAL SECTIONS OF THE LLD WERE RE-ATTACHED TOGETHER AND THE RV LEAD WAS SUCCESSFULLY EXTRACTED WITH NO REPORTED PATIENT HARM. THIS EVENT CAPTURES THE LLD THAT SEPARATED DURING USE, POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515963 ↗
• InjuryOct 12, 2021Adverse 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 A PSEUDOMONAS INFECTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LV LEAD TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED REMOVAL OF THE LV LEAD BY FIRST USING A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH BUT ENCOUNTERED STALLED PROGRESS IN THE CLAVICLE REGION. HE THEN UPSIZED TO A 14F GLIDELIGHT DEVICE, BUT MADE JUST SLIGHT PROGRESS IN THE SUBCLAVIAN VEIN. THE PHYSICIAN SWITCHED EFFORTS TO THE RA LEAD AND THE RA LEAD WAS SUCCESSFULLY REMOVED WITH USE OF THE 14F GLIDELIGHT DEVICE. ATTEMPTS WERE THEN MADE TO REMOVE THE RV LEAD BUT ENCOUNTERED STALLED PROGRESS. THE PHYSICIAN SWITCHED TOOLS TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH AND THE RV LEAD WAS SUCCESSFULLY REMOVED. THE PHYSICIAN THEN ATTEMPTED REMOVAL OF THE LV LEAD AGAIN, USING THE 14F GLIDELIGHT DEVICE, AND WAS ABLE TO ADVANCE TO THE CORONARY SINUS OS. WITHOUT LASING, THE PHYSICIAN ATTEMPTED TO ADVANCE THE GLIDELIGHT DEVICE INTO THE CORONARY SINUS MECHANICALLY TO REMOVE THE LAST 6-7 CM OF THE LV LEAD, BUT THE DEVICE WOULD NOT ADVANCE PAST THE CORONARY SINUS OS

  Patient problems: Cardiac Perforation

  MAUDE report 12615978 ↗
• InjuryJul 21, 2021Adverse 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 VENTRICULAR (RV), A LEFT VENTRICULAR (LV) AND A RIGHT ATRIAL (RA) LEAD DUE TO NON FUNCTION. THE LEADS HAD BEEN IMPLANTED FOR 219 MONTHS. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION TO AID IN THE EXTRACTIONS. THE PHYSICIAN USED MULTIPLE DEVICES TO ATTEMPT LEAD EXTRACTIONS. BEGINNING WITH THE RV LEAD, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS USED, FOLLOWED BY A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, FOLLOWING BY THE GLIDELIGHT DEVICE AGAIN, WITH THE ADDITION OF A SPECTRANETICS VISISHEATH DILATOR SHEATH. ADVANCEMENT TO THE SUPERIOR VENA CAVA (SVC) WAS ACHIEVED, AND THE RV LEAD WAS DISRUPTED BUT NOT REMOVED. ATTENTION WAS THEN TURNED TO THE LV LEAD. WHILE ATTEMPTING REMOVAL OF THE LV LEAD USING THE GLIDELIGHT DEVICE AND AN LLD TO PROVIDE TRACTION, THE GLIDELIGHT ONLY ADVANCED TO THE CORONARY SINUS OS AND DID NOT LASE WITHIN THE CORONARY SINUS. THE LV LEAD WAS SUCCESSFULLY REMOVED AND IT WAS REPORTED THAT THE RA LEAD WAS SUCCESSFULLY REMOVED AS WELL. THE PHYSICIAN THEN PLANNED A FEMORAL EXTRACTION OF THE RV LEAD. HOWEVER, AT THAT TIME THE PATIENT

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 12207804 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 4 LEADS: A RIGHT ATRIAL (RA) LEAD, TWO RIGHT VENTRICULAR (RV) LEADS AND ONE LEFT VENTRICULAR (LV) LEAD DUE TO CELLULITIS AND CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION TO AID IN THE LEADS'' EXTRACTIONS. THE LLDS WERE ABLE TO ADVANCE ALL THE WAY DOWN TO THE DISTAL TIP OF THE TWO RV LEADS AND THE RA LEAD; HOWEVER, THE LLD COULD ONLY ADVANCE PARTWAY DOWN THE LV LEAD AND WAS LOCKED IN PLACED AT APPROXIMATELY THE MID RA AREA. IT WAS REPORTED THAT THE LEADS WERE HEAVILY CALCIFIED AND ADHERED TOGETHER IN THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. THE RA AND BOTH RV LEADS WERE SUCCESSFULLY REMOVED WITH USE OF A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH. AT NO POINT WERE THERE ANY HEMODYNAMIC CHANGES, NOR ANY SLACK OR VISIBLE CHANGES OF THE LV LEAD WHILE TAKING THE OTHERS OUT. ATTENTION WAS THEN TURNED TO REMOVING THE LV LEAD. THE 13F TIGHTRAIL DEVICE WAS AGAIN USED, BUT THE LACK OF TRACTION WOULDN''T ALLOW THE TIGHTRAIL TO TRACK OVER THE LEAD PAST THE POINT WHERE THE LLD WAS LOCKED IN THE LEAD. DURING THIS TIME, THE SUTURE AND INSULATION BROKE ON TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061494 ↗
• MalfunctionApr 15, 2021Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) DUE TO CIED SYSTEM/POCKET INFECTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED WITHIN THE RV LEAD AND SUTURE WAS USED AS WELL TO PROVIDE TRACTION TO AID IN THE LEAD''S EXTRACTION. THE PHYSICIAN BEGAN THE CASE BY USING A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH TO ATTEMPT TO REMOVE THE RV LEAD FIRST. THE RA AND RV LEADS WERE REPORTEDLY STUCK TOGETHER AND HEAVILY CALCIFIED. PROGRESS WAS BEING MADE INTO THE SUPERIOR VENA CAVA (SVC) REGION WHEN FORWARD PROGRESS STALLED. THE PHYSICIAN WAS ABLE TO RETRACT THE TIGHTRAIL DEVICE WITH SOME DIFFICULTY. HE HAD TO ACTUATE THE TRIGGER AND ROTATE THE DEVICE TO RETRACT IT OUT OF THE PATIENT''S BODY. ONCE IT WAS OUT OF THE PATIENT''S BODY, THE DEVICE BECAME STUCK AND WOULD NOT COME OFF OF THE RV LEAD. AFTER SOME TIME AND FORCE APPLIED, THE LEAD, WITH THE LLD PRESENT WITHIN THE LEAD, BROKE OFF AND WAS RETAINED IN THE DEVICE (PLEASE REFERENCE MDR 1721279-2021-00058 WHICH CAPTURES THE TIGHTRAIL DEVICE THAT BECAME STUCK ON THE RV LEAD). THE PHYSICIAN WAS ABLE TO USE A COOK MEDICAL BULLDOG LEAD EXTENDER, ALONG WITH ANOTHER SUTURE TO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671328 ↗
• MalfunctionApr 1, 2021Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION TO AID IN THE LEAD'S EXTRACTION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LLD BROKE INSIDE THE LEAD WITH USE OF TRACTION. THE PHYSICIAN THEN ATTEMPTED TO EXTRACT THE LEAD BY USING JUST SUTURE, TIED TO THE INSULATION OF THE LEAD, THEN USED A COOK MEDICAL BULLDOG DEVICE TO ATTEMPT THE EXTRACTION. HOWEVER, THE LEAD TIP WOULD STILL NOT RELEASE FROM THE RV. THE PHYSICIAN PLACED A NEW LEAD WITHIN THE PATIENT, AND CHOSE TO CUT AND CAP THE RV LEAD AND ABANDONED IT WITHIN THE PATIENT'S BODY. BOTH PORTIONS OF THE LLD WERE ABLE TO BE REMOVED, SO THE LLD WAS REMOVED IN ITS ENTIRETY FROM THE LEAD AND FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. DUE TO THE LLD BREAKING WITHIN THE LEAD, THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR COMPLICATION WITH RECURRENCE. THE LLD PORTIONS, COMPRISING THE ENTIRE LLD, WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604414 ↗
• InjuryMar 4, 2021Mechanical Problem; Mechanical Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL LEAD (MODEL 7122Q) DUE TO BEING A REDUNDANT, NON FUNCTIONAL LEAD. A RIGHT VENTRICULAR (RV) AND A FUNCTIONAL RIGHT ATRIAL (RA) LEAD WERE ALSO PRESENT WITHIN THE PATIENT BUT WERE NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. IT WAS REPORTED THAT PROGRESS STALLED WITHIN THE VASCULATURE DURING THE PROCEDURE, SO THE PHYSICIAN CHOSE TO STOP THE EXTRACTION ATTEMPT. THE PHYSICIAN ATTEMPTED TO UNLOCK THE LLD FROM THE LEAD BUT WAS UNSUCCESSFUL. THE RA LEAD, WITH THE LLD PRESENT WITHIN THE LEAD, WAS CUT, CAPPED, AND REMAINED WITHIN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 11416430 ↗
• InjuryMay 4, 2020Break; Break

  THIS REPORT WAS RECEIVED FROM A DISTRIBUTOR IN (B)(4): A LEAD EXTRACTION PROCEDURE COMMENCED; IT IS UNKNOWN TO THE MANUFACTURER HOW MANY LEADS, THE LOCATION OF THE LEADS OR THE INDICATION FOR EXTRACTION. IT WAS REPORTED THAT A SPECTRANETICS LEAD LOCKING DEVICE WAS CHOSEN TO PROVIDE A TRACTION PLATFORM FOR THE LEAD, BUT THE LLD DID NOT PROGRESS TO THE DISTAL TIP OF THE LEAD. THE PHYSICIAN USED THE GUIDE WIRE FOR THE PACEMAKER TO INSERT THE LLD WITHIN THE LEAD. USING A SPECTRANETICS 9F TIGHTRAIL ROTATING DILATOR SHEATH, IT WAS REPORTED THAT THE PHYSICIAN COULD NOT GET THROUGH THE CALCIFICATION THAT WAS PRESENT WITHIN THE VESSEL, IN THE SUBCLAVIAN REGION. THE MANUFACTURER BECAME AWARE ON 14 APRIL 2020 THAT THE LEAD AND LLD REPORTEDLY BROKE AT SOME POINT DURING THE PROCEDURE, AND THE LEAD WITH A PORTION OF THE LLD INSIDE THE LEAD WERE CUT, CAPPED, AND REMAINED WITHIN THE PATIENT'S BODY. THE CASE WAS POSTPONED; THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE LLD WHICH BROKE ALONG WITH THE LEAD, AND THE LEAD/LLD CUT, CAPPED, AND REMAINED WITHIN THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source

  MAUDE report 10022741 ↗
• MalfunctionMay 29, 2019Break; Break

  THIS REPORT IS BEING SUBMITTED FOR THE LEAD LOCKING DEVICE THAT BROKE DURING THE PROCEDURE, WITH A POTENTIAL TO CAUSE SERIOUS INJURY WITH RECURRENCE. A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 2 LEADS THAT HAD BEEN IMPLANTED IN 1998: A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR (RV) LEAD AFTER AN UNSUCCESSFUL ATTEMPT AT PERFORMING A PACEMAKER GENERATOR EXTRUSION DUE TO BACTEREMIA, NON FUNCTION AND OCCLUSION; THEREFORE A TOTAL SYSTEM EXTRACTION WAS INDICATED. SPECTRANETICS DEVICES IN USE: GLIDELIGHT, TIGHTRAIL AND LEAD LOCKING DEVICES (LLD''S) PLACED IN EACH LEAD. WHILE USING THE TIGHTRAIL AND GLIDELIGHT DEVICES, IT WAS REPORTED THE PHYSICIAN HAD DIFFICULTY ADVANCING, AND REPORTED LOW EFFICIENCY WITH ATTEMPTS TO ADVANCE THE GLIDELIGHT DEVICE. IT WAS AT THAT POINT IT WAS NOTED THAT LIGHT WAS ESCAPING FROM THE GLIDELIGHT DEVICE, BEING COVERED BY THE DEVICE'S OUTER SHEATH (PLEASE REFER TO MDR #1721279-2019-00088 WHICH CAPTURES THE GLIDELIGHT PRODUCT PROBLEM). A NEW DEVICE WAS THEN NEEDED. AT THIS TIME, THE LLD, PRESENT IN THE RA LEAD, BROKE, NECESSITATING REMOVAL OF THE BROKEN LLD (WHICH WAS SUCCESSFUL) AND REPLACEMENT WITH ANOTHER LLD IN THE LEAD. UNFORTUNATELY, IT WAS NOT PO

  Patient problems: Iatrogenic Source; No Consequences Or Impact To Patient

  MAUDE report 8652424 ↗