TightRail Rotating Dilator Sheath 545-511 (UDI 00813132021641)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00813132021641), received between Mar 19, 2019 and Aug 31, 2026 — classified as 2 deaths, 27 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 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 Lead Locking Devices (LLDs) were inserted into each lead to provide traction. Beginning with multiple Spectranetics devices (GlideLight Laser Sheath, TightRail Sub-C Rotating Dilator Sheath, and 11F TightRail Rotating Dilator Sheath) the RA and RV lead were successfully removed. Targeting the remaining LV lead with the 11F TightRail, the LV lead was extracted, and the TightRail was removed from the body. However, a few minutes later, the patient's blood pressure dropped, and rescue efforts began, including bypass and sternotomy. A perforation to the coronary sinus (CS) was discovered and repaired, and the patient survived the procedure.This report captures the TightRail in use 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

  MAUDE report 50533406 ↗
• DeathApr 28, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEADS DUE TO BACTEREMIA. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING A SPECTRANETICS GLIDELIGHT LASER SHEATH AND SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, ONE RV AND THE RA LEAD WERE SUCCESSFULLY REMOVED. TARGETING THE LAST RV LEAD WITH THE 11F TIGHTRAIL, THE PATIENT¿S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, CPR, AND STERNOTOMY. PERFORATIONS TO THE RV AND SUPERIOR VENA CAVA (SVC) JUNCTION WERE DISCOVERED AND REPAIR WAS ATTEMPTED; HOWEVER, THE PATIENT DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

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

  MAUDE report 25023663 ↗
• MalfunctionMar 6, 2026Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE RV LEAD WAS REMOVED. SWITCHING TO THE RA LEAD, DENSE FIBROSIS WAS ENCOUNTERED, AND UPON ATTEMPTING REMOVAL OF THE TIGHTRAIL FROM THE LEAD, THE LEAD WAS STUCK INSIDE THE TIGHTRAIL DEVICE. SEVERAL ATTEMPTS TO FREE THE LEAD FROM THE TIGHTRAIL WERE MADE; HOWEVER, UNSUCCESSFUL. THEREFORE, THE LEAD WAS CUT, AND THE REMAINING PORTION WAS REMOVED WITH A COOK MEDICAL BULLDOG, SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, AND SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 11F TIGHTRAIL THAT ENTRAPPED THE LEAD, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536083 ↗
• InjuryFeb 24, 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 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: Fistula

  MAUDE report 24428890 ↗
• InjuryNov 14, 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 MRI. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, 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 RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 11F TIGHTRAIL DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 23560483 ↗
• InjuryMay 9, 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 BACTEREMIA WITH THROMBUS. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND SPECTRANETICS VISISHEATH DILATOR SHEATH ON THE RA LEAD, PROGRESS PAST THE CLAVICLE WAS UNSUCCESSFUL. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, ADVANCEMENT WAS MADE UP TO THE INNOMINATE AND HAD TO UTILIZE A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH (LONG) TO REMAIN COAXIAL ON THE LEAD. REACHING THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION, THE RA LEAD FREED FROM THE HEART AND WAS REMOVED. HOWEVER, THE PATIENT'S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND THORACOTOMY. A PERFORATION IN THE RA (MDR #3007284006-2025-00091) AND A SMALL PERFORATION IN THE INNOMINATE WERE DISCOVERED AND REPAIRED. THE REMAINING RV LEAD WAS REMOVED POST-THORACOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 11F TIGHTRAIL DEV

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 21995413 ↗
• InjuryDec 10, 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) AND A RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. NEXT, THE SAME 14F GLIDELIGHT WAS USED ON THE RV LEAD. ADVANCEMENT WAS SUCCESSFUL THROUGH THE RA, WHERE THE LEAD THEN TOOK A 90-DEGREE BEND INTO THE RV. DUE TO THE LEAD BEND AND BINDING NOTED IN THE REGION, THE GLIDELIGHT COULD NOT STAY COAXIAL. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE AROUND THE LEAD BEND, AND THE TIGHTRAIL WAS REMOVED. USING THE 14F GLIDELIGHT AGAIN, THE RV LEAD TIP DISLODGED, BUT THE PROXIMAL END OF THE LEAD WAS STILL BOUND TO THE RV. AFTER LASING, THE LEAD WAS FREED AND EXTRACTED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED. A PERICARDIAL EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PERICARDIOCENTESIS AND RAPID INFUSION, WHICH STABILIZED THE PATIENT. THEN, A PERICARDIAL DRAIN WAS PLACED, BUT THE BLOOD PRESSURE DROPPED AGAIN, AND THE DRAIN FI

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 20898304 ↗
• InjurySep 9, 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. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH ON THE RA LEAD, THE LEAD WAS SUCCESSFULLY EXTRACTED. NEXT, WHILE WORKING ON THE RV LEAD, THE PHILIPS LASER SYSTEM (USED TO POWER THE GLIDELIGHT) DISPLAYED AN ERROR CODE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO RESOLVE THE ERROR CODE, A SPECTRANETICS 11F TIGHTRAIL DEVICE WAS USED TO PROGRESS DOWN THE VASCULATURE. HOWEVER, AFTER REACHING THE SUPERIOR VENA CAVA (SVC) REGION, AN EFFUSION WAS NOTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), FOLLOWED BY A DROP IN THE PATIENT'S BLOOD PRESSURE. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. THE RV LEAD WAS REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 11F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE TIGHTRAIL DURING USE IN THE PROCEDURE.

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 20176959 ↗
• InjuryNov 15, 2023Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE ON THE LEAD/SUSPECTED FRACTURE. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD, WITH SUTURE BEING USED AS WELL, TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS GLIDELIGHT LASER SHEATH, FOLLOWED BY AN 11F TIGHTRAIL ROTATING DILATOR SHEATH, A ''CRUNCHING'' SOUND WAS NOTED AFTER SEVERAL TRIGGER ACTUATIONS, AND THE TIGHTRAIL STOPPED ADVANCING. UPON REMOVING THE TIGHTRAIL FROM THE PATIENT, IT BECAME STUCK ON THE LEAD APPROXIMATELY 1-2 INCHES OUTSIDE THE BODY, AND COULD NOT BE REMOVED. THEREFORE, THE LEAD WAS CUT, WHICH REMOVED THE PROXIMAL PORTION OF THE LEAD WITH THE TIGHTRAIL INTACT. TO REMOVE THE LEAD REMNANT, A COOK MEDICAL BULLDOG LEAD EXTENDER AND NEW SUTURE WERE USED AS THE TRACTION PLATFORM, AND A NEW 11F TIGHTRAIL WAS USED TO SUCCESSFULLY EXTRACT THE RV LEAD WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 11F TIGHTRAIL WHICH BECAME STUCK ON THE RV LEAD, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145316 ↗
• InjuryApr 28, 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 NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 11F TIGHTRAIL ROTATING DILATOR SHEATH) WERE USED DURING THE PROCEDURE. THE RA LEAD WAS EXTRACTED FIRST, THEN THE RV LEAD. HOWEVER, APPROXIMATELY 2-3 MINUTES AFTER THE RV LEAD WAS REMOVED, AN EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING STERNOTOMY AND BYPASS. A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED WITH A PERICARDIAL PATCH. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 11F TIGHTRAIL, THE LAST DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 16835489 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A CAPPED RIGHT ATRIAL (RA) AND A MALFUNCTIONING RIGHT VENTRICULAR (RV) LEAD, LEAVING AN ACTIVE RA LEAD WITHIN THE PATIENT, NOT TARGETED FOR EXTRACTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE CAPPED RA AND RV LEADS, AND SUTURE WAS USED AS WELL, TO PROVIDE TRACTION. THE RA LEAD WAS SUCCESSFULLY REMOVED USING SPECTRANETICS 9F AND 11F TIGHTRAIL ROTATING DILATOR SHEATHS. WHILE USING THE 11F TIGHTRAIL TO ATTEMPT REMOVAL OF THE RV LEAD, THE PHYSICIAN ENCOUNTERED STALLED PROGRESS AROUND THE TURN OF THE SUPERIOR VENA CAVA (SVC), THEREFORE THE TIGHTRAIL WAS REMOVED FROM THE PATIENT, WITH THE INTENTION OF USING A LASER CATHETER. HOWEVER, PRIOR TO THE USE OF ANOTHER DEVICE, THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. DURING REMOVAL OF THE RV LEAD POST-STERNOTOMY, THE PERFORATION RE-OPENED AGAIN, AND WAS REPAIRED. THE RV LEAD WAS SUCCESSFULLY REMOVED AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE 11F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEG

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 16517483 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A FRACTURED RIGHT VENTRICULAR (RV) LEAD, IMPLANTED IN 2010. RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE PRESENT IN THE PATIENT AS WELL, BUT WERE NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WAS USED TO BEGIN THE PROCEDURE, ADVANCING IN THE SUBCLAVIAN VEIN TO THE AREA OF THE CLAVICLE, ENCOUNTERING SIGNIFICANT BINDING BETWEEN THE LEAD''S PROXIMAL COIL AND THE CLAVICLE. AFTER LASING MULTIPLE TIMES, THE PHYSICIAN CHOSE A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, AND WAS ABLE TO ADVANCE THROUGH THE BINDING SITE DOWN TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. PROGRESS STALLED SO THE PHYSICIAN REMOVED THE TIGHTRAIL FROM THE PATIENT AND THE TIGHTRAIL''S OUTER SHEATH WAS ADDED, ADVANCING THESE DEVICES BACK INTO THE PATIENT. BINDING WAS AGAIN ENCOUNTERED IN THE SUBCLAVIAN REGION, BUT FINALLY THE OUTER SHEATH WAS ABLE TO ADVANCE, ALONG WITH THE TIGHTRAIL. THE DEVICES REACHED THE AREA OF THE TRICUSPID VALVE (TV) AND THE RV LEAD EVENTUALLY RELEASED. IT WAS NOT UNTIL THE DEVICES WERE REMOVED FROM

  Patient problems: Perforation of Vessels

  MAUDE report 16516688 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A NON-FUNCTIONAL RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. A LEFT VENTRICULAR (LV) LEAD AND A SECOND RV LEAD WERE PRESENT IN THE PATIENT AND WERE NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE WAS INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, AND AN 11F TIGHTRAIL ROTATING DILATOR SHEATH) WERE USED IN THE PROCEDURE. THE RV LEAD WAS SUCCESSFULLY REMOVED. WHILE ATTEMPTING RA LEAD REMOVAL, THE 11F TIGHTRAIL WAS THE LAST DEVICE IN USE WHEN THE RA LEAD ULTIMATELY FREED AND RETRACTED INTO THE TIGHTRAIL DEVICE. DUE TO THE OCCLUDED VESSEL, THE PHYSICIAN ATTEMPTED TO RETAIN ACCESS WITH THE TIGHTRAIL'S OUTER SHEATH TO RE-IMPLANT A NEW LEAD. HOWEVER, DUE TO THE POOR MOBILE C-ARM IMAGE QUALITY, IT COULD NOT BE DETERMINED HOW FAR THE OUTER SHEATH WAS BEYOND THE TIP OF THE RETRACTED RA LEAD. AS THE LEAD CAME BACK WITHIN THE DEVICE AT THE INNOMINATE REGION, THE PHYSICIAN ADVANCED THE OUTER SHEATH (WITHOUT TRACTION, BECAUSE THE RA LEAD WAS FREE), AND INADVERTENTLY PERFORATED THE LEFT INNOMINATE VEIN. THE OUTER SHEATH WAS LEFT IN

  Patient problems: Perforation of Vessels

  MAUDE report 16280840 ↗
• InjuryDec 12, 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 ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD, IMPLANTED FOR 254 MONTHS, AND AN RA AND RV LEAD, IMPLANTED 15 MONTHS, DUE TO BACTEREMIA. THE TWO LEADS IMPLANTED FOR 15 MONTHS PULLED OUT WITH SIMPLE TRACTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE OLDER RA AND RV LEADS TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (14F GLIDELIGHT LASER SHEATH, MEDIUM VISISHEATH DILATOR SHEATH, AND 11F TIGHTRAIL ROTATING DILATOR SHEATH) WERE USED AS THE PHYSICIAN SWITCHED BACK AND FORTH BETWEEN THE LEADS TO ATTEMPT ADVANCEMENT THROUGH THE VASCULATURE. THE PATIENT''S BLOOD PRESSURE WOULD PERIODICALLY DROP (TREATED WITH MEDICATION TO STABILIZE BLOOD PRESSURE), AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS MONITORED WITH NO EFFUSION DETECTED. AS THE 11F TIGHTRAIL (LAST DEVICE USED) WAS REMOVED FROM THE BODY, THE PATIENT''S BLOOD PRESSURE DROPPED AGAIN, AND A 1 CM PERICARDIAL EFFUSION WAS DETECTED ON TEE. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, CHEST COMPRESSIONS, BYPASS AND STERNOTOMY. A SMALL SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND SUCCESSFULLY REPAIRED. THE LEADS WERE DISCOVERED

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 15964176 ↗
• DeathNov 8, 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 ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO OCCLUSION. THE PATIENT HAD A DO NOT RESUSCITATE ORDER IN PLACE PRIOR TO THE PROCEDURE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN THE EXTRACTION ATTEMPT OF THE RA LEAD WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. PROGRESS WAS MADE THROUGH THE INNOMINATE VEIN, AND THEN EFFORTS SWITCHED TO EXTRACT THE RV LEAD, MAKING PROGRESS TO THE SUPERIOR VENA CAVA (SVC). IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS FLUCTUATING AND WAS TREATED. THE PHYSICIAN SWITCHED TO A SPECTRANETICS 11F TIGHTRAIL (LONG) ROTATING DILATOR SHEATH, AND WHILE ATTEMPTING EXTRACTION OF THE RV LEAD, SIGNIFICANT BACK BLEEDING WAS NOTED FROM THE POCKET. PROGRESS WAS MADE TO THE MIDDLE OF THE SVC, BUT TRACTION COULD NOT BE MAINTAINED DUE TO THE DENSE MAKEUP OF THE OCCLUSION AND JEOPARDIZED LEAD INTEGRITY. THE PHYSICIAN SWITCHED EFFORTS TO THE RA LEAD BUT STILL COULD NOT ADVANCE FARTHER THAN THE SVC OCCLUSION. A VENOGRAM WAS THEN PERFORMED ON THE RIGHT SIDE TO DETERMINE IF THE SVC HAD OPENED FOR POTENTIAL STENT PLACEMENT,

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 15756741 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT ATRIAL (RA, ONE ABANDONED AND ONE ACTIVE) AND ONE ACTIVE RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. THE LEADS WERE VERY OLD (ABANDONED RA AND ACTIVE RV LEADS IMPLANTED 1999, ACTIVE RA LEAD IMPLANTED IN 2005). THE ACTIVE RA LEAD WAS SEVERELY FRACTURED NEAR THE VESSEL ACCESS POINT; AS A RESULT, THE PHYSICIAN WAS UNABLE TO CREATE A TRACTION PLATFORM AND THE LEAD WAS TO BE ABANDONED. THE PHYSICIAN WANTED TO EXTRACT AS MANY LEADS AS POSSIBLE TO MAKE ROOM FOR 2 NEW LEADS. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE REMAINING RA AND RV LEADS AND ALTHOUGH BOTH LLDS COULD NOT ADVANCE ALL THE WAY TO EITHER LEAD'S DISTAL TIP, THEY WERE LOCKED INTO BOTH LEADS APPROXIMATELY 2/3 OF THE WAY DOWN. THE PHYSICIAN BEGAN THE PROCEDURE BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS VISISHEATH DILATOR SHEATH IN AN ATTEMPT TO REMOVE THE RV LEAD FIRST. STALLED PROGRESS WAS ENCOUNTERED IN THE SUBCLAVIAN REGION, SO PHYSICIAN SWITCHED TO ATTEMPT REMOVAL OF THE ABANDONED RA LEAD. SLOW PROGRESS WAS MADE ON EACH LEAD AS HE SWITCHED BACK AND FORTH BETWEEN THE LEADS, AND PROGRESSED TO THE AREA IN WHICH T

  Patient problems: Great Vessel Perforation

  MAUDE report 14940292 ↗
• MalfunctionJun 3, 2022Failure to Cut; Failure to Cut

  A LEAD EXTRACTION PROCEDURE COMMENCED, EXTRACTION AND LEAD LOCATION UNK. THE PHYSICIAN USED A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH TO AID IN LEAD EXTRACTION. PER REPORT, AFTER APPROXIMATELY 10 ACTUATIONS OF THE TIGHTRAIL TRIGGER, THE BLADES WOULD NO LONGER ROTATE. THE PROCEDURE WAS COMPLETED USING ANOTHER TIGHTRAIL WITH NO REPORTED PATIENT HARM. HOWEVER; DURING DEVICE EVALUATION ON (B)(6) 2022, IT WAS DISCOVERED THAT THE BLADES OF THE TIGHTRAIL WERE NOT RETRACTED AND WERE FOUND TO BE IN AN EXTENDED POSITION, PAST THE OUTER BAND OF THE DEVICE. THIS REPORT CAPTURES THE TIGHTRAIL WHICH WAS FOUND WITH EXTENDED BLADES DURING DEVICE EVALUATION, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14596275 ↗
• InjuryMay 11, 2022Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FAILURE (LEAD HAD BEEN IMPLANTED 343 MONTHS). A RIGHT ATRIAL (RA) LEAD WAS ALSO PRESENT IN THE PATIENT, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED FIRST. THE GLIDELIGHT ADVANCED TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION THEN PROGRESS STALLED. THE PHYSICIAN SWITCHED TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH. DURING USE, THE MECHANISM OF THE TIGHTRAIL WAS STICKING EACH TIME THE PHYSICIAN RELEASED THE HANDLE. HE BACKED THE TIGHTRAIL OUT OF THE VESSEL, BUT WAS UNABLE TO COMPLETELY BACK IT OFF THE LLD. IT WAS NOTED THAT CALCIUM WAS PRESENT AT THE INSIDE TIP OF THE TIGHTRAIL, SO HE ATTEMPTED TO FIRST CLEAR THE CALCIUM WITH A KELLY SURGICAL CLAMP, AND THEN ATTEMPTED TO FLUSH SALINE FROM THE REAR OF THE TIGHTRAIL TO PUSH THE CLOGGED TISSUE OUT; BOTH METHODS WERE UNSUCCESSFUL IN REMOVING THE TIGHTRAIL FROM THE LLD. THE PHYSICIAN CHOSE TO CUT INTO THE TIGHTRAIL WITH SURGICAL SCISSORS TO CLEAR OUT THE CALCIUM, NOT CUTTING THE LLD IN ORDER TO MAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14363818 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, BOTH CAPPED, AND AN ACTIVE RV LEAD AS WELL, DUE TO CIED SYSTEM/POCKET INFECTION. THE CENTER LUMENS OF THE CAPPED RA AND RV LEADS WERE COMPROMISED, FRACTURED YEARS AGO, SO A TRACTION PLATFORM COULD NOT BE ESTABLISHED. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE ACTIVE RV LEAD TO PROVIDE TRACTION. ALONG WITH OTHER DEVICES, THE PHYSICIAN USED A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH TO AID IN EXTRACTION. AS THE PHYSICIAN WAS WORKING ON THE ACTIVE RV LEAD USING THE TIGHTRAIL DEVICE, THE ACTIVE RV LEAD (WITH LLD INSIDE) AND BOTH CAPPED LEADS WERE SHEARED OFF IN THE INNOMINATE AREA BY THE TIGHTRAIL DEVICE (MDR #1721279-2022-00063). THE PHYSICIAN COULD NOT MAINTAIN TRACTION TO KEEP THE TIGHTRAIL COAXIAL DUE TO THE LEADS UNRAVELING, AND THE ACTIVE RV LEAD DOUBLED OVER ITSELF, CAUSING IT TO BE CUT. THE LEADS WERE ADHERED TOGETHER, SO THE PHYSICIAN DID NOT TRY ANY OTHER MEANS TO REMOVE THEM. THE LLD WAS CAPPED WITHIN THE ACTIVE RV LEAD AND REMAINED IN THE PATIENT (MDR #1721279-2022-00064). THE PHYSICIAN REFERRED THE PATIENT TO THE CARDIOTHORACIC (CT) SURGEON FOR A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14092467 ↗
• InjuryMar 8, 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 ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO ENDOCARDITIS (BOTH LEADS ORIGINALLY IMPLANTED IN 2010). A BASELINE EFFUSION WAS NOTED PRIOR TO THE CASE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD AND WERE USED TO PROVIDE TRACTION; HOWEVER NEITHER LLD REACHED THE TIPS OF THE LEADS. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO ATTEMPT REMOVAL OF THE RA LEAD. HOWEVER, THE DEVICE BECAME STUCK AT THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION AND COULD NOT BE RETRACTED BACK. SEVERAL MANEUVERS WERE PERFORMED TO FREE THE GLIDELIGHT DEVICE FROM THE LEAD AND EVENTUALLY IT FREED (MDR #1721279-2022-00043). THE PHYSICIAN THEN SWITCHED TO A SPECTRANETICS 11F TIGHT RAIL ROTATING DILATOR SHEATH TO ATTEMPT EXTRACTION OF THE RA LEAD, WHICH WAS SUCCESSFULLY REMOVED. ATTEMPTING RV LEAD REMOVAL, THE TIGHT RAIL DEVICE WAS ADVANCED TO APPROXIMATELY THE SAME REGION AS WHERE THE GLIDELIGHT DEVICE BECAME STUCK. IT WAS VERY DIFFICULT TO MAKE PROGRESS THROUGH THIS AREA. IT WAS SUGGESTED TO REMOVE THE TIGHT RAIL DEVICE FROM THE PATIENT, FLUSH IT AND TEST THE BLADE MECHANISM. AFTER NOTING THAT IT A

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pleural Effusion

  MAUDE report 13690936 ↗
• InjuryFeb 17, 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 ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN STARTED REMOVAL OF THE RV LEAD USING A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH. PROGRESS WAS MADE, WITH THE DEVICE ADVANCING DOWN TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION WHEN THE PATIENT'S BLOOD PRESSURE SUDDENLY DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY; CT SURGEON WAS ALREADY IN THE ROOM, AND STERNOTOMY WAS PERFORMED. A 2 CM PERFORATION IN THE SVC/RA JUNCTION WAS DISCOVERED. REPAIR OF THE TEAR WAS SUCCESSFUL. RV AND RA LEADS WERE REMOVED POST STERNOTOMY AND PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE IN USE WHEN THE SVC/RA JUNCTION PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 13552901 ↗
• InjuryJan 21, 2022Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD, EXTRACTION INDICATION UNK. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE RA LEAD WAS EXTRACTED WITH NO REPORTED ISSUE. THE PHYSICIAN WAS ATTEMPTING TO EXTRACT THE RV LEAD USING A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH WHEN THE TIGHTRAIL DEVICE BECAME STUCK ON THE LEAD, WITH THE SHAFT OF THE DEVICE STUCK WITHIN THE PATIENT. THIS NECESSITATED THE TIGHTRAIL DEVICE (AND THE PORTION OF THE LEAD WITHIN THE TIGHTRAIL DEVICE) TO BE CUT AND DISASSEMBLED TO REMOVE IT FROM WITHIN THE PATIENT. ALL COMPONENTS OF THE TIGHTRAIL DEVICE WERE REMOVED FROM THE PATIENT, AND THE REMAINDER OF THE RV LEAD WAS EXTRACTED FROM THE FEMORAL VEIN WITH A SNARE. THE TIP OF THE RV LEAD BROKE OFF FROM THE RV LEAD REMNANT DURING THE SNARING ATTEMPT, BUT THE LLD WHICH WAS PRESENT IN THE LEAD WAS REMOVED IN ITS ENTIRETY. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE PRESENT ON THE RV LEAD WHEN IT BECAME STUCK ON THE LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13317168 ↗
• InjuryOct 14, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO A POCKET INFECTION. THIS WAS A RIGHT SIDED PROCEDURE. PRE PROCEDURE, A LEADLESS PACEMAKER (MICRA) WAS PLACED IN THE RV SINCE THE PATIENT WAS PACEMAKER DEPENDENT. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN BEGAN BY CHOOSING A SPECTRANETICS 9F TIGHTRAIL ROTATING DILATOR SHEATH TO ATTEMPT REMOVAL OF THE RA LEAD. IT WAS OBSERVED THAT THE PHYSICIAN WAS NOT REMAINING COAXIAL ON THE LEAD AS WELL AS RAPIDLY ACTUATING THE TRIGGER OF THE TIGHTRAIL. THE 9F TIGHTRAIL CUT INTO THE INSULATION OF THE RA LEAD, BUT DID NOT BREAK IT. THE PHYSICIAN THEN ATTEMPTED TO EXTRACT THE RV LEAD WITH THE 9F TIGHTRAIL DEVICE BUT MET STALLED PROGRESS, SO THE PHYSICIAN UPSIZED TO AN 11F TIGHTRAIL DEVICE AND CONTINUED ATTEMPTS TO EXTRACT THE RV LEAD. HE WAS THEN CUTTING INTO THE INSULATION OF THE RV LEAD AS WELL, AND THE LEAD STARTED TO BREAK DOWN. HE SWITCHED EFFORTS TO EXTRACT THE RA LEAD WITH THE 11F TIGHTRAIL DEVICE, DID NOT REMAIN COAXIAL AND CUT THE RA LEAD IN HALF. THEN HE ATTEMPTED EXTRACTION OF THE RV LEAD WITH THE 11F TIGHTRAIL DEVICE AND CUT

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12632730 ↗
• InjuryMay 11, 2021Mechanical Jam; Mechanical Jam

  A LEAD EXTRACTION COMMENCED ON (B)(6) 2021 TO REMOVE A RIGHT VENTRICULAR (RV), A RIGHT ATRIAL (RA) AND A LEFT VENTRICULAR (LV) LEAD DUE TO INFECTION. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION TO AID IN THE LEADS'' EXTRACTION. BEGINNING WITH THE ATTEMPT TO EXTRACT THE LV LEAD, THE PHYSICIAN USED A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH. THE DEVICE WAS ONLY ABLE TO ADVANCE A FEW CM IN THE SUBCLAVIAN VEIN AND SO THEY FOCUSED THEIR EFFORTS ON REMOVING THE RA LEAD. ALTHOUGH REPORTED TO BE DIFFICULT, THEY WERE ABLE TO EXTRACT THE RA LEAD EXCEPT FOR THE TIP, THAT REMAINED WITHIN THE ATRIUM. EFFORTS THEN WERE FOCUSED ON REMOVAL OF THE RV LEAD. THEY USED THE TIGHTRAIL DEVICE AND AFTER SOME CM IN THE SUBCLAVIAN VEIN, THE RV LEAD STARTED TO BREAK AND SOME WIRE CAME OUT OF THE LEAD. THEY STOPPED AND TIED THE LEAD WIRES WITH VICRYL AND ADVANCED THE TIGHTRAIL DEVICE UP TO THE PROXIMAL PART OF THE SUPERIOR VENA CAVA (SVC) COIL. THEY SWITCHED BACK TO ATTEMPTED REMOVAL OF THE LV LEAD, AND THEN WORKED AGAIN TO REMOVE THE RV LEAD. WHILE WORKING ON THE RV LEAD, THE TIGHTRAIL DEVICE WAS ABLE TO GO THROUGH THE PROXIMAL PORTION OF THE LEAD'S SVC COIL

  Patient problems: Foreign Body In Patient

  MAUDE report 11810009 ↗
• InjuryMay 5, 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) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION AND OCCLUSION. A SECOND RV LEAD AND A LEFT VENTRICULAR (LV) LEAD WERE PRESENT IN THE PATIENT BUT WERE NOT TARGETED FOR EXTRACTION. TO PROVIDE TRACTION TO AID IN LEAD REMOVAL, THE PHYSICIAN CHOSE TO USE COOK LIBERATOR LOCKING STYLETS IN THE LEADS. THE PHYSICIAN THEN CHOSE A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO BEGIN THE PROCEDURE, ATTEMPTING EXTRACTION OF THE RA LEAD FIRST. DURING USE OF THE GLIDELIGHT DEVICE, THE PATIENT'S BLOOD PRESSURE DROPPED BRIEFLY BUT QUICKLY RETURNED TO NORMAL AFTER THE TEAM PAUSED WITH THE EXTRACTION. AT THAT TIME, NO EFFUSION WAS DETECTED USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE EXTRACTION THEN CONTINUED WITH USE OF THE GLIDELIGHT DEVICE, WHEN STALLED PROGRESS WAS ENCOUNTERED IN THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. THE PHYSICIAN THEN SWITCHED TOOLS TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH AND CONTINUED WITH THE EXTRACTION. PROGRESS CONTINUED TO APPROXIMATELY 2CM FROM THE TIP OF THE RA LEAD. AT THAT TIME, THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN AND AN EFFUSION WAS NOTED VIA TEE. RESCUE EFFORTS BEG

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 11778750 ↗