TightRail Sub-C Rotating Dilator Sheath 560-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00813132022792), received between Sep 28, 2018 and Dec 18, 2025 — classified as 4 deaths, 8 injuries, 6 malfunctions.

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

• InjuryDec 18, 2025Entrapment of Device; Entrapment 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. DURING USE OF A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE LEAD COULD NOT BE REMOVED FROM THE TIGHTRAIL; THEREFORE, THE TIGHTRAIL WAS DISASSEMBLED AND REMOVED FROM THE LEAD. THE PROCEDURE WAS COMPLETED, WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 11F TIGHTRAIL THAT GOT STUCK ON THE LEAD, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846141 ↗
• MalfunctionFeb 2, 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 LEFT VENTRICULAR (LV) LEAD DUE TO LEAD FRACTURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT INITIALLY TARGETED FOR EXTRACTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO THE RV AND LV LEADS TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE LV LEAD, IT APPEARED THE TIGHTRAIL CUT THE LV LEAD AND LLD IN THE SUBCLAVIAN REGION (MDR #3007284006-2024-00022). SWITCHING EFFORTS TO THE RV LEAD, MULTIPLE SPECTRANETICS DEVICES WERE USED (GLIDELIGHT LASER SHEATH, VISISHEATH DILATOR SHEATH, TIGHTRAIL (LONG) ROTATING DILATOR SHEATH) TO ATTEMPT REMOVAL, BUT WERE UNSUCCESSFUL. IT WAS DETERMINED THE RA LEAD REQUIRED REMOVAL, DUE TO LEAD ON LEAD BINDING TO THE RV AND LV LEADS. AN LLD EZ WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION, AND MULTIPLE DEVICES WERE USED TO ACHIEVE SUCCESSFUL REMOVAL OF THE LEAD. THEN, SWITCHING EFFORTS TO THE RV LEAD AGAIN, LEAD REMOVAL WAS ACHIEVED. REMOVAL OF THE LV LEAD/LLD REMNANTS WAS NOT ATTEMPTED, AND BECAUSE THE LLD WAS LIKELY CUT BY THE TIGHTRAIL SUB-C, IT COULD NOT BE UNLOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636233 ↗
• DeathNov 9, 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), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO NON FUNCTION. THE PATIENT HAD A BASELINE PERICARDIAL EFFUSION PRESENT PRE-PROCEDURE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 13F TIGHTRAIL ROTATING DILATOR SHEATH, GLIDELIGHT LASER SHEATH) WERE USED TO EXTRACT THE RA AND RV LEADS. THE RV LEAD WAS FIRMLY ADHERED WITHIN THE VESSEL; HOWEVER, THE RA AND RV LEADS WERE SUCCESSFULLY REMOVED. DURING ATTEMPTED EXTRACTION OF THE LV LEAD, SEVERAL ATTEMPTS WERE MADE BUT WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO CUT THE LV LEAD/LLD NEAR THE POCKET AND ABANDONED IT, WITH NO ATTEMPT TO UNLOCK THE LLD FROM THE LEAD. A SHORT TIME AFTER THE LEAD EXTRACTION PORTION OF THE PROCEDURE WAS COMPLETED, THE BASELINE PERICARDIAL EFFUSION WORSENED AND CARDIAC TAMPONADE RESULTED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, AND THE PATIENT STABILIZED WITHOUT FURTHER ACCUMULATION OF FLUID THROUGHOUT THE REMAINDER OF THE CASE. A RE-IMPLANTATION OF NEW RA, RV, AND LV LEADS WAS COMPLETED, AND THE

  Patient problems: Perforation of Vessels

  MAUDE report 15764662 ↗
• MalfunctionJun 21, 2022Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. THE PHYSICIAN CHOSE A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO AID IN LEAD REMOVAL. DURING THE PROCEDURE, THE TIGHTRAIL DEVICE STOPPED WORKING. THERE WAS A DIFFERENCE IN THE SOUND IT MADE AS THE PHYSICIAN SQUEEZED THE HANDLE, AS IF IT HAD BROKEN INSIDE AND WAS NO LONGER TURNING, WHICH WAS CONFIRMED UNDER FLUOROSCOPY. AFTER USE, IT WAS OBSERVED THE DEVICE''S SHAFT WAS VERY LOOSE AND FLIMSY. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE TIGHTRAIL DEVICE WAS RECEIVED IN TWO PIECES ON (B)(6) 2022. THE HANDLE AND THE SHAFT WERE SEPARATE, WHICH WOULD PREVENT THE BLADES (LOCATED AT THE DISTAL TIP OF THE DEVICE''S SHAFT) FROM ACTUATING, SINCE ACTUATION OF THE BLADES ORIGINATES IN THE DEVICE''S HANDLE. DURING DEVICE EVALUATION ON (B)(6) 2022, IT WAS DISCOVERED THAT THE BLADES OF THE TIGHTRAIL DEVICE WERE NOT RETRACTED AND WERE IN AN EXTENDED POSITION, PAST THE OUTER BAND OF THE DEVICE. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE RETURNED WITH THE SEPARATED SHAFT AND EXTENDED BLADES, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758298 ↗
• InjuryDec 15, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA AND REMOVAL OF AN ABANDONED PACEMAKER SYSTEM. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED REMOVAL OF THE RA LEAD BY USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. UPON ATTEMPTING REMOVAL OF THE LEAD FROM THE DEVICE, THE TIGHTRAIL BECAME STUCK. IT WAS NOTED THAT THERE WAS A PIECE OF CALCIUM STUCK AT THE TIP OF THE TIGHTRAIL. THE RA LEAD WAS CUT AND THE TIGHTRAIL WAS REMOVED. THE PHYSICIAN WAS UNABLE TO UNLOCK THE LLD FROM THE RA LEAD SINCE IT HAD BEEN CUT, AND BOTH THE RA LEAD WITH THE LLD INSIDE WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #1721279-2021-00246). THE PHYSICIAN THEN ATTEMPTED TO UNLOCK THE LLD FROM THE RV LEAD BUT WAS UNSUCCESSFUL, SO THE RV LEAD WITH THE LLD INSIDE WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #1721279-2021-00247). THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C DEVICE PRESENT ON THE RA LEAD WHEN IT BECAME STUCK ON THE LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014616 ↗
• InjuryDec 7, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO RIGHT VENTRICULAR (RV) (PACING AND ICD TYPES) AND TWO LEFT VENTRICULAR (LV) LEADS DUE TO CIED SYSTEM/POCKET INFECTION. DURING THE PROCEDURE, THE PHYSICIAN WAS USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO ATTEMPT TO REMOVE THE RV ICD LEAD. AS THE PHYSICIAN WAS TAKING OUT THE TIGHTRAIL DEVICE TO EXCHANGE FOR ANOTHER TOOL, THE RV ICD LEAD BECAME WEDGED INSIDE THE TIGHTRAIL DEVICE. THIS OCCURRED AFTER THE TIGHTRAIL DEVICE WAS OUTSIDE THE PATIENT''S BODY, WITH THE DEVICE BEING STUCK ON THE PROXIMAL END OF THE RV ICD LEAD. AFTER TRYING TO ROTATE THE TIGHTRAIL DEVICE BY TURNING THE ENTIRE HANDLE WHILE HOLDING ONTO THE LEAD, IT WOULD NOT MOVE. THE PHYSICIAN CUT THE LEAD WHERE IT CAME OUT OF THE TIP OF THE TIGHTRAIL DEVICE. THIS EVENT DID NOT CAUSE PATIENT HARM. ALL LEADS WERE REMOVED SUCCESSFULLY AND THE PATIENT SURVIVED THE PROCEDURE.THIS REPORT CAPTURES THE 11F TIGHTRAIL SUB-C DEVICE PRESENT ON THE RV ICD LEAD WHEN IT BECAME STUCK ON THE LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957353 ↗
• InjuryDec 7, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) ICD LEAD AND RIGHT ATRIAL (RA) LEAD DUE TO SEVERE TRICUSPID REGURGITATION WITH THE ICD LEAD, CAUSING WORSENING SYMPTOMS. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION, AND A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED DURING THE PROCEDURE. THE RA LEAD WAS SUCCESSFULLY REMOVED. WHILE ATTEMPTING TO REMOVE THE RV LEAD USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE DEVICE BECAME ENTANGLED ON THE LLD PRESENT IN THE RV LEAD. THE OPERATOR HAD TO CUT THE LLD DISTAL TO THE TIGHTRAIL DEVICE IN ORDER TO FREE THE LEAD. A (B)(4) BULLDOG LEAD EXTENDER WAS THEN USED ON THE RV LEAD TO COMPLETE THE PROCEDURE. THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED HARM. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C DEVICE WHICH BECAME ENTANGLED ON THE LLD IN THE RV LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957204 ↗
• InjuryNov 10, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FRACTURE. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD, MAKING IT DOWN TO THE BEGINNING OF THE DISTAL COIL OF THE RV LEAD. A COOK MEDICAL BULLDOG LEAD EXTENDER WAS ALSO USED ON THE RV LEAD. THE PHYSICIAN CHOSE A SPECTRANETICS TIGHTRAIL 11F SUB-C ROTATING DILATOR SHEATH TO ATTEMPT REMOVAL OF THE RV LEAD. DURING ATTEMPTED EXTRACTION, THE COOK BULLDOG DEVICE CUT THE HIGH VOLTAGE CABLES OF THE LEAD, BUT THE EXTRACTION CONTINUED. AFTER THE TIGHTRAIL SUB-C DEVICE PROGRESSED, THE PHYSICIAN NEEDED TO SWITCH TO A LONGER DEVICE. WHILE HE WAS ATTEMPTING TO TAKE THE TIGHTRAIL SUB-C DEVICE OFF THE LEAD, THE LEAD BECAME STUCK INSIDE THE TIGHTRAIL SUB-C DEVICE. TO REMOVE THE DEVICE FROM THE RV LEAD, THE PHYSICIAN CUT THE BACK END OF THE LLD WHICH FREED THE TIGHTRAIL SUB-C DEVICE. A COOK MEDICAL LEAD EXTENDER WAS THEN ADDED TO THE LLD AND A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS LOADED ONTO THE CUT LLD AND COOK MEDICAL LEAD EXTENDER TO AGAIN ATTEMPT REMOVAL OF THE RV LEAD. THE RV AND RA LEADS WERE BOUND TOGETHER, SO THE PHYSICIAN SWITCHED ATTEMPTS TO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12791039 ↗
• InjuryOct 21, 2021Entrapment of Device; Entrapment of Device

  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 (LDDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO ATTEMPT REMOVAL OF THE RV LEAD. AS THE DOCTOR WAS TRYING TO TAKE THE TIGHTRAIL DEVICE OFF THE LEAD TO USE A DIFFERENT TOOL, THE LEAD BECAME STUCK INSIDE THE TIGHTRAIL DEVICE. THE DOCTOR HAD TO CUT THE TIGHTRAIL DEVICE IN ORDER TO BREAK UP SOME OF THE TISSUE THAT WAS CAUSING THE TIGHTRAIL DEVICE TO BE STUCK. AFTER THIS, HE WAS ABLE TO BACK THE TIGHTRAIL DEVICE OFF THE LEAD. HE THEN REMOVED THE RV LEAD WITH A 13F TIGHTRAIL ROTATING DILATOR SHEATH. ALL LEADS WERE REMOVED AND NOTHING REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFUL AND THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C DEVICE WHICH BECAME STUCK ON THE RV LEAD, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674605 ↗
• DeathJun 30, 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 REDUNDANT LEAD AND NEEDING TO UPGRADE PATIENT TO AN ICD LEAD. THIS PROCEDURE WAS A RIGHT SIDED EXTRACTION. THE PHYSICIAN BEGAN THE PROCEDURE BY USING A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH. HE BEGAN BY ATTEMPTING EXTRACTION OF THE RA LEAD, BUT ENCOUNTERED STALLED PROGRESSION AT THE CLAVICLE. HE TURNED ATTENTION TOWARD EXTRACTION OF THE RV LEAD, BUT STALLED AGAIN. HE THEN CHOSE A SPECTRANETICS 11F TIGHTRAIL SUB-C DEVICE AND STALLED AT THE CLAVICLE, SWITCHED LEADS AGAIN, STALLED AGAIN, AND AT THAT TIME, BOTH LEADS PULLED BACK OUT TOGETHER. THE PATIENT'S BLOOD PRESSURE DROPPED AT THIS TIME. THE BLOOD PRESSURE DROP WAS TREATED AND THE REIMPLANTATION OF THREE NEW CHEST LEADS FOLLOWED. HOWEVER, THE BLOOD PRESSURE DROPPED AGAIN. AFTER THIS SECOND BLOOD PRESSURE DROP, THE VASCULAR SURGEON WAS CALLED BUT WAS NOT IN THE BUILDING. THERE WERE TWO CT SURGEONS THAT SCRUBBED IN TO ASSIST WITH THE INTERVENTION. IT WAS REPORTED THAT THE PATIENT'S CHEST WAS FILLING WITH BLOOD ON THE RIGHT SIDE; A STERNOTOMY WAS PERFORMED; PATIENT WAS ALSO PLACED ON BYPASS. TWO RIGHT SUBCLAVIAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 12096068 ↗
• MalfunctionApr 7, 2021Failure to Cut; Mechanics Altered; Failure to Cut; Mechanics Altered

  A PHILIPS REPRESENTATIVE WAS INFORMED ON 20 NOV 2020 THAT ON (B)(6) 2021, A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 3 LEADS DUE TO THE PATIENT NEEDING AN MRI. ACCORDING TO THE REPORT, THE PHYSICIAN STARTED TO EXTRACT THE FIRST OF 3 PACEMAKER LEADS WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH. HOWEVER, NO PROGRESS WAS MADE IN THE SUBCLAVIAN VEIN BECAUSE THE VEGETATION WAS TOO HARD. HE THEN DECIDED TO USE A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. PER REPORT, HE STARTED TO CUT WITH THE TIGHTRAIL SUB-C SHEATH AND PULLED THE HANDLE ABOUT 4 TIMES. HE FELT THAT THERE WAS NO ROTATION AT THE TIP OF THE TIGHTRAIL SUB-C SHEATH AND HE PULLED IT BACK. HE THEN PULLED THE HANDLE AGAIN AND IT WORKED. HE FELT THE BLADES WERE ROTATING, SO HE CONTINUED CUTTING THE VEGETATION. AFTER 3 TIMES PULLING THE HANDLE THERE WAS AGAIN NO ROTATION FROM THE BLADES. HE DECIDED TO THEN TAKE THE TIGHTRAIL SUB-C SHEATH OUTSIDE OF THE VEIN. HE FLUSHED THE DEVICE AND TRIED AGAIN OUTSIDE THE PATIENT TO ROTATE THE BLADES, AND IT WORKED. AGAIN HE PUSHED THE TIGHTRAIL SUB-C SHEATH INTO THE VEIN AND STARTED TO CUT. AFTER 4 TIMES PULLING THE HANDLE AGAIN THE BLADES DID NOT ROTATE. HE TOOK THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628162 ↗
• MalfunctionJun 25, 2020Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

  IT WAS REPORTED TO A PHILIPS REPRESENTATIVE TWO DAYS POST-PROCEDURE THAT A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO EXTRACT THE LEAD. WHILE ATTEMPTING TO REMOVE THE RA LEAD, IT WAS REPORTED THAT THE TIGHTRAIL DEVICE BECAME STUCK ON THE LEAD. THE PROBLEM OCCURRED WHEN THE ATTEMPT TO REMOVE THE DEVICE FROM THE LEAD PULLED OFF THE INSULATION OF THE LEAD AND COULD NOT BE REMOVED. THE PHYSICIAN HAD TO CUT THE LEAD IN ORDER TO REMOVE THE DEVICE. IT WAS REPORTED THAT BOTH LEADS WERE EXTRACTED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR SERIOUS INJURY IF THE EVENT WERE TO RECUR. THE MANUFACTURER IS ANTICIPATING RETURN OF THE DEVICE FOR EVALUATION, BUT HAS NOT YET RECEIVED IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10194469 ↗
• DeathJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD DUE TO INFECTION. IT WAS REPORTED THAT SIGNIFICANT INFECTION WAS NOTED IN THE POCKET AND SIGNIFICANT CALCIUM NOTED ON THE LEADS. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE USED IN EACH LEAD TO ACT AS TRACTION PLATOFORMS FOR THE LEADS TO AID IN LEAD REMOVAL. THE RA LEAD WAS TARGETED FOR REMOVAL FIRST. A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS USED FOR THE CASE. AS THE PHYSICIAN CAME AROUND THE CORNER TO THE SUPERIOR VENA CAVA (SVC) WITH THE DEVICE, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING USE OF RESCUE DEVICE. A STERNOTOMY REVEALED AN SVC TEAR. THE PATIENT WAS PLACED ON BYPASS PUMP AND THE PHYSICIAN ATTEMPTED TO REPAIR THE TEAR; HOWEVER, THERE WAS REPORTEDLY NOT ENOUGH TISSUE AND THE TISSUES WERE TOO FRAGILE TO SUTURE. REPAIR WAS ATTEMPTED FOR SEVERAL HOURS BUT THE PATIENT UNFORTUNATELY DIED.

  Patient problems: Death; Great Vessel Perforation; Iatrogenic Source

  MAUDE report 10153574 ↗
• InjuryOct 22, 2019Human-Device Interface Problem; Human-Device Interface Problem

  A LEAD MANAGEMENT PROCEDURE CONCLUDED WHEN IT WAS DISCOVERED THAT THE DEVICE'S OUTER TEFLON SHEATH WAS LEFT IN THE PATIENT'S SUBCLAVIAN VEIN AFTER THE PROCEDURE. THE OUTER SHEATH BECAME DISLODGED FROM THE TIGHTRAIL SUB-C DEVICE WHILE INSIDE THE PATIENT AND WAS NOT CAUGHT UPON REMOVAL OF THE DEVICE, AND WAS NOT VISUALIZED SINCE IT IS NOT RADIOPAQUE. THE DAY AFTER THE PROCEDURE, A VASCULAR SURGERY TEAM SURGICALLY REMOVED THE OUTER SHEATH BY RE-OPENING THE POCKET AND GRABBING THE OUTER SHEATH WITH FORCEPS, SAFELY PULLING OUT THE OUTER SHEATH. THERE WAS NO REPORTED PATIENT HARM DURING THE EVENT.

  Patient problems: Foreign Body In Patient; Iatrogenic Source

  MAUDE report 9221128 ↗
• MalfunctionAug 13, 2019Device Damaged by Another Device; Mechanical Jam; Device Damaged by Another Device; Mechanical Jam

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD EXTRACTION PROCEDURE A SPECTRANETICS 11FR TIGHTRAIL SUB-C MECHANICAL DILATOR SHEATH BECAME STUCK ON A LEAD WHEN USED IN CONJUNCTION WITH A COOK MEDICAL ONE-TIE DEVICE. THE PHYSICIAN USED THE COOK ONE-TIE TO BIND ALL THE CABLES OF THE ICD LEAD TOGETHER. WHEN HE TRIED TO REMOVE THE SPECTRANETICS TIGHTRAIL THERE WAS RESISTANCE. HE WAS ABLE TO REMOVE THE TIGHTRAIL FROM THE BODY, BUT NOT THE LEAD. HE THEN DISASSEMBLED THE TIGHTRAIL IN AN AGGRESSIVE FASHION AS HE DID NOT HAVE A STERILE SCREWDRIVER FOR THE SCREWS. HE WAS ABLE TO CUT AWAY THE SEGMENT OVER THE OBSTRUCTION AND FOUND IT TO BE THE TIGHTRAIL. THE PHYSICIAN HAD TO DISMANTLE THE SPECTRANETICS TIGHTRAIL DEVICE IN VIVO, BUT ATTRIBUTES THE MALFUNCTION TO THE USE OF THE COOK ONE-TIE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888846 ↗
• DeathMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 3 LEADS: A LEFT VENTRICULAR (LV) LEAD, A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR LEAD (RV) DUE TO INFECTION. SPECTRANETICS DEVICES IN USE: 14F GLIDELIGHT LASER SHEATH, 11F TIGHTRAIL SUB-C DEVICE, AND LEAD LOCKING DEVICES (LLD). THE LV LEAD WAS REMOVED WITHOUT INCIDENT WITH JUST TRACTION - NO SPNC TOOLS AT ALL (NO LLD EITHER). THE PHYSICIAN THEN PULLED ON THE RA LEAD (NO LLD AT THIS TIME) - LEAD RELEASED BUT BECAME STUCK IN THE SUPERIOR VENA CAVA (SVC)/INNOMINATE AREA. THE PHYSICIAN THEN PULLED ON THE RV LEAD (NO LLD AT THIS TIME) AND THE LEAD RELEASED BUT BECAME STUCK IN SAME AREA THAT THE RA LEAD WAS STUCK IN, AND THE LEADS BECAME CROSSED IN THIS AREA. THE PHYSICIAN THEN UTILIZED LLD''S FOR THE RA AND RV LEADS; THEY COULD NOT BE ADVANCED ALL THE WAY TO THE TIP OF THE LEADS DUE TO THE LEADS BEING CROSSED. A 14F GLIDELIGHT USED FIRST TO ATTEMPT TO GET THROUGH A BINDING SITE, AND PROGRESSION STALLED AT THE CLAVICLE. THE PHYSICIAN THEN TRIED USING THE TIGHTRAIL SUB C DEVICE TO GET PAST THE BINDING. WHILE ATTEMPTING TO GET THROUGH THIS AREA, THE PHYSICIAN LOST THE ''RAIL'' (STRAIGHTENING OF THE LEADS SO THE DEVICES COULD FOLLOW DOW

  Patient problems: Death; Iatrogenic Source; Perforation; Perforation of Vessels

  MAUDE report 8638426 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC LEAD MANAGEMENT TO EXTRACT A NON-FUNCTIONAL/REDUNDANT LEAD, THE SPECTRANETICS TIGHT-RAIL ROTATING DILATOR SHEATH WAS UTILIZED. DURING LEAD EXTRACTION A DECREASE IN THE PATIENT'S BLOOD PRESSURE WAS OBSERVED. THERE WAS AN INJURY TO THE SUPERIOR VENA CAVA (SVC)/INNOMINATE VEIN/ RIGHT INTERJUGULAR (RIJ)/ ARCH OF AZYGOS JUNCTION AREA. RESCUE PROTOCOLS WERE IMPLEMENTED. RESCUE INTERVENTION WAS SUCCESSFUL AND AT LAST REPORT THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Iatrogenic Source; Perforation of Vessels

  MAUDE report 8423153 ↗
• MalfunctionSep 28, 2018Peeled/Delaminated; Deformation Due to Compressive Stress; Difficult to Advance; Mechanical Jam; Physical Resistance/Sticking; Peeled/Delaminated; Deformation Due to Compressive Stress; Difficult to Advance; Mechanical Jam; Physical Resistance/Sticking

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC LEAD MANAGEMENT SURGERY ON (B)(6) 2018, AFTER USE IN THE PATIENT, THE DISTAL END OF THE TIGHTRAIL 560-011 DEVICE HAD SIGNIFICANT CRIMPING OF MATERIAL. THE SURGERY WAS FOR THE REMOVAL OF A SINGLE NON-FUNCTIONAL RIGHT VENTRICLE (RV) IMPLANTED CARDIAC DEFIBRILLATOR (ICD) LEAD. AFTER THE PROCEDURE, THE POCKET WAS REPORTEDLY CLOSED AND THE PATIENT WAS DISCHARGED PER OPERATIVE PLAN. ON 13 SEPTEMBER 2018, DURING DEVICE EVALUATION, A CARDIAC LEAD WAS FOUND LODGED INSIDE THE DEVICE AND A SUTURE WAS DISCOVERED EXTENDING OUT THE BACK SIDE OF THE HANDLE OF THE DEVICE. THUS, IT WAS DETERMINED THIS EVENT IS REPORTABLE BECAUSE ALTHOUGH THERE WAS NO REPORTED PATIENT HARM, THERE IS THE POTENTIAL FOR SERIOUS INJURY AND/OR DEATH WITH RECURRENCE, IF A CARDIAC LEAD OR SUTURE CANNOT BE REMOVED FROM A TIGHTRAIL DEVICE DURING A PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920061 ↗