TightRail Sub-C Rotating Dilator Sheath 560-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00813132022808), received between Jan 7, 2020 and Jan 15, 2026 — classified as 3 deaths, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THERE WAS SOME DIFFICULTY GETTING INTO THE SUBCLAVIAN VEIN, AND MORE BLEEDING THAN EXPECTED WAS COMING FROM THE POCKET. UPON REMOVAL OF THE TIGHTRAIL SUB-C, THE BLEEDING HAD WORSENED BUT WAS ATTRIBUTED TO THE ENTRY INTO THE VESSEL AND HOW DEEP THE LEAD WAS IMPLANTED. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), ADVANCEMENT WAS MADE NEAR THE TRICUSPID VALVE AND STALLED. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS REMOVED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND BLEEDING WAS NOTED ONCE AGAIN. A PERFORATION TO THE AXILLARY VEIN INTO THE SUBCLAVIAN WAS IDENTIFIED, AND RESCUE EFFORTS BEGAN, INCLUDING HOLDING PRESSURE ON THE INJURY, AND BLOOD PRODUCTS WERE ADMINISTERED. AFTER SEVERAL HOURS, THE PATIENT WAS HEMODYNAMICALLY STABLE, AND A STENT WAS PLACED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C IN USE WHEN THE PERFORATI

  Patient problems: Perforation of Vessels

  MAUDE report 24089948 ↗
• DeathDec 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 RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. THE PATIENT WAS ELDERLY AND FRAIL, AND HAD A GROSSLY INFECTED RIGHT SIDED POCKET, WHICH WAS MEDICALLY MANAGED SINCE JULY 2023. BOTH A SPECTRANETICS LEAD LOCKING DEVICE AND A COOK MEDICAL BULLDOG LEAD EXTENDER WERE USED AS TRACTION PLATFORMS (IT IS UNK WHICH DEVICE WAS USED ON WHICH LEAD). MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, VISISHEATH DILATOR SHEATH, TIGHTRAIL ROTATING DILATOR SHEATH, TIGHTRAIL 13F SUB-C ROTATING DILATOR SHEATH, AND TIGHTRAIL MINI ROTATING DILATOR SHEATH) WERE USED DURING THE PROCEDURE. EFFORTS BEGAN TO EXTRACT THE RA LEAD FIRST; HOWEVER, STALLED PROGRESS WAS ENCOUNTERED. THE PATIENT''S BLOOD PRESSURE FLUCTUATED THROUGHOUT THE EXTRACTION ATTEMPT, BUT THE PROCEDURE CONTINUED. NEXT, THE TIGHTRAIL 13F SUB-C WAS USED TO ATTEMPT REMOVAL OF THE RV LEAD, BUT THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, BYPASS, AND STERNOTOMY. A RIGHT INNOMINATE PERFORATION WAS DISCOVERED, AND ALTHOUGH EXTENSIVE EFFORTS WERE MADE TO SURGICALLY REPAIR THE AREA, THE PATIENT DID NOT

  Patient problems: Perforation of Vessels

  MAUDE report 18248984 ↗
• InjuryFeb 7, 2023Migration; Migration

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD, EXTRACTION INDICATION UNK. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS GLIDELIGHT LASER SHEATH AND A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH (AND THE TIGHTRAIL'S OUTER SHEATH) TO TREAT THE PATIENT. WHILE THE TIGHTRAIL SUB-C WAS IN USE, THE OUTER SHEATH WAS INADVERTENTLY LOST IN THE PATIENT'S VASCULATURE. USING MULTIPLE TOOLS, THE CT AND VASCULAR SURGEONS ASSISTED IN SUCCESSFULLY RETRIEVING THE OUTER SHEATH FROM THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. THE RV LEAD WAS SUCCESSFULLY REMOVED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE TIGHTRAIL SUB-C'S OUTER SHEATH WHICH MIGRATED INTO THE VASCULATURE, REQUIRING INTERVENTION FOR RETRIEVAL. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 16315256 ↗
• DeathSep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AND REPLACE THE PATIENT'S PACEMAKER DEVICE, ALONG WITH A RIGHT VENTRICULAR (RV), RIGHT ATRIUM (RA), AND LEFT VENTRICULAR LEAD (LV) BECAUSE OF AN INFECTION THAT HAD BEEN DISCOVERED A WEEK PRIOR TO THE PROCEDURE. THE PATIENT HAD THE PACEMAKER DEVICE SWITCHED OUT FIVE YEARS AGO DUE TO AGE OF THE DEVICE. AT THAT TIME, IT WAS BELIEVED THAT SHE HAD A URINARY TRACT INFECTION (UTI) AND WAS GIVEN ANTIBIOTICS. HOWEVER, THE PATIENT CONTINUED TO HAVE ELEVATED WHITE BLOOD CELL COUNT; THEREFORE, THE DECISION WAS MADE TO START MAINTENANCE ANTIBIOTIC THERAPY. ADDITIONALLY, THE PATIENT WAS MISDIAGNOSED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND HAD BEEN ON LONG TERM STEROIDS. WHEN STARTING THE PROCEDURE, THE PHYSICIAN DISCOVERED THE INFECTION WAS WORSE THAN EXPECTED AND THE POCKET WAS ERODED. THE PHYSICIAN PREPPED ALL LEADS WITH SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WITHOUT ANY DIFFICULTY. THE RA LEAD WAS SUCCESSFULLY EXTRACTED FIRST WITH MINIMAL TRACTION. THE PHYSICIAN MOVED ON TO THE RV LEAD WHERE SEVERAL ADHESIONS WERE NOTED IN THE SUBCLAVIAN AREA, AND PROCEEDED WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C. HE ADVANCED APPROXIMATELY THRE

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 15433477 ↗
• MalfunctionAug 16, 2022Device Damaged by Another Device; Mechanics Altered; Device Damaged by Another Device; Mechanics Altered

  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. WHILE THE PHYSICIAN WAS USING A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO ATTEMPT REMOVAL OF RA LEAD, THE LEAD WAS INADVERTENTLY CUT BY THE TIGHTRAIL, AND THERE APPEARED TO BE SOMETHING HARD IN THE MECHANISM. THERE WAS NO DAMAGE PRESENT TO THE LLD IN THE RA LEAD, SO IT REMAINED FUNCTIONAL TO PROVIDE TRACTION. THE PHYSICIAN USED A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND A 13F TIGHTRAIL TO SUCCESSFULLY REMOVE BOTH THE RA AND RV LEADS WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 13F TIGHTRAIL SUB-C WHICH INADVERTENTLY CUT THE RA LEAD, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235998 ↗
• InjuryMar 11, 2022Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED EXTRACTION OF BOTH LEADS, USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH. THE PHYSICIAN THEN SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE TWO LEADS. WHILE WORKING TO REMOVE THE RA LEAD, THE TIGHTRAIL SUB-C DEVICE BECAME STUCK ON THE LEAD, REQUIRING ADDITIONAL INTERVENTION TO REMOVE THE DEVICE FROM THE LEAD, BUT WAS SUCCESSFUL (MDR #1721279-2022-00048). THE 16F GLIDELIGHT DEVICE WAS USED AGAIN, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. ATTEMPTING REMOVAL OF THE RV LEAD, THE PHYSICIAN USED THE 16F GLIDELIGHT DEVICE, THEN SWITCHED TO A SPECTRANETICS TIGHTRAIL (LONG) DEVICE. THIS DEVICE BECAME STUCK ON THE RV LEAD, AT THE AREA OF THE LEAD'S SUPERIOR VENA CAVA (SVC) COIL, REQUIRING INTERVENTION TO REMOVE THE DEVICE FROM THE RV LEAD, BUT WAS SUCCESSFUL (MDR #1721279-2022-00049). ONCE OUT OF THE BODY, THERE WAS DENSE, CALCIFIC TISSUE VISIBLE AT THE DISTAL TIP OF THE TIGHTRAIL (LONG) DEVICE. AFTER THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737433 ↗
• InjuryNov 16, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE THREE LEADS: A RIGHT ATRIAL (RA), AN ACTIVE RIGHT VENTRICULAR (RV) AND A CAPPED RV LEAD DUE TO THE NEED FOR AN MRI. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION FOR THE LEADS. THE PHYSICIAN BEGAN BY USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS 33 CM VISISHEATH DILATOR SHEATH TO ATTEMPT TO REMOVE THE ACTIVE RV LEAD. HE ENCOUNTERED STALLED PROGRESSION AS A RESULT OF SEVERE CALCIFICATION AND LEAD ON LEAD BINDING, AND CHOSE TO CHANGE TO A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO CLEAR A PATHWAY TO THE SUPERIOR VENA CAVA (SVC). HE WAS SUCCESSFUL WITH NAVIGATING THROUGH THE CLAVICULAR REGION ALTHOUGH THERE APPEARED TO BE SOME ''SNOWPLOWING'' (WHERE THE LEAD JACKET BUNCHES UP ON ITSELF) ON THE ADJACENT LEADS. THE TIGHTRAIL SUB-C DEVICE WAS THEN DEPLOYED ON THE ADJACENT CAPPED RV LEAD. THIS RESULTED IN THE TIGHTRAIL SUB-C SEVERING THE CAPPED RV LEAD. HE THEN SWITCHED BACK TO THE 14F GLIDELIGHT DEVICE ON THE ACTIVE RV LEAD AND EXPERIENCED MORE STALLED PROGRESSION. HE UPSIZED TO A 16F GLIDELIGHT DEVICE, AND WAS SUCCESSFUL IN REMOVING THE ACTIVE RV LEAD. HOWEVER,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824406 ↗
• InjuryApr 22, 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 VENTRICULAR (RV), A RIGHT ATRIAL (RA) AND A LEFT VENTRICULAR (LV) LEAD DUE TO A REDUNDANT LEAD. IT WAS NOTED THAT THE IMPLANT DURATION OF THE RA AND RV LEADS WAS 280 MONTHS. SPECTRANETICS LEAD EXTRACTION TOOLS WERE USED IN THIS PROCEDURE; HOWEVER WHEN THE PHYSICIAN WAS USING A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WITHIN THE SUBCLAVIAN REGION, AND WHEN THE RA AND RV LEADS WERE FREED SIMULTANEOUSLY FROM A POINT WITHIN THE SUBCLAVIAN AS WELL, THE PATIENT'S BLOOD PRESSURE DROPPED. IT WAS ALSO REPORTED AT THIS TIME THAT THE LV LEAD ALSO BECAME CAUGHT IN THE SUBCLAVIAN AREA, BUT WAS SUCCESSFULLY REMOVED WITH TRACTION. REPORTEDLY, THE PATIENT'S BLOOD PRESSURE DROP WAS NOT ACCOMPANIED BY AN APPARENT INJURY FOR APPROXIMATELY 45 MINUTES, AND THE PATIENT WAS RESPONDING TO OTHER TREATMENT. HOWEVER, EVIDENCE OF AN INJURY WAS SEEN ON FLUOROSCOPY APPROXIMATELY 45 MINUTES AFTER THE INITIAL BLOOD PRESSURE DROP. RESCUE EFFORTS BEGAN, INCLUDING BYPASS AND STERNOTOMY. A LEFT SUBCLAVIAN TEAR WAS DISCOVERED AND WAS SUCCESSFULLY REPAIRED. IT IS UNKNOWN WHETHER THE TEAR OCCURRED WITH USE OF THE TIGHTRAIL SUB-C DEVICE, OR FROM THE

  Patient problems: Perforation of Vessels

  MAUDE report 11706683 ↗
• InjuryMar 17, 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 LEAD FRACTURE AND PATIENT''S SYMPTOM OF DIZZINESS. A TEMPORARY PACEMAKER WAS THEN DEPLOYED IN THE RV AT 60 BEATS PER MINUTE (BPM) AS THE PATIENT WAS PACEMAKER DEPENDENT. SPECTRANETICS LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH OF THE LEADS TO PROVIDE THE TRACTION PLATFORMS TO AID IN THE LEADS'' EXTRACTIONS. THE PHYSICIAN INSERTED X 2 A 7F PEEL-AWAY SHEATH INTO THE SUBCLAVIAN VEIN. THE CAS HAD ASKED THE PHYSICIAN IF ALL EQUIPMENT AND MECHANICAL DEVICE WOULD FIT INTO THE SUBCLAVIAN VEIN BASED ON THE VENOGRAM. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL MINI ROTATING DILATOR SHEATH, THE PHYSICIAN FOCUSED EFFORTS TO REMOVE THE RA LEAD AND BECAME CAUGHT IN THE MID SUBCLAVIAN REGION. HE THEN SWITCHED EFFORTS TO REMOVAL OF THE RV LEAD. THIS WAS REPEATED TWO MORE TIMES. SOME BLEEDING WAS NOTED IN THE POCKET, BUT PATIENT WAS HEMODYNAMICALLY STABLE. WHEN THE 11F TIGHTRAIL MINI COULD NOT ADVANCE, A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS USED. AT THIS POINT, BOTH THE CAS AND CARDIOLOGIST THOUGHT THAT THERE WAS LEAD ON LEAD BINDING AT THIS PARTICULAR P

  Patient problems: Perforation of Vessels

  MAUDE report 11507179 ↗
• DeathNov 20, 2020Adverse 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 RV LEAD MALFUNCTION AND DUE TO PATIENT'S EJECTION FRACTION (EF) BEING >70%, IT WAS THOUGHT THAT IF THE LEADS WERE REMOVED, THAT THE PATIENT MIGHT NOT ANY LONGER NEED THEM. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE PLACED WITHIN EACH LEAD TO PROVIDE TRACTION DURING LEAD REMOVAL. THE CASE BEGAN WITH THE SURGEON USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO EXTRACT THE RA LEAD; ULTIMATELY THE RA LEAD RELEASED, RETRACTED INTO THE GLIDELIGHT'S SHEATH, AND WAS REMOVED. SIGNIFICANT SCARRING WAS NOTED AROUND THIS LEAD, RESEMBLING A ''SLEEVE'' OF SCAR TISSUE (BOTH RA AND RV LEADS WERE IMPLANTED (B)(6) 2010). HOWEVER, WHILE CALIBRATING A 16F GLIDELIGHT DEVICE TO BEGIN WORKING ON THE RV LEAD, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED A GROWING EFFUSION. THE SURGEON WAS SCRUBBED IN FOR THE CASE AND PERFORMED A PARTIAL STERNOTOMY IN HOPE THAT A FULL STERNOTOMY WOULDN'T BE NEEDED, SINCE THE EFFUSION STOPPED GROWING. HOWEVER, THE DECISION WAS MADE TO PERFORM A FULL STERNOTOMY AND A PERFORATION OF THE RA WAS NOTED. REPAIR TO THE AREA WAS SUCCESSFULLY MADE. FROM THE POCKET

  Patient problems: Death; Iatrogenic Source; Perforation of Vessels

  MAUDE report 10878418 ↗
• InjuryJan 7, 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) LEAD AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE PLACE IN BOTH LEADS TO PROVIDE TRACTION ON THE LEADS DURING REMOVAL ATTEMPTS. A SPECTRANETICS GLIDELIGHT LASER SHEATH WAS USED FIRST TO ATTEMPT REMOVAL OF THE RV LEAD BUT THE PHYSICIAN EXPERIENCED STALLED PROGRESSION IN THE INNOMINATE VEIN. HE THEN UTILIZED A SPECTRANETICS MEDIUM 43CM VISISHEATH ALONG WITH THE 14F GLIDELIGHT, BUT COULD NOT GET DOWN TO THE SUPERIOR VENA CAVA (SVC) ON EITHER LEAD. THE PHYSICIAN THEN CHOSE TO USE A 16F GLIDELIGHT DEVICE WITH A LARGE 33CM VISISHEATH AND COULD ADVANCE A LITTLE FURTHER DOWN THE LEADS. HE THEN CHOSE TO USE A SPECTRANETICS 13F TIGHTRAIL DEVICE ON BOTH THE RA AND RV LEADS, AND ALTHOUGH THE PHYSICIAN STILL HAD TRACTION, THE LEADS LOOKED LIKE THEY WERE UNRAVELING. HE MET STALLED PROGRESSION WHERE THE INNOMINATE VEIN TRANSITIONED INTO THE SVC. THERE APPEARED TO BE A LARGE CALCIFICATION ON BOTH LEADS RIGHT NEAR THE SVC, SO THE PHYSICIAN SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C DEVICE. HE WAS ABLE TO MAKE SOME PROGRESS AS HE ATTEMPTED TO REMOVE THE RA LEA

  Patient problems: Great Vessel Perforation; Iatrogenic Source

  MAUDE report 9559521 ↗