TightRail Rotating Dilator Sheath 545-511 (UDI 00813132020880)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813132020880), received between Jun 16, 2020 and Dec 20, 2023 — classified as 3 deaths, 4 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD. THE TRACTION PLATFORM USED FOR THE RA LEAD IS UNK, BUT A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND ALTERNATING BETWEEN THE RA AND RV LEADS, THE RA LEAD WAS ULTIMATELY EXTRACTED WITH NO ISSUES. THEN, ATTEMPTING TO EXTRACT THE RV LEAD WITH THE SAME 16F GLIDELIGHT, PROGRESS STALLED AT THE TOP OF THE SUPERIOR VENA CAVA (SVC). SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, ADVANCEMENT WAS REACHED 3-4 CM FROM THE RV LEAD TIP; HOWEVER, THE TIGHTRAIL BECAME STUCK ON THE LEAD. REPEATED TRACTION ATTEMPTS LED TO ECTOPIC HEART BEATS AND INTERMITTENT DROPS IN THE PATIENT'S BLOOD PRESSURE (BP), CONCOMITANT WITH EACH TRACTION PULL. AT THAT TIME, THE LLD IN THE RV LEAD SNAPPED NEAR THE LLD'S PROXIMAL END, OUT OF THE PATIENT'S BODY (MDR #3007284006-2023-00098). TO ATTEMPT REMOVAL AND TO EXPOSE THE LLD, THE TIGHTRAIL'S OUTER JACKET WAS INCISED (MDR #3007284006-2023-00093). AN ARTERY FORCEP WAS USED TO CLAMP THE LLD, THEREBY ALLOWING A TRACTION PLATFORM. THEN, THE LLD,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369689 ↗
• DeathNov 8, 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 CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL (LONG) ROTATING DILATOR SHEATH ON THE RA LEAD, ADVANCEMENT WAS UNSUCCESSFUL. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, PROGRESS WAS MADE TO THE SUPERIOR VENA CAVA (SVC). ONCE REACHING THIS AREA, THE TIGHTRAIL SUB-C WAS REMOVED, AND REPLACED WITH THE SAME 11F TIGHTRAIL (LONG). HOWEVER, THE PATIENT'S BLOOD PRESSURE SUDDENLY DROPPED. AN ICE CATHETER CONFIRMED THERE WAS NO EFFUSION OR HEMOTHORAX, THE BLOOD PRESSURE IMPROVED OVER TIME, AND THE RA LEAD WAS REMOVED WITHOUT DIFFICULTY. A SPECTRANETICS GLIDELIGHT LASER SHEATH WAS REPORTEDLY USED, BUT TIME OF USE IS UNKNOWN. NEXT, THE LV LEAD WAS TARGETED FOR REMOVAL. USING THE TIGHTRAIL SUB-C, PROGRESS WAS MADE TO THE SVC, THEN REPLACED WITH THE SAME TIGHTRAIL (LONG), WHICH ADVANCED TO THE CORONARY SINUS (CS) OS. THE LV LEAD APPEARED TO BE STUCK IN THE MID-LATERAL CS, BUT FREED WITH MILD TRACTION. WHEN THE TIGHTRA

  Patient problems: Perforation of Vessels

  MAUDE report 18095496 ↗
• DeathAug 4, 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 THE SYSTEM GIVING INAPPROPRIATE SHOCKS. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 11F TIGHTRAIL LONG) WERE USED TO ULTIMATELY EXTRACT ALL THREE LEADS. HOWEVER, WHILE REMOVING THE RA LEAD USING THE 11F TIGHTRAIL (LONG), A CONTINUOUS PERFORATION (EXTENDING FROM THE INNOMINATE VEIN THROUGH THE SUPERIOR VENA CAVA (SVC) TO THE RIGHT ATRIUM) WAS DISCOVERED. RESCUE EFFORTS BEGAN, INCLUDING BYPASS AND STERNOTOMY. PATCHES WERE PLACED THROUGH THE ENTIRE PERFORATED REGION AND 3 NEW LEADS WERE IMPLANTED THROUGH THE PATCHES. THE PATIENT SURVIVED THE PROCEDURE, BUT DIED THE FOLLOWING DAY. THIS REPORT CAPTURES THE 11F TIGHTRAIL LONG, 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; Perforation of Vessels

  MAUDE report 17460240 ↗
• InjuryMar 31, 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. A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WITH ITS TEFLON OUTER SHEATH, ALONG WAS USED TO ATTEMPT EXTRACTION. THE PHYSICIAN ALTERNATED ATTEMPTS BACK AND FORTH BETWEEN THE RA AND RV LEADS DUE TO LEAD ON LEAD BINDING, AND THE RV LEAD BEGAN PULLING APART DURING THE EXTRACTION ATTEMPTS. THE RA LEAD WAS ULTIMATELY EXTRACTED WITH NO ISSUES. SINCE THE RV LEAD WAS PULLING APART, A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH WITH ITS OUTER SHEATH WAS USED TO ATTEMPT EXTRACTION OF THE RV LEAD. ADVANCEMENT WAS MADE, THROUGH A BINDING SITE TO THE TIP OF THE RV LEAD, AND THE LEAD WAS ABLE TO BE REMOVED. THE PATIENT''S BLOOD PRESSURE DROPPED, AND ANESTHESIA NOTED AN EFFUSION PRESENT AT THE APEX OF THE RV VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING PERICARDIOCENTESIS; HOWEVER, NO BLOOD WAS WITHDRAWN. A STERNOTOMY FOLLOWED AND A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS

  Patient problems: Great Vessel Perforation

  MAUDE report 16659668 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, 13F TIGHTRAIL ROTATING DILATOR SHEATH) WERE USED IN THE PROCEDURE. THE RA WAS SUCCESSFULLY REMOVED. DURING REMOVAL OF THE RV LEAD USING THE 13F TIGHTRAIL AND ITS OUTER SHEATH, THE OUTER SHEATH ENCOUNTERED DENSE TISSUE. ONCE IT PASSED THROUGH THE TISSUE, UNINTENDED FORWARD MOMENTUM CAUSED IT TO PERFORATE THE RV. THE PATIENT''S BLOOD PRESSURE DROPPED AND IMAGING DETECTED THE INJURY. THE RV LEAD WAS REMOVED. RESCUE EFFORTS BEGAN, INCLUDING BYPASS AND STERNOTOMY. THE RV PERFORATION WAS REPAIRED AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE 13F TIGHTRAIL''S OUTER SHEATH WHICH CAUSED THE PERFORATION, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 16432763 ↗
• InjuryOct 19, 2022Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem; Device Damaged by Another Device; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A PREVIOUSLY FRACTURED RIGHT VENTRICULAR (RV) LEAD DUE TO NON FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS ALSO PRESENT IN THE PATIENT BUT WAS NOT INITIALLY TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH AND SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE PHYSICIAN SUCCESSFULLY EXTRACTED THE RV LEAD. HOWEVER, THE RA LEAD WAS TESTED AND WAS NOT FUNCTIONING PROPERLY; IT WAS BELIEVED THAT THE TIGHTRAIL BLADES HAD DAMAGED THE LEAD, REQUIRING LEAD REMOVAL. AN LLD WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION, AND THE 14F GLIDELIGHT AND MEDIUM VISISHEATH WERE USED TO REMOVE THE LEAD. THE HELIX OF THE RA LEAD TIP COULD NOT BE RETRACTED. IT WAS DISCOVERED THAT THE LEAD TIP WAS BENT (REPORTEDLY FROM TRACTION FORCES DURING THE PROCEDURE), AND WHEN THE LEAD TIP FINALLY FREED AND THE LEAD WAS BEING PULLED OUT FROM THE BODY, THE PATIENT''S BLOOD PRESSURE INITIALLY WENT UP, THEN DROPPED. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, BYPASS, AND STERNOTOMY. A SUPERIOR VENA C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635373 ↗
• DeathJun 16, 2020Adverse 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 ATRIAL (RA), RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. THE REP PRESENT AT THE PROCEDURE STATED THE LEADS HAD TO COME OUT DUE TO THE INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLD'S) WERE INSERTED IN EACH LEAD TO ACT AS TRACTION PLATFORMS TO AID IN LEAD EXTRACTION. A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED TO SUCCESSFULLY REMOVE THE RV AND RA LEADS; THE LV LEAD WAS LEFT TO EXTRACT LAST BECAUSE THE TEAM ANTICIPATED THAT THE TYPE OF LV LEAD (STARFIX) WAS LIKELY TO BE EXTREMELY DIFFICULT TO REMOVE. USING THE TIGHTRAIL DEVICE, THE PHYSICIAN FREED UP THE LV LEAD ALL THE WAY TO THE CORONARY SINUS (CS) OPENING (OS) BUT COULD NOT GET THE LOBES OF THE LV LEAD TO RETRACT BACK. IT WAS REPORTED THAT USING THE TIGHTRAIL AND TRACTION, IT APPEARED THAT THE CORONARY SINUS WAS INVERTING ON ITSELF, AND WAS DIFFICULT TO TELL AT TIMES WHERE THE TIGHTRAIL DEVICE WAS LOCATED WITHIN THE VASCULATURE. WHILE THE TIGHTRAIL WAS IN USE NEAR THE AREA OF THE CS OS, THE PATIENT'S BLOOD PRESSURE DROPPED. THE SURGEON PERFORMED A SUBXYPHOID WINDOW AND DRAINED THE PERICARDIUM,

  Patient problems: Death; Iatrogenic Source; Perforation of Vessels

  MAUDE report 10157659 ↗