TightRail Rotating Dilator Sheath 545-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813132021634), received between Nov 12, 2019 and Jul 14, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO FRACTURE. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ), ALONG WITH A COOK MEDICAL ONE-TIE COMPRESSION COIL, WERE INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 9F TIGHTRAIL ROTATING DILATOR SHEATH, THE OUTER SHEATH WOULD NOT ENTER THE ACCESS SITE AT THE SUBCLAVIAN VEIN, THUS UNABLE TO ADVANCE TO THE SUPERIOR VENA CAVA (SVC)/RA JUNCTION. DURING REMOVAL, THE TIGHTRAIL GOT STUCK ON THE LLD EZ (MDR #3007284006-2025-00137), AND BOTH WERE REMOVED TOGETHER, ALONG WITH THE ONE-TIE. UPON REMOVAL, THE LLD EZ AND ONE-TIE COULD NOT BE REMOVED FROM THE TIGHTRAIL; THEREFORE, THE TIGHTRAIL WAS CUT TO PRESERVE THE LEAD AND LLD EZ LENGTH. A COOK MEDICAL NEEDLE¿S EYE SNARE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 9F TIGHTRAIL THAT GOT STUCK ON THE CONCOMITANT DEVICES THAT HAD TO BE REMOVED AS A SYSTEM, POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493188 ↗
• InjurySep 4, 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 LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. USING A SPECTRANETICS 9F TIGHTRAIL ROTATING DILATOR SHEATH, THE RV LEAD WAS REMOVED FIRST, THEN THE RA LEAD. WHEN THE TIGHTRAIL WAS REMOVED, A SUBCLAVIAN PERFORATION WAS DETECTED, RESULTING IN A LARGE LOSS OF BLOOD TO THE PATIENT. A RESCUE BALLOON WAS USED TO TEMPORARILY OCCLUDE THE PERFORATION, FOLLOWED BY PLACEMENT OF 3 STENTS TO REPAIR THE PERFORATION. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE TIGHTRAIL IN USE WITHIN THE AREA 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 20141591 ↗
• MalfunctionDec 1, 2022Sharp Edges; Sharp Edges

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD IN A RIGHT SIDED APPROACH, DUE TO OCCLUSION AND NON FUNCTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH AND FIAB DILATOR SHEATHS WERE USED IN THE PROCEDURE WITH NO COMPLICATIONS. THE PHYSICIAN THEN CHOSE A SPECTRANETICS 9F TIGHTRAIL (LONG) TO ATTEMPT REMOVAL OF THE RA LEAD. THE TIGHTRAIL WAS ACTIVATED SEVERAL TIMES THROUGH THE RIGHT SUBCLAVIAN VEIN AND INTO THE PROXIMAL SUPERIOR VENA CAVA (SVC), WHERE PROGRESS STALLED. THE TIGHTRAIL STOPPED TRACKING DOWN THE RA LEAD, SO THE PHYSICIAN SWITCHED TO ATTEMPT REMOVAL OF THE RV LEAD AND REMOVED THE TIGHTRAIL FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED A PIECE OF METAL WAS PROTRUDING FROM THE TIGHTRAIL'S PROXIMAL END. THE PHYSICIAN GENTLY PULLED THIS PIECE OF METAL, AND PULLED OUT WHAT APPEARED TO BE THE INTERNAL MECHANISM OF THE TIGHTRAIL. THE PHYSICIAN THEN USED A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO ATTEMPT REMOVAL OF THE RA LEAD. THE GLIDELIGHT ADVANCED DOWN THE SUBCLAVIAN AND REACHED THE PROXIMAL SVC, WHERE AN OBSTRUCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898297 ↗
• MalfunctionNov 12, 2019Material Integrity Problem; Material Integrity Problem

  DURING A LEAD EXTRACTION PROCEDURE, IT WAS REPORTED THAT WHILE USING A SPECTRANETICS TIGHTRAIL DEVICE, THE LEAD AND THE SPECTRANETICS LLD BEING USED COULD NOT BE THREADED THROUGH THE TIGHTRAIL DEVICE. THE PHYSICIAN STATED HE FELT AN OBSTRUCTION IN THE INNER LUMEN OF THE TIGHTRAIL DEVICE. IT WAS ALSO REPORTED THAT WHEN REMOVING THE TIGHTRAIL, IT FELT TIGHT WITHIN THE INNER LUMEN. A LARGER SIZE DEVICE WAS USED TO COMPLETE THE CASE, WITH NO REPORTED PATIENT HARM. DURING THE DEVICE EVALUATION ON 16 OCT 2019, A SMALL PARTICLE, APPEARING TO BE METAL, WAS DETECTED ON THE DEVICE'S DISTAL BAND. SINCE THERE WOULD BE THE POTENTIAL FOR SERIOUS INJURY (EMBOLIZATION) IF THIS EVENT WERE TO RECUR, THIS REPORT IS BEING SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9313179 ↗