TightRail Mini Rotating Dilator Sheath 540-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813132021627), received between Feb 12, 2020 and Oct 23, 2023 — classified as 1 injury, 1 malfunction.

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

• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS (ONE ABANDONED AND THE OTHER ONE ACTIVE AND LUMENLESS) FOR AN UPGRADE TO A CRT-D SYSTEM. A RIGHT ATRIAL (RA) LEAD WAS ALSO PRESENT IN THE PATIENT, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE ABANDONED RV LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH, PROGRESS STALLED IN THE INNOMINATE REGION. THEN, A SPECTRANETICS 11F TIGHTRAIL MINI ROTATING DILATOR SHEATH WAS USED TO PROGRESS SLOWLY INTO THE SUPERIOR VENA CAVA (SVC), WITH ADVANCEMENT BEING DIFFICULT DUE TO TIGHT SPACE WITHIN THE VASCULATURE. THE PATIENT''S BLOOD PRESSURE DROPPED AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED THE PRESENCE OF A PERICARDIAL EFFUSION. RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A SMALL (APPROXIMATELY 1-1 1/2 CM) SVC LATERAL WALL PERFORATION WAS DISCOVERED AND REPAIRED. AFTER REPAIR WAS COMPLETED, A 13F TIGHTRAIL WAS USED POST-STERNOTOMY TO ATTEMPT REMOVAL OF THE ABANDONED RV LEAD. HOWEVER, WHEN THE TIGHTRAIL ADVANCED TO THE AREA OF INJURY, THE PERF

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 17992728 ↗
• MalfunctionFeb 12, 2020Mechanical Problem; Mechanical Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE ONE RIGHT VENTRICLE (RV) LEAD DUE TO NON FUNCTION; FIVE OTHER LEADS WERE PRESENT BUT THEY WERE NOT TARGETED FOR EXTRACTION. THE SUBCLAVIAN TO SUPERIOR VENA CAVA (SVC) WAS OCCLUDED MAKING IT DIFFICULT TO ADVANCE A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH. SINCE THE GLIDELIGHT WAS UNABLE TO MOVE THROUGH THE SUBCLAVIAN, A SPECTRANETICS 11F TIGHTRAIL MINI WAS USED TO CLEAR THE OCCLUSION. AFTER ADVANCEMENT WAS MADE WITH THE TIGHTRAIL MINI, A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND SPECTRANETICS VISISHEATH WERE INTRODUCED INTO THE SUBCLAVIAN. THE GLIDELIGHT LASER AND VISISHEATH THEN STALLED MAKING LITTLE TO NO PROGRESS. AFTER THE GLIDELIGHT LASER AND VISISHEATH STALLED THE TIGHTRAIL MINI WAS REINTRODUCED BACK INTO THE SUBCLAVIAN. THIS DEVICE MADE SLOW PROGRESS THROUGH THE OCCLUSION. IT WAS DURING THIS ADVANCEMENT THAT THE HANDLE OF THE TIGHTRAIL MINI STOPPED TRIGGERING MAKING THE BLADES UNABLE TO ACTUATE. A NEW SPECTRANETICS 11FR TIGHTRAIL MINI WAS INTRODUCED BACK INTO THE SUBCLAVIAN, THIS NEW TIGHTRAIL MINI MADE SLOW PROGRESS AND THEN STALLED. THE PHYSICIAN THEN ELECTED TO TRY A SPECTRANETICS 13F TIGHTRAIL SUB-C DEVICE FOLLOWED BY A

  Patient problems: Iatrogenic Source; No Known Impact Or Consequence To Patient

  MAUDE report 9700048 ↗