TightRail Mini 540-011Recalls & reported problems
Spectranetics Corporation · TightRail Mini Rotating Dilator Sheath · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132020866), received between Oct 5, 2018 and Oct 5, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Iatrogenic Source1
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2018Adverse 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 PROCEDURE 5 LEADS WERE TO BE EXTRACTED. THE PHYSICIAN UTILIZED THE 12FR GLIDELIGHT LASER SHEATH FIRST, THE 9FR LONG TIGHTRAIL ROTATING DILATOR SHEATH SECOND, AND THEN AN 11FR TIGHTRAIL MINI ROTATING DILATOR SHEATH 540-011 WITH A LEAD LOCKING DEVICE (LLD). AFTER THE RIGHT ATRIUM TENDRIL LEAD WAS EXTRACTED UTILIZING THE SPECTRANETICS TIGHTRAIL MINI 540-011, THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY. AN EFFUSION WAS VISIBLE ON IMAGING. THERE WAS AN INJURY TO THE SUPERIOR VENA CAVA (SVC)/RIGHT ATRIAL (RA) JUNCTION. RESCUE EFFORTS COMMENCED AND WERE SUCCESSFUL. PATIENT SURVIVED THE PROCEDURE AND ALL 5 LEADS INTENDED FOR REMOVAL WERE SUCCESSFULLY EXTRACTED.
Patient problems: Iatrogenic Source; Perforation of Vessels
MAUDE report 7940904 ↗
Other Dilator, Vessel, For Percutaneous Catheterization devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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