TightRail Sub-C Rotating Dilator Sheath 560-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813132022785), received between Oct 24, 2019 and Jul 5, 2024 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 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), A RIGHT VENTRICULAR (RV), AND A LEFT VENTRICULAR (LV) LEAD DUE TO OCCLUSION OF THE SUPERIOR VENA CAVA (SVC). SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH ON THE LV LEAD, PROGRESS STALLED. NEXT, A SPECTRANETICS 11F TIGHTRAIL SUB-C WAS USED, ALTERNATING BETWEEN THE THREE LEADS TO ATTEMPT ADVANCEMENT DOWN THE VASCULATURE. WHILE THE TIGHTRAIL SUB-C WAS ON THE RA LEAD IN THE SVC REGION, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING STERNOTOMY, AND AN SVC PERFORATION WAS DISCOVERED AND REPAIRED. AFTER THE REPAIR WAS COMPLETE, THE LLD EZS WERE UNLOCKED FROM THE LEADS AND REMOVED, AND THE LEADS WERE ABANDONED IN THE PATIENT. AT THAT TIME, THE DECISION WAS MADE TO REPLACE THE TRICUSPID VALVE (TV), SINCE THE VALVE WAS PREVIOUSLY DETERMINED TO HAVE SEVERE TRICUSPID REGURGITATION (TR). WHILE WORKING ON THE VALVE, IT WAS DIFFICULT TO CONTROL THE BLEEDING, REQUIRING PHARMACOLOGIC HELP, AS THE PATIENT HAD A COAGULATION DISORDER. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE. THE SURGEO

  Patient problems: Great Vessel Perforation

  MAUDE report 19680211 ↗
• InjuryApr 28, 2022Entrapment of Device; Entrapment of Device

  A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS RECEIVED IN THE PHILIPS DECONTAMINATION LABORATORY ON 05 APR 2022, SENT FROM ABBOTT. NO COMPLAINT FORM OR ANY OTHER INFORMATION WAS PROVIDED REGARDING THIS DEVICE; THEREFORE, THE EVENT DATE IS LISTED AS 05 APRIL 2022. THE TIGHTRAIL DEVICE WAS RECEIVED DISASSEMBLED, WITH THE TWO HANDLE HALVES SEPARATED AND INTERNAL MECHANISMS LOOSE WITHIN A BIOHAZARD BAG. HOWEVER, A VISUAL INSPECTION WAS NOT PERFORMED UNTIL 08 APRIL 2022. ON THE TIGHTRAIL DEVICE, A TAG WAS PRESENT THAT STATES "STUCK ON ICD". AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS A KNOWN TYPE OF CARDIAC LEAD. WITHIN THE DEVICE'S INNER LUMEN, AN UNIDENTIFIED OBJECT WAS PRESENT. FURTHER INFORMATION WILL BE AVAILABLE UPON THE COMPLETION OF THE DEVICE EVALUATION AND INVESTIGATION. THIS EVENT IS BEING REPORTED CONSERVATIVELY DUE TO THE NATURE OF THE RETURNED TIGHTRAIL DEVICE. DUE TO THE DISASSEMBLED DEVICE, IT IS LIKELY THAT INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE FROM A LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246512 ↗
• MalfunctionOct 24, 2019Mechanical Jam; Mechanical Jam

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) PACING LEAD DUE TO BACTEREMIA. A SPECTRANETICS 9F TIGHTRAIL SUB-C DEVICE AND A LEAD LOCKING DEVICE (LLD EZ) WERE UTILIZED TO ASSIST WITH REMOVAL OF THE LEAD. THE LEAD WAS PREPARED BY PLACING THE LLD EZ DOWN IN THE LEAD LUMEN TO THE TIP OF THE LEAD, AND A BRAIDED SILK SUTURE WAS TIED AROUND THE OUTER INSULATION OF THE LEAD. THE LEAD AND ALL OF THE AFOREMENTIONED COMPONENTS WERE LOADED INTO THE TIGHTRAIL SUB-C DEVICE, AND THE DEVICE WAS UTILIZED TO FREE THE LEAD FROM BINDING SITES FROM THE ENTRY INTO THE PECTORAL POCKET TO THE LEFT-BRACHIOCEPHALIC/SUPERIOR VENA CAVA (SVC) JUNCTION. THE PHYSICIAN DESIRED TO SWITCH TO A DIFFERENT TOOL, AND ATTEMPTED TO REMOVE THE TIGHTRAIL SUB-C FROM AROUND THE LEAD. ONCE THE TIGHTRAIL SUB-C WAS REMOVED FROM THE PATIENT (BUT THE LEAD WAS STILL WITHIN IT), THE DEVICE BECAME STUCK ON THE LEAD. THE PHYSICIAN COULD NOT REMOVE THE LEAD FROM WITHIN THE DEVICE, AND ULTIMATELY CUT THE LEAD AND THE LLD TO FREE THE TOOL. A SILK SUTURE WAS TIED AROUND THE REMAINING COMPONENTS OF THE LEAD, AND THE LEAD WAS SUCCESSFULLY EXTRACTED, USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, FROM THE PAT

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

  MAUDE report 9234599 ↗