TightRail Sub-C Rotating Dilator SheathRecalls & reported problems across all models

We found 3 models of TightRail Sub-C Rotating Dilator Sheath by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2018 and Jan 15, 2026 — classified as 7 deaths, 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TightRail Sub-C Rotating Dilator Sheath problems

TightRail Sub-C Rotating Dilator Sheath models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TightRail Sub-C Rotating Dilator Sheath 560-011

  Dilator, Vessel, For Percutaneous Catheterization
  4 deaths18 reports
• TightRail Sub-C Rotating Dilator Sheath 560-013

  Dilator, Vessel, For Percutaneous Catheterization
  3 deaths11 reports
• TightRail Sub-C Rotating Dilator Sheath 560-009

  Dilator, Vessel, For Percutaneous Catheterization
  3 reports

Recent TightRail Sub-C Rotating Dilator Sheath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO NON-FUNCTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THERE WAS SOME DIFFICULTY GETTING INTO THE SUBCLAVIAN VEIN, AND MORE BLEEDING THAN EXPECTED WAS COMING FROM THE POCKET. UPON REMOVAL OF THE TIGHTRAIL SUB-C, THE BLEEDING HAD WORSENED BUT WAS ATTRIBUTED TO THE ENTRY INTO THE VESSEL AND HOW DEEP THE LEAD WAS IMPLANTED. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH (LONG), ADVANCEMENT WAS MADE NEAR THE TRICUSPID VALVE AND STALLED. SWITCHING TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, THE RV LEAD WAS REMOVED; HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND BLEEDING WAS NOTED ONCE AGAIN. A PERFORATION TO THE AXILLARY VEIN INTO THE SUBCLAVIAN WAS IDENTIFIED, AND RESCUE EFFORTS BEGAN, INCLUDING HOLDING PRESSURE ON THE INJURY, AND BLOOD PRODUCTS WERE ADMINISTERED. AFTER SEVERAL HOURS, THE PATIENT WAS HEMODYNAMICALLY STABLE, AND A STENT WAS PLACED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C IN USE WHEN THE PERFORATI

  Patient problems: Perforation of Vessels

  MAUDE report 24089948 ↗
• InjuryDec 18, 2025Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. DURING USE OF A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE LEAD COULD NOT BE REMOVED FROM THE TIGHTRAIL; THEREFORE, THE TIGHTRAIL WAS DISASSEMBLED AND REMOVED FROM THE LEAD. THE PROCEDURE WAS COMPLETED, WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 11F TIGHTRAIL THAT GOT STUCK ON THE LEAD, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846141 ↗
• 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 ↗
• MalfunctionFeb 2, 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 VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO LEAD FRACTURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT AS WELL, BUT WAS NOT INITIALLY TARGETED FOR EXTRACTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO THE RV AND LV LEADS TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE LV LEAD, IT APPEARED THE TIGHTRAIL CUT THE LV LEAD AND LLD IN THE SUBCLAVIAN REGION (MDR #3007284006-2024-00022). SWITCHING EFFORTS TO THE RV LEAD, MULTIPLE SPECTRANETICS DEVICES WERE USED (GLIDELIGHT LASER SHEATH, VISISHEATH DILATOR SHEATH, TIGHTRAIL (LONG) ROTATING DILATOR SHEATH) TO ATTEMPT REMOVAL, BUT WERE UNSUCCESSFUL. IT WAS DETERMINED THE RA LEAD REQUIRED REMOVAL, DUE TO LEAD ON LEAD BINDING TO THE RV AND LV LEADS. AN LLD EZ WAS INSERTED INTO THE RA LEAD TO PROVIDE TRACTION, AND MULTIPLE DEVICES WERE USED TO ACHIEVE SUCCESSFUL REMOVAL OF THE LEAD. THEN, SWITCHING EFFORTS TO THE RV LEAD AGAIN, LEAD REMOVAL WAS ACHIEVED. REMOVAL OF THE LV LEAD/LLD REMNANTS WAS NOT ATTEMPTED, AND BECAUSE THE LLD WAS LIKELY CUT BY THE TIGHTRAIL SUB-C, IT COULD NOT BE UNLOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636233 ↗
• DeathDec 1, 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 CIED SYSTEM/POCKET INFECTION. THE PATIENT WAS ELDERLY AND FRAIL, AND HAD A GROSSLY INFECTED RIGHT SIDED POCKET, WHICH WAS MEDICALLY MANAGED SINCE JULY 2023. BOTH A SPECTRANETICS LEAD LOCKING DEVICE AND A COOK MEDICAL BULLDOG LEAD EXTENDER WERE USED AS TRACTION PLATFORMS (IT IS UNK WHICH DEVICE WAS USED ON WHICH LEAD). MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, VISISHEATH DILATOR SHEATH, TIGHTRAIL ROTATING DILATOR SHEATH, TIGHTRAIL 13F SUB-C ROTATING DILATOR SHEATH, AND TIGHTRAIL MINI ROTATING DILATOR SHEATH) WERE USED DURING THE PROCEDURE. EFFORTS BEGAN TO EXTRACT THE RA LEAD FIRST; HOWEVER, STALLED PROGRESS WAS ENCOUNTERED. THE PATIENT''S BLOOD PRESSURE FLUCTUATED THROUGHOUT THE EXTRACTION ATTEMPT, BUT THE PROCEDURE CONTINUED. NEXT, THE TIGHTRAIL 13F SUB-C WAS USED TO ATTEMPT REMOVAL OF THE RV LEAD, BUT THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, BYPASS, AND STERNOTOMY. A RIGHT INNOMINATE PERFORATION WAS DISCOVERED, AND ALTHOUGH EXTENSIVE EFFORTS WERE MADE TO SURGICALLY REPAIR THE AREA, THE PATIENT DID NOT

  Patient problems: Perforation of Vessels

  MAUDE report 18248984 ↗
• InjuryFeb 7, 2023Migration; Migration

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD, EXTRACTION INDICATION UNK. A RIGHT ATRIAL (RA) LEAD WAS PRESENT IN THE PATIENT BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. THE PHYSICIAN CHOSE A SPECTRANETICS GLIDELIGHT LASER SHEATH AND A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH (AND THE TIGHTRAIL'S OUTER SHEATH) TO TREAT THE PATIENT. WHILE THE TIGHTRAIL SUB-C WAS IN USE, THE OUTER SHEATH WAS INADVERTENTLY LOST IN THE PATIENT'S VASCULATURE. USING MULTIPLE TOOLS, THE CT AND VASCULAR SURGEONS ASSISTED IN SUCCESSFULLY RETRIEVING THE OUTER SHEATH FROM THE INNOMINATE/SUPERIOR VENA CAVA (SVC) JUNCTION. THE RV LEAD WAS SUCCESSFULLY REMOVED, AND THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE TIGHTRAIL SUB-C'S OUTER SHEATH WHICH MIGRATED INTO THE VASCULATURE, REQUIRING INTERVENTION FOR RETRIEVAL. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Foreign Body Embolism

  MAUDE report 16315256 ↗
• DeathNov 9, 2022Adverse 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 NON FUNCTION. THE PATIENT HAD A BASELINE PERICARDIAL EFFUSION PRESENT PRE-PROCEDURE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, 13F TIGHTRAIL ROTATING DILATOR SHEATH, GLIDELIGHT LASER SHEATH) WERE USED TO EXTRACT THE RA AND RV LEADS. THE RV LEAD WAS FIRMLY ADHERED WITHIN THE VESSEL; HOWEVER, THE RA AND RV LEADS WERE SUCCESSFULLY REMOVED. DURING ATTEMPTED EXTRACTION OF THE LV LEAD, SEVERAL ATTEMPTS WERE MADE BUT WERE UNSUCCESSFUL. THE PHYSICIAN ELECTED TO CUT THE LV LEAD/LLD NEAR THE POCKET AND ABANDONED IT, WITH NO ATTEMPT TO UNLOCK THE LLD FROM THE LEAD. A SHORT TIME AFTER THE LEAD EXTRACTION PORTION OF THE PROCEDURE WAS COMPLETED, THE BASELINE PERICARDIAL EFFUSION WORSENED AND CARDIAC TAMPONADE RESULTED. RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS, AND THE PATIENT STABILIZED WITHOUT FURTHER ACCUMULATION OF FLUID THROUGHOUT THE REMAINDER OF THE CASE. A RE-IMPLANTATION OF NEW RA, RV, AND LV LEADS WAS COMPLETED, AND THE

  Patient problems: Perforation of Vessels

  MAUDE report 15764662 ↗
• DeathSep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AND REPLACE THE PATIENT'S PACEMAKER DEVICE, ALONG WITH A RIGHT VENTRICULAR (RV), RIGHT ATRIUM (RA), AND LEFT VENTRICULAR LEAD (LV) BECAUSE OF AN INFECTION THAT HAD BEEN DISCOVERED A WEEK PRIOR TO THE PROCEDURE. THE PATIENT HAD THE PACEMAKER DEVICE SWITCHED OUT FIVE YEARS AGO DUE TO AGE OF THE DEVICE. AT THAT TIME, IT WAS BELIEVED THAT SHE HAD A URINARY TRACT INFECTION (UTI) AND WAS GIVEN ANTIBIOTICS. HOWEVER, THE PATIENT CONTINUED TO HAVE ELEVATED WHITE BLOOD CELL COUNT; THEREFORE, THE DECISION WAS MADE TO START MAINTENANCE ANTIBIOTIC THERAPY. ADDITIONALLY, THE PATIENT WAS MISDIAGNOSED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND HAD BEEN ON LONG TERM STEROIDS. WHEN STARTING THE PROCEDURE, THE PHYSICIAN DISCOVERED THE INFECTION WAS WORSE THAN EXPECTED AND THE POCKET WAS ERODED. THE PHYSICIAN PREPPED ALL LEADS WITH SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WITHOUT ANY DIFFICULTY. THE RA LEAD WAS SUCCESSFULLY EXTRACTED FIRST WITH MINIMAL TRACTION. THE PHYSICIAN MOVED ON TO THE RV LEAD WHERE SEVERAL ADHESIONS WERE NOTED IN THE SUBCLAVIAN AREA, AND PROCEEDED WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C. HE ADVANCED APPROXIMATELY THRE

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 15433477 ↗
• MalfunctionAug 16, 2022Device Damaged by Another Device; Mechanics Altered; Device Damaged by Another Device; Mechanics Altered

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD, EXTRACTION INDICATION UNK. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. WHILE THE PHYSICIAN WAS USING A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO ATTEMPT REMOVAL OF RA LEAD, THE LEAD WAS INADVERTENTLY CUT BY THE TIGHTRAIL, AND THERE APPEARED TO BE SOMETHING HARD IN THE MECHANISM. THERE WAS NO DAMAGE PRESENT TO THE LLD IN THE RA LEAD, SO IT REMAINED FUNCTIONAL TO PROVIDE TRACTION. THE PHYSICIAN USED A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH AND A 13F TIGHTRAIL TO SUCCESSFULLY REMOVE BOTH THE RA AND RV LEADS WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 13F TIGHTRAIL SUB-C WHICH INADVERTENTLY CUT THE RA LEAD, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235998 ↗
• MalfunctionJun 21, 2022Break; Break

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. THE PHYSICIAN CHOSE A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO AID IN LEAD REMOVAL. DURING THE PROCEDURE, THE TIGHTRAIL DEVICE STOPPED WORKING. THERE WAS A DIFFERENCE IN THE SOUND IT MADE AS THE PHYSICIAN SQUEEZED THE HANDLE, AS IF IT HAD BROKEN INSIDE AND WAS NO LONGER TURNING, WHICH WAS CONFIRMED UNDER FLUOROSCOPY. AFTER USE, IT WAS OBSERVED THE DEVICE''S SHAFT WAS VERY LOOSE AND FLIMSY. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE TIGHTRAIL DEVICE WAS RECEIVED IN TWO PIECES ON (B)(6) 2022. THE HANDLE AND THE SHAFT WERE SEPARATE, WHICH WOULD PREVENT THE BLADES (LOCATED AT THE DISTAL TIP OF THE DEVICE''S SHAFT) FROM ACTUATING, SINCE ACTUATION OF THE BLADES ORIGINATES IN THE DEVICE''S HANDLE. DURING DEVICE EVALUATION ON (B)(6) 2022, IT WAS DISCOVERED THAT THE BLADES OF THE TIGHTRAIL DEVICE WERE NOT RETRACTED AND WERE IN AN EXTENDED POSITION, PAST THE OUTER BAND OF THE DEVICE. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE RETURNED WITH THE SEPARATED SHAFT AND EXTENDED BLADES, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14758298 ↗
• 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 ↗
• InjuryMar 11, 2022Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED EXTRACTION OF BOTH LEADS, USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH. THE PHYSICIAN THEN SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE TWO LEADS. WHILE WORKING TO REMOVE THE RA LEAD, THE TIGHTRAIL SUB-C DEVICE BECAME STUCK ON THE LEAD, REQUIRING ADDITIONAL INTERVENTION TO REMOVE THE DEVICE FROM THE LEAD, BUT WAS SUCCESSFUL (MDR #1721279-2022-00048). THE 16F GLIDELIGHT DEVICE WAS USED AGAIN, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. ATTEMPTING REMOVAL OF THE RV LEAD, THE PHYSICIAN USED THE 16F GLIDELIGHT DEVICE, THEN SWITCHED TO A SPECTRANETICS TIGHTRAIL (LONG) DEVICE. THIS DEVICE BECAME STUCK ON THE RV LEAD, AT THE AREA OF THE LEAD'S SUPERIOR VENA CAVA (SVC) COIL, REQUIRING INTERVENTION TO REMOVE THE DEVICE FROM THE RV LEAD, BUT WAS SUCCESSFUL (MDR #1721279-2022-00049). ONCE OUT OF THE BODY, THERE WAS DENSE, CALCIFIC TISSUE VISIBLE AT THE DISTAL TIP OF THE TIGHTRAIL (LONG) DEVICE. AFTER THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737433 ↗
• InjuryDec 15, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA AND REMOVAL OF AN ABANDONED PACEMAKER SYSTEM. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE PHYSICIAN ATTEMPTED REMOVAL OF THE RA LEAD BY USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. UPON ATTEMPTING REMOVAL OF THE LEAD FROM THE DEVICE, THE TIGHTRAIL BECAME STUCK. IT WAS NOTED THAT THERE WAS A PIECE OF CALCIUM STUCK AT THE TIP OF THE TIGHTRAIL. THE RA LEAD WAS CUT AND THE TIGHTRAIL WAS REMOVED. THE PHYSICIAN WAS UNABLE TO UNLOCK THE LLD FROM THE RA LEAD SINCE IT HAD BEEN CUT, AND BOTH THE RA LEAD WITH THE LLD INSIDE WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #1721279-2021-00246). THE PHYSICIAN THEN ATTEMPTED TO UNLOCK THE LLD FROM THE RV LEAD BUT WAS UNSUCCESSFUL, SO THE RV LEAD WITH THE LLD INSIDE WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #1721279-2021-00247). THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C DEVICE PRESENT ON THE RA LEAD WHEN IT BECAME STUCK ON THE LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014616 ↗
• InjuryDec 7, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA), TWO RIGHT VENTRICULAR (RV) (PACING AND ICD TYPES) AND TWO LEFT VENTRICULAR (LV) LEADS DUE TO CIED SYSTEM/POCKET INFECTION. DURING THE PROCEDURE, THE PHYSICIAN WAS USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH TO ATTEMPT TO REMOVE THE RV ICD LEAD. AS THE PHYSICIAN WAS TAKING OUT THE TIGHTRAIL DEVICE TO EXCHANGE FOR ANOTHER TOOL, THE RV ICD LEAD BECAME WEDGED INSIDE THE TIGHTRAIL DEVICE. THIS OCCURRED AFTER THE TIGHTRAIL DEVICE WAS OUTSIDE THE PATIENT''S BODY, WITH THE DEVICE BEING STUCK ON THE PROXIMAL END OF THE RV ICD LEAD. AFTER TRYING TO ROTATE THE TIGHTRAIL DEVICE BY TURNING THE ENTIRE HANDLE WHILE HOLDING ONTO THE LEAD, IT WOULD NOT MOVE. THE PHYSICIAN CUT THE LEAD WHERE IT CAME OUT OF THE TIP OF THE TIGHTRAIL DEVICE. THIS EVENT DID NOT CAUSE PATIENT HARM. ALL LEADS WERE REMOVED SUCCESSFULLY AND THE PATIENT SURVIVED THE PROCEDURE.THIS REPORT CAPTURES THE 11F TIGHTRAIL SUB-C DEVICE PRESENT ON THE RV ICD LEAD WHEN IT BECAME STUCK ON THE LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957353 ↗
• InjuryDec 7, 2021Entrapment of Device; Entrapment of Device

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) ICD LEAD AND RIGHT ATRIAL (RA) LEAD DUE TO SEVERE TRICUSPID REGURGITATION WITH THE ICD LEAD, CAUSING WORSENING SYMPTOMS. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION, AND A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED DURING THE PROCEDURE. THE RA LEAD WAS SUCCESSFULLY REMOVED. WHILE ATTEMPTING TO REMOVE THE RV LEAD USING A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, THE DEVICE BECAME ENTANGLED ON THE LLD PRESENT IN THE RV LEAD. THE OPERATOR HAD TO CUT THE LLD DISTAL TO THE TIGHTRAIL DEVICE IN ORDER TO FREE THE LEAD. A (B)(4) BULLDOG LEAD EXTENDER WAS THEN USED ON THE RV LEAD TO COMPLETE THE PROCEDURE. THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED HARM. THIS REPORT CAPTURES THE TIGHTRAIL SUB-C DEVICE WHICH BECAME ENTANGLED ON THE LLD IN THE RV LEAD, REQUIRING INTERVENTION FOR LEAD REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957204 ↗

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