TightRail Rotating Dilator SheathRecalls & reported problems across all models

We found 5 models of TightRail Rotating Dilator Sheath by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 137 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2018 and Sep 29, 2026 — classified as 29 deaths, 85 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (13 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 Rotating Dilator Sheath problems

TightRail Rotating Dilator Sheath models

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

• TightRail Rotating Dilator Sheath 545-513

  Dilator, Vessel, For Percutaneous Catheterization
  20 deaths74 reports
• TightRail Rotating Dilator Sheath 545-511

  Dilator, Vessel, For Percutaneous Catheterization
  2 deaths34 reports
• TightRail Rotating Dilator Sheath 545-513

  Dilator, Vessel, For Percutaneous Catheterization
  4 deaths18 reports
• TightRail Rotating Dilator Sheath 545-511

  Dilator, Vessel, For Percutaneous Catheterization
  3 deaths7 reports
• TightRail Rotating Dilator Sheath 545-509

  Dilator, Vessel, For Percutaneous Catheterization
  4 reports

Recent TightRail 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.

• InjurySep 29, 2026Entrapment of Device

  A lead extraction procedure commenced to remove a right ventricular (RV) and right atrial (RA) lead due to CIED System/Pocket Infection. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with a Spectranetics 13F TightRail Rotating Dilator Sheath on the RV lead, the TightRail became stuck on the lead and LLD EZ, requiring intervention by cutting the RV lead and LLD EZ (MDR #3007284006-2026-00459). Therefore, the RV lead and LLD EZ remnant remained in the patient (3007284006-2026-00463). The extraction procedure continued, a new TightRail was used, and the RA lead was successfully removed. The patient survived the procedure.This report captures the 13F TightRail that entrapped the lead and LLD, requiring intervention.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937831 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), and left ventricular (LV) lead due to bacteremia. Spectranetics LLD Lead Locking Devices (LLDs) were inserted into each lead to provide traction. Beginning with multiple Spectranetics devices (GlideLight Laser Sheath, TightRail Sub-C Rotating Dilator Sheath, and 11F TightRail Rotating Dilator Sheath) the RA and RV lead were successfully removed. Targeting the remaining LV lead with the 11F TightRail, the LV lead was extracted, and the TightRail was removed from the body. However, a few minutes later, the patient's blood pressure dropped, and rescue efforts began, including bypass and sternotomy. A perforation to the coronary sinus (CS) was discovered and repaired, and the patient survived the procedure.This report captures the TightRail in use 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 50533406 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove two right ventricular (RV), a right atrial (RA), and a left ventricular (LV) lead due to bacteremia. Spectranetics LLD Lead Locking Devices (LLDs) were inserted into each lead to provide traction. Beginning with a 14F GlideLight Laser Sheath, the LV and one RV lead were successfully removed. Next, the RA lead and remaining RV lead were targeted with a Spectranetics 13F TightRail Rotating Dilator Sheath. However, once the RV lead was removed and the TightRail came out of the body, the patient's blood pressure dropped, and rescue efforts began, including pericardiocentesis and sternotomy. A superior vena cava (SVC) perforation was discovered, and repaired, and the RA lead was removed post-sternotomy. The patient survived the procedure. This report captures the TightRail in use when the perforation occurred, requiring intervention. There was no alleged malfunction of any Spectranetics devices in use during the procedure.

  Patient problems: Great Vessel Perforation

  MAUDE report 50506809 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50224395 ↗
• DeathAug 12, 2026Adverse Event Without Identified Device or Use Problem

  A lead extraction procedure commenced to remove a right atrial (RA), right ventricular (RV), and left ventricular (LV) leads due to bacteremia. Spectranetics LLD EZ Lead Locking Devices (LLD EZs) were inserted into each lead to provide traction. Beginning with multiple Spectranetics devices (11F TightRail Sub-C Rotating Dilator Sheath, 11F TightRail Rotation Dilator Sheath (long), and 14F GlideLight Laser Sheath) on the RV lead, resistance was met under the clavicle with lead on lead binding. Upon reaching the innominate/superior vena cava (SVC) junction, the decision was made to switch the RA lead; however, encountered the same binding. Utilizing a Spectranetics 13F TightRail Rotating Dilator Sheath, advancement was made down to the SVC/RA junction, when the RA lead came free. A pericardial effusion was detected via intracardiac echocardiography (ICE), and rescue efforts began, including rescue balloon, pericardiocentesis, CPR, and sternotomy. A large SVC perforation was discovered, but was unable to be repaired, and the patient did not survive the procedure.This report captures the TightRail in use when the perforation occurred, requiring intervention, but resulting in death. The

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 50221186 ↗
• DeathApr 28, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEADS DUE TO BACTEREMIA. SPECTRANETICS LLD LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. UTILIZING A SPECTRANETICS GLIDELIGHT LASER SHEATH AND SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, ONE RV AND THE RA LEAD WERE SUCCESSFULLY REMOVED. TARGETING THE LAST RV LEAD WITH THE 11F TIGHTRAIL, THE PATIENT¿S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, CPR, AND STERNOTOMY. PERFORATIONS TO THE RV AND SUPERIOR VENA CAVA (SVC) JUNCTION WERE DISCOVERED AND REPAIR WAS ATTEMPTED; HOWEVER, THE PATIENT DID NOT SURVIVE THE PROCEDURE. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 25023663 ↗
• DeathMar 25, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO RIGHT VENTRICULAR (RV) LEADS (ONE PACING AND ONE ICD) DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE PRESENT WITHIN THE PATIENT BUT NOT TARGETED FOR EXTRACTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SHOCKWAVE MEDICAL BALLOON, LARGE AMOUNTS OF AIR WAS OBSERVED, ALONG WITH FAULT CODES, SO ANOTHER BALLOON WAS USED THROUGHOUT THE INNOMINATE AND SUPERIOR VENA CAVA (SVC) WITH NO ISSUE. THEN, UTILIZING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE RV PACING LEAD WAS REMOVED. NEXT, USING A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH, LITTLE FORWARD PROGRESS WAS MADE SO SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C. ALMOST REACHING THE SVC, THE SAME 16F GLIDELIGHT WAS USED AGAIN, WITH SLOW ADVANCEMENT THROUGH THE INNOMINATE TO THE SVC. AT THE MID SVC, THE RV ICD LEAD, ALONG WITH THE LLD EZ BROKE (MDR #3007284006-2026-00101), AND THE DECISION WAS MADE TO SWITCH TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR S

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 24690906 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO BACTEREMIA. SPECTRANETICS LLD #2 LEAD LOCKING DEVICES (LLD #2S) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH ON THE RV LEAD, PROGRESS STALLED WITHIN THE SUBCLAVIAN REGION, AND THE PATIENT'S BLOOD PRESSURE DROPPED. A PERFORATION TO THE AXILLARY VEIN WAS DISCOVERED, AND RESCUE EFFORTS BEGAN, INCLUDING EXPANDING THE POCKET IN ORDER TO REPAIR THE PERFORATION. THE PATIENT STABILIZED, AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER PATIENT HARM. THIS REPORT CAPTURES THE TIGHTRAIL IN USE 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 24598013 ↗
• MalfunctionMar 6, 2026Entrapment 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. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE RV LEAD WAS REMOVED. SWITCHING TO THE RA LEAD, DENSE FIBROSIS WAS ENCOUNTERED, AND UPON ATTEMPTING REMOVAL OF THE TIGHTRAIL FROM THE LEAD, THE LEAD WAS STUCK INSIDE THE TIGHTRAIL DEVICE. SEVERAL ATTEMPTS TO FREE THE LEAD FROM THE TIGHTRAIL WERE MADE; HOWEVER, UNSUCCESSFUL. THEREFORE, THE LEAD WAS CUT, AND THE REMAINING PORTION WAS REMOVED WITH A COOK MEDICAL BULLDOG, SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, AND SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE 11F TIGHTRAIL THAT ENTRAPPED THE LEAD, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536083 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT ON THE RA LEAD, STEADY PROGRESSION WAS MADE DOWN THE INNOMINATE, THROUGH THE SUPERIOR VENA CAVA (SVC), AND DOWN TO THE RIGHT ATRIUM. THEN, TARGETING THE RV LEAD WITH THE 14F GLIDELIGHT, ADVANCEMENT WAS MADE TO THE INNOMINATE/SVC JUNCTION, BUT BINDING WAS ENCOUNTERED. SWITCHING TO A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE PAST THE BINDING SITE, AND THE RA LEAD WAS REMOVED. WHEN REMOVING THE TIGHTRAIL FROM THE PATIENT, THE BLOOD PRESSURE DROPPED, AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON. THE BLOOD PRESSURE STABILIZED; HOWEVER, THE ABDOMEN BECAME EXTENDED AND IT WAS UNCLEAR WHERE THE BLEEDING WAS COMING FROM. THEREFORE, A STERNOTOMY AND EXPLORATORY LAPAROTOMY WERE PERFORMED, BUT UNABLE TO FIND THE SOURCE OF THE BLEEDING. ANGIOGRAPHIC IMAGING WAS PERFORMED, AND DETECTED A FISTULA BETWEEN THE AORTA AND INNOMINATE VEIN (MDR #3007284006-2026-00060). THE DECISION WAS MADE TO ABANDON TH

  Patient problems: Fistula

  MAUDE report 24428890 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 3 RIGHT VENTRICULAR (RV) AND 2 RIGHT ATRIAL (RA) LEADS DUE TO NON-FUNCTION AND MRI. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH, MINIMAL ADVANCEMENT WAS MADE; THEREFORE, SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH. ALTERNATING BETWEEN LEADS, LITTLE PROGRESS WAS MADE, AND SWITCHED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ALONG WITH A SPECTRANETICS LARGE VISISHEATH. THEN, UTILIZING A SPECTRANETICS 13F TIGHTRAIL (LONG) ROTATING DILATOR SHEATH IN HEAVY CALCIFICATION, THE BLADES WOULD NO LONGER ROTATE. A SECOND 13F TIGHTRAIL (LONG) WAS USED, AND ONE RV AND ONE RA LEAD WERE REMOVED. WHEN TRYING TO LOAD THE SAME 13F TIGHTRAIL (LONG) ONTO THE NEXT RV LEAD AND LLD EZ, THE INSIDE OF THE TIGHTRAIL PUSHED OUT THE BACK. A THIRD 13F TIGHTRAIL (LONG) WAS USED, BUT THE SAME ISSUE OCCURRED, AND A FOURTH 13F TIGHTRAIL (LONG) WAS UTILIZED, BUT GOT STUCK ON THE RV LEAD, AND WHEN REMOVING THE 13F TIGHTRAIL (LONG) FROM THE BODY, THE INSIDE CAME OUT AGAIN, THUS WAS REMOVED FROM THE PATIENT. S

  Patient problems: Perforation of Vessels

  MAUDE report 24305745 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD DUE TO MRI AND NON-FUNCTION. SPECTRANETICS LLD EZ LEAD LOCKING DEVICES (LLD EZS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE RA LEAD WAS SUCCESSFULLY REMOVED. HOWEVER, WHEN REMOVING THE RV LEAD, A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON AND STERNOTOMY. A PERFORATION EXTENDING FROM THE INNOMINATE TO THE SUPERIOR VENA CAVA (SVC) AND INTO THE RIGHT ATRIUM WAS DISCOVERED AND REPAIRED. THE DECISION WAS MADE TO ABANDON THE EXTRACTION; THEREFORE, THE LLD EZ, ALONG WITH THE RV LEAD, WERE CUT AND CAPPED AND REMAINED IN THE PATIENT (MDR #3007284006-2026-00039). THERE WAS NO ATTEMPT MADE TO UNLOCK THE LLD EZ. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24264141 ↗
• InjuryNov 14, 2025Adverse 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) LEAD DUE TO MRI. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH, THE RA LEAD WAS REMOVED. HOWEVER, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). RESCUE EFFORTS BEGAN, INCLUDING RESCUE BALLOON, PERICARDIOCENTESIS, AND STERNOTOMY. A PERFORATION IN THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 11F TIGHTRAIL DEVICE IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 23560483 ↗
• InjuryAug 14, 2025Adverse 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) LEAD DUE TO NON-FUNCTION. A RIGHT ATRIAL (RA) LEAD WAS PRESENT WITHIN THE PATIENT, BUT NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD EZ LEAD LOCKING DEVICE (LLD EZ) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT, DENSE BINDING IN THE INNOMINATE WAS ENCOUNTERED. THEN, SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, ADVANCEMENT WAS MADE TO THE SUPERIOR VENA CAVA (SVC)/INNOMINATE JUNCTION, WHEN THE LEAD BROKE. ADVANCEMENT CONTINUED DOWN THE SVC/RA JUNCTION, BUT BINDING WAS ENCOUNTERED AGAIN. WHEN REMOVING THE TIGHTRAIL FROM THE PATIENT, THE BLOOD PRESSURE DROPPED, AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). RESCUE EFFORTS BEGAN, INCLUDING PERICARDIOCENTESIS AND STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. THE LLD EZ WAS REMOVED FROM THE RV LEAD, AND THE LEAD WAS CUT AND CAPPED AND REMAINED IN THE PATIENT. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE T

  Patient problems: Cardiac Perforation; Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22806171 ↗
• InjuryAug 7, 2025Adverse 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) LEAD DUE TO FRACTURE. A RIGHT ATRIAL (RA) LEAD WAS PRESENT, BUT WAS NOT TARGETED FOR EXTRACTION. A SPECTRANETICS LLD LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, ADVANCEMENT PAST THE SUBCLAVIAN INTO THE INNOMINATE WAS UNSUCCESSFUL DUE TO CALCIFICATION. SWITCHING TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, PROGRESS WAS MADE THROUGH THE CLAVICLE AND INTO THE SUPERIOR VENA CAVA (SVC), BUT THEN STALLED. THE DECISION WAS MADE TO REMOVE THE RA LEAD AS A RESULT OF THE CALCIFICATION, SO THE TIGHTRAIL WAS REMOVED FROM THE BODY. UPON REMOVAL, THERE WAS A SUDDEN DROP IN BLOOD PRESSURE, AND A PERICARDIAL EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. PERFORATIONS IN THE INNOMINATE VEIN AND THE SVC WERE DISCOVERED AND REPAIRED. THE RV AND RA LEADS WERE REMOVED POST-STERNOTOMY, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE WHEN THE PERFORATIONS OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDU

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 22742996 ↗

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