TightRail Rotating Dilator Sheath 545-513 (UDI 00813132020897)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00813132020897), received between Oct 3, 2018 and May 15, 2024 — classified as 4 deaths, 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (3 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, 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 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) AND A RIGHT VENTRICULAR (RV) LEAD DUE TO BACTEREMIA. 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 RA LEAD, THE LEAD WAS SUCCESSFULLY REMOVED. NEXT, USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH, THE POCKET WAS CLEARED TO THE CLAVICLE. THEN, A SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS USED TO PROGRESS TO THE INNOMINATE REGION. DEVICES SWITCHED BACK TO THE SAME 13F TIGHTRAIL (USED ON THE RA LEAD), AND DESPITE STALLING AROUND THE TRICUSPID VALVE REGION, THE TIGHTRAIL ADVANCED TO THE TIP OF THE RV LEAD, AND THE PATIENT'S BLOOD PRESSURE DROPPED SLIGHTLY. THE PROCEDURE CONTINUED, AND THE RV LEAD WAS EXTRACTED. WHILE REMOVING THE TIGHTRAIL, THE BLOOD PRESSURE DROPPED SIGNIFICANTLY. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON AND STERNOTOMY. A LARGE SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED AND REPAIRED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL IN USE IN THE AREA WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTIO

  Patient problems: Great Vessel Perforation

  MAUDE report 19326134 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE 2 RIGHT ATRIAL (RA) LEADS (ONE CAPPED, ONE ACTIVE), A RIGHT VENTRICULAR (RV) LEAD AND A LEFT VENTRICULAR (LV) LEAD DUE TO BACTEREMIA. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH ON THE ACTIVE RA LEAD, AN EXTREME AMOUNT OF CALCIUM WAS NOTED IN THE SUBCLAVIAN REGION, BUT ADVANCEMENT WAS SUCCESSFUL. NEXT, A 13F TIGHTRAIL (LONG) WITH THE TIGHTRAIL'S OUTER SHEATH WAS USED TO ADVANCE AROUND THE CURVE OF THE SUPERIOR VENA CAVA (SVC). AS THE PHYSICIAN WAS APPLYING TRACTION AND ADVANCING THE TIGHTRAIL, THE SCRUB TECH WAS CONTROLLING THE TIGHTRAIL'S OUTER SHEATH, AND REPORTEDLY JAMMED IT FORWARD. THE RA LEAD RELEASED AND THE PATIENT'S CONDITION DETERIORATED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING STERNOTOMY. A PERFORATION FROM THE RA UP INTO THE SVC WAS DISCOVERED AND REPAIRED. IT IS UNK IF THE REMAINING THREE LEADS WERE REMOVED. THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE 13F TIGHTRAIL (LONG) OUTER SHEATH WHICH LIKELY CAUSED THE PERFORATION, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF

  Patient problems: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 18370316 ↗
• InjuryDec 5, 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), A RIGHT VENTRICULAR (RV), AND A LEFT VENTRICULAR (LV) LEAD DUE TO INFECTION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. THE RA AND LV LEADS WERE REMOVED SUCCESSFULLY WITHOUT ANY ISSUES. THEN, USING A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH TO REMOVE THE RV LEAD, THE HELIX OF THE LEAD DID NOT COME BACK AFTER USE OF LASING AND TRACTION. DEVICES SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH; AND ALTHOUGH PROGRESS WAS BEING MADE, THE LEAD HAD NOT COMPLETELY FREED WHEN THE PATIENT''S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING BYPASS AND STERNOTOMY. A PERFORATION OF THE INFERIOR VENA CAVA (IVC)/RA JUNCTION WAS DISCOVERED AND REPAIRED. THE RV LEAD WAS REMOVED COMPLETELY POST-STERNOTOMY, AND 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: Cardiac Perforation; Great Vessel Perforation

  MAUDE report 18271314 ↗
• DeathJul 7, 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), A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV) LEAD DUE TO OCCLUSION. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD, ALONG WITH USE OF SUTURE, TO PROVIDE TRACTION. OCCLUSION WAS NOTED IN THE SUPERIOR VENA CAVA (SVC) REGION, REQUIRING THE USE OF MULTIPLE SPECTRANETICS DEVICES (12F GLIDELIGHT LASER SHEATH, 14F GLIDELIGHT, 16F GLIDELIGHT, VISISHEATH DILATOR SHEATH, 11F TIGHTRAIL ROTATING DILATOR SHEATH AND 13F TIGHTRAIL) TO ACHIEVE ADVANCEMENT. ALL THREE LEADS WERE REMOVED; HOWEVER, DURING REMOVAL OF THE RA LEAD, WITH THE 13F TIGHTRAIL AS THE LAST DEVICE IN USE, THE PATIENT''S CONDITION DETERIORATED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN SVC/RA JUNCTION PERFORATION WAS DISCOVERED AND REPAIRED. UNFORTUNATELY, THE PATIENT NEVER LEFT THE HOSPITAL AND DIED 2 DAYS POST-PROCEDURE FROM SURGICAL COMPLICATIONS. THIS REPORT CAPTURES THE 13F TIGHTRAIL, THE LAST 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

  MAUDE report 17279634 ↗
• DeathMay 23, 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 VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS USED IN THE RV LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED TO ATTEMPT REMOVAL OF THE RV LEAD, BUT PROGRESS STALLED IN THE SUBCLAVIAN. A SPECTRANETICS 11F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED NEXT, THEN UPSIZED TO A 13F TIGHTRAIL DUE TO THE SUPERIOR VENA CAVA (SVC) BEING VERY NARROW AND HEAVILY CALCIFIED. THE PHYSICIAN WORKED FOR A SIGNIFICANT AMOUNT OF TIME USING THE 13F TIGHTRAIL TO FREE THE RV LEAD, AND WHILE IN USE, A PIECE OF CALCIUM PULLED OFF, FROM THE WALL OF THE SVC. IT WAS UNDERSTOOD THAT THE CALCIUM REMAINED ATTACHED TO THE RV LEAD AND DID NOT EMBOLIZE; HOWEVER, IT CREATED AN SVC PERFORATION WHERE THE CALCIUM DETACHED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING RESCUE BALLOON, BYPASS, AND STERNOTOMY. THE SVC WAS FOUND TO BE SEVERELY CALCIFIED, WITH THIN VESSEL WALL. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE. THE PHYSICIAN SPECULATED THAT THE RV LEAD MANY HAVE EXTERNALIZED IN THE SVC AND THE TIGHTRAIL JUST FOLLOWED THE LEAD. IT IS UNK IF THE RA LEAD WAS REMOVED. THIS REPORT CAPTURES T

  Patient problems: Great Vessel Perforation

  MAUDE report 16988237 ↗
• InjuryMay 3, 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 AND ONGOING MALAISE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (16F GLIDELIGHT LASER SHEATH, 1-11F AND 2-13F TIGHTRAIL (LONG) ROTATING DILATOR SHEATHS, 13F TIGHTRAIL SUB-C) WERE USED TO ATTEMPT EXTRACTION OF THE LEADS. DURING USE OF THE 11F TIGHTRAIL ON THE RA LEAD, SIGNIFICANT CALCIUM WAS NOTED. THE MAJORITY OF THE RA LEAD WAS REMOVED, EXCEPT FOR A 2-3 CM PORTION OF THE OUTER INSULATION STUCK IN THE INNOMINATE/SUPERIOR VENA CAVA JUNCTION, AND REMAINED IN THE PATIENT. ATTEMPTING TO REMOVE THE RV LEAD, MULTIPLE DEVICES WERE USED AGAIN, WITH A 13F TIGHTRAIL (LONG) ADVANCING DOWN TO THE RV. HOWEVER, THE RV LEAD WOULD NOT RELEASE FROM THE HEART, SO A COOK MEDICAL NEEDLE'S EYE SNARE WAS USED TO ATTEMPT TO REMOVE THE LEAD. THE PATIENT'S BLOOD PRESSURES WERE LOW DURING THE EXTRACTION, AND BLEEDING WAS NOTED IN THE INNOMINATE REGION. AN INNOMINATE PERFORATION WAS DISCOVERED AND REPAIRED IN THE CATH LAB, AND THE PATIENT'S CONDITION STABILIZED. THE PATIENT WAS MOVED TO THE OPE

  Patient problems: Perforation of Vessels

  MAUDE report 16864859 ↗
• InjuryMar 28, 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) AND TWO RIGHT ATRIAL (RA) LEADS DUE TO CIED SYSTEM/POCKET INFECTION. SPECTRANETICS LEAD LOCKING DEVICES WERE INSERTED INTO EACH LEAD TO PROVIDE TRACTION. MULTIPLE SPECTRANETICS DEVICES (GLIDELIGHT LASER SHEATH, 13F TIGHTRAIL ROTATING DILATOR SHEATH, TORQMAX SHEATH GRIP ACCESSORY, VISISHEATH DILATOR SHEATH) WERE USED DURING THE COMPLEX AND LENGTHY PROCEDURE, AS HEAVY CALCIFICATION WAS ENCOUNTERED THROUGHOUT THE VASCULATURE. WHILE THE 13F TIGHTRAIL WAS IN USE, THE PATIENT''S BLOOD PRESSURE DROPPED SIGNIFICANTLY AND A PERICARDIAL EFFUSION WAS DETECTED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING CPR, PERICARDIOCENTESIS, AND STERNOTOMY. A SMALL PERFORATION ON THE LATERAL WALL OF THE SUPERIOR VENA CAVA (SVC) WAS DISCOVERED AND REPAIRED. 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 DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Great Vessel Perforation; Pericardial Effusion

  MAUDE report 16631484 ↗
• DeathMay 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 CIED SYSTEM/POCKET INFECTION. THE LV LEAD WAS REMOVED WITH GENTLE TRACTION ALONE. SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE RA AND RV LEADS TO PROVIDE TRACTION; COOK MEDICAL BULLDOG LEAD EXTENDERS WERE ALSO ATTACHED TO BOTH LEADS, PROVIDING ADDITIONAL TRACTION. ATTEMPTING TO REMOVE THE RA LEAD, THE PHYSICIAN USED A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH AND ITS OUTER SHEATH. THE DEVICE ADVANCED TO THE BEGINNING OF WHERE THE FIRST DUAL COIL WAS PRESENT ON THE RV LEAD; HOWEVER IT WAS DIFFICULT TO ADVANCE FURTHER AS THERE WAS LEAD ON LEAD BINDING AND ADHERENCE TO THE VESSEL WALL. EVENTUALLY, THE RA LEAD BECAME FREE, BUT THIS TOOK EFFORT USING THE TIGHTRAIL'S OUTER SHEATH. ATTEMPTED REMOVAL OF THE RV LEAD USING THE TIGHTRAIL WAS NEXT, AGAIN ENCOUNTERING STALLED PROGRESS AFTER REACHING THE BEGINNING OF THE FIRST DUAL COIL. THE OUTER SHEATH COULD NOT ADVANCE PAST HALF THE LENGTH OF THE FIRST DUAL COIL, SO THE PHYSICIAN SWITCHED TO A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH WITH ITS OUTER SHEATH. THE OUTER SHEATH WOULD N

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 14342524 ↗
• MalfunctionFeb 24, 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 INFECTION AND RV LEAD FRACTURE (IMPLANTED IN (B)(6)). THE RA LEAD WAS SUCCESSFULLY REMOVED. THE RV LEAD WAS SEVERELY CALCIFIED. THE PHYSICIAN FIRST TRIED A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND THEN UPSIZED TO A 16F GLIDELIGHT DEVICE WITH USE OF A SPECTRANETICS VISISHEATH DILATOR SHEATH. THE PHYSICIAN SWITCHED TO A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH DUE TO SLOW PROGRESS. THE TIGHTRAIL DEVICE GOT STUCK ON THE LEAD''S COIL NEAR THE BRACHIOCEPHALIC REGION AND THE PHYSICIAN WAS UNABLE TO BACK IT OFF THE LEAD. IT WAS NOTED THAT THE TIGHTRAIL DEVICE BECAME STUCK AT A POINT ON THE RV LEAD WHERE IT HAD PREVIOUSLY BEEN FRACTURED. THE PHYSICIAN DECIDED TO JUST PULL THE LEAD WITH THE TIGHTRAIL ON IT. PULLING WITH TRACTION SHOWED NO HEMODYNAMIC CHANGES SO HE CONTINUED TO PULL. THE RV LEAD EVENTUALLY FREED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE WHICH BECAME ENTRAPPED ON THE RV LEAD, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595884 ↗
• InjuryNov 17, 2021Adverse 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 NONFUNCTION. BOTH OF THESE LEADS HAD BEEN CUT (AT THE LEVEL OF THE RA) BY A SURGEON IN A PRIOR OPEN HEART PROCEDURE (THE LEADS WERE CUT AND LISTED INACTIVE ON (B)(6) 2020). FOR THE LEAD EXTRACTION PROCEDURE, BOTH OF THE LEADS WERE PREPPED WITH A COOK MEDICAL LIBERATOR TIP LOCKING DEVICE, TO PROVIDE TRACTION. A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED, AND THE PHYSICIAN ADVANCED OVER THE LEADS, FOLLOWED BY A SPECTRANETICS 16F GLIDELIGHT LASER SHEATH, AND BACK TO THE 13F TIGHTRAIL DEVICE. DURING ITS USE IN THE PROCEDURE, THE 16F GLIDELIGHT DEVICE BROKE WHERE THE CATHETER CONNECTS TO THE LASER SHEATH ''HUB'' AND EXPOSED FIBERS WERE OBSERVED, OUTSIDE OF THE PATIENT. THE CAUSE OF THE BREAK WAS REPORTED TO BE FROM TORQUING THE CATHETER (MDR 1721279-2021-00027). WHILE REMOVING THE FINAL LEAD (UNABLE TO DETERMINE LEAD LOCATION SINCE BOTH LEADS HAD BEEN PREVIOUSLY CUT) AND WHILE THE 13F TIGHTRAIL DEVICE WAS IN USE, THE PATIENT'S BLOOD PRESSURE DROPPED THEN STABILIZED. THE PHYSICIAN NOTED THERE WAS HIGHER PRESSURE BLOOD LOSS FROM THE POCKET, AND THE PATIENT'S MEDIA

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 12829467 ↗
• MalfunctionOct 21, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD DYSFUNCTION. A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. THE PHYSICIAN USED A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH AND SUCCESSFULLY REMOVED THE LEAD. THE PHYSICIAN CUSTOMARILY PULLS THE FREED LEAD OUT OF THE PROXIMAL END OF THE TIGHTRAIL DEVICE. IN THIS EVENT, IT WAS DIFFICULT TO REMOVE THE LEAD OUT THE PROXIMAL END, AND WHEN THE LEAD WAS REMOVED FROM THE PROXIMAL END AFTER THE TIGHTRAIL DEVICE WAS OUT OF THE PATIENT'S BODY, THE INNER MECHANISM OF THE TIGHTRAIL DEVICE CAME OUT WITH THE LEAD. THE INNER MECHANISM WAS WRAPPED AROUND THE LEAD AND STRETCHED, CONFIRMED BY PHOTOS PROVIDED TO THE MANUFACTURER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM AND NO INTERVENTION WAS REQUIRED. THIS REPORT CAPTURES THE TIGHTRAIL DEVICE IN USE WHEN THE INNER MECHANISM OF THE DEVICE CAME OUT THE PROXIMAL END ALONG WITH THE LEAD, WITH A POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674772 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO A PHILIPS REPRESENTATIVE ON 22 MAR 2021 THAT ON (B)(6) 2021, A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A RIGHT ATRIAL (RA) LEAD DUE TO REDUNDANT LEADS (CLASS 2 INDICATION). IT WAS REPORTED THAT THE PATIENT HAD A DUAL CHAMBER SYSTEM. PRIOR TO THE PROCEDURE, BOTH LEADS WERE CUT AND PREPPED IN NORMAL FASHION FOR EXTRACTION. THE RV LEAD LUMEN HAD AN OBSTRUCTION AND A SPECTRANETICS LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE RV LEAD, BUT WAS NOT ABLE TO PASS FURTHER THAN THE SUBCLAVIAN VESSEL. IT WAS NOTED BY A CARDIAC MANAGEMENT REPRESENTATIVE PRESENT IN THE CASE THAT THE SURGEON APPLIED A LOT OF FORCE TRYING TO ADVANCE A CLEARING STYLET THROUGH THE OBSTRUCTION PRESENT IN THE RV LEAD. IT WAS DECIDED AT THAT TIME TO ONLY PURSUE EXTRACTION OF THE RA LEAD. A SPECTRANETICS GLIDELIGHT LASER SHEATH WAS USED FIRST TO ATTEMPT EXTRACTION OF THE RA LEAD, BUT PROGRESS STALLED. NEXT, A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH WAS USED, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. THE RV LEAD WAS CAPPED AND ABANDONED (THE LLD HAD BEEN REMOVED FROM THE RV LEAD PRIOR, SO ONLY THE RV LEAD ITSELF WAS CAPPED). SHEATHS WERE PULLED, AND T

  Patient problems: Great Vessel Perforation; Perforation of Vessels

  MAUDE report 11689680 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUMMARY OF THE TRANSLATION FROM SPANISH TO ENGLISH: A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD, INDICATION FOR REMOVAL UNKNOWN. ALSO UNKNOWN WAS IF THERE WERE ANY ADDITIONAL LEADS TARGETED FOR REMOVAL. THE LEAD WAS PREPPED USING A SPECTRANETICS LEAD LOCKING DEVICE (LLD) TO ACT AS A TRACTION PLATFORM. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH TO ATTEMPT EXTRACTION OF THE RV LEAD. PROGRESS WAS MADE THROUGH THE SUBCLAVIAN REGION, AND WHEN REACHING THE LEAD'S PROXIMAL COIL AT THE HEIGHT OF THE SUPERIOR VENA CAVA (SVC), THEY EXPERIENCED DIFFICULTY WITH ADHESIONS. AT THIS TIME, THE PATIENT'S BLOOD PRESSURE SUDDENLY DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY, INCLUDING USE OF A RESCUE DEVICE. CARDIAC ARREST OCCURRED; CHEST COMPRESSIONS BEGAN. THE TIME OF CARDIAC ARREST WAS APPROXIMATELY 10 MINUTES. A STERNOTOMY WAS PERFORMED AND AN EXTENSIVE SVC PERFORATION WAS DISCOVERED. EXTERNAL PERFUSION WAS APPLIED, ALONG WITH ADMINISTERING RED BLOOD CELLS, PLASMA AND FLUIDS TO THE PATIENT. THE SVC PERFORATION WAS SUCCESSFULLY REPAIRED, AND THE PATIENT WAS STABILIZED AFTER FOUR HOURS OF SURGERY. THERE WAS QUESTION REGARDING THE

  Patient problems: Great Vessel Perforation; Iatrogenic Source

  MAUDE report 9946534 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, A CARDIAC LEAD MANAGEMENT PROCEDURE COMMENCED TO REMOVE 3 LEADS DUE TO INFECTION. THE PATIENT HAD A BIVENTRICULAR ICD, THE LEADS WERE 4076 IN THE RIGHT ATRIUM (RA), A 6935 IN THE RIGHT VENTRICLE (RV), AND A 4195 STARFIX LEAD IN THE LEFT VENTRICLE (LV). LEADS WERE IMPLANTED ON (B)(6) 2010, (B)(6) 2018, AND (B)(6) 2012 RESPECTIVELY. THE PHYSICIAN UTILIZED A SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH WHILE ATTEMPTING TO REMOVE THE STARFIX LEAD, AND THEN THE PATIENT'S BLOOD PRESSURE DROPPED. THERE APPEARED TO BE AN EFFUSION. A STERNOTOMY WAS PERFORMED. RESCUE EFFORTS WERE SUCCESSFUL. ALL LEADS WERE REMOVED. ON (B)(6) 2019 THE PHYSICIAN REPORTED THAT A CORONARY SINUS TEAR OCCURRED AND PATIENT NEEDED SURGICAL INTERVENTION TO REPAIR. HE ALSO SAID IT WAS UNRELATED TO THE USE OF THE SPECTRANETICS TIGHTRAIL DEVICE.

  Patient problems: Iatrogenic Source; Perforation of Vessels; Pericardial Effusion

  MAUDE report 8965146 ↗
• DeathNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 27, 2018, THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE FACILITY VIA EMAIL, PROVIDING ADDITIONAL DETAILS OF THIS EVENT. THERE WAS NO ALLEGED REPORTED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE EVENT. THE FACILITY DIRECTOR OF CARDIOLOGY REPORTED THE PATIENT SUSTAINED ONLY AN AZYGOS TEAR, AND NOT AN SVC TEAR AS INITIALLY REPORTED. THE TWO LEADS PLANNED FOR EXTRACTION WERE A RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. BOTH LEADS REPORTEDLY CONTAINED SPECTRANETICS LEAD LOCKING DEVICES BEING USED FOR TRACTION PLATFORMS. ONLY THE RV LEAD WAS EXTRACTED DURING THE CASE; THE RA LEAD WAS NOT EXTRACTED; IT WAS ABANDONED DUE TO CASE COMPLEXITY. THE SUSPECTED CAUSE OF THE INJURY WAS REPORTEDLY A COMBINATION OF THE SPECTRANETICS TIGHTRAIL DEVICE AND PULLING FORCES (SPECTRANETICS LLD) THAT WERE BOTH IN USE AT THE TIME OF THE EVENT. THE MODEL AND LOT NUMBERS OF THE LLD DEVICE PRESENT IN THE RV LEAD ARE NOT AVAILABLE.

  Patient problems: Cardiomyopathy; Death; Endocarditis; Great Vessel Perforation; Iatrogenic Source; Perforation of Vessels; Pulmonary Embolism; Sepsis

  MAUDE report 8120618 ↗
• MalfunctionOct 5, 2018Failure to Align; Material Deformation; Mechanical Jam; Noise, Audible; Physical Resistance/Sticking; Sharp Edges; Failure to Align; Material Deformation; Mechanical Jam; Noise, Audible; Physical Resistance/Sticking; Sharp Edges

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC LEAD MANAGEMENT PROCEDURE ON (B)(6) 2018, THE HANDLE OF THE TIGHTRAIL 545-513 DEVICE MALFUNCTIONED. THE BLADES WERE NOT ROTATING, AND THE HANDLE MADE A CLICKING NOISE. NO PATIENT HARM OCCURRED. IT WAS REPORTED THAT THIS WAS A RIGHT SIDED ENTRY INTO THE BODY, WITH EXTREME CALCIUM LESIONS. THE SUSPECT TIGHTRAIL 545-513 DEVICE WAS RETURNED FOR EVALUATION AND IT WAS FOUND DURING EVALUATION ON 14SEP2018, THAT THE INNER COIL WAS HERNIATED. THE HERNIATION CAUSED THE BLADES TO BE STUCK IN THE EXTENDED POSITION. THESE EVALUATION FINDINGS MADE THE MANUFACTURER AWARE THAT THIS ISSUE COULD LEAD TO PATIENT INJURY IF IT WERE TO RECUR, AS THE BLADES EXTENDING THROUGH THE TIP OF THE DEVICE COULD LEAD TO UNINTENDED TISSUE DAMAGE AND/OR EMBOLI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7940901 ↗
• MalfunctionOct 4, 2018Failure to Align; Deformation Due to Compressive Stress; Noise, Audible; Physical Resistance/Sticking; Sharp Edges; Failure to Align; Deformation Due to Compressive Stress; Noise, Audible; Physical Resistance/Sticking; Sharp Edges

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC LEAD MANAGEMENT PROCEDURE ON (B)(6) 2018, THE HANDLE OF THE TIGHTRAIL 545-513 DEVICE MALFUNCTIONED. THE BLADES WERE NOT ROTATING, AND THE HANDLE MADE A CLICKING NOISE. NO PATIENT HARM OCCURRED. IT WAS REPORTED THAT THIS WAS A RIGHT SIDED ENTRY INTO THE BODY, WITH EXTREME CALCIUM LESIONS. THE SUSPECT TIGHTRAIL 545-513 DEVICE WAS RETURNED FOR EVALUATION AND IT WAS FOUND DURING EVALUATION ON 13SEP2018, THAT THE INNER COIL WAS HERNIATED. THE HERNIATION CAUSED PIECES OF THE COIL TO EXTEND OUT OF THE TIP OF THE DEVICE. THESE EVALUATION FINDINGS MADE THE MANUFACTURER AWARE THAT THIS ISSUE COULD LEAD TO PATIENT INJURY IF IT WERE TO RECUR, AS THE COIL EXTENDING THROUGH THE TIP OF THE DEVICE COULD LEAD TO UNINTENDED TISSUE DAMAGE AND/OR EMBOLI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7933959 ↗
• MalfunctionOct 3, 2018Failure to Align; Deformation Due to Compressive Stress; Noise, Audible; Physical Resistance/Sticking; Sharp Edges; Failure to Align; Deformation Due to Compressive Stress; Noise, Audible; Physical Resistance/Sticking; Sharp Edges

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING A CARDIAC LEAD MANAGEMENT PROCEDURE ON (B)(6) 2018, THE HANDLE OF THE TIGHTRAIL 545-513 DEVICE MALFUNCTIONED. THE BLADES WERE NOT ROTATING, AND THE HANDLE MADE A CLICKING NOISE. NO PATIENT HARM OCCURRED. IT WAS REPORTED THAT THIS WAS A RIGHT SIDED ENTRY INTO THE BODY, WITH EXTREME CALCIUM LESIONS. THE SUSPECT TIGHTRAIL 545-513 DEVICE WAS RETURNED FOR EVALUATION AND IT WAS FOUND DURING EVALUATION ON (B)(6) 2018, THAT THE INNER COIL WAS HERNIATED. THE HERNIATION CAUSED PIECES OF THE COIL TO EXTEND OUT OF THE TIP OF THE DEVICE. ALSO, THE BLADES WERE STUCK IN THE EXTENDED POSITION. THESE EVALUATION FINDINGS MADE THE MANUFACTURER AWARE THAT THIS ISSUE COULD LEAD TO PATIENT INJURY IF IT WERE TO RECUR, AS THE BLADES AND COIL EXTENDING THROUGH THE TIP OF THE DEVICE COULD LEAD TO UNINTENDED TISSUE DAMAGE AND/OR EMBOLI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7932408 ↗