Indigo System LITNG12HTORQ100-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00815948022553), received between Aug 7, 2020 and Dec 18, 2025 — classified as 1 death, 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM LIGHTNING ASPIRATION TUBING (LIGHTNING), A SHEATH, AN ANGIOGRAPHIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY CLEARED THE LEFT IVC USING THE CAT12 AND THE LIGHTNING. WHILE ADVANCING THE ANGIOGRAPHIC CATHETER TO THE RIGHT SIDE, THE PHYSICIAN EXPERIENCED DIFFICULTY. THE CAT12 ALSO EXPERIENCED DIFFICULTY ADVANCING TO THE RIGHT SIDE AND IT FRACTURED ON THE DISTAL LENGTH. A SNARE DEVICE WAS THEN USED TO RETRIEVE THE FRACTURED SEGMENT OF THE CAT12. AT THIS POINT, THE PHYSICIAN DECIDED TO STOP THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840172 ↗
• MalfunctionJun 30, 2023Break; Material Fragmentation; Physical Resistance/Sticking; Break; Material Fragmentation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR FEMORAL VEIN (SFV) USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH AT THE TARGET LOCATION AND ADVANCED THE GUIDEWIRE THROUGH THE SHEATH. THEN, THE PHYSICIAN ADVANCED THE CAT12 THROUGH THE SHEATH OVER THE GUIDEWIRE. THE GUIDEWIRE WAS REMOVED, AND THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES USING THE CAT12. NEXT, WHILE ATTEMPTING TO COMPLETE A THIRD PASS, THE PHYSICIAN NOTICED THAT THE CAT12 WAS KINKED AT THE MIDSHAFT UNDER FLUOROSCOPY. THE PHYSICIAN BEGAN TO STRAIGHTEN OUT THE CAT12 BY PULLING BACK THE CAT12. WHILE PULLING BACK THE CAT12, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE CAT12 WAS BREAKING APART. NEXT, THE PHYSICIAN WAS ABLE TO PULL THE CAT12 BACK INTO THE SHEATH AND REMOVED THE CAT12 AND THE SHEATH TOGETHER. IT WAS REPORTED THAT THE CAT12 WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243956 ↗
• MalfunctionAug 22, 2022Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MAIN PULMONARY ARTERY, RIGHT PULMONARY ARTERY, LEFT PULMONARY ARTERY, LEFT INTERLOBAR, LINGUAL ARTERY AND RIGHT LOWER LOBAR USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A NON-PENUMBRA GUIDE SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED EIGHT TO NINE PASSES IN THE TARGET VESSEL USING THE CAT12. WHILE ATTEMPTING THE FINAL PASS AND WHEN TORQUING THE CAT12, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE CAT12 WAS KINKED. SUBSEQUENTLY, THE CAT12 FRACTURED APPROXIMATELY 3 INCHES FROM THE DISTAL END OF THE CATHETER. THE PHYSICIAN THEN RE-ADVANCED THE GUIDEWIRE THROUGH THE CAT12, INFLATED A 4MM BALLOON AT THE FRACTURE LOCATION TO PROVIDE SUPPORT. THE CAT12 WITH THE INFLATED BALLOON WAS PULLED BACK INTO THE GUIDE SHEATH. SUBSEQUENTLY, THE CAT12 ALONG WITH THE INFLATED BALLOON AND THE GUIDE SHEATH WERE REMOVED FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263724 ↗
• DeathDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER INTO THE PULMONARY ARTERY AND INJECTED FOUR MILLIGRAMS OF TISSUE PLASMINOGEN ACTIVATOR (TPA) IN BOTH THE RIGHT AND LEFT LUNG. NEXT, THE CAT12 WAS INSERTED INTO THE MAIN PULMONARY ARTERY ON THE LEFT SIDE TO BEGIN ASPIRATING THE THROMBUS. IT WAS REPORTED THAT THE PHYSICIAN DID NOT FEEL ANY RESISTANCE DURING ADVANCEMENT OF THE CAT12 INTO THE PULMONARY ARTERY OR WHILE ASPIRATING IN THE LEFT MAIN MEDIAL PART OF THE PULMONARY ARTERY USING THE CAT12 AND SEP12. AFTER A COUPLE OF MINUTES OF ASPIRATION, THE PATIENT BEGAN TO EXPERIENCE HEMOPTYSIS AND, THEREFORE, THE PHYSICIAN STOPPED ASPIRATION AND THE PATIENT STABILIZED. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A HAND INJECTED ANGIOGRAPHY THAT DID NOT REVEAL ANY SIGNS OF TRAUMA; HOWEVER, THE PHYSICIAN DID NOTICE INFILTRATION IN THE LUNGS. IT WAS ALSO REPORTED THE CAUSE OF THE INFILTRATION OF THE LUNGS WAS UNKNOWN. THE PHYSICIAN DECIDED TO END THE

  Patient problems: Hemoptysis; Perforation of Vessels

  MAUDE report 13031210 ↗
• MalfunctionOct 23, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE ROTATING HEMOSTASIS VALVE (RHV) BROKE INTO TWO PIECES. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686580 ↗
• MalfunctionOct 15, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON FEMORAL VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHILE INITIALLY SETTING UP THE LIGHTNING UNIT ON THE BACK TABLE AND WHEN ATTEMPTING TO USE THE LIGHTNING AFTER ADVANCING THE CAT12 INTO THE TARGET LOCATION, THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED RED. THE PHYSICIAN ATTEMPTED TO UNPLUG AND PLUG THE LIGHTNING UNIT BACK INTO THE USB PORT ON THE ENGINE TO TROUBLESHOOT; HOWEVER, THE INDICATOR LIGHT ON THE LIGHTNING REMAINED RED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND CAT12. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641056 ↗
• MalfunctionSep 26, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PORTAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE SEP12 HAD BEEN USED FOR APPROXIMATELY 15 MINUTES WHEN THE CAT12 BECAME CLOGGED. THE PHYSICIAN REMOVED THE SEP12 AND NOTICED THE BULB OF THE SEP12 WAS UNABLE TO ADVANCE THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) SMOOTHLY BUT WAS ABLE TO ADVANCE WHEN THE RHV WAS COMPLETELY OPEN. THE CAT12 WAS THEM REMOVED TO FLUSH OUT ANY EXISTING CLOT. ONCE THE CAT12 WAS CLEANED, IT WAS REINTRODUCED BACK INTO THE SHEATH. WHEN THE CAT12 WAS IN PLACE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE SEP12 INTO THE OPENED RHV, BUT THE SEP12 WOULD NOT ADVANCE. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN REQUESTED A NEW RHV. THEREFORE, THE INITIAL RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME CAT12 AND SEP12. IT WAS REPORTED THAT THE NEW RHV WAS PLACED ONTO THE CAT12, AND THE SEP12 WAS ADVANCED THROUGH WITHOUT DIFFICULTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530934 ↗
• MalfunctionSep 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, AS THE ROTATING HEMOSTASIS VALVE (RHV) WAS BEING LOOSENED AND TIGHTENED ACCORDINGLY TO TAKE THE SEPARATOR WIRE IN AND OUT, THE RHV CAME APART AND WAS LEAKING. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470854 ↗
• MalfunctionAug 27, 2021No Flow; No Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT ATRIUM USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12). DURING THE PROCEDURE, UPON PLUGGING IN THE LIGHTNING UNIT, THE INDICATOR LIGHT ON THE LIGHTNING UNIT INITIALLY TURNED GREEN AND THEN IMMEDIATELY TURNED SOLID RED. IT WAS ALSO REPORTED THAT THE PHYSICIAN UNPLUGGED AND PLUGGED THE LIGHTNING UNIT BACK INTO THE USB PORT TO TROUBLESHOOT; HOWEVER, THE LIGHTNING UNIT REMAINED SOLID RED. THEREFORE, THE LIGHTNING UNIT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING UNIT AND THE SAME CAT12. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380398 ↗
• MalfunctionAug 24, 2021Failure to Power Up; Failure to Power Up

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT AND RIGHT PULMONARY ARTERIES USING LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, AFTER CONNECTING THE LIGHTNING TO THE ENGINE, THE LIGHTNING UNIT LIGHT WOULD NOT TURN ON. THE ENGINE WAS POWER-CYCLED AND THE LIGHTNING USB CABLE WAS RE-CONNECTED WITHOUT SUCCESS. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE ANOTHER ENGINE WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN DECIDED TO EXCHANGE THE LIGHTNING FOR A NEW ONE, AND SUCCESSFUL THROMBECTOMY WAS PERFORMED USING THE NEW LIGHTNING AND THE SAME CAT12. NEXT, WHILE CATHETERIZING THE LEFT PULMONARY ARTERY, THE LIGHTNING UNIT BECAME CLOGGED. THE TUBING WAS FLUSHED WITH SALINE AND SUBSEQUENTLY, THE LIGHTNING UNIT INDICATOR LIGHT TURNED RED AND DID NOT RESOLVE. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362750 ↗
• MalfunctionAug 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE PULMONARY ARTERY USING A ROTATING HEMOSTASIS VALVE (RHV) PACKAGED WITH THE LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SEP12 THROUGH THE VALVE OF THE RHV. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST ATTEMPTED TO BACKLOAD THE SEP12 THROUGH THE RHV; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV WITH THE SAME CAT12 AND SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310692 ↗
• MalfunctionJul 27, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL AND SUPERFICIAL FEMORAL VEIN (SFV) TO THE COMMON FEMORAL USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT IMMEDIATELY TURNED SOLID RED AFTER PLUGGING INTO THE ENGINE. THE PHYSICIAN UNPLUGGED AND PLUGGED THE LIGHTNING UNIT MULTIPLE TIMES TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE ENGINE WAS REMOVED AND REPLACED WITH ANOTHER ENGINE, BUT THE INDICATOR LIGHT ON THE LIGHTNING UNIT REMAINED SOLID RED WHEN PLUGGED INTO THE SECOND ENGINE. THEREFORE, THE LIGHTNING UNIT WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN OPENED A NEW LIGHTNING KIT AND PLUGGED IN THE LIGHTNING UNIT INTO THE ENGINE; HOWEVER, THE INDICATOR LIGHT FOR THE LIGHTNING UNIT TURNED SOLID RED AS WELL. THE LIGHTNING UNIT WAS THEREFORE, REMOVED. THE PROCEDURE WAS COMPLETED USING THE ASPIRATION TUBING (TUBING) FROM AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WITH THE SAME CAT12 FROM THE FIRST LIGHTNING KIT AND THE FIRST ENGINE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. IT WAS ALSO REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232356 ↗
• MalfunctionJul 27, 2021Noise, Audible; Noise, Audible

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC AND FEMORAL VEIN USING A LIGHTING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE LIGHTNING UNIT WOULD NOT STOP PRODUCING AUDIBLE CLICKING SOUND EVEN THOUGH THE TIP OF THE CAT12 WAS ENGAGED IN THROMBUS. THEREFORE, THE LIGHTNING WAS REMOVED. IT SHOULD BE NOTED THAT THERE WAS NO ISSUE WITH THE ENGINE AND ALL THE 4 LIGHTS ON THE ENGINE WERE ILLUMINATED. IT WAS ALSO REPORTED THAT THE TECHNICIAN MIGHT HAVE DAMAGED THE VALVE OF THE LIGHTNING WHILE TAKING IT OUT OF THE PACKAGING. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229692 ↗
• MalfunctionJun 10, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIOFEMORAL VEIN USING A ROTATING HEMOSTASIS VALVE (RHV) PACKAGED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE CAT12 WAS ADVANCED TO FACE THE CLOT AND THE PHYSICIAN ATTEMPTED TO OPEN THE STOPCOCK CONNECTED TO THE SIDE PORT OF THE RHV TO BEGIN ASPIRATION. HOWEVER, AFTER NUMEROUS ATTEMPTS, THE PHYSCIAN WAS UNABLE TO OPEN THE STOPCOCK; THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978244 ↗
• MalfunctionJun 8, 2021Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT12 OVER A GUIDEWIRE TO THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN REMOVED THE GUIDEWIRE AND INITIATED ASPIRATION. SUBSEQUENTLY, IT WAS NOTICED THAT THERE WAS AN AIR LEAK ON THE ROTATING HEMOSTASIS VALVE (RHV) OF THE CAT12. CONSEQUENTLY, AIR WAS BEING SUCKED INTO THE LIGHTNING ASPIRATION TUBING (LIGHTNING). THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV, THE SAME CAT12 AND THE SAME LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958602 ↗
• MalfunctionJun 4, 2021Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, AS THE PHYSICIAN WAS USING THE CAT12 FOR ASPIRATION, THEY UNSCREWED THE ROTATING HEMOSTASIS VALVE (RHV), AND THE RHV SUBSEQUENTLY BROKE. IT WAS REPORTED THE CAT12 WAS LEAKING BLOOD AND WOULD NOT ACCEPT A SEPARATOR. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942280 ↗
• MalfunctionMay 11, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN AND VENA CAVA USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, AFTER SUCCESSFUL REMOVAL OF THE CLOT IN THE LEFT ILIAC AND VENA CAVA, THE PHYSICIAN WENT UP AND OVER TO TAKE THE CLOT OUT OF THE RIGHT. WHEN THE PHYSICIAN GRABBED THE CAT12 OUTSIDE OF THE PATIENT TO START ON THE RIGHT SIDE, THE CAT12 BROKE AT THE HUB. THEREFORE, THE CAT12 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809552 ↗
• MalfunctionApr 20, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, THE BACK OF THE ROTATING HEMOSTASIS VALVE (RHV) CAME OFF. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697266 ↗
• MalfunctionJan 11, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTING ASPIRATION TUBING (LIGHTNING) AND INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE LIGHTNING UNIT ILLUMINATED A YELLOW INDICATOR LIGHT WHEN TURNED ON. THE LIGHTNING UNIT WAS THEN RESET TO GET A GREEN INDICATOR LIGHT. SUBSEQUENTLY, A FEW SECONDS AFTER SUCTION THROMBECTOMY IN THE PATIENT, THE LIGHTNING UNIT TURNED TO A SOLID RED INDICATOR LIGHT AND STOPPED WORKING. TO TROUBLESHOOT, THE HOSPITAL STAFF POWERED THE LIGHTNING ON AND OFF MULTIPLE TIMES, AND THE INDICATOR LIGHT REMAINED SOLID RED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11149951 ↗
• MalfunctionJan 9, 2021Obstruction of Flow; Free or Unrestricted Flow; Obstruction of Flow; Free or Unrestricted Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING A LIGHTING ASPIRATION TUBING (LIGHTNING) AND INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE CAT12 WAS ADVANCED INTO THE CLOT AND BECAME OCCLUSIVE IN CLOT. IT WAS REPORTED THERE WAS SLOW MOVEMENT OF THE CLOT ADVANCING UP THROUGH THE LIGHTNING. ONCE THE CLOT HIT THE FLOW SWITCH, THE LIGHTNING UNIT TURNED SOLID RED. TO TROUBLESHOOT, THE LIGHTNING WAS UNPLUGGED FROM THE ENGINE AND RESET. THE RED INDICATOR LIGHT REMAINED SOLID RED, RESULTING IN NO ADDITIONAL VACUUM PRESSURE. AT THIS POINT, BLOOD BEGAN LEAKING OUT OF THE FLOW SWITCH AND ONTO THE TABLE. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED BY HOOKING UP A SYRINGE TO THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11143704 ↗
• MalfunctionDec 21, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT) USING A LIGHTNING ASPIRATION TUBING (TUBING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHILE ASPIRATING USING A CAT12 WITHOUT THE USE OF A SEP12, THE PHYSICIAN NOTICED THAT THE INDICATOR LIGHT ON THE LIGHTING TURNED RED. THEN, THE PHYSICIAN TURNED THE FLOW SWITCH OFF AND THE LIGHTNING UNIT WAS UNPLUGGED FROM THE BACK OF THE ENGINE. AFTER THIRTY SECONDS, THE LIGHTNING UNIT WAS PLUGGED BACK IN AND IT WAS NOTICED THAT THE INDICATOR LIGHT ON THE LIGHTNING WAS GREEN. HOWEVER, AFTER A FEW SECONDS LATER, THE INDICATOR LIGHT ON THE LIGHTNING TURNED BACK RED. THEREFORE, THE LIGHTNING UNIT WAS REMOVED AND REPLACED. AFTERWARDS, THE PHYSICIAN DECIDED TO CONTINUE THE CASE USING AN INDIGO SYSTEM SEPARATOR 12 (SEP12). THEREFORE, THE ROTATING HEMOSTASIS VALVE (RHV) WAS CONNECTED TO THE CAT12 OUTSIDE THE PATIENT AND WHILE LOOSENING THE VALVE TO ALLOW THE SEP12 TO BE INSERTED INTO THE CAT12, THE VALVE CAME OFF AND WOULD NOT GO BACK ON. MULTIPLE ATTEMPTS WERE MADE TO HAVE THE VALVE BACK ON THE RHV; HOW

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11051881 ↗
• MalfunctionDec 21, 2020Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT) USING A LIGHTNING ASPIRATION TUBING (TUBING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHILE ASPIRATING USING A CAT12 WITHOUT THE USE OF A SEP12, THE PHYSICIAN NOTICED THAT THE INDICATOR LIGHT ON THE LIGHTING TURNED RED. THEN, THE PHYSICIAN TURNED THE FLOW SWITCH OFF AND THE LIGHTNING UNIT WAS UNPLUGGED FROM THE BACK OF THE ENGINE. AFTER THIRTY SECONDS, THE LIGHTNING UNIT WAS PLUGGED BACK IN AND IT WAS NOTICED THAT THE INDICATOR LIGHT ON THE LIGHTNING WAS GREEN. HOWEVER, AFTER A FEW SECONDS LATER, THE INDICATOR LIGHT ON THE LIGHTNING TURNED BACK RED. THEREFORE, THE LIGHTNING UNIT WAS REMOVED AND REPLACED. AFTERWARDS, THE PHYSICIAN DECIDED TO CONTINUE THE CASE USING AN INDIGO SYSTEM SEPARATOR 12 (SEP12). THEREFORE, THE ROTATING HEMOSTASIS VALVE (RHV) WAS CONNECTED TO THE CAT12 OUTSIDE THE PATIENT AND WHILE LOOSENING THE VALVE TO ALLOW THE SEP12 TO BE INSERTED INTO THE CAT12, THE VALVE CAME OFF AND WOULD NOT GO BACK ON. MULTIPLE ATTEMPTS WERE MADE TO HAVE THE VALVE BACK ON THE RHV; HOW

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11051812 ↗
• MalfunctionDec 19, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT IMMEDIATELY TURNED SOLID RED AFTER PLUGGING IN. THE PHYSICIAN TURNED OFF THE SYSTEM, THEN UNPLUGGED AND PLUGGED BACK IN THE LIGHTNING UNIT TO TROUBLESHOOT; HOWEVER, THE INDICATOR LIGHT REMAINED SOLID RED AND THERE WAS NO ASPIRATION. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11042922 ↗
• MalfunctionDec 17, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING LIGHTING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE LIGHTNING MICROPROCESSOR INDICATOR LIGHT TURNED RED DURING THE MIDDLE OF THE CASE. THEREFORE, THE TECHNICIAN DISCONNECTED THE LIGHTNING AND FLUSHED THE TUBING USING A 30 ML SYRINGE AND A THREE-WAY STOPCOCK. THE LIGHTNING WAS ALSO UNPLUGGED AND PLUGGED INTO THE ENGINE MULTIPLE TIMES; HOWEVER, THE ISSUE PERSISTED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SECOND LIGHTNING AND THE SAME CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11031926 ↗
• MalfunctionDec 12, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND INFERIOR VENA CAVA (IVC) USING A LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, WHILE ASPIRATING IN THE TARGET VESSEL, THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED FROM GREEN TO SOLID RED. IT WAS ALSO REPORTED THAT THE PHYSICIAN UNPLUGGED AND PLUGGED BACK IN THE LIGHTNING TWICE; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE LIGHTNING UNIT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10995747 ↗