Indigo System LITNG12HTORQ115-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00815948022577), received between Aug 11, 2020 and Mar 29, 2024 — classified as 4 deaths, 6 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (28 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 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL VEIN USING A INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). AFTER REMOVING THE CAT12 FROM ITS PACKAGING BEFORE USE, THE PHYSICIAN FOUND A FRACTURE MID-SHAFT. HOWEVER, THE PHYSICIAN DID NOT HAVE A REPLACEMENT CAT12 AND DECIDED TO USE THE DAMAGED CAT12 IN THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN GENTLY HELD THE FRACTURED PART OF THE CAT12 WITH GAUZE DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE CAT12. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001573 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT COMMON ILIAC, LEFT COMMON FEMORAL, LEFT FEMORAL, AND LEFT POPLITEAL VEINS USING AN INDIGO SYSTEM LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND AN INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED MULTIPLE PASSES USING THE CAT12 AND SEP12 FROM THE LEFT COMMON ILIAC VEIN TO THE ABOVE-KNEE POPLITEAL VEIN. STENOSIS OF THE LEFT COMMON FEMORAL VEIN WERE TREATED WITH VENOPLASTY AND THE DEPLOYMENT OF 3 STENTS. STENTS WERE PLACED FROM THE LEFT COMMON ILIAC TO THE COMMON FEMORAL VEIN. BASED ON SATISFACTORY RESULTS AND GIVEN PATIENT'S DISCOMFORT, THE PROCEDURE WAS TERMINATED. THERE WERE NO COMPLICATIONS ENCOUNTERED DURING THE PROCEDURE. ESTIMATED BLOOD LOSS WAS 400 ML. IT WAS REPORTED THAT THE PATIENT HAD LOW HEMOGLOBIN TO BEGIN WITH. ON (B)(6) 2022 POST OPERATIVE DAY 1, THE SUBJECT DID NOT HAVE A FEVER, CHILLS, COUGH, OR NAUSEA. THE PATIENT COMPLAINED OF LOWER EXTREMITY FULLNESS AND HEAVINESS AND HAD SHORTNESS OF BREATH AND TACHYCARDIA WITH EXERTION WHICH WERE DEEMED LIKELY RELATED TO HER PE. A HEMOGLOBIN DROP FROM 8.3 G/DL TO 6.8 G/DL WAS

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18773778 ↗
• DeathFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT A MEDICAL PROCEDURE USING AN INDIGO ASPIRATION SYSTEM. ON (B)(6) 2022, THE PATIENT'S BASELINE HEMOGLOBIN DECREASED, AND THE PATIENT RECEIVED A TRANSFUSION TO KEEP HEMOGLOBIN GREATER THAN 7. THE SAME DAY, THE HEMOGLOBIN AT BASELINE DROPPED FURTHER TO 2.15. ANEMIA AND WORSENING ANEMIA WERE REPORTED TO BE ADVERSE EVENTS WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE AND IS UNRESOLVED. ON (B)(6) 2022, THE SITE REPORTED PATIENT EXPIRED ON (B)(6) 2022. MASSIVE RECURRENT PULMONARY EMBOLUS WAS REPORTED AS THE CAUSE OF DEATH AND WAS NOT RELATED TO THE INDIGO ASPIRATION SYSTEM. ON (B)(6) 2022, THE INVESTIGATOR REASSESSED THE ANEMIA AND WORSENING ANEMIA RELATIONSHIP TO INDIGO DEVICE FROM POSSIBLY RELATED TO UNRELATED. ON (B)(6) 2023, THE INDEPENDENT MEDICAL REVIEWER (IMR) RE-ADJUDICATED THE RECURRENT PULMONARY EMBOLUS FROM UNRELATED TO PROBABLY RELATED TO THE INDEX PROCEDURE AND THE INDIGO ASPIRATION SYSTEM. ON (B)(6) 2023, AN UPDATE WAS RECEIVED INDICATING RIGHT VENTRICULAR (RV) FAILURE AND CARDIOVASCULAR COLLAPSE AFTER RECURRENT PULMONARY EMBOLUS. THE IMR ADJUDICATED THE RV FAILURE AND CAR

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 16456846 ↗
• MalfunctionFeb 17, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE RETRACTING THE CAT12 TO FLUSH IT AFTER COMPLETING A PASS, THE DISTAL END OF THE CAT12 BROKE INSIDE THE SHEATH. THEREFORE, THE SHEATH CONTAINING THE CAT12 WAS REMOVED AND THE BROKEN CAT12 WAS RETRIEVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT12 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399565 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT A MEDICAL PROCEDURE IN THE LEFT PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). ON (B)(6) 2022, TWO DAYS POST PROCEDURE, A CT SCAN SHOWED A NEW PULMONARY EMBOLUS. THE PATIENT WAS TREATED WITH MEDICATION. IT IS UNKNOWN IF THE SECONDARY EMBOLI IS AN ADDITIONAL THROMBOEMBOLIC EVENT OR DUE TO THROMBUS MIGRATION DURING THE PROCEDURE. LEFT PULMONARY EMBOLUS WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND INDEX PROCEDURE. THE EVENT IS CONSIDERED ONGOING.

  Patient problems: Thromboembolism

  MAUDE report 15874252 ↗
• DeathNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT BILATERAL PULMONARY EMBOLISM USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), A NON-PENUMBRA SHEATH AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT12 OVER THE GUIDEWIRE TO THE FACE OF THE CLOT. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE, INTRODUCED THE SEP12 AND STARTED ASPIRATION. WITHIN THE FIRST MINUTE OF ASPIRATION, THE PATIENT BEGAN COUGHING UP BLOOD. THEREFORE, THE PHYSICIAN STOPPED ASPIRATION AND NOTICED THROUGH AN ANGIOGRAM A PERFORATION IN THE PULMONARY ARTERY. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE CAT12 AND THE SEP12. THE PROCEDURE WAS ABORTED AT THIS POINT AND THE PATIENT WAS PLACED ON ECMO. A BALLOON WAS PUT IN THE PULMONARY ARTERY TO STOP THE BLEEDING AND THE NEXT DAY, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING A NON-PENUMBRA DEVICE. IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER AND WAS SLOWLY WEANED OFF ECMO. IT WAS ALSO REPORTED THAT THE PHYSICIAN BELIEVED THAT THE PERFORATION OF THE VESSEL OCCURRED DURING INSERTION OF THE SHEATH AND COULD NOT BE ATTRIBUTED TO ANY PENUMBRA DEVICES USED IN THE PRO

  Patient problems: Hemoptysis; Perforation of Vessels

  MAUDE report 15820515 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). IT WAS REPORTED THE PATIENT HAD PREVIOUS INTERVENTION ON THE AFFECTED LIMB, AND THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE. THE POST-TREATMENT ANGIOGRAM SHOWED A SIGNIFICANT AMOUNT OF RESIDUAL THROMBUS REQUIRING SECONDARY INTERVENTION. THE RETAINED THROMBUS WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE CAT12 AND THE INDEX PROCEDURE.

  Patient problems: Thromboembolism

  MAUDE report 14963131 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY USING THE LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY OBTAINED ACCESS IN THE MAIN PULMONARY ARTERY (MPA) USING A 6F SHEATH AND A DIAGNOSTIC CATHETER. THE PHYSICIAN THEN UPSIZED TO A SECOND SHEATH AND COMPLETED TWO PASSES USING THE CAT12. SUBSEQUENTLY, WHILE USING THE CAT12 IN THE LEFT PULMONARY ARTERY (LPA), THE PHYSICIAN NOTICED A PERFORATION. IT WAS REPORTED THAT THE CAT12 WAS NOT ADVANCED PAST THE LPA. THE PHYSICIAN THEN PERFORMED MULTIPLE ANGIOGRAMS OF THE MPA AND LPA; HOWEVER, THE LOCATION OF THE PERFORATION COULD NOT BE LOCATED. CONSEQUENTLY, THE PATIENT EXPIRED. IT IS UNKNOWN IF THE PERFORATION OR PATIENT'S DEATH WAS RELATED TO THE USE OF THE CAT12.

  Patient problems: Perforation of Vessels

  MAUDE report 14473821 ↗
• MalfunctionDec 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL AND LEFT ILIAC VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AND ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY THREE TO FOUR PASSES USING THE CAT12. THE PHYSICIAN WAS THEN REMOVING THE CAT12 TO BE FLUSHED WITH ASPIRATION ON WHEN THE INDICATOR LIGHT ON THE LIGHTNING TURNED YELLOW. SUBSEQUENTLY, AFTER REMOVING THE CAT12, THE PHYSICIAN NOTICED THE THREADS ON THE RHV TO BE BROKEN UPON SEPARATING THE CAT12 FROM THE RHV. THEREFORE, THE CAT12 AND RHV WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT12 AND RHV WITH THE SAME LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12945930 ↗
• MalfunctionNov 19, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) IN THE LOWER LEFT EXTREMITY USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12). DURING THE PROCEDURE, AFTER COMPLETING TWO PASSES IN THE TARGET LOCATION WITH THE CAT12, THE HOSPITAL STAFF OPENED THE BACK OF THE RHV. SUBSEQUENTLY, THE ROTOR CAP OF THE RHV CAME OFF. THE STAFF THEN TRIED TO PUT THE RHV BACK; HOWEVER, AIR WAS BEING SUCKED INTO THE SYSTEM. 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 12849432 ↗
• InjuryNov 18, 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 RIGHT AND LEFT PULMONARY ARTERIES USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12) AND AN INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED THROMBECTOMY IN THE RIGHT PULMONARY ARTERY USING THE CAT12. THE PHYSICIAN THEN COMPLETED THREE PASSES IN THE LEFT PULMONARY ARTERY. SUBSEQUENTLY, WHILE PERFORMING ASPIRATION DURING THE NEXT PASS, THE PATIENT STARTED COUGHING AND EXPERIENCED HEMOPTYSIS. THEREFORE, THE CAT12 WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT EXPERIENCE RESISTANCE WHILE USING THE CAT12 AND SEP12. IT WAS ALSO REPORTED THAT THERE WAS NO NOTICEABLE DAMAGE TO THE CAT12 OR SEP12. THE PROCEDURE ENDED AT THIS POINT AND THE PATIENT WAS INTUBATED AND WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT) SCAN.

  Patient problems: Cough; Hemoptysis

  MAUDE report 12835910 ↗
• MalfunctionNov 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A 12F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ASPIRATING CLOT FOR APPROXIMATELY FIVE TO TEN MINUTES USING THE LIGHTNING AND CAT12, THE LIGHTNING UNIT TURNED SOLID RED. IT WAS REPORTED BY THE PHYSICIAN THAT FLUIDS WERE LEAKING FROM THE BOTTOM OF THE LIGHTNING UNIT WHERE IT ATTACHES TO THE CANISTER. THEREFORE, THE LIGHTNING AND CAT12 WERE REMOVED. IT SHOULD BE NOTED THAT THERE WAS NO REPORTED ISSUE WITH THE CAT12. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755695 ↗
• MalfunctionNov 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), A NON-PENUMBRA DIAGNOSTIC CATHETER, A NON-PENUMBRA SHEATH, AND GLIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO ADVANCE THE DIAGNOSTIC CATHETER OVER THE GLIDEWIRE AND INTO THE TARGET VESSEL. AFTERWARDS, WHILE ATTEMPTING TO MAKE THE FIRST PASS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE CAT12 OVER A GLIDEWIRE AND INTO THE TARGET LOCATION. THEREFORE, THE CAT12 AND LIGHTNING WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ENDOVASCULAR SYSTEM. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733964 ↗
• MalfunctionOct 12, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN, ILIAC VEIN, AND INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES ON THE LEFT SIDE TARGET VESSELS USING THE CAT12 AND SEP12. THE PHYSICIAN THEN COMPLETED ONE PASS ON THE RIGHT SIDE TARGET VESSELS USING THE CAT12 AND SEP12. WHILE REMOVING THE CAT12 TO FLUSH, THE PHYSICIAN NOTICED TWO KINKS ON THE MID-SHAFT OF THE CAT12. THEREFORE, THE CAT12 WAS REMOVED. IT WAS REPORTED THAT SUCTION WITH THE CAT12 WAS GREATLY DECREASED AFTER MULTIPLE PASSES WERE COMPLETED. THE PROCEDURE WAS COMPLETING USING THE SAME SEP12, A NEW CAT12, AND A NEW ROTATING HEMOSTASIS VALVE (RHV). IT SHOULD BE NOTED THAT THERE WAS NO ISSUE WITH THE FIRST RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619377 ↗
• MalfunctionOct 5, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PORTAL VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHEN THE PHYSICIAN WENT TO TURN ON THE FLOW SWITCH TO INITIATE ASPIRATION USING THE LIGHTNING, THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED SOLID RED. THE PHYSICIAN MADE SEVERAL ATTEMPTS TURNING OFF THE ENGINE AS WELL AS UNPLUGGING AND PLUGGING IN THE LIGHTING TO THE USB PORT ON THE BACK OF THE ENGINE TO TROUBLESHOOT; HOWEVER, THE INDICATOR LIGHT ON THE LIGHTNING REMAINED SOLID RED. THEREFORE, THE LIGHTNING AND CAT12 WERE 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 12579464 ↗
• MalfunctionSep 29, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT12 PROXIMAL TO THE CLOT IN THE TARGET VESSEL, WHEN THE PHYSICIAN PLUGGED THE LIGHTNING UNIT INTO THE USB PORT ON THE BACK OF THE ENGINE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT BRIEFLY POWERED ON WITH THE GREEN INDICATOR LIGHT AND THEN TURNED OFF. THE ENGINE WOULD POWER ON WITH ALL FOUR INDICATOR LIGHTS ILLUMINATED; HOWEVER, THERE WAS NO ASPIRATION AT THE TIP OF THE CAT12 OR THE TUBING. IT WAS ALSO REPORTED THAT WHEN THE HOSPITAL STAFF REMOVED THE LIGHTNING FROM THE CANISTER, THE CANISTER WAS ABLE TO BUILD PRESSURE. THE HOSPITAL STAFF ALSO MADE MULTIPLE ATTEMPTS TO DISCONNECT AND RECONNECT THE LIGHTNING UNIT INTO THE USB PORT ON THE ENGINE TO TROUBLESHOOT; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE LIGHTNING WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO USE TWO NEW LIGHTNINGS WITH A NEW CAT12, A NEW CAT8, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550962 ↗
• MalfunctionSep 21, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE LIGHTNING TO THE CAT12 AND PLUGGED THE LIGHTNING INTO THE ENGINE; HOWEVER, THE LIGHTNING UNIT FAILED TO ILLUMINATE. SUBSEQUENTLY, WHEN ASPIRATION WAS INITIATED, THE LIGHTNING FAILED TO ASPIRATE. IT WAS REPORTED THAT THE LIGHTNING WAS NOT CLICKING OR ASPIRATING WHEN THE FLOW SWITCH WAS IN THE ON POSITION. TO TROUBLESHOOT, THE PHYSICIAN PUSHED THE USB CABLE DOWN ON THE USB-C PORT; HOWEVER, THE LIGHTNING UNIT WOULD ONLY ILLUMINATE GREEN INTERMITTENTLY FOR APPROXIMATELY ONE SECOND. 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 12510782 ↗
• MalfunctionSep 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO INSERT THE SEP12 THROUGH THE RHV ON THE FIRST ATTEMPT; HOWEVER, UPON REMOVING THE SEP12 AND ATTEMPTING TO REINSERT IT THROUGH THE RHV AGAIN, THE SEP12 WOULD NOT GO INTO THE RHV. SUBSEQUENTLY, THE PHYSICIAN REMOVED AND REPLACED THE RHV WITH A NEW RHV FROM ANOTHER LIGHTNING KIT; HOWEVER, WHEN ATTEMPTING TO INSERT THE SEP12 THROUGH THE RHV, THE SAME ISSUE OCCURRED. THEREFORE, THE RHV AND SEP12 WERE REMOVED. NEXT, THE PHYSICIAN OPENED A NEW LIGHTNING 8 KIT TO OBTAIN A SMALLER RHV AND COMPLETED ONE PASS USING THE SMALLER RHV AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). WHILE USING THE SEP8 DURING THE SECOND PASS, THE PHYSICIAN NOTICED THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD BROKEN OFF IN THE RIGHT PULMONARY ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN SEP8. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT12 FROM THE FIRST LIGHTNING KIT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458532 ↗
• MalfunctionAug 27, 2021Material Separation; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BILATERAL PULMONARY ARTERY USING THE LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, WHILE MAKING THE FINAL PASS, THE PHYSICIAN REMOVED THE SEP12 AND, CONSEQUENTLY, THE RHV CAME APART. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO PUT THE RHV BACK TOGETHER AFTER MAKING SEVERAL ATTEMPTS. 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 12379901 ↗
• MalfunctionAug 18, 2021Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENA CAVA USING THE LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12). DURING THE PROCEDURE, AFTER MAKING MULTIPLE PASSES USING THE CAT12, THE PHYSICIAN NOTICED AIR WAS LEAKING OUT FROM THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV WITH THE SAME CAT12 AND LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339810 ↗
• MalfunctionAug 3, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT AND LEFT PULMONARY ARTERIES USING LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE BACKEND OF THE ROTATING HEMOSTASIS VALVE (RHV) CAME APART AND COULD NOT BE REASSEMBLED. THEREFORE, THE RHV WAS REMOVED. IT WAS REPORTED THAT THERE WAS SOME BLOOD LOSS DURING TROUBLESHOOTING. THE PROCEDURE WAS COMPLETED USING A NEW RHV, THE SAME 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 12270158 ↗
• 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 12232352 ↗
• MalfunctionJul 23, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING LIGHTNING ASPIRATION TUBING (LIGHTNING) IN THE PULMONARY ARTERY. DURING THE PROCEDURE, THE INDICATOR LIGHT ON A LIGHTNING WAS SOLID RED AT THE START OF THE CASE. THE LIGHTNING WAS THEN REMOVED, AND THE HOSPITAL STAFF USED A NEW LIGHTNING TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222087 ↗
• MalfunctionJul 22, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A ROTATING HEMOSTASIS VALVE (RHV) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE LEFT PULMONARY ARTERY AND RETRACTED THE CAT12 TO UNCLOG IT. THE PHYSICIAN THEN ATTEMPTED TO RE-ADVANCE THE CAT12 INTO THE SHEATH, OVER THE GUIDEWIRE AND TURNED THE ASPIRATION ON; HOWEVER, THE RHV WOULD NOT MAINTAIN A SEAL AND FULL ASPIRATION COULD NOT BE PERFORMED. THE PHYSICIAN ALSO TRIED TO TROUBLESHOOT THE ISSUE BY TIGHTENING THE RHV; HOWEVER, THE RHV COULD NOT BE RESEALED, AND THE ISSUE REMAINED UNRESOLVED. 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 12213002 ↗
• MalfunctionJul 15, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON ILIAC VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHEN THE PHYSICIAN ACCESSED THE RIGHT POPLITEAL, THEY TURNED ON THE LIGHTNING, AND THE INDICATOR LIGHT ON THE LIGHTNING UNIT FLASHED GREEN AND RED. AFTER FLIPPING THE POWER CORD ON THE BACK SIDE OF THE ENGINE, THE LIGHTNING UNIT CONTINUED TO FLICKER BETWEEN GREEN AND RED. IT IS UNKNOWN IF THE RED INDICATOR LIGHT WAS SOLID RED OR FLASHING RED. 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

  MAUDE report 12176610 ↗