Indigo System LITNG12XTORQ100-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00815948022560), received between Aug 7, 2020 and Feb 2, 2024 — classified as 1 death, 5 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (17 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 80 reports, in the reporter's own words as published by the FDA.

• DeathFeb 2, 2024Adverse 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 PULMONARY ARTERY USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), A PENUMBRA ENGINE (ENGINE), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE TARGET LOCATION VIA THE INTERNAL JUGULAR VEIN. THE LOWER RIGHT LOBE WAS TREATED WITH THE CAT12. THE PHYSICIAN THEN ADVANCED THE CAT12 INTO THE UPPER LOBE. THE PHYSICIAN WAS TORQUING THE CATHETER CAUSING THE CAT12 TO SUDDENLY JUMP FORWARD AND THEN THE PATIENT STARTED TO COUGH BLOOD. IT WAS REPORTED THAT THE TORQUING OF THE CAT12 MAY HAVE CAUSED A PERFORATION IN THE UPPER LOBE. THE CAT12 WAS REMOVED AND THE PATIENT WAS MADE TO SIT UPRIGHT. IT WAS REPORTED THE SHEATH WAS INADVERTENTLY PULLED FROM THE ACCESS SITE IN THE PATIENT¿S NECK WHEN THE PATIENT SAT UP. THE SHEATH WAS COMPLETELY REMOVED AFTER THE PHYSICIAN HAD THE PATIENT SIT UPRIGHT. MANUAL PRESSURE WAS APPLIED TO THE ACCESS SITE. THE PATIENT CONTINUED COUGHING BLOOD AND, SUBSEQUENTLY, BECAME UNRESPONSIVE. LATER, THE PATIENT EXPIRED.

  Patient problems: Great Vessel Perforation; Hemoptysis

  MAUDE report 18636334 ↗
• MalfunctionFeb 17, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED RIGHT COMMON FEMORAL ACCESS USING THE CAT12 AND THE SHEATH. SUBSEQUENTLY, AFTER COMPLETING 2-3 PASSES, WHILE ADVANCING THE CAT12 INTO THE POPLITEAL VESSEL OF THE LEFT LEG, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTICED A KINK ON THE CAT12 UNDER FLUOROSCOPY. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE CAT12. WHILE RETRACTING THE CAT12, THE CAT12 BROKE INTO TWO PIECES AT MID-SHAFT. THE PHYSICIAN THEN USED A SNARE DEVICE AND REMOVED THE REMAINING PART OF THE CAT12 FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING A NEW CAT12 AND A NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401000 ↗
• InjuryOct 21, 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 TO REMOVE CLOT LOCATED AT THE BASELINE (BL) AND TREATMENT (TX) USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND LIGHTNING ASPIRATION TUBING (LIGHTNING). IT WAS REPORTED THAT HYPOTENSION WAS ENCOUNTERED DURING THE PROCEDURE. THE PATIENT REQUIRED FLUID BOLUS, NEO-SYNEPHRINE, AND LEVOPHED INFUSION WITH RETURNING OF BASELINE BLOOD PRESSURE TO 106/49 MMHG AND HEART RATE OF 72 BPM. THE CLINICAL DETERIORATION WAS REPORTED TO BE ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND INDEX PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 15649741 ↗
• InjuryJun 1, 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 PULMONARY ARTERY USING THE LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND GUIDEWIRE (AMPLATZ). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE LEFT LOWER LOBE USING THE GUIDEWIRE AND THEN ADVANCED THE CAT12 OVER THE GUIDEWIRE. NEXT, THE PHYSICIAN MADE THREE PASSES USING THE SEP12 AND NOTICED THERE WAS NO FLOW BACK THROUGH THE CAT12. THE PHYSICIAN THEN DECIDED TO RETRACT THE SEP12 ALL THE BACK TO THE ROTATING HEMOSTASIS VALVE (RHV) AND RE-ADVANCED THE SEP12 TO THE DISTAL END OF THE CAT12. SUBSEQUENTLY, WHILE ADVANCING AND RETRACTING THE SEP12, THE PHYSICIAN PULLED BACK THE CAT12 AND THE PATIENT STARTED COUGHING UP BLOOD. THEREFORE, THE SEP12 AND CAT12 WERE REMOVED. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. THE PATIENT WAS THEN INTUBATED, AND THE PHYSICIAN PERFORMED A BRONCHOSCOPY THE SAME DAY THAT REVEALED BLOOD IN THE LUNGS. IT WAS ALSO REPORTED THAT THREE DAYS LATER, A FOLLOW UP PULMONARY ANGIOGRAM WAS PERFORMED THAT REVEALED LITTLE CLOT IN THE LEFT LOBE AND SHOWED NO NEGATIVE OUTCOME TO THE PULMONARY ARTERY. ALL CLOTS WERE REMOVED F

  Patient problems: Hemoptysis

  MAUDE report 14565884 ↗
• MalfunctionNov 30, 2021Peeled/Delaminated; Peeled/Delaminated

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A ARTERIOVENOUS (AV) GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY THREE PASSES USING THE CAT12. WHILE ADVANCING THE CAT12 DURING THE FOURTH PASS, THE PHYSICIAN NOTICED THAT THE COATING AT THE DISTAL END OF THE CAT12 HAD STARTED TO PEEL OFF. THEREFORE, THE CAT12 WAS REMOVED. 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 12900594 ↗
• MalfunctionNov 29, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PORTAL VEIN USING LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A PENUMBRA ENGINE CANISTER (CANISTER), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE CAT12 WITH SALINE AND ATTACHED A ROTATING HEMOSTASIS VALVE (RHV) TO THE CAT12. THEN THE CAT12 WAS ADVANCED INTO THE SHEATH AND THE LIGHTNING WAS PLACED ONTO THE CANISTER. SUBSEQUENTLY, THE LIGHTNING WAS PLUGGED INTO THE ENGINE AND THE INDICATOR LIGHT ON THE LIGHTNING UNIT ILLUMINATED GREEN. NEXT, UPON CONNECTING THE LIGHTNING TUBING TO THE RHV, THE LIGHTNING UNIT TURNED SOLID RED. TO TROUBLESHOOT, THE LIGHTNING WAS UNPLUGGED FROM THE ENGINE FOR 30 SECONDS AND REPLUGGED, AND THE ENGINE WAS UNPLUGGED FROM THE POWER OUTLET FOR 30 SECONDS AND REPLUGGED; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT12 AND CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888873 ↗
• MalfunctionNov 22, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT12 INTO THE SHEATH VALVE, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE CAT12 AT THE DISTAL END. THEREFORE, THE CAT12 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857993 ↗
• MalfunctionNov 18, 2021Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS IN THE FEMORAL VEIN USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET VESSEL USING THE LIGHTNING AND CAT12. IT WAS REPORTED THAT THE CAT12 WAS REMOVED AFTER EACH PASS TO CLEAR IT OF CLOT. UPON REMOVAL OF THE CAT12 AFTER THE FOURTH PASS, THE PHYSICIAN NOTICED THAT THE CAT12 HAD UNRAVELED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING A NEW 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 12840745 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT POPLITEAL VEIN, COMMON FEMORAL VEIN, AND EXTERNAL AND COMMON ILIAC VEINS USING A PENUMBRA ENGINE (ENGINE), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12) WITH LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), NON-PENUMBRA CATHETERS, AND A NON-PENUMBRA STENT WITH AN EXCESSIVE BLOOD LOSS (EBL) OF 500 ML. POST PROCEDURE, ON (B)(6) 2021, THE PHYSICIAN PERFORMED ANOTHER THROMBECTOMY PROCEDURE ON THE PATIENT FOR RE-THROMBOSIS WHICH RESULTED WITH EBL OF 550 ML. ON (B)(6) 2021, PATIENT RECEIVED TWO UNITS PACKED RED BLOOD CELLS. IT WAS REPORTED THAT THE PATIENT¿S HGB DECREASED TO 6.6 G/DL. ON (B)(6) 2021, PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE ANEMIA WAS REPORTED TO BE SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO SYSTEM AND INDEX PROCEDURE.

  Patient problems: Anemia

  MAUDE report 12797338 ↗
• MalfunctionOct 28, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, A LIGHTNING TURNED SOLID RED LIGHT AFTER SOME TIME DURING THE PROCEDURE. TO TROUBLESHOOT, THE LIGHTNING WAS UNPLUGGED FROM THE USB PORT AND THEN REINSERTED MULTIPLE TIMES IN THE ATTEMPT TO RESET IT. HOWEVER, THE ISSUE WITH THE LIGHTNING WAS UNRESOLVED. THEREFORE, THE LIGHTNING AND CAT12 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND NEW CAT12. IT WAS REPORTED THERE WAS NO ISSUE WITH THE CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712179 ↗
• MalfunctionOct 19, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT LEG USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), PENUMBRA ENGINE (ENGINE), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE POPLITEAL ARTERY USING THE SHEATH. SUBSEQUENTLY, WHEN THE LIGHTNING WAS CONNECTED TO THE ENGINE, THERE WAS NO INDICATOR LIGHT ILLUMINATING ON THE LIGHTNING AND NO ASPIRATION. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661660 ↗
• 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 12550950 ↗
• MalfunctionSep 12, 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 12457854 ↗
• MalfunctionAug 27, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC AND FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING A CAT12 THROUGH THE SHEATH, THE PHYSICIAN KINKED THE CAT12 AT THE DISTAL ONE THIRD. THEREFORE, THE CAT12 WAS REMOVED. IT WAS NOTED THAT THE PHYSICIAN WAS ADVANCING THE CAT12 TOO FAR FROM THE HUB OF THE SHEATH. 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 12378994 ↗
• MalfunctionAug 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND 12F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INTRODUCING THE CAT12 INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE CAT12 KINKED AT THE DISTAL END. THEREFORE, THE CAT12 WAS REMOVED. 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 12345995 ↗
• MalfunctionJul 30, 2021Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR VENA CAVA (SVC) USING A ROTATING HEMOSTASIS VALVE (RHV) PACKAGED WITH THE LIGHTNING ASPIRATION TUBING (LIGHTNING) AND INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE RHV WAS OPENED AND CLOSED MULTIPLE TIMES. CONSEQUENTLY, THE RHV STARTED LEAKING AND THE TOP PART OF THE RHV WOULD NOT CLOSE. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV WITH THE SAME LIGHTNING AND CAT12. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12255120 ↗
• MalfunctionJun 23, 2021Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL VEIN (SFV) USING LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT12 OVER THE GUIDEWIRE TO THE TARGET VESSEL AND INITIATED ASPIRATION. SUBSEQUENTLY, IT WAS NOTICED THAT THE ROTATING HEMOSTASIS VALVE (RHV) WOULD NOT TIGHTEN ON THE CAT12 AND THAT AIR WAS LEAKING THROUGH THE RHV. THEREFORE, THE RHV WAS REMOVED. IT WAS REPORTED THAT AN ATTEMPT TO ASPIRATE CLOT USING A SMALLER RHV WAS MADE; HOWEVER, THE ASPIRATED CLOT BECAME STUCK IN THE RHV. THEREFORE, THIS RHV WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME LIGHTNING AND CAT12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054713 ↗
• MalfunctionJun 17, 2021Leak/Splash; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE ROTATING HEMOSTASIS VALVE (RHV) OF THE CAT12 WAS CAUSING AN AIR LEAK IN THE SYSTEM. THEREFORE, THE RHV WAS REMOVED. NEXT, THE PHYSICIAN USED A NON-PENUMBRA TUOHY; HOWEVER, THE TUOHY KEPT CLOGGING; THEREFORE, THE TUOHY WAS ALSO 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 12014453 ↗
• MalfunctionJun 10, 2021Break; Leak/Splash; Failure to Advance; Break; Leak/Splash; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A SEP12 THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND COULD NOT ADVANCE THE SEP12. THEY THEN LOOSENED THE RHV. THE RHV CAP CAME OFF, AND THE O RING FELL OUT. THEY COULD NOT PUT THE O RING BACK INTO PLACE NOR REATTACH THE RHV CAP. WHEN THEY WERE ABLE TO, THE CAT12 WAS LEAKING AIR. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND THE SAME CAT12 AND SAME SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979562 ↗
• MalfunctionJun 7, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), PENUMBRA ENGINE (ENGINE), AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, AFTER APPROXIMATELY FIVE MINUTES OF USING THE LIGHTNING, THE INDICATOR LIGHT STARTED FLASHING RED. THE PHYSICIAN UNPLUGGED AND PLUGGED THE LIGHTNING UNIT BACK INTO THE ENGINE TO TROUBLESHOOT; HOWEVER, THE INDICATOR LIGHT TURNED FROM GREEN TO FLASHING RED WHEN THE SWITCH WAS TURNED INTO THE ON POSITION. IT WAS ALSO REPORTED THAT THE CANISTER WAS COMPLETELY SEATED ON THE ENGINE AND THE LID WAS TIGHTLY SEALED. THEREFORE, THE LIGHTNING UNIT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING WITH THE SAME CAT12, ENGINE, AND CANISTER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953377 ↗
• MalfunctionJun 2, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE PORTAL VEIN 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, WHILE REMOVING THE SEP12 OUT FROM THE RHV, THE BACK OF THE RHV POPPED OFF. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV WITH THE SAME LIGHTNING, CAT12, AND SEP12. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925708 ↗
• MalfunctionMay 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES USING THE CAT12. AFTERWARDS, WHILE THE CAT12 WAS NEAR THE FLAT PART OF A PREVIOUSLY PLACED STENT, THE DISTAL END OF THE CAT12 KINKED. THEREFORE, THE CAT12 WAS REMOVED. 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 11868223 ↗
• MalfunctionMay 22, 2021Leak/Splash; Failure to Advance; Leak/Splash; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (B)(6), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE CAT12 AND THE ROTATING HEMOSTASIS VALVE (RHV) FOR APPROXIMATELY TWENTY MINUTES AND COMPLETED A FEW PASSES. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE (B)(6) THROUGH THE RHV; HOWEVER, IT WOULD NOT ADVANCE. IT WAS THEN NOTICED THAT THE RHV WAS LEAKING AIR AND THE RHV COULD NOT BE RESEALED; THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RHV, THE SAME CAT12, AND THE SAME (B)(6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11868002 ↗
• MalfunctionMay 19, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MAIN PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHEN THE LIGHTENING WAS INITIALLY PLUGGED INTO THE ENGINE, A SOLID RED INDICATOR LIGHT WAS OBSERVED. THE LIGHTNING WAS UNPLUGGED AND REPLUGGED BACK INTO THE ENGINE MULTIPLE TIMES BUT HAD THE SAME RESULT. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847447 ↗
• MalfunctionMay 18, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN LEFT LUNG USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND INDIGO SYSTEM SEPARATOR 12 (SEP12). DURING THE PROCEDURE, WHEN THE PHYSICIAN INSERTED THE SEP12 INTO THE CAT12, THE ROTATING HEMOSTASIS VALVE (RHV)''S RUBBER WASHER FELL OUT AND WAS UNABLE TO BE USED. 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 11841619 ↗