Indigo System LITNG8XTORQ115-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00815948022546), received between Jul 17, 2020 and Oct 28, 2021 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715736 ↗
• InjuryJun 9, 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 POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). 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 SMALL AMOUNT OF THROMBUS THAT WAS NOTED IN THE DISTAL PLANTAR ARCH. THERE WAS NO FLOW BEYOND THE THROMBUS, AND NO INTERVENTION WAS DONE. THE EVENT WAS RESOLVED THE SAME DAY. THE PERIPHERAL/ DISTAL EMBOLISM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE CAT8 AND THE INDEX PROCEDURE.

  Patient problems: Thromboembolism

  MAUDE report 11971277 ↗
• MalfunctionApr 28, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING THE LIGHTNING ASPIRATION TUBING (LIGHTNING) PACKAGED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, BEFORE THE TUBING WAS CONNECTED TO THE PATIENT, THE LIGHTNING MICROPROCESSOR INDICATOR LIGHT TURNED RED IMMEDIATELY AFTER PLUGGING IT INTO THE ENGINE USB PORT. AFTER UNPLUGGING THE LIGHTNING AND PLUGGING IT IN AGAIN, THE LIGHT TURNED GREEN; THEREFORE, THE PHYSICIAN PROCEEDED WITH THE CASE. APPROXIMATELY FIVE MINUTES INTO THE CASE, THE FLOW SWITCH WAS SWITCHED INTO THE ''OFF'' POSITION AND THE LIGHTNING INDICATOR LIGHT TURNED RED. WHEN THE FLOW SWITCH WAS SWITCHED BACK INTO THE ''ON'' POSITION, NO ASPIRATION WAS PRODUCED. THE LIGHTNING DEVICE WAS TROUBLESHOT BY UNPLUGGING THE UNIT AND FLUSHING THE TUBING; HOWEVER, THE ISSUES WERE UNRESOLVED. THEREFORE, THE LIGHTNING AND TUBING WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND NEW TUBING WITH THE SAME CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742159 ↗
• MalfunctionApr 7, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL ARTERY AND LEFT POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING THE CAT8 THROUGH THE POPLITEAL ARTERY AND EXPERIENCED RESISTANCE AT THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN STOPPED AND AS THEY WERE PULLING THE CAT8 OUT OF THE SHEATH, THEY NOTICED THE CAT8 HAD OVALIZED AT THE MID-SEGMENT. THE PHYSICIAN BELIEVED THE CAT8 HAD BENT AT A STEEP CURVE AS THE CAT8 WAS PULLED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED BY USING A NEW CAT8 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 11631896 ↗
• MalfunctionMar 18, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED SOLID RED AFTER TURNING THE FLOW SWITCH TO THE ON POSITION. TO TROUBLESHOOT, THE PHYSICIAN UNPLUGGED AND PLUGGED BACK IN THE CORD FROM THE LIGHTNING TO THE USB PORT ON THE ENGINE, FLUSHED THE CAT8 AND TUBING, AS WELL AS MAKING SURE THAT THE CANISTER WAS SEATED PROPERLY ON THE ENGINE. HOWEVER, THE LIGHTNING UNIT REMAINED SOLID RED AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. SUBSEQUENTLY, THE LIGHTNING WAS REMOVED AND EXCHANGED FOR A NEW LIGHTNING, BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN THEN EXCHANGED THE ENGINE FOR A SECOND ENGINE, BUT THE LIGHTNING UNIT REMAINED SOLID RED AND NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE ILLUMINATED. THEREFORE, THE PHYSICIAN REMOVED THE CANISTER. IT WAS ALSO REPORTED THAT THE FIRST ENGINE WAS TESTED WITH THE NEW CANISTER AND IT WAS NOTED THAT THE ENGINE WAS ABLE TO ACHIEVE FULL ASPIRATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510454 ↗
• MalfunctionJan 29, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE CAT8 OVER A GUIDEWIRE THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY KINKED THE CAT8. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 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; No Consequences Or Impact To Patient

  MAUDE report 11252424 ↗
• MalfunctionJan 13, 2021Material Deformation; Suction Failure; Material Deformation; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT HAD A TORTUOUS AORTA-ILIAC BIFURCATION. DURING THE PROCEDURE, AFTER SEVERAL PASSES WERE COMPLETED USING THE CAT8, THE PHYSICIAN LOST SUCTION WHILE TORQUING THE CAT8 AND UPON REMOVAL, REALIZED IT WAS KINKED MID-SHAFT. THEREFORE, THE CAT8 WAS REMOVED AND A NEW CAT8 WAS USED TO CONTINUE THE PROCEDURE. NEXT, AFTER A FEW PASSES WERE COMPLETED WITH THE SECOND CAT8, THE PHYSICIAN LOST SUCTION AFTER TORQUING THE CAT8 ON THE FINAL PASS. UPON REMOVAL, THE CAT8 BROKE INTO TWO PIECES. IT WAS REPORTED THAT THE HUB OF THE CAT8 WAS PULLED OUT AND THE DISTAL HALF OF THE CATHETER WAS CONTAINED IN THE SHEATH. THEREFORE, THIS SHEATH WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT AND NO ADDITIONAL PASSES WERE NEEDED. 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 11167743 ↗
• MalfunctionDec 22, 2020Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PORTAL VEIN USING LIGHTING ASPIRATION TUBING (LIGHTING) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, AFTER APPROXIMATELY TWENTY-FIVE MINUTES HAD ELAPSED, THE LIGHTNING MICROPROCESSOR LIGHT TURNED SOLID RED AND THE TUBING WAS FOUND TO BE CLOGGED. AFTER CLEARING THE TUBING BY SUBMERGING IN A BOWL OF SALINE, THE INDICATOR LIGHTNING MICROPROCESSOR LIGHT REMAINED RED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT8. 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 11060288 ↗
• MalfunctionDec 13, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES IN THE TARGET LOCATION USING THE CAT8. SUBSEQUENTLY, AFTER THE THIRD PASS, THE PHYSICIAN DISCONNECTED THE LIGHTNING FROM THE ROTATING HEMOSTASIS VALVE (RHV) TO CLEAN THE LIGHTNING, AND THE INDICATOR LIGHT ON THE LIGHTNING TURNED FROM GREEN TO SOLID RED. AT THIS POINT, THERE WAS NOT A LOT OF CLOT BURDEN IN THE LIGHTNING. THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT THE LIGHTNING BY FLUSHING THE LIGHTNING WITH A 60CC SYRINGE AND STOPCOCK, FOLLOWED BY UNPLUGGING THE LIGHTNING FROM THE ENGINE AND PLUGGING THE LIGHTNING BACK INTO THE ENGINE. HOWEVER, THE INDICATOR LIGHT REMAINED SOLID RED. THEREFORE, THE LIGHTNING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING AND THE SAME CAT8. 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 10998236 ↗
• MalfunctionDec 3, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE POPLITEAL ARTERY, AND THE TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT8 AND SHEATH, THEN REMOVED THE CAT8 FROM THE PATIENT. WHILE ATTEMPTING TO RE-INTRODUCE THE CAT8 INTO THE ROTATING HEMOSTASIS VALVE (RHV) OF THE SHEATH USING THE PEEL-AWAY SHEATH, THE TIP OF THE CAT8 OVALIZED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND THE SAME SHEATH. 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 10939043 ↗
• MalfunctionNov 24, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE CAT8 AND LIGHTNING. THE INDICATOR LIGHT ON THE LIGHTNING UNIT THEN TURNED SOLID RED. THE PHYSICIAN UNPLUGGED AND RE-PLUGGED THE LIGHTNING UNIT SEVERAL TIME TO TROUBLESHOOT; HOWEVER, THE INDICATOR LIGHT ON THE LIGHTNING REMAINED SOLID RED. IT WAS REPORTED THAT THE LIGHTNING TUBING WAS NOT FLUSHED. THEREFORE, IT 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 10897678 ↗
• MalfunctionNov 12, 2020Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, WHILE PERFORMING BALLOON ANGIOPLASTY, THE PHYSICIAN TURNED OFF THE LIGHTNING UNIT AND TURNED IT BACK ON. HOWEVER, AFTER TURNING THE LIGHTNING UNIT BACK ON, THE LIGHTNING TUBING WAS OBSTRUCTED WITH CLOT. SUBSEQUENTLY, A GUIDEWIRE WAS ADVANCED APPROXIMATELY HALFWAY INTO THE LIGHTNING TUBING TO AGITATE THE CLOT AND THE INDICATOR LIGHT ON THE LIGHTNING UNIT TURNED FLASHING RED. IT WAS REPORTED THAT IT IS UNKNOWN WHETHER THE INDICATOR ON THE LIGHTNING UNIT WAS FLASHING RED BEFORE OR AFTER ADVANCING THE GUIDEWIRE. THE HOSPITAL STAFF UNPLUGGED THE LIGHTNING UNIT AND PLUGGED BACK IN BUT, IT WAS UNSUCCESSFUL. UPON FURTHER INSPECTION OF THE LIGHTNING UNIT, BLOOD WAS FOUND TO BE LEAKING FROM THE SEAL BETWEEN THE LIGHTNING UNIT AND CANISTER. THE PROCEDURE WAS COMPLETING USING A NEW LIGHTNING AND SAME CANISTER. 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 10831487 ↗
• MalfunctionOct 26, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) IN THE INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE SHEATH INTO THE TARGET LOCATION, THEN INITIATED ASPIRATION. HALFWAY THROUGH THE PROCEDURE, NO ASPIRATION WAS OBSERVED AND SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE CAT8. UPON REMOVAL OF THE CAT8, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT8 WAS OVALIZED; THEREFORE, IT WAS NOT USE FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND THE SAME SHEATH. 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 10737630 ↗
• MalfunctionOct 10, 2020Electrical /Electronic Property Problem; Obstruction of Flow; Electrical /Electronic Property Problem; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, PRIOR TO USE WITH THE PATIENT, THE INDICATOR LIGHT OF THE LIGHTNING IMMEDIATELY TURNED SOLID RED WHEN THE LIGHTNING WAS CONNECTED TO THE ENGINE ON THE BACK TABLE. THE LIGHTNING WAS REBOOTED THREE TIMES; HOWEVER, THE INDICATOR LIGHT REMAINED RED. THE ISSUE WITH THE LIGHTNING OCCURRED PRIOR TO USE AND, THEREFORE, THE LIGHTNING WAS NOT USED IN THE PROCEDURE. NEXT, THE PHYSICIAN USED THE LIGHTNING FROM AN INDIGO SYSTEM LIGHTNING 8 WITH THE SAME CAT12. WHEN THE LIGHTNING WAS CONNECTED TO THE ENGINE, THE INDICATOR LIGHT ALSO TURNED RED. THE LIGHTNING WAS SUCCESSFULLY REBOOTED AND WAS USED WITH THE PATIENT. APPROXIMATELY TEN MINUTES INTO THE ASPIRATION, THE LIGHTNING AND CAT12 BECAME FULL OF CLOT AND THE INDICATOR LIGHT OF THE LIGHTNING TURNED RED AGAIN. THEREFORE, THE LIGHTNING WAS DISCONNECTED, FLUSHED WITH A 10 CC SYRINGE AND REBOOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME LIGHTNING, CAT12, AND ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT T

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

  MAUDE report 10659932 ↗
• MalfunctionOct 7, 2020Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE INTERNAL JUGULAR VEIN AND PROCEEDED TO CLEAR THE PULMONARY EMBOLISM (PE) USING THE CAT8. THE CAT8 WAS WORKING WELL INITIALLY. HOWEVER, WHILE THE PHYSICIAN WAS ASPIRATING CLOT, THE VACUUM PRESSURE SUDDENLY STOPPED, AND THE INDICATOR LIGHT ON THE LIGHTNING TURNED FROM GREEN TO SOLID RED. SUBSEQUENTLY, THE PHYSICIAN MADE ATTEMPTS TO TROUBLESHOOT THE CLOGGED LIGHTNING. THE ENGINE WAS UNPLUGGED AND POWERED OFF. NEXT, AN ATTEMPT WAS MADE TO CLEAR THE LIGHTNING BY DIPPING THE LIGHTNING INTO SALINE WITH ASPIRATION ON, PUTTING A FINGER OVER THE END OF THE LIGHTING AND TAPPING THE LIGHTNING WHILE SUBMERGED IN SALINE. ADDITIONALLY, A DILATOR WAS USED TO GENTLY FLUSH THE END OF THE LIGHTNING WITH ASPIRATION ON. HOWEVER, THE ISSUE WITH THE LIGHTNING WAS UNABLE TO BE RESOLVED. THEREFORE, THE LIGHTNING WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER LIGHTNING AND THE SAME CAT8. THERE WAS NO REPORT OF AN ADVERSE

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

  MAUDE report 10640907 ↗
• MalfunctionSep 25, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A LIGHTNING ASPIRATION TUBING (LIGHTNING), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 THROUGH THE SHEATH AND WHILE TORQUEING THE HUB OF THE CAT8; THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE CAT8 BROKE AT THE HUB; THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT8, THE SAME LIGHTNING AND THE SAME SHEATH. 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 10588547 ↗
• MalfunctionJul 17, 2020Improper or Incorrect Procedure or Method; Obstruction of Flow; Improper or Incorrect Procedure or Method; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIOFEMORAL VEIN USING AN INDIGO SYSTEM LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, THE LIGHTNING TUBING APPEARED TO BE CLOGGED WITH THE CLOT; THEREFORE, THE PHYSICIAN DISCONNECTED THE LIGHTNING TUBING FROM THE CATHETER. THEN, ATTEMPTED TO CONNECT A 30CC SYRINGE TO THE LIGHTNING TUBING AND FLUSH IT TO THE CANISTER. HOWEVER, THE UNIT TURNED RED WHEN THE PHYSICIAN FLUSHED WITH THE SALINE. THE LIGHTNING UNIT WAS POWER CYCLED; HOWEVER, THE UNIT STAYED RED. THEREFORE, THE LIGHTNING WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LIGHTNING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292837 ↗