Indigo System LITNG7XTORQ130-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00815948022584), received between Apr 14, 2021 and May 2, 2025 — classified as 11 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Break” (52 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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL AND POPLITEAL BYPASS GRAFT USING AN INDIGO SYSTEM CATHETER 7 (CAT7), A LIGHTNING ASPIRATION TUBING (LIGHTNING), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE CLOT BURDEN WAS CHRONIC. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT7. WHILE TORQUING THE CAT7 THROUGH THE SHEATH, THE CAT7 FRACTURED AT THE MIDSHAFT. THE FRACTURED CAT7 WAS PULLED OUT BY HAND. THE PHYSICIAN EXCHANGED THE SHEATH FOR ANOTHER NON-PENUMBRA SHEATH. THE PHYSICIAN THEN COMPLETED ANOTHER PASS USING THE SECOND CAT7. WHILE TORQUING THE SECOND CAT7, THE PHYSICIAN DAMAGED THE SECOND CAT7 AT THE MIDSHAFT. THEREFORE, THE SECOND CAT7 WAS ALSO REMOVED. THE PHYSICIAN THEN COMPLETED EIGHT TO TEN PASSES USING THE THIRD CAT7. IT WAS REPORTED THAT THERE WERE LITTLE RESULTS, AND THE CLOT BURDEN WAS CHRONIC. THE THIRD CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A LYTIC CATHETER. IMAGES TAKEN POST-PROCEDURE WERE CLEAR. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952544 ↗
• InjuryMar 25, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A DIAGNOSTIC CATHETER, AND A GUIDEWIRE. IT SHOULD BE REPORTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS IN THE TARGET LOCATION USING THE CAT7. WHILE ADVANCING THE CAT7 DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE CAT7 WAS FRACTURED AT THE DISTAL LENGTH. THE FRACTURED CAT7 SEGMENT WAS RETRIEVED FROM THE PATIENT USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW CAT7.

  Patient problems: Foreign Body In Patient

  MAUDE report 18968484 ↗
• MalfunctionAug 11, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES IN THE TARGET VESSEL USING THE CAT7. WHILE ATTEMPTING TO MAKE THE NEXT PASS, THE CAT7 FRACTURED INTO TWO PIECES WHILE TORQUING IN THE VESSEL. IT WAS REPORTED THAT THE CAT7 FRACTURED INSIDE OF THE SHEATH. THEREFORE, THE SHEATH CONTAINING THE FRACTURED CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 WITH THE SAME LIGHTNING AND SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510517 ↗
• MalfunctionJul 7, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7 THROUGH THE STENTS, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE CAT7. WHILE RETRACTING THE CAT7, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE DISTAL END OF THE CAT7 BROKE. THE PHYSICIAN THEN REMOVED MOST OF THE BROKEN DISTAL END USING A SNARE DEVICE AND STENTED THE REMAINING PORTION AGAINST THE VESSEL WALL. 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 17281293 ↗
• MalfunctionJun 26, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT HAD A STENT IN THE ILIAC ARTERY PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7 THROUGH THE STENT, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE CAT7 WAS REMOVED. UPON REMOVAL, THE MID-SHAFT OF THE CAT7 WAS FOUND TO BE KINKED. THE PHYSICIAN THEN ADVANCED THE SHEATH CLOSER TO THE STENT AND USED ANOTHER CAT7 TO COMPLETE FOUR PASSES. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE CAT7 WAS BROKEN AT THE HUB. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY "TORQUING" THE CAT7 WITHIN THE STENT DUE TO A CHRONIC CLOT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200909 ↗
• MalfunctionJun 23, 2023Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES USING THE CAT7. SUBSEQUENTLY, WHILE TORQUING THE CAT7, THE PHYSICIAN KINKED THE CAT7. WHEN THE CAT7 WAS REMOVED TO PERFORM ANGIO, THE PHYSICIAN NOTICED THE CAT7 TO BE BROKEN AT THE PROXIMAL END. IT WAS REPORTED THAT THE CAT7 WAS BROKEN BUT IT REMAINED CONNECTED. THEREFORE, THE CAT7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 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 17192691 ↗
• MalfunctionJun 16, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A LIGHTNING ASPIRATION TUBING (LIGHTNING), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS WITH A STEEP BIFURCATION. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 TO THE TARGET LOCATION WITH THE RESISTANCE. NEXT, THE PHYSICIAN COMPLETED THREE PASSES USING THE CAT7. THE PHYSICIAN THEN DECIDED TO REMOVE THE CAT7 TO TAKE A PICTURE UNDER FLUOROSCOPY. WHILE REMOVING THE CAT7, THE PHYSICIAN EXPERIENCED RESISTANCE, AND NOTICED UNDER FLUOROSCOPY THAT THE CAT7 WAS BROKEN IN HALF AT THE MID-SHAFT INSIDE THE PATIENT. THE PHYSICIAN THEN ADVANCED AN ANGIOPLASTY BALLOON THROUGH THE BROKEN PIECE OF THE CAT7 AND INFLATED ONCE DISTAL TO THE BROKEN PORTION OF THE CAT7 AND PULLED THE REMAINING PIECE OF THE CAT7 FROM THE PATIENT. 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 17144822 ↗
• MalfunctionMay 25, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). DURING THE PROCEDURE, AFTER COMPLETING THE FIRST PASS, THE PHYSICIAN NOTICED THAT THE ASPIRATION HAD DECREASED. UPON INSPECTION, THE CAT7 WAS FOUND TO BE BROKEN AT THE HUB. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17005264 ↗
• MalfunctionApr 20, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT7. SUBSEQUENTLY, WHILE RETRACTING THE CAT7 FROM THE PATIENT'S BODY IN ORDER TO FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE CAT7 BROKE AT THE PROXIMAL END. A PART OF THE CAT7 WAS INSIDE THE SHEATH; THEREFORE, THE SHEATH CONTAINING THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 AND A NEW SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781986 ↗
• MalfunctionMar 21, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES. NEXT, THE PHYSICIAN REMOVED THE CAT7 TO PERFORM AN ANGIOGRAM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE CAT7 THROUGH THE SHEATH TO COMPLETE THE THIRD PASS, AND SUBSEQUENTLY, THE PROXIMAL END OF THE CAT7 BROKE OUTSIDE OF THE PATIENT. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATHETER 8 (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

  MAUDE report 16588456 ↗
• MalfunctionMar 21, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET VESSEL WITHOUT REMOVING THE CAT7 FROM THE PATIENT''S BODY. WHILE ATTEMPTING TO MAKE THE THIRD PASS, THE PHYSICIAN HEARD AIR LEAKING AND UPON INSPECTION, A HOLE WAS NOTICED AT THE HUB AND THE CATHETER TRANSITION POINT. THEREFORE, THE PHYSICIAN INSERTED THE GUIDEWIRE TO REMOVE THE CAT7. UPON REMOVAL, THE CAT7 FRACTURED AT THE HUB; THEREFORE, THE REMAINDER PORTION OF THE CAT7 WAS PULLED OUT OF THE PATIENT''S BODY OVER THE GUIDEWIRE. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584515 ↗
• MalfunctionMar 6, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES IN THE TARGET VESSEL USING THE CAT7. THE PHYSICIAN THEN DECIDED TO REMOVE THE CAT7 TO BE FLUSHED; HOWEVER, THE HUB OF THE CAT7 COMPLETELY BROKE OFF FROM THE REST OF THE CAT7 WHILE BEING REMOVED OUT FROM THE PATIENT. THEREFORE, THE PHYSICIAN PULLED AND REMOVED THE BROKEN CAT7 SUCCESSFULLY OUT FROM THE SHEATH. IT WAS ALSO REPORTED THE LIGHTNING UNIT WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7, A NEW LIGHTNING, 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 16487114 ↗
• MalfunctionFeb 2, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND TIBIAL ARTERY USING AN INDIGO SYSTEM CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE CAT7 AT THE PROXIMAL LOCATION NEAR THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE CAT7 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATHETER 6 (CAT6) 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 16285710 ↗
• MalfunctionJan 30, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM SEPARATOR 7 (SEP7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE APPROXIMATELY TWO TO THREE PASSES USING THE CAT7 AND SEP7. SUBSEQUENTLY, THE PHYSICIAN USED THE DILATOR TO OPEN THE CAT7 BACK UP AND THEN ATTEMPTED TO LOAD THE SEP7 INTO THE CAT7; HOWEVER, THE PHYSICIAN PINCHED THE CAT7 TOO HARD AND BROKE IT AT THE HUB. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) 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 16268941 ↗
• MalfunctionJan 20, 2023Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT COMMON FEMORAL ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 OVER THE GUIDEWIRE; HOWEVER, THE CAT7 WOULD NOT TORQUE IN THE DIRECTION THE PHYSICIAN WANTED. THEREFORE, THE PHYSICIAN REMOVED THE GUIDEWIRE AND ATTEMPTED TO ADVANCE THE CAT7. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE CAT7 WAS NOT ADVANCING AND UNDER FLUOROSCOPY FOUND THAT THE CAT7 HAD BROKEN AT THE MID SHAFT. THEREFORE, THE SHEATH WITH THE DISTAL END OF THE CAT7 WAS REMOVED BY PULLING IT OUT. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218301 ↗
• MalfunctionDec 2, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE CAT7 THROUGH THE SHEATH TO THE TARGET VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO TORQUE THE CAT7, THE PHYSICIAN FELT A SNAP AND NOTICED UNDER FLUOROSCOPY THAT THE CAT7 HAD BROKEN AT THE MID-SHAFT. THE PHYSICIAN THEN ADVANCED A BALLOON OVER THE GUIDEWIRE INTO THE CAT7, INFLATED THE BALLOON INSIDE THE CAT7 AND PULLED THE CAT7 OUT. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 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 15908931 ↗
• MalfunctionNov 10, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIOPERONEAL TRUNK USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY NOTICED THE CAT7 TO BE FRACTURED AT THE PROXIMAL END. THEREFORE, THE CAT7 WAS REMOVED ALONG WITH THE SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 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 15774337 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMERAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 INTO THE SHEATH AND BEGAN ASPIRATION. NEXT, WHEN THE PHYSICIAN REMOVED THE CAT7, IT WAS NOTICED TO BE FRACTURED AT THE PROXIMAL END AT THE SHEATH HUB. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE CAT7. IT WAS REPORTED THAT A SECOND CAT7 ALSO FRACTURED AT THE SHEATH HUB. THE PROCEDURE WAS COMPLETED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND TPA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686585 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMERAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 INTO THE SHEATH AND BEGAN ASPIRATION. NEXT, WHEN THE PHYSICIAN REMOVED THE CAT7, IT WAS NOTICED TO BE FRACTURED AT THE PROXIMAL END AT THE SHEATH HUB. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE CAT7. IT WAS REPORTED THAT A SECOND CAT7 ALSO FRACTURED AT THE PROXIMAL END AT THE SHEATH HUB. THE PROCEDURE WAS COMPLETED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND TPA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686584 ↗
• MalfunctionSep 29, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEPHALIC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A 7F NON-PENUMBRA SHEATH, AND A GUIDEWIRE (.035). DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CAT7 OVER THE GUIDEWIRE INTO THE SHEATH TO THE TARGET LOCATION. WHILE ADJUSTING THE CAT7, THE PHYSICIAN NOTICED IT WAS NOT MOVING CORRECTLY AND FOUND THE DISTAL TIP OF THE CAT7 HAD FRACTURED AND BROKEN OFF. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE CAT7 AND INSERTED A BALLOON TO REMOVE THE REMAINING BROKEN DISTAL PIECE OF THE CAT7 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506525 ↗
• InjurySep 12, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN AN ARTERY OF THE RIGHT LEG USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), LIGHTING ASPIRATION TUBING (LIGHTNING), AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT7 THROUGH THE SHEATH TO THE TARGET LOCATION AND SUBSEQUENTLY, BROKE THAT CAT7 AT THE MID-SHAFT WITHIN THE SHEATH. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE BROKEN PART OF THE CAT7. IT WAS ALSO REPORTED THAT THERE WAS PERFORATION OF THE AORTA THAT WAS THEN STENTED. IT IS UNKNOWN IF THE PERFORATION WAS RELATED TO THE CAT7. THE PROCEDURE WAS COMPLETED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NEW NON-PENUMBRA SHEATH.

  Patient problems: Perforation of Vessels

  MAUDE report 15407099 ↗
• InjurySep 7, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PERIPHERAL BYPASS GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A 7FR NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED APPROXIMATELY FIVE PASSES IN THE TARGET LOCATION USING THE CAT7. UPON REMOVAL OF THE CAT7 FROM THE PATIENT AFTER COMPLETION OF THE THROMBECTOMY, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE CAT7 IN HALF AND NOTICED UNDER FLUOROSCOPY THAT A PIECE OF THE CAT7 REMAINED IN THE PATIENT¿S ARTERIAL BYPASS GRAFT. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE SHEATH AND GAINED ADDITIONAL ACCESS VIA CUTDOWN TECHNIQUE TO OPEN THE PATIENT¿S GRAFT AND REMOVED THE BROKEN DISTAL PIECE OF THE CAT7. 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 15374934 ↗
• MalfunctionAug 26, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A FEMOROPOPLITEAL BYPASS USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT A STENT WAS PLACED INSIDE THE PATIENT PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 THROUGH THE STENT, REMOVED THE GUIDEWIRE AND COMPLETED COUPLE OF PASSES USING THE CAT7. SUBSEQUENTLY, WHILE ATTEMPTING TO REMOVE THE CAT7 OUT OF THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT7 BECAME STUCK. THE PHYSICIAN ATTEMPTED TO PULL THE CAT7; HOWEVER, THE CAT7 BROKE IN HALF. THE PHYSICIAN THEN USED A PAIR OF HEMOSTATS AND REMOVED THE BROKEN END OF THE CAT7. THE PROCEDURE WAS COMPLETED BY PLACING A STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302697 ↗
• InjuryAug 13, 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 IN THE SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY, TIBIOPERONEAL TRUNK, AND POPLITEAL STENT GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A LIGHTNING ASPIRATION TUBING (LIGHTNING), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED 20 PASSES USING THE CAT7 AND LIGHTNING. FOLLOWING THE PROCEDURE, AN ANGIOGRAPHY WAS PERFORMED AND SHOWED 50%-99% STENOSIS IN THE DISTAL POPLITEAL ARTERY. ON (B)(6) 2022, THE PATIENT¿S LEFT LOWER EXTREMITIES PULSE SIGNALS DIMINISHED. AN ANGIOGRAPHY AND BALLOON ANGIOPLASTY OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND LEFT POPLITEAL ARTERY WAS PERFORMED, AND THE PATIENT WAS TREATED WITH A CONTINUATION OF THROMBOLYSIS. ON (B)(6) 2022, AN ANGIOGRAPHY WAS PERFORMED IN THE LEFT LOWER EXTREMITIES FOLLOWED BY A TERMINATION OF THROMBOLYSIS. ON (B)(6) 2022, AMPUTATIONS OF THE LEFT SECOND TOE AT THE PROXIMAL PHALANGEAL BONE AND OF THE LEFT GREAT TOE AT THE PROXIMAL INTERPHALANGEAL BONE WERE PERFORMED. ON (B)(6) 2022, A LEFT SFA AND POPLITEAL BYPASS WAS PERFORMED WITH A RECURRENT VARICOSE VEIN OF THE GREAT SAPHENOUS VEIN (RGSV) FROM THE LEFT LOWER EXTREMITY. AN ANGI

  Patient problems: Ischemia

  MAUDE report 15222668 ↗
• MalfunctionJul 26, 2022Break; Difficult to Advance; Physical Resistance/Sticking; Break; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM SEPARATOR 7 (SEP7), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES IN THE TARGET VESSEL USING THE CAT7 AND SEP7. WHILE ADVANCING THE SEP7 THROUGH THE CAT7 DURING THE THIRD PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SEP7 PAST THE PROXIMAL ONE THIRD OF THE CAT7 NEAR THE HUB. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE SEP7 AND ATTEMPTED TO ADVANCE THE GUIDEWIRE THROUGH THE CAT7 INTO THE TARGET VESSEL TO KEEP ACCESS; HOWEVER, THE GUIDEWIRE WAS UNABLE TO BE RE-ADVANCED THROUGH THE CAT7. THEREFORE, THE PHYSICIAN RETRACTED THE CAT7 SLOWLY FROM THE PATIENT USING FLUOROSCOPY. UPON REMOVAL OF THE CAT7, THE PHYSICIAN BROKE THE CAT7 AT THE PROXIMAL END. IT WAS REPORTED THAT THE CAT7 WAS REMOVED INTACT; HOWEVER, THE CATHETER BECAME TWISTED, AND THE INNER BRAIDING OF CATHETER BECAME EXPOSED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 AND THE SAME SEP7 AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108754 ↗