Indigo System LITNGBT7TQ130-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00815948025462), received between Apr 5, 2023 and May 27, 2026 — classified as 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Fracture” (37 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH (7F). THE PHYSICIAN PERFORMED NINE PASSES USING THE CAT7. AFTER COMPLETION OF THE THROMBECTOMY PROCEDURE, THE PHYSICIAN REMOVED THE CAT7 TO DELIVER A NON-PENUMBRA STENT TO THE TARGET LOCATION. AT THIS TIME, THE PHYSICIAN WAS UNAWARE THAT THE CAT7 FRACTURED, LEAVING A FRAGMENT WITHIN THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT, THE VESSEL WAS FOUND TO BE OBSTRUCTED. IT WAS NOTED THAT THE FRACTURED CAT7 FRAGMENT WAS LODGED IN THE SHARP CURVE OF THE ARTERIOVENOUS (AV) FISTULA. A NON-PENUMBRA BALLOON DEVICE (2.5 X 40MM) WAS USED TO SUCCESSFULLY REMOVE THE CAT7 FRAGMENT. ALL CAT7 FRAGMENTS WERE FULLY RETRIEVED FROM THE PATIENT. THE STENT WAS THEN PLACED IN THE AV FISTULA, AND 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 25299844 ↗
• MalfunctionApr 23, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AND A NON-PENUMBRA SHEATH. THE SHEATH WAS ADVANCED UP AND OVER THE BIFURCATION TO THE TARGET LOCATION AND THROMBECTOMY WAS PERFORMED USING THE CAT7. UPON TORQUING THE CAT7, THE PHYSICIAN OBSERVED THAT THE DISTAL END OF THE CAT7 WAS NOT ROTATING UNDER FLUOROSCOPY. THE SHEATH CONTAINING THE FRACTURED PORTION OF THE CAT7 WAS REMOVED 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 24965967 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A CANISTER, AND A PENUMBRA ENGINE (ENGINE). ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT HAD RIGHT FOOT PAIN AND A RIGHT FOOT ISCHEMIC ULCER. IT WAS NOTED THAT THERE WAS A DISSECTION TO THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY (PROXIMAL) THAT REQUIRED A STENT PLACEMENT. THE PHYSICIAN STATED THAT HE DID NOT SEE THE DISSECTION ON THE POST-TREATMENT ANGIOGRAPHY ON (B)(6) 2025 BUT CANNOT SAY WITH CERTAINTY IF THE DISSECTION IS RELATED. ARTERIAL DISSECTION WAS DETERMINED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM (CAT7) AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS ONGOING.

  Patient problems: Vascular Dissection

  MAUDE report 24674978 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT LOWER EXTREMITY (RLE) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AN INDIGO SYSTEM SEPARATOR 7 (SEP7), A GUIDEWIRE (0.035), AND A SHEATH (45CM) VIA THE LEFT GROIN. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED, BUT FLOW WAS NOT ABLE TO BE RESTORED THROUGH THE LIMB. HEMOSTASIS WAS ACHIEVED WITH A COLLAGEN PLUG. POST-PROCEDURE, THE PATIENT HAD CONTINUED PAIN WITH A COOL AND MOTTLED RIGHT FOOT WITH DECREASED SENSATION, AND PULSES WERE ONLY PRESENT AT THE BYPASS GRAFT SITE. THE PATIENT REQUIRED A RIGHT ABOVE THE KNEE AMPUTATION (AKA) AND IN-PATIENT HOSPITALIZATION DUE TO THE LIMB ISCHEMIA. THE EVENT WAS CONSIDERED RESOLVED ON 13-OCT-2025. RIGHT LOWER EXTREMITY ISCHEMIA WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. ON 24-OCT-2025, ADDITIONAL INFORMATION WAS RECEIVED FROM CLINICAL THAT RIGHT LOWER EXTREMITY ISCHEMIA WAS DETERMINED TO BE A SERIOUS ADVERSE EVENT WITH AN UNRELATED RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND AN UNRELATED REL

  Patient problems: Ischemia

  MAUDE report 24594339 ↗
• MalfunctionFeb 27, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING TWO INDIGO SYSTEM ASPIRATION CATHETER 7 UNITS (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), TWO NON-PENUMBRA SHEATHS, AND A GUIDEWIRE. A CAT7 AND SHEATH WERE USED TO COMPLETE ONE PASS. UPON RETRACTION, THE CAT7 FRACTURED AT THE MIDSHAFT WITHIN THE SHEATH. THE SHEATH CONTAINING THE FRACTURED CAT7 WAS REMOVED FROM THE PATIENT. THE SHEATH WAS ALSO REPORTED TO BE KINKED, WHICH LIKELY CONTRIBUTED TO THE CAT7 DAMAGE. FLUOROSCOPY WAS PERFORMED AND CONFIRMED NO PORTION OF THE CAT7 WAS LEFT IN 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 24475119 ↗
• MalfunctionFeb 5, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH (7F), AND A GUIDEWIRE. IT WAS REPORTED A STENT WAS PLACED IN THE COMMON FEMORAL ARTERY (CFA) EXTENDING THROUGH THE SFA AND THE POPLITEAL ARTERY. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES USING THE CAT7. WHILE TORQUING THE CAT7 AT 180 DEGREES WITHIN THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE CAT7 FRACTURED AT THE DISTAL END IN THE SFA. IT WAS REPORTED THAT THE CAT7 BECAME STUCK ON THE INNER PORTION OF THE SHEATH. THE SHEATH WAS NOT DAMAGED. THE PROXIMAL END OF THE CAT7 WAS REMOVED, AND A SNARE DEVICE WAS USED TO REMOVE THE REMAINING PORTION OF THE CAT7. NO PART OF THE CAT7 WAS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT7, THE SAME SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269589 ↗
• InjuryJan 9, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 UP AND OVER FROM THE CONTRALATERAL SIDE TO THE TARGET LOCATION OVER THE GUIDEWIRE. THE PHYSICIAN REMOVED THE GUIDEWIRE AND COMPLETED A PASS WITH THE CAT7 IN THE TARGET LOCATION. WHILE WITHDRAWING THE CAT7, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT7 WAS NOT MOVING UNDER FLUOROSCOPY. THE PROXIMAL END OF THE CAT7 WAS REMOVED FROM THE PATIENT. THE PATIENT WAS TRANSFERRED TO AN OPERATING ROOM (OR) TO REMOVE THE FRACTURED PORTION OF THE CAT7. THE PHYSICIAN THEN COMPLETED THE PROCEDURE WITH A BYPASS. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24028717 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  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. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION WITH THE CAT7. WHILE ADVANCING THE CAT7 THROUGH A NEWLY PLACED STENT, THE CAT7 KINKED NEAR THE PROXIMAL LENGTH. THE CAT7 WAS REMOVED. THE PHYSICIAN OPENED A NEW CAT7 AND WHILE ADVANCING IT TO THE TARGET LOCATION, THE CAT7 FRACTURED NEAR THE PROXIMAL LENGTH WITHIN THE SHEATH. IT WAS REPORTED THAT THE PHYSICIAN WAS TORQUING THE CAT7 MULTIPLE TIMES WHEN IT FRACTURED. THE PROXIMAL PORTION OF THE CAT7 WAS REMOVED. THE PHYSICIAN CUT THE SHEATH AND USED HEMOSTATS TO REMOVE THE DISTAL SEGMENT OF THE CAT7 FROM THE PATIENT. THE THROMBECTOMY PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484595 ↗
• MalfunctionJun 23, 2025Fracture; Physical Resistance/Sticking; Fracture; 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 NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE CAT7. IT WAS REPORTED THAT THE PHYSICIAN NOTED RESISTANCE WHILE ADVANCING THE SHEATH PRIOR TO ADVANCING THE CAT7. WHILE TORQUING THE CAT7 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE CAT7. WHILE REMOVING THE CAT7, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTICED THAT THE CAT7 WAS FRACTURED AT THE MID-SHAFT. THE GUIDEWIRE WAS ADVANCED AND THE FRACTURED CAT7 WAS REMOVED OVER THE WIRE WITH THE SHEATH. 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 22311670 ↗
• MalfunctionJun 17, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AND A SHEATH (7F). IT WAS REPORTED THE PATIENT HAD A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED FOUR TO FIVE PASSES USING THE CAT7. WHILE REMOVING THE CAT7, THE CAT7 FRACTURED ON THE DISTAL LENGTH. THE PHYSICIAN ADVANCED A BALLOON CATHETER THROUGH THE PROXIMAL CAT7 TO PIN THE FRACTURED SEGMENT OF THE CAT7 TO THE SHEATH. THE CAT7, BALLOON CATHETER, AND SHEATH WERE REMOVED TOGETHER. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22241124 ↗
• InjuryJun 13, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT COMMON ILIAC ARTERY USING AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH (7F X 10CM), A NON-PENUMBRA CATHETER (65CM), A NON-PENUMBRA BALLON DEVICE (8X60), A GLIDE WIRE (0.035), AND A GUIDEWIRE (0.014 300CM) . DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 OVER THE GUIDEWIRE THROUGH THE SHEATH AND COMPLETED TWO PASSES IN THE PREVIOUSLY PLACED STENT. THE PHYSICIAN THEN PERFORMED AN ANGIOGRAM AND DECIDED TO USE A NON-PENUMBRA BALLOON DEVICE. AFTER BALLOONING, THE CAT7 WAS ADVANCED OVER THE GUIDEWIRE TO COMPLETE THE NEXT PASS. ANOTHER ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN DECIDED TO PLACE A NON-PENUMBRA STENT. THE CAT7 WAS REMOVED. WHILE PLACING THE STENT, THE PHYSICIAN NOTICED THE DISTAL PORTION OF THE CAT7 WAS IN THE RIGHT ILIAC ARTERY. DUE TO THE NON-AVAILABILITY OF A SNARE DEVICE THE PHYSICIAN USED A BALLOON DEVICE TO REMOVE THE FRACTURED PORTION OF THE CAT7 WITHOUT SUCCESS. THE PATIENT WAS TRANSFERRED TO AN OUTSIDE FACILITY FOR A VASCULAR SURGERY TO BE PERFORMED. ON 13JUN2025, ADDITIONAL INFORMATION W

  Patient problems: Foreign Body In Patient

  MAUDE report 22205961 ↗
• MalfunctionMay 1, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON FEMORAL ARTERY (CFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE CAT7. WHILE ADVANCING THE CAT7 TO THE TARGET LOCATION, THE PHYSICIAN WAS UNABLE TO TORQUE THE CAT7 AND NOTICED THE CAT7 FRACTURED ON THE DISTAL END. THE PROXIMAL PORTION CAT7 WAS REMOVED. THE PHYSICIAN ADVANCED A BALLOON CATHETER OVER THE FRACTURED SEGMENT OF THE CAT7 AND PULLED INTO THE SHEATH. THE PROCEDURE WAS COMPLETED BY CONNECTING THE LIGHTING BOLT DIRECTLY TO THE SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943629 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 OVER THE GUIDEWIRE TO THE TARGET LOCATION AND THEN REMOVED THE GUIDEWIRE. THE PHYSICIAN BEGAN TO TORQUE THE CAT7. WHILE TORQUING, THE CAT7 FRACTURED AT THE HUB. IT WAS REPORTED THAT A WIRE WAS BACKLOADED THROUGH THE CAT7 AND THE CAT7 WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW CAT7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910356 ↗
• MalfunctionApr 17, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE POPLITEAL AND TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A 7F NON-PENUMBRA SHORT SHEATH, AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT), A 10F NON-PENUMBRA SHEATH, AND A GUIDEWIRE (.014). DURING THE PROCEDURE, WHILE ADVANCING THE CATRX TO MAKE THE FIRST PASS, THE CATRX KEPT GETTING STUCK ON THE GUIDEWIRE. IT WAS REPORTED THAT THERE WAS POSSIBLE DAMAGE TO THE MIDSHAFT OF THE CATRX. THEREFORE, THE CATRX WAS REMOVED. THE PHYSICIAN THEN ADVANCED A CAT7 AND MADE ONE PASS IN THE TARGET LOCATION. WHILE ADVANCING THE CAT7 DOWN THE SFA FOR THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE DISTAL END OF THE CAT7 HAD PROLAPSED AND FRACTURED IN THE SFA. THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE PROXIMAL END OF THE CAT7. THE 7F SHEATH WAS REMOVED AND EXCHANGED TO A 10F SHEATH. A SNARE DEVICE WAS THEN USED THROUGH THE 10F SHEATH TO REMOVE THE FRACTURED DISTAL SEGMENT OF THE CAT7. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862269 ↗
• MalfunctionFeb 24, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL JUGULAR VEIN, SIGMOID, AND SINUS USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE CAT7 WITH A SUPPORT MICROCATHETER INTO THE RIGHT TRANSVERSE SINUS. NEXT, THE PHYSICIAN BEGAN ASPIRATION USING THE LIGHTNING BOLT ASPIRATION TUBING UNDER MODULATED ASPIRATION MODE WHILE TORQUING, RETRACTING, AND ADVANCING THE CAT7 OVER THE GUIDEWIRE. IT WAS REPORTED THE GUIDEWIRE WAS REMOVED FOR OPTIMAL ASPIRATION AND THE PHYSICIAN COMPLETED TWO PASSES IN THE VESSEL. AFTER THE PASS, THE PHYSICIAN ADVANCED THE CAT7 OVER THE GUIDEWIRE BACK INTO THE TRANSVERSE SINUS. THE GUIDEWIRE WAS REMOVED, AND THE PHYSICIAN STARTED TO TORQUE THE CAT7 WHILE ADVANCING AND RETRACTING THE CATHETER UNDER ASPIRATION. HOWEVER, WHILE RETRACTING THE CAT7, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT7 HAD FRACTURED AND COULD NOT BE RETRACTED WITH THE REST OF THE CATHETER. THEREFORE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21442975 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY AND THE TIBIPERONEAL TRUNK (TP TRUNK) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH, AND AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT7 AND THE LIGHTNING BOLT. WHILE REMOVING THE CAT7, THE PHYSICIAN NOTICED THAT THE CAT7 WAS FRACTURED. THE PROXIMAL LENGTH OF THE CAT7 WAS REMOVED, AND THE DISTAL LENGTH REMAINED IN THE SHEATH. THE SHEATH CONTAINING THE DISTAL LENGTH OF THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A LASER SYSTEM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437791 ↗
• MalfunctionDec 27, 2024Fracture; Failure to Advance; Material Deformation; Fracture; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ARTERIOVENOUS (AV) FISTULA USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), AND A 7F SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY THREE PASSES IN THE TARGET LOCATION USING THE CAT7. THE CAT7 WAS REMOVED OUT FROM THE SHEATH TO BE FLUSHED. WHILE ADVANCING THE CAT7 FOR THE NEXT PASS, THE PHYSICIAN NOTICED THE CAT7 WOULD NOT REMAIN STRAIGHT AND HAD FOLDED BACK INTO THE ACCESS POINT DUE TO THE PLACEMENT OF THE CAT7. THE CAT7 WOULD NO LONGER ADVANCE IN THE VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE CAT7 AND NOTICED THE DISTAL END OF THE CAT7 HAD FRACTURED AND REMAINED IN THE VESSEL. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED DISTAL END OF THE CAT7 USING A SNARE DEVICE, BUT THE ATTEMPT WAS UNSUCCESSFUL. THE SHEATH WAS THEN REMOVED, AND IT WAS DISCOVERED THAT THE FRACTURED PORTION OF THE CAT7 WAS ATTACHED TO THE SHEATH. BOTH THE SHEATH AND FRACTURED PORTION OF THE CAT7 WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 AND THE SAME LIGHTNING BOLT ASPIRATION TUBING. THERE WAS NO REPORT OF AN ADVERSE E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028410 ↗
• MalfunctionDec 13, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE TIBIAL ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES USING THE CAT7. AFTER COMPLETION OF THE PROCEDURE, WHILE REMOVING THE CAT7 FROM THE SHEATH, THE PHYSICIAN NOTICED THAT THE CAT7 FRACTURED AT THE MIDSHAFT. THE PROXIMAL FRACTURED PORTION OF THE CAT7 WAS REMOVED. THE SHEATH CONTAINING THE REMAINING PORTION OF THE CAT7 WAS REMOVED. 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 20931936 ↗
• MalfunctionNov 22, 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 NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT HAD PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT7. AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE CAT7 FROM THE SHEATH AND NOTICED THAT THE CAT7 FRACTURED AT THE MIDSHAFT. THE PHYSICIAN REMOVED THE PROXIMAL PORTION OF THE CAT7. FLUOROSCOPIC IMAGING REVEALED THE REMAINING FRACTURED PORTION OF THE CAT7 WAS INSIDE OF THE SHEATH. THE SHEATH CONTAINING THE FRACTURED PORTION OF THE CAT7 WAS REMOVED. 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 20761014 ↗
• MalfunctionNov 15, 2024Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT POSTERIOR TIBIAL ARTERY AND RIGHT LATERAL PLANTAR ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7 INTO THE RIGHT COMMON FEMORAL ARTERY THROUGH THE SHEATH, THE PHYSICIAN FRACTURED THE MIDSHAFT OF THE CAT7. THEREFORE, THE PHYSICIAN SLOWLY PULLED AND REMOVED THE CAT7 UNDER FLUOROSCOPY OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW CAT7,A NEW LIGHTNING BOLT ASPIRATION TUBING, 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 20699211 ↗
• MalfunctionNov 1, 2024Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA RENAL GUIDE SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE GUIDE SHEATH INTO THE RIGHT FEMORAL ARTERY AND THEN INSERTED THE CAT7 INTO THE GUIDE SHEATH TO PLACE THE CAT7 IN THE LEFT LOWER EXTREMITY (LLE) ARTERY. WHILE ADVANCING AND TORQUING THE CAT7, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE CAT7. IT WAS NOTICED UNDER FLUOROSCOPY THAT THE CAT7 AND THE SHEATH WERE KINKED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE GUIDEWIRE THROUGH THE CAT7 BUT WAS UNSUCCESSFUL. WHILE ATTEMPTING TO REMOVE THE CAT7, THE CAT7 FRACTURED AT THE KINKED LOCATION AND ONLY PORTION OF THE CAT7 WAS REMOVED. THE SHEATH WAS ALSO NOTICED TO BE FRACTURED. THE PHYSICIAN THEN REMOVED THE REMAINDER OF THE CAT7 AND SHEATH. IT IS UNKNOWN HOW THE REMAINDER OF THE CAT7 AND THE SHEATH WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THE TORTUOUS ANATOMY WAS THE CAUSE OF THE FRACTURE. THE PROCEDURE WAS TERMINATED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588260 ↗
• MalfunctionSep 6, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL JUGULAR VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA SHEATH (7F), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 OVER THE GUIDEWIRE TO THE TARGET LOCATION AND COMPLETED THREE PASSES. IT WAS REPORTED THAT WHILE ASPIRATING, THE PHYSICIAN WAS SPINNING AND MANIPULATING THE CAT7 TO GET CIRCUMFERENTIAL COVERAGE OF THE VESSEL. NEXT, WHILE TORQUING THE CAT7, THE HUB OF THE CAT7 SEPARATED FROM THE CAT7; THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW CAT7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20162768 ↗
• MalfunctionAug 21, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT7 THROUGH THE SHEATH, THE PHYSICIAN FELT THAT THE CAT7 WAS FRACTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE CAT7 AND ONLY PART OF THE CAT7 CAME OUT. THE PHYSICIAN THEN REMOVED THE REMAINING PART OF THE CAT7 BY PULLING OUT THE SHEATH FROM THE BODY. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT AND SCHEDULED THE PATIENT FOR A SURGICAL THROMBECTOMY WITH FOGARTY BALLOON. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015631 ↗
• MalfunctionJul 26, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), A NON-PENUMBRA SHEATH, AND GUIDEWIRES (0.035 AND 0.014). IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT PERIPHERAL VASCULAR DISEASE (PVD), A PREVIOUSLY PLACED STENT, AND A BYPASS GRAFT. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE TO FOUR PASSES USING THE CAT7 AND LIGHTNING BOLT ASPIRATION TUBING. WHILE ADVANCING THE CAT7 OVER THE 0.035 GUIDEWIRE THROUGH THE SHEATH AND THE STENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE CAT7 WAS STUCK. THE 0.035 GUIDEWIRE WAS THEN EXCHANGED FOR THE 0.014 GUIDEWIRE. IT IS UNKNOWN WHETHER THE CAT7 WAS STUCK WITHIN THE STENT. THE PHYSICIAN THEN NOTICED THAT THE CAT7 APPEARED TO BE FRACTURED AT THE DISTAL END UNDER FLUOROSCOPY. WHILE REMOVING THE CAT7, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE CAT7 WAS ALSO TWISTED NEAR THE FRACTURE AT THE DISTAL END. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE FRACTURED PART OF THE CAT7. THE PATIENT WAS PLACED ON TISSUE PLASMINOGEN ACTIVATOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19843314 ↗
• MalfunctionMay 10, 2024Fracture; Difficult to Advance; Material Deformation; Fracture; Difficult to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 OVER THE GUIDEWIRE INTO THE TARGET LOCATION. IT WAS REPORTED THAT A PREVIOUSLY PLACED STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MADE IT DIFFICULT TO ADVANCE THE CAT7 INTO THE DISTAL AREA OF THE TARGET LOCATION. THE PHYSICIAN TORQUED THE CAT7 TO REDIRECT THE DISTAL END OF THE CAT7 PAST THE STENT AND NOTICED A KINK AT THE PROXIMAL END OF THE CAT7. THE PHYSICIAN THEN TRIED TO STRAIGHTEN OUT THE KINK WHEN THE CAT7 FRACTURED AT THE PROXIMAL END WHERE THE KINK HAD OCCURRED. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7, SAME LIGHTNING BOLT ASPIRATION TUBING, 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 19294214 ↗