Indigo System CATRXKITRecalls & reported problems

Summary

The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 00814548017556), received between Aug 30, 2017 and Apr 24, 2026 — classified as 1 death, 29 injuries, 309 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (130 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 339 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES TO PLACE A FEMORO-POPLITEAL BYPASS GRAFT USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE CATRX. WHILE ASPIRATING AND RETRACTING THE CATRX, THE CATRX FRACTURED MID-SHAFT WITHIN THE SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED SEGMENT FROM THE SHEATH WITH A SNARE DEVICE BUT WAS UNSUCCESSFUL. A BALLOON CATHETER WAS USED TO PIN THE FRACTURED SEGMENT OF THE CATRX TO THE SHEATH AND THE SHEATH CONTAINING THE FRACTURED SEGMENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW SHEATH AND LYSIS INFUSION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987933 ↗
• MalfunctionApr 11, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN A CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A GUIDEWIRE. DURING ADVANCEMENT OF THE CATRX OVER THE GUIDEWIRE AND INTO THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE CATRX BECAME STUCK ON THE GUIDEWIRE. WHILE RETRACTING THE CATRX AGAINST RESISTANCE IN ORDER TO CLEAN THE GUIDEWIRE, THE CATRX FRACTURED AT THE PROXIMAL END OF THE GUIDEWIRE LUMEN. IT WAS NOTED THAT ALL PORTIONS OF THE CATRX WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849082 ↗
• MalfunctionApr 1, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, A GUIDE CATHETER (6F), AND A GUIDEWIRE. TWO PASSES WERE COMPLETED USING THE CATRX. THE CATRX WAS THEN REMOVED FOR FLUSHING. UPON REMOVAL, THE CATRX FRACTURED. THE GUIDE CATHETER CONTAINING THE FRACTURED CATRX SEGMENT WAS REMOVED. IT WAS REPORTED THAT NO PORTION OF THE CATRX WAS LEFT IN THE PATIENT. THE PROCEDURE ENDED AT THIS POINT AND THE PATIENT WAS ADMINISTERED TISSUE PLASMINOGEN ACTIVATOR (TPA). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758657 ↗
• InjuryMar 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. THE PHYSICIAN COMPLETED ONE PASS USING THE CATRX. AFTER THE COMPLETION OF THE PROCEDURE, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE CATRX FRACTURED AT THE DISTAL END IN THE COMMON FEMORAL ARTERY (CFA). THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND A CUTDOWN SURGERY WAS PERFORMED TO REMOVE THE FRACTURED CATRX. NO PORTION OF THE CATRX WAS LEFT IN THE PATIENT'S BODY. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED THE NEXT DAY AND WAS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24602356 ↗
• MalfunctionDec 18, 2025Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA ASPIRATION CATHETER, AND A GUIDEWIRE. WHILE ADVANCING THE CATRX TOWARDS THE TARGET VESSEL THROUGH THE GUIDE CATHETER, THE PHYSICIAN DECIDED TO RETRACT THE CATRX TO GAIN BETTER ACCESS. RESISTANCE WAS ENCOUNTERED WHILE RETRACTING THE CATRX AND THE CATRX STRETCHED AND FRACTURED AT ITS DISTAL LENGTH. THE PHYSICIAN THEN USED A BALLOON CATHETER TO SECURE THE FRACTURED CATRX WITHIN THE GUIDE CATHETER AND THE SYSTEM WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838672 ↗
• MalfunctionDec 18, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE CATRX, SO THE PHYSICIAN DECIDED TO REMOVE THE CATRX. WHILE WITHDRAWING THE CATRX, THE CATRX FRACTURED AT THE MID-SHAFT. THE FRACTURED CATRX PIECE WAS RETRIEVED WITH A SNARE DEVICE. THE PROCEDURE WAS COMPLETED WITH AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837372 ↗
• MalfunctionOct 28, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT FEMORAL ARTERY THROUGH THE TIBIOFIBULAR TRUNK USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH DUE TO THROMBUS THAT TRAVELED DISTAL WITHIN THE VESSEL TOWARD THE FOOT DURING AN ANGIOPLASTY. DURING THE THROMBECTOMY PROCEDURE, AFTER ADVANCING THE CATRX INTO THE SHEATH AND CONNECTING THE TUBING, THE CATRX WAS NOTICED TO BE FRACTURED AT THE HUB. THEREFORE, THE CATRX WAS REMOVED BY HAND. A SECOND CATRX WAS OPENED. THE SECOND CATRX WAS ADVANCED INTO THE SHEATH AND WAS CONNECTED TO THE TUBING. THERE WAS NO FLOW INTO THE CANISTER. THE PHYSICIAN THEN NOTICED THE CATRX WAS FRACTURED. THE PROXIMAL PORTION OF THE CATRX WAS REMOVED. THE PHYSICIAN PERFORMED OPEN SURGERY TO REMOVE THE FRACTURED DISTAL SEGMENT OF THE CATRX. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401359 ↗
• MalfunctionSep 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED CONTRALATERAL ACCESS USING THE SHEATH. THE PHYSICIAN THEN ADVANCED THE CATRX THROUGH THE SHEATH TO THE TARGET LOCATION AND COMPLETED ONE PASS. WHILE ADVANCING THE CATRX OVER THE GUIDEWIRE THROUGH THE CATRX RAPID EXCHANGE LUMEN AND INTO THE SHEATH, THE CATRX BECAME DAMAGED AT THE DISTAL END. WHILE REMOVING THE CATRX, THE PHYSICIAN NOTICED THAT THE CATRX COMPLETELY FRACTURED AT THE PROXIMAL END. THE SHEATH CONTAINING THE CATRX FRACTURED SEGMENT WAS REMOVED. NO FRAGMENT OF THE CATRX REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER CATRX, 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 23101900 ↗
• MalfunctionSep 4, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, WHILE TORQUING THE CATRX IN THE TARGET LOCATION, THE CATRX FRACTURED AT THE MID-SHAFT. A SNARE DEVICE WAS USED TO RETRIEVE THE FRACTURED END OF THE CATRX. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964556 ↗
• MalfunctionAug 27, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RADIAL AND ULNAR ARTERIES USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE CATRX WAS ADVANCED VIA RADIAL ACCESS TO THE RADIAL ARTERY AND THROMBUS WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE CATRX TO THE ULNAR ARTERY, BUT IT WAS UNABLE TO TURN INTO THE ULNAR ARTERY USING RADIAL ACCESS. THE CATRX WAS REMOVED AND READVANCED INTO THE PATIENT USING THE RIGHT GROIN ACCESS. WHILE ATTEMPTING TO ADVANCE THE CATRX TO THE ULNAR ARTERY, THE CATRX FRACTURED IN TWO LOCATIONS. THE FRACTURED SEGMENTS OF THE CATRX WERE REMOVED USING A SNARE DEVICE. IT IS UNKNOWN IF A GUIDEWIRE WAS USED IN THE PROCEDURE. 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 22903179 ↗
• MalfunctionAug 25, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, NON-PENUMBRA GUIDE SHEATH, AND A .014 GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX OVER A GUIDEWIRE TO THE TARGET LOCATION FOR THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE CATRX. UPON RETRACTING THE CATRX, THE PHYSICIAN CONTINUED TO EXPERIENCE RESISTANCE AND THE CATRX FRACTURED OVER THE GUIDEWIRE. THE PHYSICIAN REMOVED THE GUIDEWIRE AND THE FRACTURED CATRX TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA CATHETER WITH THE SAME SHEATH AND SAME GUIDE SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885370 ↗
• MalfunctionAug 13, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL ULNAR ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH (6F). DURING THE PROCEDURE, WHILE ADVANCING THE CATRX TO THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE CATRX FRACTURED AT THE DISTAL END. THE PROXIMAL END OF THE CATRX WAS REMOVED AND A SNARE DEVICE WAS USED TO RETRIEVE THE CATRX FRACTURED SEGMENT. NO FRAGMENT OF THE CATRX WAS LEFT IN THE PATIENT. 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 22794834 ↗
• MalfunctionJul 30, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH (6FR). DURING THE PROCEDURE, WHILE ADVANCING THE CATRX, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CATRX HAD FRACTURED IN THE COMMON ILIAC ARTERY. THE CATRX WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW CATRX 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 22668630 ↗
• MalfunctionJul 24, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THE SHEATH WAS ALREADY IN PLACE PRIOR TO THE START OF THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET LOCATION USING THE CATRX. AFTER THE PASS, THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE CATRX OUT FROM THE SHEATH, BUT EXPERIENCED RESISTANCE AND NOTICED THE SHEATH HAD KINKED. IT WAS ALSO REPORTED THAT THE GUIDEWIRE WAS WRAPPED AROUND THE CATRX AND THE CATRX BECAME STUCK INSIDE THE SHEATH. WHILE PULLING BACK ON THE CATRX, THE PHYSICIAN NOTICED THE DISTAL END OF THE CATRX HAD FRACTURED IN THE PATIENT. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL END OF THE FRACTURED CATRX AND SHEATH. THE PHYSICIAN INSERTED A NEW NON-PENUMBRA SHEATH AND USED THE INDIGO SYSTEM LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) TO REMOVE THE DISTAL FRACTURED PORTION OF THE CATRX FROM THE PATIENT. THE ENTIRE FRACTURED CATRX WAS REMOVED AND NO PART OF THE CATRX WAS LEFT IN THE PATIENT. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22596322 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET LOCATION WITH THE CATRX. WHILE RETRACTING THE CATRX FROM POSTERIOR TIBIAL ARTERY, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE CATRX HAD FRACTURED. THE PROXIMAL PORTION OF THE CATRX WAS REMOVED. A SNARE DEVICE WAS USED TO REMOVE THE DISTAL PORTION OF THE CATRX. THE PROCEDURE WAS COMPLETED WITH A BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502702 ↗
• MalfunctionJul 10, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE MYOCARDIAL INFARCTION (AMI) WITH AN INFERIOR ST ELEVATION USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE MANIPULATING THE CATRX UP THE DISTAL THIRD OF THE TORTUOUS TARGET VESSEL, THE PHYSICIAN FRACTURED THE CATRX. THEREFORE, THE CATRX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469976 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE BIFURCATION WAS NOT STEEP, AND THE SHEATH WAS UP AND OVER ONTO THE CONTRALATERAL SIDE. IT WAS REPORTED THAT A STENT WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PRIOR TO THE USE OF CATRX. THE PHYSICIAN DECIDED TO USE THE CATRX TO REMOVE THE THROMBUS DISTAL TO THE STENT IN THE TIBIAL ARTERY. DURING THE PROCEDURE, THE CATRX WAS ADVANCED TO THE TARGET LOCATION, AND ONE PASS WAS COMPLETED. WHILE REMOVING THE CATRX, THE CATRX FRACTURED MID-SHAFT. THE PROXIMAL PORTION OF THE CATRX WAS REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DISTAL PORTION OF THE CATRX USING A SNARE DEVICE, HOWEVER, THE ATTEMPT WAS NOT SUCCESSFUL. A BALLOON CATHETER WAS USED TO REMOVE THE DISTAL SEGMENT OF THE CATRX. 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 22398445 ↗
• MalfunctionMay 30, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE CATRX WAS ADVANCED TO THE TARGET LOCATION TO ASPIRATE CLOT. THE PHYSICIAN DECIDED TO RETRACT THE CATRX. WHILE RETRACTING, RESISTANCE WAS EXPERIENCED. THE PHYSICIAN CONTINUED TO RETRACT AND FRACTURED THE CATRX AT THE MIDSHAFT IN THE TARGET VESSEL. THE BREAK WAS IDENTIFIED UNDER FLUOROSCOPY. A VASCULAR SURGEON PERFORMED A SURGICAL CUT DOWN TO REMOVE THE FRACTURED SEGMENT OF THE CATRX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119950 ↗
• MalfunctionApr 29, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY (AT) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM LIGHTNING BOLT ASPIRATION TUBING (LIGHTNING BOLT ASPIRATION TUBING), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN REMOVED THROMBUS IN THE POPLITEAL AND SUPERFICIAL FEMORAL ARTERY (SFA) USING THE CAT7 AND THE LIGHTNING BOLT ASPIRATION TUBING. IT WAS NOTED THAT THERE WAS STILL THROMBUS IN THE DISTAL AT VESSEL AND THE DECISION WAS MADE TO USE A CATRX. THE PHYSICIAN ADVANCED A GUIDEWIRE INTO THE DISTAL TIBIAL VESSEL AND INSERTED THE CATRX USING THE PEEL AWAY INTRODUCER OVER THE GUIDEWIRE AND INTO THE SHEATH VIA IPSILATERAL ACCESS. NEXT, THE PHYSICIAN MADE ONE PASS DOWN THE DISTAL AT USING THE CATRX AND DECIDED TO REMOVE THE CATRX TO BE FLUSHED. WHILE REMOVING THE CATRX UNDER ASPIRATION, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE PULLING BACK ON THE CATRX AFTER THE RAPID EXCHANGE PORT OF THE CATRX WAS OUTSIDE OF THE SHEATH. THE HOSPITAL TECHNOLOGIST CONTINUED TO PULL BACK ON THE CATRX AND UPON REMOVING THE MAJORITY OF THE CATRX OUT FROM THE SHEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931412 ↗
• MalfunctionApr 4, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER COMPLETING ONE PASS USING THE CATRX, THE CATRX WAS REMOVED TO BE FLUSHED. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE CATRX WAS DAMAGED. THEREFORE, THE CATRX WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774610 ↗
• InjuryMar 27, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, WHILE REMOVING THE CATRX, THE PROXIMAL END AND DISTAL END OF THE CATRX FRACTURED. THE PATIENT WAS TRANSFERRED TO AN OPERATING ROOM TO PERFORM OPEN SURGERY TO REMOVE THE FRACTURED DISTAL SEGMENT OF THE CATRX.

  Patient problems: Foreign Body In Patient

  MAUDE report 21709358 ↗
• MalfunctionMar 21, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NON-PENUMBRA SHEATH (6FR). DURING THE PROCEDURE, WHILE ADVANCING THE CATRX DOWN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PROXIMAL END OF THE CATRX. THE PHYSICIAN THEN ATTEMPTED TO STRAIGHTEN IT OUT; HOWEVER, THE CATRX FRACTURED. A SNARE DEVICE WAS USED TO REMOVE THE DISTAL PORTION OF THE CATRX. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATRX 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 21664747 ↗
• MalfunctionMar 20, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX THOUGH THE GUIDE CATHETER TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE CATRX. WHILE REMOVING THE CATRX, THE CATRX FRACTURED AT THE MIDSHAFT. THEREFORE, THE GUIDE CATHETER CONTAINING THE FRACTURED CATRX WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21659647 ↗
• MalfunctionFeb 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE CATRX INTO A CATHETER, THE DISTAL END OF THE CATRX FRACTURED. THE ENTIRE CATRX WAS THEN REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416581 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE CATRX WAS ADVANCED OVER THE GUIDEWIRE AND WAS SUCCESSFULLY USED IN ONE OF THE VESSELS. THE CATRX WAS ADVANCED TO A DIFFERENT VESSEL AS A DIAGNOSTIC CATHETER. AFTER THE CATRX WAS REMOVED, IT WAS NOTICED TO BE FRACTURED AT THE MID-SHAFT OVER THE GUIDEWIRE. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT EXPIRED. IT WAS REPORTED THAT THE PATIENT WAS EXTREMELY FRAGILE AND WAS CRASHING DURING THE ENTIRE CASE. THE PHYSICIAN DID NOT ATTRIBUTE THE DEATH TO THE PENUMBRA DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085850 ↗