Indigo System CAT3-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00814548016085), received between Dec 30, 2015 and Jun 28, 2024 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT3 THROUGH THE SHEATH AND PLACED IT IN THE TARGET LOCATION USING RIGHT FEMORAL ARTERY ACCESS. UPON RETRACTING THE CAT3, AFTER ASPIRATING CLOT FROM THE TARGET VESSEL, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE CAT3 WAS FRACTURED AT THE DISTAL END. THE FRACTURED SEGMENT OF THE CAT3 WAS RETRIEVED BY USING A 2MM BALLOON CATHETER AND FULLY 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 19639886 ↗
• MalfunctionMay 27, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE CAT3 FRACTURED. THEREFORE, THE CAT3 WAS REMOVED. 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 17015598 ↗
• MalfunctionMar 21, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) A NON-PENUMBRA SHEATH, A NON-PENUMBRA STENT, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT3. IT WAS REPORTED THE PHYSICIAN EXPERIENCED RESISTANCE DURING THE ENTIRE CASE DUE TO POTENTIALLY CHRONIC OR ATRIAL FIBRILLATION (AFIB) CLOT. WHILE RETRACTING THE CAT3 AFTER COMPLETION OF THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, UPON REMOVAL FROM THE PATIENT, THE PHYSICIAN NOTICED THE CAT3 BROKE OFF IN THE ILIAC ARTERY. IT WAS ALSO REPORTED THE CAT12, CAT8, AND CAT3 WERE USED COAXIALLY TO PERFORM THE ASPIRATION. NEXT, THE PHYSICIAN ATTEMPTED TO USE A BALLOON CATHETER TO SNARE THE BROKEN CAT3 FROM THE PATIENT; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN COMPLETED THE PROCEDURE BY STENTING THE BROKEN PIECE OF THE CAT3 AGAINST THE VESSEL WALL AND SURGICALLY REMOVED THE BROKEN CAT3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588463 ↗
• MalfunctionMar 20, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND A GUIDEWIRE. DURING THE PROCEDURE, IT WAS REPORTED THE CAT3 BROKE WHILE ADVANCING. NO ADDITIONAL INFORMATION ABOUT THE PROCEDURE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576577 ↗
• MalfunctionMay 18, 2021Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), AN INDIGO SYSTEM SEPARATOR 3 (SEP3), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A CAT3 TO THE TARGET VESSEL AND INITIATED ASPIRATION. WHILE ASPIRATING, THE PHYSICIAN NOTICED THE CAT3 WAS GETTING CLOGGED UP WITH THROMBUS. THEREFORE, THE PHYSICIAN DECIDED TO USE A SEP3 TO ASSIST THE CAT3. HOWEVER, WHILE ADVANCING THE SEP3 THROUGH THE CAT3, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SEP3 EXITED THE SIDE WALL OF THE CAT3 INSTEAD OF THE DISTAL END; THEREFORE, THE CAT3 AND SEP3 WERE REMOVED. UPON REMOVAL OF THE CAT3, THE PHYSICIAN NOTICED THAT THE LUMEN OF THE CAT3 WAS PUNCTURED APPROXIMATELY A FEW INCHES PROXIMAL FROM THE DISTAL END. IT WAS NOTED THAT THE SEP3 WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A LYSIS CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842253 ↗
• MalfunctionJul 8, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL AND POSTERIOR ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND INDIGO SYSTEM SEPARATOR 3 (SEP3). IT WAS REPORTED THAT A STENT WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) A FEW DAYS PRIOR TO THE PROCEDURE, AND AFTER THE STENT PLACEMENT, THE VESSELS BELOW-THE-KNEE (BTK) WERE FOUND OCCLUDED. DURING THE PROCEDURE, WHILE INSERTING THE SEP3 INTO THE CAT3, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SEP3 WAS LYING NEXT TO THE CAT3 INSTEAD OF BEING ADVANCED THROUGH THE CAT3. IT WAS CONCLUDED THERE WAS A HOLE SOMEWHERE ON THE CAT3. THEREFORE, THE CAT3 AND SEP3 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT3 AND THE SAME SEP3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248672 ↗
• MalfunctionJun 22, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND SHEATH. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE CAT3 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE CAT3 WAS REMOVED. UPON REMOVAL, THE MID-SHAFT OF THE CAT3 WAS OBSERVED TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT3. IT IS NOT KNOWN IF THE SAME SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10182212 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, WHILE LOADING THE CAT3 ON THE TERUMO GLIDEWIRE, THE HUB OF THE CAT3 BECAME BENT AND KINKED. THEREFORE, THE CAT3 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967996 ↗
• MalfunctionMar 27, 2020Break; Material Deformation; Suction Failure; Break; Material Deformation; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT3 THROUGH THE SHEATH, THEN INITIATED THE ASPIRATION; HOWEVER, NO ASPIRATION WAS OBSERVED AND THE CAT3 WAS THEREFORE REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE CAT3 WAS KINKED AT THE MIDSHAFT. THE PHYSICIAN THEN FLUSHED THE CAT3 AND IT SEPARATED IN TWO PIECES EXPOSING THE INNER COILING. THE PROCEDURE WAS COMPLETED USING A NEW CAT3 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892120 ↗
• MalfunctionMay 1, 2019Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN MADE FOUR SUCCESSFUL PASSES USING THE CAT6 WITH A NON-PENUMBRA SHEATH. THE PHYSICIAN THEN REMOVED THE ACCESS SHEATH IN EXCHANGE FOR A NEW NON-PENUMBRA SHEATH. HOWEVER, WHILE ATTEMPTING TO MAKE A FIFTH PASS, THE PHYSICIAN WAS UNABLE TO INSERT THE SAME CAT6 INTO THE NEW SHEATH USING THE CROSSCUT VALVE AND, THEREFORE, IT WAS REMOVED AND A NEW CAT6 WAS USED. NEXT, THE HOSPITAL TECHNICIAN OPENED A CAT3 AND WAS FOUND TO BE CRACKED. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT3 TO REMOVE THE THROMBUS DISTAL IN THE TIBIAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8571190 ↗
• MalfunctionApr 22, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3), THE PHYSICIAN REPORTED THAT THE CAT3 FRACTURED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8537685 ↗
• InjuryMar 29, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL PERONEAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE CAT3 WITHIN A NON-PENUMBRA SHEATH AND WAS ABLE TO REMOVE MOST OF THE THROMBUS. DURING A SECOND PASS, THE TIP OF THE CAT3 BROKE OFF WITHIN THE PATIENT IN THE DISTAL PERONEAL ARTERY. THE PHYSICIAN THEN USED A SNARE TO REMOVE THE TIP. THE PROCEDURE ENDED AT THIS POINT BECAUSE ALL THE THROMBUS HAD BEEN REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463024 ↗
• MalfunctionMar 6, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PROXIMAL END OF AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) BROKE IN THE PACKAGING. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT3.

  Patient problems: No Patient Involvement

  MAUDE report 8394232 ↗
• InjuryJan 10, 2019Material Fragmentation; Material Fragmentation

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE TIBIAL VESSEL ON (B)(6) 2018 USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). WHILE REMOVING THE CAT3 FROM THE NON-PENUMBRA SHEATH, THE CAT3 BEGAN TO DEFORM AND STRETCH. HOWEVER, THE PHYSICIAN THOUGHT THE ENTIRE CAT3 HAD BEEN REMOVED. THE PHYSICIAN THEN PERFORMED A FLUOROSCOPY AND CONFIRMED THE VESSEL WAS CLEAR OF THROMBUS, SO THE PROCEDURE ENDED AFTER THE CAT3 HAD BEEN REMOVED. ON (B)(6) 2018 OR (B)(6) 2018, THE PATIENT UNDERWENT A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND IT WAS CONFIRMED THAT THE VESSELS WERE STILL PATENT AND NO RETAINED FOREIGN BODY WAS REPORTED. HOWEVER, THE PATIENT PRESENTED WITH LEG PAIN AND WAS READMITTED WITH RE-OCCLUSION OF THE LEFT POPLITEAL ARTERY ON (B)(6) 2018. AN INITIAL ULTRASOUND SCAN OF THE LEFT POPLITEAL ARTERY REVEALED OCCLUSION WITH A LINEAR "TUBE LIKE" STRUCTURE WITHIN IT. A CT WAS ALSO PERFORMED SHOWING A RETAINED FOREIGN BODY WITHIN THE LEFT POPLITEAL ARTERY. THE PHYSICIAN THEN FOUND THAT 15 CM OF THE CAT3 HAD BROKEN OFF DURING THE INITIAL PROCEDURE IN THE PATIENT¿S POPLITEAL ARTERY, CAUSING THE VESSEL TO REOCCLUDE. THE PHYSICIAN THEREFORE PERFORMED ANOTHER PROCEDURE AND USED A SNARE D

  Patient problems: Reocclusion

  MAUDE report 8234332 ↗
• MalfunctionNov 23, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, WHILE ATTEMPTING TO CROSS A PARTIALLY DISSECTED SUPERFICIAL FEMORAL ARTERY (SFA), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE CAT3 BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING BALLOON CATHETERS. IT SHOULD BE NOTED THAT THERE IS NO RELATIONSHIP BETWEEN THE CAT3 AND THE SFA DISSECTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100104 ↗
• MalfunctionNov 12, 2018Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE CAT3 THROUGH A NON-PENUMBRA SHEATH AND IT BECAME KINKED. THE CAT3 WOULD NOT ADVANCE ANY FURTHER AND WAS, THEREFORE, REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT3 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059534 ↗
• MalfunctionOct 18, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING A CAT3 AND A NON-PENUMBRA SHEATH, THEN REMOVED THE CAT3 FOR CLEANING AS IT WAS NOT ASPIRATING WELL. WHILE REMOVING THE CAT3 FROM THE SHEATH, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE CAT3 WAS BROKEN. THEREFORE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7979175 ↗
• MalfunctionSep 27, 2018Stretched; Material Deformation; Stretched; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND MADE A PASS USING THE CAT3 IN THE TARGET LOCATION. UPON REMOVAL OF THE CAT3, THE HOSPITAL STAFF NOTICED THAT THE DISTAL THIRD OF THE CATHETER WAS COMPLETELY FLATTENED, COMPRESSED, AND APPEARED TO BE ELONGATED. THE PHYSICIAN FLUSHED THE CAT3 AND FOUND THROMBUS WAS PRESENT. THE PROCEDURE WAS COMPLETED USING A NEW CAT3 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916880 ↗
• MalfunctionSep 17, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING PREPARATION FOR A THROMBECTOMY, THE HOSPITAL TECHNOLOGIST FOUND THAT THE INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) WAS CUT IN HALF UPON REMOVAL FROM THE DISPENSER HOOP AND FLUSHING THE CAT3. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT3 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT3.

  Patient problems: No Patient Involvement

  MAUDE report 7881881 ↗
• MalfunctionSep 13, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A TIBIAL DISEASE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD A CAT3 OVER A GUIDEWIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT3 WOULD NOT ADVANCE. THE PHYSICIAN THEN CONTINUED TO ADVANCE THE CAT3 AND ITS DISTAL TIP BECAME CRUMPLED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873215 ↗
• MalfunctionSep 5, 2018Unraveled Material; Device Damaged Prior to Use; Unraveled Material; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) WAS UNRAVELING UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT3 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT3.

  Patient problems: No Patient Involvement

  MAUDE report 7847355 ↗
• MalfunctionAug 16, 2018Break; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Break; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT THERE WAS A KINK IN THE INDIGO SYSTEM CAT 3 ASPIRATION CATHETER (CAT3) AND IT LOOKED LIKE IT WAS COMING APART UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT3 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT3.

  Patient problems: No Patient Involvement

  MAUDE report 7791838 ↗
• MalfunctionJul 16, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). DURING THE PROCEDURE, AFTER REMOVING THE CLOT FROM THE TARGET VESSEL USING A CAT3 AND A NON-PENUMBRA SHEATH , THE PHYSICIAN REMOVED THE CAT3 TO TAKE AN ANGIOGRAM. UPON REMOVAL, IT WAS NOTICED THAT THE CAT3 WAS ALMOST CUT IN HALF. THE PROCEDURE WAS COMPLETED BY ADMINISTERING TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR A SECOND NIGHT DUE TO SUBOPTIMAL RESULTS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692327 ↗
• MalfunctionJun 29, 2018Hole In Material; Device Damaged Prior to Use; Out-Of-Box Failure; Hole In Material; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN FOUND THAT THE INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) WAS TORN AT THE HUB UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT3 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT3 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT3.

  Patient problems: No Patient Involvement

  MAUDE report 7651125 ↗
• InjuryJun 27, 2018Break; Physical Resistance; Mechanical Jam; Break; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIAL VASCULAR DISEASE USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A CAT3 THROUGH A NON-PENUMBRA SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND REMOVED THE CAT3. IT WAS REPORTED THAT THE SHEATH WAS KINKED CAUSING THE CAT3 TO GET STUCK AND BREAK AT THE TRANSITION POINT. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN CAT3 PIECE FROM THE PATIENT. THE PATIENT WAS PLACED ON LYSIS (THROMBOLYTIC) FOR ANOTHER DAY BECAUSE THE DISEASE WAS CHRONIC IN NATURE AND MINIMAL CLOT WAS REMOVED WITH THE CAT3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7642467 ↗