Indigo System CAT6KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 00815948020405), received between Mar 22, 2019 and Dec 2, 2021 — classified as 1 injury, 108 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (83 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 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Material Deformation; Physical Resistance/Sticking; Suction Failure; Material Deformation; Physical Resistance/Sticking; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE GREATER SAPHENOUS VEIN (GSV) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED FEW PASSES USING THE CAT6. WHILE ATTEMPTING TO MAKE THE NEXT PASS, THE PHYSICIAN NOTICED A LOSS OF SUCTION. THEREFORE, THE CAT6 WAS REMOVED. UPON REMOVAL, THE PROXIMAL END OF THE CAT6 WAS FOUND TO BE KINKED. IT WAS REPORTED THAT SOME RESISTANCE WAS ENCOUNTERED BY THE PHYSICIAN WHILE ADVANCING AND RETRACTING THE CAT6. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER 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 12920843 ↗
• MalfunctionNov 24, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE CAT6 INTO THE SHEATH USING THE DILATOR, THE PHYSICIAN KINKED THE CAT6 AT THE DISTAL END. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (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 12872397 ↗
• MalfunctionOct 21, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING INDIGO SYSTEM ASPIRATION CATHETER 6S (CAT6), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ASPIRATED SOME CLOT USING THE NON-PENUMBRA CATHETER. THEN, THE PHYSICIAN ADVANCED A CAT6 TO THE TARGET VESSEL THROUGH THE SHEATH. IT IS UNKNOWN IF A PEEL AWAY SHEATH WAS USED WITH THE CAT6. SUBSEQUENTLY, THE PHYSICIAN ASPIRATED AND REMOVED CLOT USING THE CAT6. UPON REMOVAL OF THE CAT6, THE PHYSICIAN NOTICED THE CAT6 WAS KINKED AT THE DISTAL END. IT WAS ALSO REPORTED THAT THE PHYSICIAN FLUSHED AND WIPED THE CAT6 WITH SALINE PRIOR TO INSERTION AND THAT THE CAT6 WAS NOT ADVANCING AS WELL AS NORMAL. NEXT, WHILE ADVANCING ANOTHER CAT6 TO THE TARGET VESSEL THROUGH THE SHEATH USING THE PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT6 AT THE DISTAL END. THEREFORE, THE CAT6 WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN FLUSHED AND WIPED THE CAT6 WITH SALINE PRIOR TO INSERTION. THE PROCEDURE WAS COMPLETED USING THE PREVIOUSLY USED NON-PENUMBRA CATHETER AND ANOTHER NON-PENUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12675173 ↗
• MalfunctionOct 8, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY (POP) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6)AND NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT6 INTO THE GUIDE SHEATH FOR THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE CAT6. UPON REMOVAL OF THE CAT6, THE PHYSICIAN NOTICED THE DISTAL END OF THE CAT6 WAS KINKED. THEREFORE, THE CAT6 WAS NOT USED. IT WAS REPORTED THAT THE PHYSICIAN USED THE CAT6 PEEL AWAY SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW 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 12601743 ↗
• MalfunctionSep 30, 2021Break; 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 6 (CAT6) AND A NON PENUMBRA 6 FR GUIDE SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT6 THROUGH THE GUIDE SHEATH AND INTO THE TARGET LOCATION THROUGH A CONTRALATERAL APPROACH AND ASPIRATED SOME CLOT; HOWEVER, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE. ON THE SECOND PASS, THE PHYSICIAN ENCOUNTERED MORE RESISTANCE AND THOUGHT THAT THE CAT6 HAD BECOME STUCK IN A PREVIOUSLY PLACED STENT. WHILE RETRACTING THE CAT6, THE PHYSICIAN ENCOUNTERED MORE RESISTANCE AND SUBSEQUENTLY NOTICED THAT THE DISTAL TIP OF THE CAT6 WAS SEPARATED BUT STILL INTACT. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO RETRIEVE THE DISTAL TIP OF THE CAT6 AND THE CAT6 WITHOUT ANY MEDICAL INTERVENTION. 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 12558222 ↗
• MalfunctionSep 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ARTERIAL POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), ASPIRATION TUBING (TUBING), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE CAT6 THROUGH THE SHEATH. THEREFORE, THE CAT6 AND PEEL AWAY SHEATH WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 AND A NEW PEEL AWAY SHEATH WITH THE SAME TUBING AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12500906 ↗
• MalfunctionSep 14, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA GUIDE SHEATH AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT6. WHILE ADVANCING THE CAT6 THROUGH A CALCIFIED LESION TO MAKE ANOTHER PASS, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CAT6. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6, A GUIDEWIRE 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 12471746 ↗
• MalfunctionAug 31, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE COMMON POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT HAD HEAVY CLOT BURDEN AND WAS UNCOOPERATIVE. DURING THE PROCEDURE, THE PEEL-AWAY INTRODUCER SHEATH WAS USED TO INTRODUCE THE CAT6 TO THE SHEATH. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED IMMEDIATELY UPON INTRODUCTION TO THE SHEATH AND THE DISTAL TIP OF A CAT6 BECAME OVALIZED. THEREFORE, THE CAT6 WAS REMOVED. NEXT, WHILE ADVANCING A CAT8 INTO THE SHEATH, THE SAME ISSUE OCCURRED. THEREFORE, THE CAT8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (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 12399242 ↗
• MalfunctionAug 26, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIOPERONEAL (TP) TRUNK USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE PASSES IN THE TARGET LOCATION USING THE CAT6. IT WAS REPORTED THAT A PEEL AWAY SHEATH WAS USED INITIALLY BUT NOT IN THE LATER PASSES. SUBSEQUENTLY, THE TIP OF THE CAT6 WAS KINKED WHILE ADVANCING IT THROUGH THE SHEATH. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12374948 ↗
• MalfunctionAug 23, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHEN ADVANCING THE CAT6 WITHOUT A PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE CAT6 BECAME STUCK IN THE SHEATH. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12354181 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL AND ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, THE CAT6 WAS OBSERVED TO BE KINKED MIDSHAFT UPON REMOVAL AFTER MULTIPLE PASSES WERE MADE THROUGH THE PERONEAL AND ANTERIOR TIBIAL ARTERY. SUBSEQUENTLY, THE CATRX ALSO KINKED MIDSHAFT UPON REMOVAL AFTER MULTIPLE PASSES THROUGH ANTERIOR TIBIAL ARTERY. IT WAS REPORTED THAT AT LEAST FIVE TO SIX PASSES WERE SUCCESSFULLY MADE WITH BOTH DEVICES PRIOR TO KINKING. THE PROCEDURE WAS COMPLETED USING A NEW CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12213175 ↗
• MalfunctionJul 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT6 INTO THE SHEATH USING THE PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND, SUBSEQUENTLY, KINKED THE DISTAL TIP OF THE CAT6. THEREFORE, THE CAT6 AND THE SHEATH WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 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 12186821 ↗
• MalfunctionJun 30, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN USED A CAT8 BUT REMOVED IT DUE TO THE OUTER DIAMETER BEING TOO BIG TO FIT INSIDE THE TARGET VESSEL. SUBSEQUENTLY, WHILE INSERTING THE CAT6 INTO THE SHEATH AND WITHOUT A PEEL AWAY SHEATH, THE TIP OF THE CAT6 OVALIZED. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12096083 ↗
• MalfunctionJun 29, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE CAT6 WITH THE SHEATH AND GUIDEWIRE TO ACCESS THE TIBIAL ARTERY. WHEN REMOVING THE CAT6 FROM THE TIBIAL ARTERY ON THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE DISTAL TIP OF THE CAT6 STRETCHED. IT WAS REPORTED THAT NO GUIDEWIRE WAS USED ON REMOVAL SO AS TO NOT DISLODGE ANY CLOT. THE PROCEDURE WAS COMPLETED USING A NEW 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 12088995 ↗
• MalfunctionJun 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE RIGHT CORONARY ARTERY (RCA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), NON-PENUMBRA GUIDE CATHETER AND 0.014 GUIDEWIRE. DURING THE PROCEDURE, THE CAT6 WITH A GUIDEWIRE WAS UNABLE TO ADVANCE PAST 5CM INTO THE GUIDE CATHETER, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE CAT6 WAS REMOVED. IT WAS REPORTED THAT A PEEL AWAY SHEATH WAS NOT USED WITH THE CAT6. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE THE THROMBUS USING A CATRX BUT WAS UNSUCCESSFUL. THE PROCEDURE ENDED AT THIS POINT, AND THE PATIENT WILL UNDERGO SURGERY FOR VEIN GRAFT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035176 ↗
• MalfunctionJun 4, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND PERONEAL ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A 7F NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A CAT6 TO THE TARGET VESSEL USING THE NON-PENUMBRA SHEATH, THE CAT6 WOULD NOT ADVANCE THROUGH THE TIBIAL ARTERY; THEREFORE, THE CAT6 WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE DISTAL TIP OF THE CAT6 WAS KINKED. NEXT, THE PHYSICIAN ADVANCED THE CATRX OVER THE GUIDEWIRE THROUGH THE GUIDEWIRE LUMEN AND COMPLETED APPROXIMATELY FIVE TO SEVEN PASSES IN THE TARGET VESSEL. WHILE RETRACTING THE CATRX AFTER THE COMPLETION OF THE LAST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL TIP OF THE CATRX BROKE OFF. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED DISTAL TIP OF THE CATRX. THE PROCEDURE WAS COMPLETED USING A NEW CATRX, THE SAME SHEATH, AND ANOTHER GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939436 ↗
• MalfunctionMay 27, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT6 BECAME KINKED AT THE HUB AS THE PHYSICIAN ADVANCED IT THROUGH THE SHEATH AND, THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898126 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL (AT) ARTERY AND THE DORSALIS PEDIS (DP) ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE CAT6 INTO THE SHEATH USING THE PEEL AWAY SHEATH, THE CAT6 KINKED NEAR THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 11806826 ↗
• MalfunctionApr 26, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN USED THE PEEL AWAY SHEATH TO INSERT THE CAT6 INTO THE SHEATH AND MADE ONE PASS. HOWEVER, THE PEEL AWAY SHEATH WAS NOT USED IN SUBSEQUENT PASSES WITH THE CAT6. WHILE INSERTING THE CAT6 AGAIN THROUGH THE SHEATH, THE CAT6 WAS KINKED AT THE DISTAL TIP. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 WITH THE PEEL AWAY SHEATH 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 11725439 ↗
• MalfunctionApr 22, 2021Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT6. WHILE ADVANCING THE CAT6 TO MAKE THE NEXT PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE DISTAL TIP OF THE CAT6 BECAME OVALIZED WHILE CROSSING AN OCCLUSION. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 WITH THE SAME SHEATH AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WITH A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710803 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY TWO TO THREE PASSES USING THE CAT6. SUBSEQUENTLY, WHILE TRACKING THE CAT6 THROUGH THE CLOT, THE TIP OF THE CAT6 BECAME KINKED. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (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 11682505 ↗
• MalfunctionMar 26, 2021Suction Problem; Material Deformation; Physical Resistance/Sticking; Suction Problem; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL TIBIAL ARTERIES AND TIBIOPERONEAL USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA. DURING THE PROCEDURE, UPON THE INITIAL ADVANCEMENT OF THE CAT6 THROUGH THE SHEATH AND WITH A PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. UNDER FLUOROSCOPY, THERE SEEMED TO BE MILD OVALIZATION OF CAT6 AT THE TIP. AFTER POSITIONING THE CAT6 TOWARDS THE CLOT AND TURNING ON TO NEGATIVE, THE CAT6 WAS NOT ASPIRATING OPTIMALLY. THEREFORE, THE CAT6 WAS REMOVED, AND THERE WAS A VISIBLE KINK APPROXIMATELY 2-3CM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (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 11577393 ↗
• MalfunctionMar 26, 2021Material Deformation; Physical Resistance/Sticking; Suction Failure; Material Deformation; Physical Resistance/Sticking; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), INDIGO SYSTEM SEPARATOR 6 (SEP6), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT6 WAS INSERTED INTO THE SHEATH AND ADVANCED TO THE TARGET LOCATION WITH THE PEEL AWAY SHEATH. IT WAS REPORTED THAT SLIGHT RESISTANCE WAS EXPERIENCED. SUBSEQUENTLY, THE PHYSICIAN BEGAN TO ASPIRATE BUT WAS NOT GETTING BLOOD RETURN. THE PHYSICIAN THEN INSERTED THE SEP6 INTO THE CAT6, BUT THE SEP6 WOULD NOT EXIT THE DISTAL END OF THE CAT6. THEREFORE, THE CAT6 AND SEP6 WERE REMOVED, AND THE PHYSICIAN FOUND THE DISTAL END OF THE CAT6 WAS KINKED. THE PROCEDURE WAS COMPLETED BY USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (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 11576599 ↗
• MalfunctionMar 16, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD THE CAT6 ONTO THE GUIDEWIRE, THE HOSPITAL TECHNOLOGIST KINKED THE DISTAL TIP OF THE CAT6. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497592 ↗
• MalfunctionMar 9, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), ASPIRATION TUBING (TUBING), AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE CAT6 WAS ADVANCED OVER THE GUIDEWIRE AND INTO THE PATIENT. SUBSEQUENTLY, THE GUIDEWIRE WAS REMOVED, AND THE PHYSICIAN NOTICED THAT THE CAT6 WAS NOT ASPIRATING AFTER CONNECTING TO THE TUBING AND CANISTER. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6, TUBING AND THE SAME CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445375 ↗