Indigo System CAT6Recalls & reported problems

Summary

The FDA's MAUDE database contains 408 adverse event reports that list this exact device (DI 00814548016245), received between Oct 15, 2015 and Oct 11, 2022 — classified as 2 deaths, 7 injuries, 399 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (178 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 408 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND A POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A 7F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT6 THROUGH THE DISTAL PORTION OF THE SHEATH TO MAKE THE FIRST PASS, THE PHYSICIAN BROKE THE CAT6 IN HALF INTO TWO SEPARATE PIECES. THEREFORE, THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE BROKEN CAT6 THAT WAS IN THE SHEATH. THE PHYSICIAN DECIDED TO DO OPEN EMBOLECTOMY TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583685 ↗
• MalfunctionApr 5, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THROMBUS MASS HAD BEEN SEATED INSIDE AN UNCOVERED STENT CLOSE TO THE TIBIOPERONEAL TRUNK. DURING THE PROCEDURE, THE PHYSICIAN USED AN ANTEGRADE FEMORAL APPROACH TO PLACE THE SHEATH IN THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED THE CAT6 OVER THE GUIDEWIRE PROXIMAL TO THE THROMBUS IN FRONT OF THE STENT. NEXT, THE PHYSICIAN COMPLETELY REMOVED THE CLOT FROM THE STENT USING THE CAT6 UNDER CONTINUOUS ASPIRATION. AFTERWARDS, IT WAS NOTICED THAT ADDITIONAL THROMBUS MASS WAS LOCATED DISTAL TO THE STENT DUE TO THE STENT IMPLANTATION. THE THROMBUS WAS NOT PREVIOUSLY NOTICED. AS AN ADDITIONAL STEP, THE PHYSICIAN DECIDED TO REMOVE THE ADDITIONAL THROMBUS MASS THAT WAS DISTAL TO THE STENT. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT6 OVER THE GUIDEWIRE DURING THE ATTEMPT TO MAKE THE FIRST PASS. HOWEVER, THE PHYSICIAN CONTINUED TO ATTEMPT TO ADVANCE THE CAT6 OVER THE GUIDEWIRE. AFTER SEVERAL ATTEMPTS WERE MADE, THE PHYSICIAN WAS ABLE TO ADVANCE THE CAT6 OVER TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015636 ↗
• MalfunctionOct 12, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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 ONE PASS USING THE CAT6. AFTERWARDS, THE PHYSICIAN NOTICED THAT THE APPROXIMATELY THREE CENTIMETERS OF THE DISTAL END WAS OVALIZED. THEREFORE, THE CAT6 WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT6. THE PROCEDURE WAS COMPLETED USING A NEW CAT6, AN INDIGO SYSTEM SEPARATOR 6 (SEP6), 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 12619278 ↗
• MalfunctionSep 15, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENA CAVA USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE USING THE CAT6. IT SHOULD BE NOTED THAT THE SUPPLIED PEEL AWAY SHEATH WAS NOT USED WITH THE CAT6. WHEN THE CAT6 WAS REMOVED, THE DISTAL END OF THE CAT6 WAS OBSERVED TO BE KINKED. SUBSEQUENTLY, THE PHYSICIAN USED A SECOND CAT6. A PEEL AWAY SHEATH WAS NOT USED WITH THIS CAT6. AS THE PHYSICIAN TURNED ON ASPIRATION WHEN ADVANCING THE CAT6, THE DISTAL END OF THE CAT6 WAS NOTICED UNDER FLUOROSCOPY TO HAVE COLLAPSED. IT WAS REPORTED THE CAT6 WAS STILL IN THE INTRODUCER SHEATH. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NEW GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478202 ↗
• MalfunctionSep 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENA CAVA USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE USING THE CAT6. IT SHOULD BE NOTED THAT THE SUPPLIED PEEL AWAY SHEATH WAS NOT USED WITH THE CAT6. WHEN THE CAT6 WAS REMOVED, THE DISTAL END OF THE CAT6 WAS OBSERVED TO BE KINKED. SUBSEQUENTLY, THE PHYSICIAN USED A SECOND CAT6. A PEEL AWAY SHEATH WAS NOT USED WITH THIS CAT6. AS THE PHYSICIAN TURNED ON ASPIRATION WHEN ADVANCING THE CAT6, THE DISTAL END OF THE CAT6 WAS NOTICED UNDER FLUOROSCOPY TO HAVE COLLAPSED. IT WAS REPORTED THE CAT6 WAS STILL IN THE INTRODUCER SHEATH. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A NEW GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478197 ↗
• MalfunctionSep 10, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE, IN THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT 6) AND AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). DURING THE PROCEDURE, WHILE RETRACTING THE CAT 6 THROUGH THE CATD AT THE END OF THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, UPON REMOVAL, THE PHYSICIAN STRETCHED AND BROKE THE CAT 6 AT THE MID-SHAFT. 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 12456962 ↗
• MalfunctionSep 1, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) USING A PENUMBRA ENGINE (ENGINE), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM ASPIRATION TUBING (TUBING), AND A 6F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT6 AND THE TUBING WERE CONNECTED TO THE ENGINE. WHILE ADVANCING THE CAT6 THROUGH THE PROXIMAL THIRD OF THE SHEATH USING THE PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, RETRACTED THE CAT6. UPON REMOVAL OF THE CAT6, THE PHYSICIAN NOTICED THAT THE DISTAL ONE CENTIMETER OF THE CAT6 WAS KINKED. IT SHOULD BE NOTED THAT THERE WAS NO REPORTED ISSUE WITH THE TUBING. THE PROCEDURE WAS COMPLETED USING A NEW INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND A NEW 7F NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411543 ↗
• MalfunctionAug 11, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL AND POSTERIOR TIBIAL USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING A CAT6 USING A PEEL-AWAY SHEATH INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN STRETCHED AND OVALIZED THE DISTAL TIP OF THE CAT6; THEREFORE, THE CAT6 WAS REMOVED. THE PHYSICIAN THEN COMPLETED ONE PASS USING A NEW CAT6 THAT REMOVED SOME CLOT. AFTERWARDS, WHILE RE-INSERTING THE CAT6 THROUGH THE PEEL-AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE CAT6. SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT6; THEREFORE, THE CAT6 WAS REMOVED. THEN, WHILE ATTEMPTING TO ADVANCE A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN OVALIZED THE DISTAL END OF THE ACE68. THEREFORE, THE ACE68 AND 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 12307585 ↗
• MalfunctionAug 11, 2021Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL AND POSTERIOR TIBIAL USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING A CAT6 USING A PEEL-AWAY SHEATH INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN STRETCHED AND OVALIZED THE DISTAL TIP OF THE CAT6; THEREFORE, THE CAT6 WAS REMOVED. THE PHYSICIAN THEN COMPLETED ONE PASS USING A NEW CAT6 THAT REMOVED SOME CLOT. AFTERWARDS, WHILE RE-INSERTING THE CAT6 THROUGH THE PEEL-AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE CAT6. SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT6; THEREFORE, THE CAT6 WAS REMOVED. THEN, WHILE ATTEMPTING TO ADVANCE A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN OVALIZED THE DISTAL END OF THE ACE68. THEREFORE, THE ACE68 AND 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 12307580 ↗
• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT6 TO THE TARGET VESSEL AND INITIATED ASPIRATION. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE CAT6 WAS KINKED AND OVALIZED UPON REMOVAL. 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 12267217 ↗
• MalfunctionJul 22, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE CAT6 TO THE TARGET VESSEL USING THE PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND, SUBSEQUENTLY, KINKED THE PROXIMAL END OF THE CAT6. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5) 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 12210989 ↗
• MalfunctionJul 14, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PEEL-AWAY INTRODUCER SHEATH WAS USED TO INTRODUCE THE CAT6 TO THE SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE CAT6 THROUGH THE HEMOSTASIS VALVE. SUBSEQUENTLY, THE PHYSICIAN NOTICED CAT6 TO BE KINKED AT THE PROXIMAL END. THEREFORE, THE CAT6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A 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 12170091 ↗
• MalfunctionJun 30, 2021Failure to Advance; Material Deformation; Failure to Advance; 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 SHEATH. DURING THE PROCEDURE, UPON INTRODUCING THE CAT6 INTO THE SHEATH, THE CAT6 "ACCORDIONED" AND WOULD NOT ADVANCE. IT IS UNKNOWN IF A PEEL AWAY SHEATH WAS USED WITH THE CAT6. 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 12094941 ↗
• MalfunctionJun 10, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY USING AN INDIGO ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PEEL-AWAY INTRODUCER SHEATH WAS USED TO INTRODUCE THE CAT6 TO THE SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE THE CAT6 WAS PASSING THROUGH THE TUOHY AND THE DISTAL TIP OF THE CAT6 WOULD NOT ADVANCE MORE THAN TEN CENTIMETERS INTO THE SHEATH. UPON REMOVAL, THE PHYSICIAN NOTICED THE CAT6 WAS KINKED AND NEARLY BROKEN NEAR THE DISTAL SHAFT. THEREFORE, THE CAT6 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT6 AND A NEW TUOHY WITH THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977472 ↗
• MalfunctionJun 10, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, A CAT6 WOULD NOT ADVANCE 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 ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972139 ↗
• MalfunctionJun 7, 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 SHEATH. DURING THE PROCEDURE, THE CAT6 WAS NOTICED TO BE KINKED AT THE MIDSHAFT AND DISTAL END AFTER THE FIRST ASPIRATION. THEREFORE, THE CAT6 WAS NOT FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BALLOONING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953385 ↗
• MalfunctionMay 28, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BYPASS SYNTHETIC GRAFT FROM THE FEMORAL TO PERINEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE THE FIRST PASS USING THE CAT6, THE PHYSICIAN WAS UNABLE TO ADVANCE THE CAT6 PAST THE CLOT. CONSEQUENTLY, THE TIP OF THE CAT6 BECAME OVALIZED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A MANUAL ASPIRATION CATHETER AND BALLOONING WITH THE SAME SHEATH. IT WAS ALSO REPORTED THAT TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED OVERNIGHT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904653 ↗
• MalfunctionMay 27, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE MANDREL AT THE DISTAL END OF THE CAT6 WAS NOT INTACT AND THE DISTAL TIP OF THE CAT6 WAS KINKED UPON OPENING OF THE PACKAGING. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ADVANCE A GUIDEWIRE THROUGH THE CAT6 TO SEE IF THE GUIDEWIRE WOULD EXIT THE DISTAL END OF THE KINKED CAT6 BUT WAS UNSUCCESSFUL. CONSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RESHAPE THE TIP OF THE CAT6 AND ATTEMPT TO ASPIRATE; HOWEVER, LITTLE BLOOD WAS OBSERVED COMING THROUGH THE ASPIRATION TUBING, AND NO SUCTION OF THE CLOT WAS NOTED. THEREFORE, THE CAT6 WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO USE A RE-USED CAT6 THAT WAS PARTIALLY KINKED IN MULTIPLE PLACES DUE TO PREVIOUS USAGE BUT WAS UNSUCCESSFUL. THEREFORE, THE CAT6 WAS ALSO REMOVED. THE PROCEDURE ENDED AT THIS POINT. THE PHYSICIAN DECIDED TO ABANDON THE THROMBUS ASPIRATION AND OPTED TO PUT THE PATIENT IN SYSTEMIC THROMBOLYSIS FOR TWENTY-FOUR HOURS POST-PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898119 ↗
• MalfunctionMay 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT6. WHILE INSERTING THE CAT6 INTO THE SHEATH USING THE PEEL AWAY SHEATH TO MAKE ANOTHER PASS, THE PHYSICIAN KINKED THE DISTAL TIP OF THE CAT6. 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 11868015 ↗
• MalfunctionMay 20, 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 NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT6 WITH THE PEEL AWAY SHEATH UP AND OVER INTO THE CONTRA LATERAL SFA. IT WAS REPORTED THE PHYSICIAN HAD EXPERIENCED RESISTANCE WHILE ADVANCING THE CAT6 THROUGH THE SHEATH. WHEN THE CAT6 MET THE CLOT, THE CAT6 KINKED AT THE DISTAL END. THEREFORE, THE CAT6 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 11859459 ↗
• MalfunctionMay 5, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE CAT6 WAS ADVANCED OVER THE GUIDEWIRE AND INTO THE TARGET VESSEL. THE GUIDEWIRE WAS THEN REMOVED, AND THE FIRST PASS WAS COMPLETED USING THE CAT6. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN REINTRODUCING THE GUIDEWIRE BACK INTO THE CAT6; THEREFORE, THE CAT6 AND GUIDEWIRE WERE REMOVED AS A SYSTEM. CONSEQUENTLY, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE CAT6 TO BE KINKED WHEN RETRACTING THE GUIDEWIRE OUT FROM THE CAT6. THEREFORE, THE CAT6 WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETE 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 11780197 ↗
• MalfunctionApr 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A FISTULAGRAM USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHEN ADVANCING THE SHEATH WITH THE PEEL AWAY SHEATH OF THE CAT6 TO PENETRATE THE VALVE AND ACCESS THE VEIN, THE PEEL AWAY SHEATH OVERLAPPED WITH ITSELF, MAKING IT SO THAT CAT6 COULD NOT ADVANCE THROUGH THE PEEL AWAY SHEATH AND INTO THE PATIENT. THEREFORE, THE CAT6 WAS REMOVED. THE PHYSICIAN DECIDED TO USE BALLOONING TO DISSIPATE THE CLOT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734436 ↗
• MalfunctionApr 26, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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, WHILE ADVANCING THE CAT6 THROUGH THE SHEATH USING A PEEL AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE DISTAL TIP OF THE CAT6 BECAME OVALIZED. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND A BALLOON CATHETER WITH THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727324 ↗
• MalfunctionMar 8, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; 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. DURING THE PROCEDURE, WHILE INSERTING THE CAT6 INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE DISTAL END OF THE CAT6. THEREFORE, THE CAT6 WAS REMOVED. 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 11437818 ↗
• MalfunctionJan 29, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN USED THE TIP PROTECTOR TO INTRODUCE THE CAT6 TO THE SHEATH AND ENCOUNTERED RESISTANCE. THE CAT6 WAS THEN REMOVED AND THE PHYSICIAN NOTICED THE DISTAL TIP WAS STRETCHED. THEREFORE, THE CAT6 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT6, THE SAME GUIDEWIRE, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11254948 ↗