Indigo System CAT7DKIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00815948023970), received between May 6, 2021 and Apr 11, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA IN THE ARM USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH. THE CAT7D WAS ADVANCED TO THE TARGET LOCATION. UPON INITIATION OF ASPIRATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE CAT7D HAD FRACTURED. THE PHYSICIAN ELECTED TO REMOVE THE CAT7D. DURING WITHDRAWAL THROUGH THE SHEATH, THE CAT7D SEPARATED INTO TWO PIECES OUTSIDE THE PATIENT. THE DEVICE WAS REMOVED FROM THE ACCESS SITE WITHOUT THE NEED FOR A SNARE. THE PROCEDURE WAS ABORTED AT THAT POINT. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO A DIFFERENT OPERATING ROOM; HOWEVER, THIS WAS STATED TO BE UNRELATED TO THE CAT7D FRACTURE. THE PHYSICIAN ELECTED TO PROCEED USING A DIFFERENT TREATMENT APPROACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848757 ↗
• MalfunctionNov 20, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE UPPER ARM GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH (8F). THE PHYSICIAN PERFORMED ASPIRATION USING THE CAT7D. IT WAS UNKNOWN HOW PASSES WERE COMPLETED USING THE CAT7D. WHILE REMOVING THE CAT7D FROM THE SHEATH, THE PHYSICIAN NOTICED THAT THE CAT7D FRACTURED IN HALF. THE PROXIMAL END OF THE CAT7 WAS REMOVED. THE PHYSICIAN PERFORMED SURGICAL CUT DOWN AND REMOVED THE REMAINING DISTAL PORTION OF THE CAT7D. THE PROCEDURE WAS COMPLETED WITH AN OPEN THROMBECTOMY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604310 ↗
• MalfunctionDec 10, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A FISTULA USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A FEW PASSES USING THE CAT7D. NEXT, THE PHYSICIAN OVER TORQUED THE CAT7D AND SUBSEQUENTLY NOTICED UNDER FLUOROSCOPY THAT THE CAT7D FRACTURED AT THE MID-SHAFT IN THE PATIENT'S ARM. THE PHYSICIAN THEN REMOVED THE FRACTURED PART OF THE CAT7D USING A SNARE DEVICE AND ADDITIONALLY PERFORMED A CUT DOWN TO ACCOMMODATE THE CATHETER COMING OUT OF THE VESSEL AND INSERTED A NEW SHEATH TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894163 ↗
• MalfunctionOct 13, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEPHALIC VEIN GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7D THROUGH THE SHEATH AND TO THE FACE OF THE CLOT IN THE ARTERIOVENOUS (AV) GRAFT. WHILE ADVANCING AND RETRACTING THE CAT7D WITH ASPIRATION FOR APPROXIMATELY 90 SECONDS TO REMOVE CLOT IN THE VESSEL, THE PHYSICIAN FRACTURED THE CAT7D AT THE PROXIMAL END THAT WAS OUTSIDE OF THE SHEATH¿S VALVE. IT WAS REPORTED THAT APPROXIMATELY ONE INCH OF THE FRACTURED CAT7D WAS OUTSIDE OF THE SHEATH. THE PHYSICIAN INSERTED A GUIDEWIRE THROUGH THE FRACTURED CAT7D AND THEN INTENTIONALLY CUT THE PROXIMAL END OF THE CAT7D TO ADVANCE THE GUIDEWIRE FURTHER THROUGH THE CAT7D. AFTERWARDS, THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE FRACTURED CAT7D AND GUIDEWIRE TOGETHER AS A UNIT OUT FROM THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (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 17936041 ↗
• MalfunctionJan 4, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT BRACHIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 7D (SEP7D), AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D), INDIGO SYSTEM SEPARATOR 7 (SEP7), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE CAT7D AND SEP7D. WHILE MAKING THE SECOND PASS, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CAT7D, BUT THE PHYSICIAN DECIDED TO CONTINUE TO USE THE KINKED CAT7D. NEXT, UPON COMPLETING THE THIRD PASS, THE PHYSICIAN WAS REMOVING THE SEP7D; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE WIRE AT THE DISTAL BULB OF THE SEP7D BROKE OFF WITHIN THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE REMOVING THE CAT7D AND BROKE IT INTO TWO SEPARATE PIECES AT THE PROXIMAL END WHERE THE KINK HAD OCCURRED. THEREFORE, THE CAT7D WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PHYSICIAN DETERMINED IT WAS SAFE TO LEAVE THE BROKEN WIRE OF THE SEP7D IN THE VESSEL AND DECIDED TO PLACE A STENT TO COVER THE BROKEN WIRE INTO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED USING A NEW CAT7, LIGHTNING, AND A NEW SEP7. THERE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099672 ↗
• MalfunctionSep 22, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D). DURING THE PROCEDURE, WHILE TORQUEING THE CAT7 D IN THE TARGET LOCATION TO REMOVE CLOT, THE DISTAL END OF THE CAT7 D BROKE OFF. IT WAS REPORTED THERE WAS CHRONIC CLOT IN THE ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE BROKEN CAT7 D; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE REMAINING BROKEN CAT7 D. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15466120 ↗
• MalfunctionAug 20, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ARTERIOVENOUS FISTULA (AVF) VENOUS SEGMENT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE CAT7 D THROUGH THE SHEATH, THE PHYSICIAN WAS EXPERIENCING RESISTANCE AND WAS UNABLE TO ADVANCE THE CAT7 D. SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT7 D AT THE TRANSITION ZONE AND DECIDED TO REMOVE IT. HOWEVER, WHILE REMOVING THE CAT7 D OUT FROM THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND BROKE THE CAT7 D INTO TWO SEPARATE PIECES APPROXIMATELY 10 TO 15 CENTIMETERS FROM THE DISTAL END. IT WAS REPORTED THAT THERE WAS ENOUGH OF THE BROKEN PIECE OF THE CAT7 D OUT OF FROM THE SHEATH TO HOLD ONTO TO REMOVE IT. THEREFORE, THE CAT7 D WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 D 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 15263001 ↗
• MalfunctionAug 3, 2022Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEPHALIC VEIN AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7 D), AN 8F NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE CAT7 D WITH THE GUIDEWIRE INTO THE SHEATH USING THE INTRODUCER. NEXT, THE INTRODUCER WAS PUSHED TO THE PROXIMAL END OF THE CAT7 D, THE GUIDEWIRE WAS THEN REMOVED, AND THE PHYSICIAN-INITIATED ASPIRATION. AFTER ADVANCING AND RETRACING MULTIPLE TIMES WITH THE CAT7 D IN THE VESSEL, THE PHYSICIAN DECIDED TO REMOVE THE CAT7 D TO BE FLUSHED. HOWEVER, WHILE RETRACTING, THE PHYSICIAN KINKED THE CAT7 D APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL END AND CONSEQUENTLY, THE CAT7 D BROKE AT THE KINKED LOCATION. THEREFORE, THE CAT7 D WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 D WITH THE SAME INTRODUCER AND SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156805 ↗
• MalfunctionJun 14, 2022Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DIALYSIS GRAFT USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D) AND AN 8FR NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 D INTO THE CLOT, TORQUED IT THROUGH THE GRAFT, AND COMPLETED TWO PASSES USING THE CAT7 D. NEXT, THE PHYSICIAN ADVANCED THE CAT7 D WITH RESISTANCE TO THE TARGET LOCATION AND ASPIRATED CLOT FOR THE THIRD PASS. SUBSEQUENTLY, THE CAT7 D BECAME CLOGGED, AND THE PHYSICIAN REMOVED IT TO FLUSH. UPON FLUSHING THE CAT7 D, SALINE WAS NOTICED TO BE LEAKING AT THE MID-SHAFT AND THE CAT7 D WAS NOTICED TO BE BENT AT THE MID-SHAFT. THEREFORE, THE CAT7 D WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA BALLOON 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 14686376 ↗
• MalfunctionNov 23, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AND A 7F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT7 THROUGH THE SHEATH AND WHILE TORQUING, THE CAT7 BECAME OVALIZED. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863519 ↗
• MalfunctionOct 15, 2021Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA USING A ROTATING HEMOSTASIS VALVE (RHV), AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND AN INDIGO SYSTEM SEPARATOR 7 (SEP7). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES USING THE CAT7 AND THE SEP7. AFTER THE SECOND PASS, THE PHYSICIAN NOTICED THAT THE RHV WAS LEAKING BLOOD AND WOULD NOT HOLD ANY SUCTION. SUBSEQUENTLY, THE DISTAL PART OF THE RHV WAS FOUND TO BE BROKEN. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED BY BALLOONING THE TARGET VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12641268 ↗
• MalfunctionOct 2, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A VENOUS FISTULA USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA GUIDE SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES USING THE CAT7. NEXT, THE PHYSICIAN REMOVED THE CAT7 TO BE FLUSHED; HOWEVER, WHILE RETRACTING, RESISTANCE WAS ENCOUNTERED AND THE MID-SHAFT OF THE CAT7 WAS FOUND TO BE BROKEN UPON REMOVAL. THEREFORE, THE CAT7 WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12566313 ↗
• MalfunctionSep 3, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D). DURING THE PROCEDURE, WHILE ATTEMPTING TO TORQUE THE CAT7 D FROM THE ROTATING HEMOSTASIS VALVE (RHV) WHILE ASPIRATING CLOT, THE BACKEND OF THE RHV CAME APART AND COULD NOT BE PUT BACK INTO POSITION. THEREFORE, THE RHV AND THE CAT7 D WERE REMOVED. IT SHOULD BE NOTED THAT THERE WAS NO REPORTED ISSUE WITH THE CAT7 D. THE PROCEDURE WAS COMPLETED USING A NEW RHV AND A NEW CAT7 D. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424818 ↗
• MalfunctionJul 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE 3-5 PASSES USING THE CAT7; HOWEVER, DURING THE NEXT PASS WHILE ADVANCING THE CAT7 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT7 KINKED AT THE DISTAL END CLOSE TO THE TIP. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174692 ↗
• MalfunctionJun 17, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT ARTERIOVENOUS FISTULA (AVF) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY 3 PASSES USING THE CAT7. AFTERWARDS, IT WAS NOTICED THAT THE DISTAL TIP OF THE CAT7 WAS OVALIZED. THE TECHNICIAN TRIED TO FIX THE OVALIZED DISTAL TIP AND SUBSEQUENTLY MADE IT WORSE. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT7 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021167 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). DURING THE PROCEDURE, THE ROTATING HEMOSTASIS VALVE (RHV) BROKE WHEN TIGHTENING IT AND WAS UNABLE TO FORM A SEAL. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED BY PLACING THE TUBING DIRECTLY ON THE BACK OF THE CAT7 TO FINISH THE LAST PASS, AND A NEW RHV WAS NOT USED. IT WAS REPORTED THAT DISTAL EMBOLIZATION WAS NOTED AFTER ASPIRATION WITH THE CAT7. THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS GIVEN IA RTPA, AND A BALLOON ANGIOPLASTY PERFORMED. THIS EVENT WAS RESOLVED THE NEXT DAY ON (B)(6) 2021. THE PATIENT HAD IMPROVED FROM BASELINE. THE PERIPHERAL/ DISTAL EMBOLIZATION WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE CAT7 AND THE INDEX PROCEDURE.

  Patient problems: Thromboembolism

  MAUDE report 11972204 ↗
• MalfunctionJun 3, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT BRACHIAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE CAT7 INTO THE SHEATH, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE CAT7 WAS OVALIZED, AND THEREFORE, THE CAT7 COULD NOT ADVANCE PAST THE HUB OF THE SHEATH. CONSEQUENTLY, THE CAT7 WAS REMOVED AND NOT USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT METHOD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935441 ↗
• MalfunctionJun 3, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE MID SHAFT OF THE CAT7 BECAME KINKED UPON INSERTING INTO THE SHEATH AND PASSING THE LESION. THEREFORE, THE CAT7 WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTICED THERE WAS HYDROPHILIC COATING COVERING THE TIP OF THE CAT7 AFTER REMOVAL. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) 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 11931409 ↗
• MalfunctionMay 18, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ARTERIOVENOUS (AV) FISTULA USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7) AND NON-PENUMBRA SHEATH (8FR). DURING THE PROCEDURE, THE CAT7 KINKED AROUND THE MIDSHAFT WHEN ADVANCING THROUGH THE SHEATH. THEREFORE, THE CAT7 AND SHEATH WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATD AND NEW NON-PENUMBRA 8FR SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842132 ↗
• MalfunctionMay 6, 2021Break; Break

  ON (B)(6) 2021, THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). DURING THE PROCEDURE, THE ROTATING HEMOSTASIS VALVE (RHV) BROKE WHEN TIGHTENING IT AND WAS UNABLE TO FORM A SEAL. THEREFORE, THE RHV WAS REMOVED. THE PROCEDURE WAS COMPLETED BY PLACING THE TUBING DIRECTLY ON THE BACK OF THE CAT7 TO FINISH THE LAST PASS, AND A NEW RHV WAS NOT USED. IT WAS REPORTED THAT DISTAL EMBOLIZATION WAS NOTED AFTER ASPIRATION WITH THE CAT7. THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS GIVEN IA RTPA, AND A BALLOON ANGIOPLASTY PERFORMED. THIS EVENT WAS RESOLVED THE NEXT DAY ON (B)(6) 2021. THE PATIENT HAD IMPROVED FROM BASELINE. THE PERIPHERAL/ DISTAL EMBOLIZATION WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE CAT7 AND THE INDEX PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784815 ↗