Indigo System SEP8-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00814548017440), received between Oct 20, 2016 and Jun 1, 2021 — classified as 2 deaths, 18 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Break” (38 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT POPLITEAL VEIN USING INDIGO SYSTEM SEPARATORS 8 (SEP8S) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, AFTER ADVANCING AND RETRACTING A SEP8 WITHIN THE CAT8 TO BREAK UP AND ASPIRATE CLOT FOR APPROXIMATELY ONE HOUR, THE WIRE DISTAL TO THE SEP8 BULB BROKE IN FRONT OF THE DISTAL TIP OF THE CAT8 IN THE TARGET VESSEL. THE PHYSICIAN THEN ASPIRATED THE BROKEN WIRE OF THE SEP8 USING THE CAT8. AN X-RAY CONFIRMED THAT THE WIRE DISTAL TO THE SEP8 BULB WAS NOT LEFT IN THE PATIENT AFTER ASPIRATION. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SEP8 INTO THE CLOT. NEXT, THE PHYSICIAN PROCEEDED WITH THE PROCEDURE USING A SECOND SEP8. AFTER ADVANCING AND RETRACTING THE SEP8 WITHIN THE CAT8 TO BREAK UP AND ASPIRATE CLOT FOR APPROXIMATELY TWO AND A HALF HOURS, THE WIRE DISTAL TO THE SEP8 BULB BECAME DAMAGED. THE PHYSICIAN THEN RETRACTED THE ENTIRE SEP8 OUT OF THE PATIENT¿S BODY. WHILE INSPECTING THE SEP8 ON THE BACK TABLE, THE WIRE DISTAL TO THE SEP8 BULB BROKE, AND THE PHYSICIAN OBSERVED THAT THE WIRE WAS STRETCHED. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917376 ↗
• MalfunctionNov 10, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA, ILIAC AND FEMORAL VEINS USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES USING THE SEP8 AND CAT8. AFTERWARDS, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 BROKE OFF. THEREFORE, THE BROKEN SEP8 DISTAL WIRE WAS ASPIRATED OUT USING THE CAT8. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT8. 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 10818097 ↗
• MalfunctionOct 23, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIOFEMORAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND A PENUMBRA ENGINE CANISTER. IT WAS NOTED THAT THE PATIENT HAD SEVERE ILIOFEMORAL DEEP VEIN THROMBOSIS. DURING THE PROCEDURE, THE SEP8 BULB BROKE OFF IN THE PATIENT. THE PHYSICIAN WAS ABLE TO CONTINUE THE THROMBECTOMY, AND SUCCESSFULLY ASPIRATED THE SEVERED TIP INTO THE CANISTER. 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 10731201 ↗
• MalfunctionOct 20, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL, POPLITEAL AND TRIFURCATION ARTERIES USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA SHEATH, A NON-PENUMBRA CATHETER AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES USING THE CAT8 AND SEP8. DURING THE FOURTH PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ASPIRATING THE CLOT IN THE FEMORAL ARTERY USING THE CAT8 AND SEP8. SUBSEQUENTLY, THE DISTAL END OF THE CAT8 KINKED AND THE DISTAL END OF THE SEP8 BENT THEN STRETCHED. THEREFORE, THE SEP8 AND CAT8 WERE REMOVED. NEXT, THE PHYSICIAN EXPERIENCE RESISTANCE WHILE ATTEMPTING TO ASPIRATE THROMBUS IN THE TRIFURCATION ARTERY USING THE CAT6 WITHOUT A SEPARATOR. SUBSEQUENTLY, THE DISTAL END OF THE CAT6 KINKED AND THEREFORE IT WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE USING A NON-PENUMBRA CATHETER BUT ENCOUNTERED DIFFICULTIES DUE TO THE THROMBUS BEING CHRONIC. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH AND CATHETER. 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 10708491 ↗
• MalfunctionOct 9, 2020Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE PASSES WITH THE DEVICES IN AN ATTEMPT TO CLEAR EXTENSIVE DEEP VEIN THROMBOSIS (DVT). SUBSEQUENTLY, THE SEP8 WAS WITHDRAWN IN ORDER TO FLUSH CLOT FROM THE CAT12. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE SEP8 WAS STRETCHED PROXIMAL TO THE BULB. THEREFORE, THE SEP8 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT12. 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 10656533 ↗
• InjuryAug 22, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC AND FEMORAL VEINS USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE TIP OF THE SEP8 BULB BROKE OFF AND LODGED IN THE CLOT WHILE USING THE SEP8 WITH THE CAT8. THEREFORE, THE SEP8 WAS REMOVED AND NO LONGER USED. NEXT, THE PHYSICIAN MADE SEPARATE ATTEMPTS TO REMOVE THE SEP8 TIP USING A SNARE DEVICE AND A BALLOON DEVICE. HOWEVER, ATTEMPTS TO RETRIEVE THE SEP8 TIP WERE UNSUCCESSFUL AND THE PHYSICIAN DECIDED TO LEAVE IT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440528 ↗
• InjuryJul 24, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) IN THE LEFT ILIAC ARTERY AND FEMORAL VEINS USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND, NON-PENUMBRA SHEATH (TERUMO). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE SEP8 AND CAT8. WHILE ADVANCING THE SEP8 FOR ANOTHER PASS, THE PHYSICIAN NOTICED AFTER SOME TIME THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 BROKE OFF IN THE LEFT ILIOFEMORAL VEIN. THE CAT8 AND SEP8 WERE THEREFORE REMOVED. IT WAS REPORTED THAT THE CAT8 WAS FOUND TO BE KINKED NEAR THE DISTAL TIP. THE PHYSICIAN THEN ADVANCED A NEW CAT8 TO ASPIRATE AND REMOVE THE BROKEN WIRE OF THE SEP8. IT WAS ALSO REPORTED THAT THE BROKEN PIECE OF THE SEP8 WAS OBSERVED ON THE BACK TABLE AND FLUOROSCOPY CONFIRMED THAT THE ENTIRE BROKEN WIRE PIECE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED THAT THE THROMBECTOMY PORTION OF THE PROCEDURE WAS SUFFICIENT AND COMPLETED THE PROCEDURE USING BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320422 ↗
• InjuryJun 19, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH IN THE RIGHT PULMONARY ARTERY, THEN ADVANCED THE CAT8 OVER THE GUIDEWIRE THROUGH THE SHEATH AND INTO THE LOWER LOBE OF THE RIGHT LUNG. NEXT, THE PHYSICIAN REMOVED THE GUIDEWIRE, ADVANCED THE SEP8 THROUGH THE CAT8 AND MADE TWO PASSES WITH ASPIRATION. THE SEP8 WAS THEN REMOVED AND THE PHYSICIAN ADVANCED THE GUIDEWIRE AND A 6F SELECT THROUGH THE CAT8 INTO THE RIGHT UPPER LUNG. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND 6F SELECT, THEN ADVANCED THE SEP8 THROUGH THE CAT8. NEXT, ASPIRATION WAS INITIATED. WHILE ADVANCING AND RETRACTING THE SEP8, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE SEP8 HAD BROKEN OFF. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE BROKEN DISTAL TIP OF THE SEP8 USING THE CAT8, HOWEVER IT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE PHYSICIAN THOUGHT THAT THE BROKEN DISTAL TIP OF THE SEP8 WAS STUCK IN THE CLOT; THEREFORE, THE PHYSICIAN USED A NEW SEP8 TO ATTEMPT

  Patient problems: Death; Heart Failure

  MAUDE report 10174399 ↗
• MalfunctionMay 15, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) IN THE FEMORAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN USED THE SEP8 WITH THE CAT8 SEVERAL TIMES TO REMOVE MUCH OF THE EXISTING THROMBUS. AFTER APPROXIMATELY ONE HOUR, THE PHYSICIAN OBSERVED THAT NO THROMBUS WAS BEING ASPIRATED OUT EVEN THOUGH THE SEP8 WAS BEING USED. THE PHYSICIAN THEN NOTICED THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 BROKE OFF IN THE CAT8. THEREFORE, THE SEP8 WAS REMOVED AND THE BROKEN WIRE OF THE SEP8 WAS ASPIRATED THROUGH THE CAT8 INTO THE CANISTER. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 WITH THE SAME CAT8 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10061495 ↗
• InjuryApr 13, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND, NON-PENUMBRA SHEATH. AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN NOTICED THE DISTAL PART OF THE SEP8 WAS LODGED INTO THE VESSEL WALL UNDER FLUOROSCOPY. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DISTAL PART OF THE SEP8; HOWEVER, IT WAS UNSUCCESSFUL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9954457 ↗
• MalfunctionFeb 19, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND, A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER USING THE SEP8 AND CAT8 IN THE TARGET VESSEL FOR APPROXIMATELY 10 MINUTES, THE PHYSICIAN REMOVED THE SEP8 AND FOUND THE DISTAL TIP TO BE KINKED. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8, SHEATH AND BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729828 ↗
• MalfunctionFeb 1, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA 9F SHEATH INTRODUCER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 OVER THE GUIDEWIRE THROUGH THE 9F SHEATH TO THE TARGET SITE. THE GUIDEWIRE WAS THEN REMOVED AND THE SEP8 WAS ADVANCED THROUGH THE CAT8. NEXT, ASPIRATION WAS INITIATED. WHILE ADVANCING THE SEP8 IN AND OUT OF THE CAT8, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 WAS BROKEN. THEREFORE, THE BROKEN SEP8 WAS ASPIRATED OUT USING THE CAT8. THE PROCEDURE WAS COMPLETED USING THE CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656399 ↗
• MalfunctionFeb 1, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA 9F SHEATH INTRODUCER, AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT8 OVER THE GUIDEWIRE THROUGH THE 9F SHEATH TO THE TARGET SITE. THE GUIDEWIRE WAS THEN REMOVED AND THE SEP8 WAS ADVANCED THROUGH THE CAT8. NEXT, ASPIRATION WAS INITIATED. WHILE ADVANCING THE SEP8 IN AND OUT OF THE CAT8, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 WAS BROKEN. THEREFORE, THE BROKEN SEP8 WAS ASPIRATED OUT USING THE CAT8. THE PROCEDURE WAS COMPLETED USING THE CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656361 ↗
• MalfunctionDec 23, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A FEMOROPOPLITEAL BYPASS USING INDIGO SYSTEM SEPARATORS 8 (SEP8S), AN INDIGO SYSTEM ASPIRATION CATHETER 8, AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE CAT8 WAS PLACED THROUGH THE SHEATH IN THE TARGET VESSEL. WHILE ADVANCING THE SEP8 IN AND OUT OF THE CAT8, THE PHYSICIAN WAS INITIALLY ABLE TO ASPIRATE THE FRESH CLOT QUICKLY BUT SUDDENLY NOTICED THERE WAS NO ONE-TO-ONE MOVEMENT WITH THE SEP8 AND CAT8. SUBSEQUENTLY, THE SEP8 WAS REMOVED, AND UPON REMOVAL, THE PHYSICIAN NOTICED THE TIP OF THE SEP8 HAD BROKEN OFF INSIDE THE VESSEL. THE CAT8 WAS THEN REMOVED, FLUSHED, AND RE-ADVANCED THROUGH THE SHEATH TO SUCCESSFULLY ASPIRATE AND RETRIEVE THE BROKEN TIP. THE PHYSICIAN CONTINUED THE PROCEDURE AND ATTEMPTED TO USE A SECOND SEP8 WITH THE CAT8 TO ASPIRATE BUT THE DISTAL CLOT WAS TOO OLD AND ORGANIZED; THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. UPON REMOVAL, THE DISTAL END OF THE CAT8 APPEARED ¿SQUEEZED,¿ BUT THERE WAS NO NOTICEABLE DAMAGE TO THE SECOND SEP8. THE PHYSICIAN THEN PERFORMED OPEN SURGERY VIA CUTDOWN TECHNIQUE TO REMOVE THE DISTAL CLOT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513539 ↗
• InjuryDec 11, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUDED ARTERIOVENOUS (AV) FISTULA GRAFT USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES USING THE SEP8 WITH AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) AND A SHEATH. WHILE REMOVING THE SEP8 AFTER COMPLETION OF THE PROCEDURE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE WIRE ON THE DISTAL TIP OF THE SEP8 HAD BROKEN OFF. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE THE BROKEN WIRE AND CAPTURE IT USING A NON-PENUMBRA EMBOLIC PROTECTION DEVICE; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO LEAVE THE BROKEN WIRE AND BELIEVED THERE WAS NO RISK TO THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9452375 ↗
• MalfunctionNov 25, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING AN INDIGO SYSTEM SEPARATOR 8S (SEP8S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA 9F SHEATH. NEXT, THE PHYSICIAN REMOVED THE SEP8 TO BE FLUSHED; HOWEVER, WHILE RETRACTING, RESISTANCE WAS ENCOUNTERED AND THE SEP8 DISTAL TIP WAS FOUND TO BE KINKED UPON REMOVAL. THE PHYSICIAN ADVANCED A NEW SEP8 AND MADE ANOTHER PASS; HOWEVER, WHILE REMOVING THE SEP8 TO BE FLUSHED, THE PHYSICIAN ENCOUNTERED THE SAME RESISTANCE AND THE DISTAL TIP OF THE SEP8 WAS FOUND TO BE KINKED UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER SEP8, THE SAME CAT8 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372157 ↗
• MalfunctionNov 25, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING AN INDIGO SYSTEM SEPARATOR 8S (SEP8S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA 9F SHEATH. NEXT, THE PHYSICIAN REMOVED THE SEP8 TO BE FLUSHED; HOWEVER, WHILE RETRACTING, RESISTANCE WAS ENCOUNTERED AND THE SEP8 DISTAL TIP WAS FOUND TO BE KINKED UPON REMOVAL. THE PHYSICIAN ADVANCED A NEW SEP8 AND MADE ANOTHER PASS; HOWEVER, WHILE REMOVING THE SEP8 TO BE FLUSHED, THE PHYSICIAN ENCOUNTERED THE SAME RESISTANCE AND THE DISTAL TIP OF THE SEP8 WAS FOUND TO BE KINKED UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER SEP8, THE SAME CAT8 AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372152 ↗
• MalfunctionNov 22, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT SUBCLAVIAN VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY FOUR PASSES IN THE TARGET VESSEL USING THE SEP8 AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). ON THE NEXT PASS, THE PHYSICIAN NOTICED THAT THE TIP OF THE SEP8 HAD BROKEN OFF IN THE PULMONARY ARTERY UNDER FLUOROSCOPY; THEREFORE, THE PHYSICIAN ATTEMPTED TO SUCK OUT THE THE TIP USING THE CAT8 BUT WAS UNABLE TO RETRIEVE IT. SUBSEQUENTLY, THE TIP WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO GET THE REST OF THE CLOT OUT, AND THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9364097 ↗
• MalfunctionNov 20, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND RETRACTED THE SEP8 WITHIN AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) TO BREAK UP AND ASPIRATE THE CLOT FOR APPROXIMATELY 20 MINUTES. IT WAS REPORTED THAT THE PHYSICIAN INTERMITTENTLY ENCOUNTERED SLIGHT RESISTANCE WHILE RETRACTING THE SEP8 IN THE CAT8. THE PHYSICIAN THEN PERFORMED FLUOROSCOPY VISUALIZATION AND NOTICED THAT THE DISTAL WIRE TIP OF THE SEP8 HAD SEPARATED FROM THE BULB AND REMAINED IN THE PATIENT'S VESSEL. AN ATTEMPT WAS MADE TO ASPIRATE THE WIRE TIP USING THE CAT8; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO END THE PROCEDURE AND THE WIRE TIP REMAINED IN THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350126 ↗
• MalfunctionNov 12, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE LEFT POPLITEAL VEIN, FEMORAL VEIN, AND ILIAC VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). IT WAS NOTED THAT THE PATIENT HAD A VERY HIGH CLOT BURDEN EXTENDING FROM THE POPLITEAL VEIN UP TO THE BIFURCATION. PRIOR TO THE PROCEDURE THE PATIENT WAS GIVEN A LYSIS TREATMENT IN THE TARGET AREA FOR 40 HOURS TO SOFTEN THE CLOT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) INTO THE TARGET AREA AND REALIZED THAT A SEP8 WAS NEEDED. THE CAT8 WAS THEN REMOVED, FLUSHED, AND RE-ADVANCED INTO THE TARGET AREA FOLLOWED BY THE SEP8. THE PHYSICIAN PROCEEDED TO MAKE SEVERAL PASSES WITH THE CAT8 AND SEP8 BEFORE THE CAT8 BECAME FULL OF CLOT. THE CAT8 AND SEP8 WERE THEN REMOVED. WHILE FLUSHING THE CAT8 AND INDIGO SYSTEM ASPIRATION TUBING (TUBING) WITH A SYRINGE OF SALINE, THE NURSE NOTICED THAT CLOT WAS STUCK SOMEWHERE IN THE FLOW SWITCH. THE NURSE BEGAN FLUSHING THE FLOW SWITCH WITH SALINE AND FOUND THAT THE DISTAL WIRE TIP OF THE SEP8 HAD BROKEN OFF DURING THE PROCEDURE AND HAD BEEN ASPIRATED INTO THE FLOW SWITCH. THE TIP WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW SEP8, THE SAME CAT8, AND T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9311273 ↗
• MalfunctionSep 24, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM CAT 8 ASPIRATION CATHETER (CAT8). DURING THE PROCEDURE, WHILE ADVANCING THE SEP8 IN AND OUT OF THE CAT8 IN THE TARGET VESSEL, THE SEP8 BECAME STUCK IN THE CAT8; THEREFORE, THE SEP8 AND CAT8 WERE REMOVED TOGETHER AS ONE UNIT. UPON REMOVAL, THE DISTAL TIP OF THE CAT8 WAS NOTICED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110051 ↗
• MalfunctionAug 28, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SEP8 THROUGH THE CAT8. SUBSEQUENTLY, THE SEP8 BECAME STUCK AT THE DISTAL END OF THE CAT8. THE SEP8 AND CAT8 WERE THEN REMOVED TOGETHER FROM THE PATIENT AND WERE NO LONGER USED IN THE PROCEDURE. UPON REMOVAL OF THE CAT8, THE PHYSICIAN NOTED A SMALL PINCH IN THE CATHETER AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941145 ↗
• MalfunctionJul 31, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INFERIOR VENA CAVA (IVC) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE WIRE TIP DISTAL TO THE SEP8 BULB BROKE OFF AND LODGED INTO THE WALL OF FIBROTIC CLOT IN THE TARGET VESSEL. THE PHYSICIAN MADE A DECISION TO LEAVE THE WIRE TIP IN THE CLOT AND REMOVE THE SEP8 FROM THE PROCEDURE. THE PROCEDURE WAS THEN COMPLETED USING A NEW SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847324 ↗
• MalfunctionJul 19, 2019Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN, COMMON FEMORAL VEIN AND FEMORAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). IT WAS NOTED THAT THE PATIENT HAD A HEAVY CLOT BURDEN. DURING THE PROCEDURE, AFTER COMPLETION OF A PASS USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH, THE SEP8 WAS REMOVED. IT WAS REPORTED THAT WHILE USING THE SEP8, NO RESISTANCE WAS EXPERIENCED; HOWEVER, UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE SEP8 WAS STRETCHED. THEREFORE, THE SEP8 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SEP8, THE SAME CAT8 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 8807792 ↗
• MalfunctionJul 17, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, AS THE PHYSICIAN WAS PASSING THE CAT8 THROUGH THE SHEATH, THE CAT8 KINKED. THE PHYSICIAN WAS ABLE TO SUCTION THE CLOT THROUGH THE CAT8 AND PASS THE SEP8 THROUGH THE DAMAGED PORTION OF THE CAT8 UNTIL IT WAS NO LONGER ABLE TO ADVANCE AT ALL DUE TO THE DAMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW CAT8 AND SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800603 ↗