Indigo System SEP8Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00814548016153), received between Aug 14, 2015 and Oct 28, 2021 — classified as 7 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT8. NEXT, THE PHYSICIAN DECIDED TO USE A SEP8. SUBSEQUENTLY, AFTER COMPLETING A PASS USING THE SEP8 AND CAT8, IT WAS NOTICED THAT THE BULB OF THE SEP8 BROKE OFF WITHIN THE CAT8. THEREFORE, THE CAT8 CONTAINING THE BROKEN BULB OF THE SEP8 WAS REMOVED AND BROKEN BULB OF THE SEP8 WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8. IT WAS REPORTED THAT THE PATIENT WAS ON SYSTEMIC THROMBOLYSIS FOR TWELVE HOURS AFTER THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715967 ↗
• MalfunctionMar 8, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ILLIO FEMORAL DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS USING THE SEP8 AND CAT8. THE SEP8 WAS THEN RETRACTED BACK INTO THE CAT8 TO CLEAR ANY CLOT AT THE TIP OF THE CAT8. HOWEVER, WHILE RE-ADVANCING THE SEP8, THE PHYSICIAN NOTICED THE DISTAL BULB OF THE SEP8 BROKE OFF. THE PHYSICIAN COULD NOT LOCATE THE BROKEN BULB OF THE SEP8 AND CONTINUED THE PROCEDURE USING THE CAT8 WITH ASPIRATION TO REMOVE THE CLOT AND CLEAR THE VESSEL. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE PHYSICIAN FOUND HARD MATERIAL ON THE FILTRATION INSIDE THE CANISTER WHICH WAS BELIEVED TO BE PIECES OF THE BROKEN BULB OF THE SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434613 ↗
• MalfunctionOct 2, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE SEP8. AFTER THE TWO PASSES, THE PATIENT BEGAN EXPERIENCING HEMOPTYSIS, AND THE SEP8 WAS REMOVED. UPON REMOVAL, THE BULB OF THE SEP8 WAS NOTICED TO BE SCRAPED ON THE PROXIMAL END AND APPEARED TO BE ON THE VERGE OF COMING OFF. THE PROCEDURE ENDED AT THIS POINT, AND THE PHYSICIAN DECIDED TO POSTPONE THE PROCEDURE. THE HEMOPTYSIS WAS REPORTED TO BE UNRELATED TO THE SEP8.

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

  MAUDE report 10622902 ↗
• MalfunctionAug 14, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT8 AND SEP8. SUBSEQUENTLY, THE BULB OF THE SEP8 DISLODGED AND BECAME STUCK INSIDE THE PATIENT¿S LEFT LUNG. THE PHYSICIAN DECIDED THAT IT MAY BE DETRIMENTAL TO THE PATIENT TO REMOVE THE BULB; THEREFORE, NO ATTEMPTS WERE MADE TO REMOVE THE BULB FROM THE LUNG. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8. 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 10409689 ↗
• MalfunctionAug 14, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL TO THE COMMON ILIAC VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE CAT8 AND SEP8. DURING THE THIRD PASS, IT WAS NOTICED THAT NO THROMBUS WAS BEING ASPIRATED OUT AFTER SOME TIME; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SEP8. UPON REMOVAL, IT WAS NOTICED THAT THE BULB OF THE SEP8 WAS MISSING. UNDER FLUOROSCOPY, THE PHYSICIAN SEARCHED FOR THE BULB OF THE SEP8; HOWEVER, THE PHYSICIAN DID NOT FIND THE BULB INSIDE THE PATIENT. IT WAS REPORTED THAT THE CANISTER WAS EMPTIED OUT BECAUSE THE PHYSICIAN SUSPECTED THAT THE BULB OF THE SEP8 MIGHT HAVE BEEN ASPIRATED WITH THE THROMBUS AFTER BREAKING OFF FROM THE SEP8. THE PROCEDURE WAS COMPLETED AFTER ASPIRATING A FEW MORE TIMES 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 10408933 ↗
• MalfunctionApr 17, 2019Physical Resistance/Sticking; 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 MADE MULTIPLE SUCCESSFUL PASSES USING THE CAT8 WITH THE SEP8 AND A NON-PENUMBRA SHEATH. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL TIP OF THE CAT8 WAS COLLAPSING; THEREFORE THE CAT8 WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ADVANCING THE SEP8, RESISTANCE WAS MET AFTER THE CAT8 COLLAPSED AND BECAME OVALIZED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT8 THE SAME SEP8 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 8525057 ↗
• MalfunctionJun 20, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE SEP8 BROKE AND EMBOLIZED. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE BROKEN SEP8 DUE TO THE PATIENT'S EXISTING CONDITIONS. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO A MASSIVE PULMONARY EMBOLISM, AND THE DEATH WAS UNRELATED TO THE INDIGO SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621572 ↗
• MalfunctionJun 18, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE SEP8 BROKE AND EMBOLIZED. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE BROKEN SEP8 DUE TO THE PATIENT''S EXISTING CONDITIONS. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO A MASSIVE PULMONARY EMOBLISM, AND THE DEATH WAS UNRELATED TO THE INDIGO SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7611868 ↗
• MalfunctionJan 4, 2018Break; Detachment Of Device Component; Material Separation; Break; Detachment Of Device Component; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, WHILE USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) WITH NO MENTION OF RESISTANCE, THE PHYSICIAN THOUGHT THAT THE SEP8 BULB HAD DETACHED AND DECIDED TO REMOVE THE SEP8. UPON REMOVAL, THE PHYSICIAN NOTED THAT THE SEP8 BULB WAS MISSING. THEREFORE, HE ATTEMPTED TO RETRIEVE THE DETACHED SEP8 BULB BY USING A FILTER THROUGH THE CAT8. AFTER THE FIRST ASPIRATION, THE PHYSICIAN NOTICED THAT ONLY ONE COMPONENT OF THE SEP8 CAME OUT SO HE PERFORMED A SECOND ASPIRATION AND WAS ABLE TO REMOVE THE SECOND COMPONENT. THE PROCEDURE WAS THEN COMPLETED USING THE SAME CAT8 AND ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163132 ↗
• MalfunctionJan 3, 2018Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, AFTER MULTIPLE PASSES WERE MADE USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), THE TIP AND BULB OF THE SEP8 BROKE OFF INSIDE OF THE CAT8. THE PHYSICIAN DID NOT MENTION FEELING ANY RESISTANCE WHILE USING THE SEP8 WITHIN THE CAT8. THEREAFTER, THE PHYSICIAN TURNED ON ASPIRATION AND ASPIRATED THE SEP8 TIP AND BULB OUT OF THE CAT8. THE PROCEDURE WAS THEN COMPLETED USING THE SAME CAT8 AND A NEW SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162899 ↗
• MalfunctionJun 29, 2017Device Slipped; Device Handling Problem; Device Slipped; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, AN INDIGO SYSTEM SEPARATOR 8 (SEP8) SLIPPED OFF THE TABLE AND BECAME CONTAMINATED. THE SEP8 SLIPPED OFF THE TABLE PRIOR TO USE AND THEREFORE, THE SEP8 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW INDIGO SYSTEM SEPARATOR 8 (SEP8).

  Patient problems: No Patient Involvement

  MAUDE report 6677647 ↗
• MalfunctionMay 30, 2017Fracture; Physical Resistance; Fracture; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN INFERIOR VENA CAVA (IVC) THROMBOSIS USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE SEP8 FROM AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AFTER COMPLETING A PASS. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE BULB OF THE SEP8 HAD FRACTURED IN THE CAT8 ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE RHV WAS REMOVED FROM THE CAT8 AND THE DETACHED BULB WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW SEP8, THE SAME RHV AND CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6598835 ↗
• MalfunctionMay 26, 2017Break; Physical Resistance; Break; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, AFTER MAKING SEVERAL PASSES WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), THE PHYSICIAN INSERTED THE SEP8 USING THE INTRODUCER SHEATH. RESISTANCE WAS EXPERIENCED WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SEP8 THROUGH THE HUB OF THE CAT8, THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SEP8. IT WAS THEN NOTICED THAT THE TIP OF THE SEP8 WAS MISSING. THE PHYSICIAN PERFORMED AN ANGIOGRAPHY TO SEARCH FOR THE TIP; HOWEVER THE PHYSICIAN COULD NOT FIND IT WITHIN THE PATIENT AND, THEREFORE, ASSUMED THE TIP HAD BEEN ASPIRATED AND WAS INSIDE THE CANISTER. THE PROCEDURE WAS THEN 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 6593896 ↗
• MalfunctionMay 17, 2017Bent; Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A SEP8 THROUGH AN INDIGO ASPIRATION SYSTEM CATHETER 8 (CAT8) ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN INADVERTENTLY BENT THE DISTAL TIP OF THE SEP8. THEREFORE, THE SEP8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT8 WITHOUT ANY ISSUE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572810 ↗
• InjuryApr 28, 2017Break; Material Separation; Device Dislodged or Dislocated; Break; Material Separation; Device Dislodged or Dislocated

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DEEP VEIN THROMBOSIS (DVT) IN THE LOWER LEFT EXTREMITY (LLE) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, WHILE USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), THE PHYSICIAN DID NOT MENTION ANY RESISTANCE; HOWEVER, THE BULB OF THE SEP8 BECAME DISLODGED FROM THE WIRE. THEREFORE, THE CAT8 AND THE REMAINDER OF THE SEP8 WERE REMOVED AND A SNARE DEVICE WAS USED TO REMOVE THE DISLODGED BULB. THE PHYSICIAN THEN RE-INSERTED THE CAT8 INTO THE PATIENT¿S BODY AND REMOVED THE REMAINING THROMBUS. A STENT WAS THEN PLACED TO TREAT THE ILIAC NARROWING AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6531982 ↗
• MalfunctionMar 31, 2017Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON FEMORAL VEIN USING INDIGO SYSTEM SEPARATOR 8 (SEP8) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) DEVICES. DURING THE PROCEDURE, WHILE IN USE WITH A CAT8, THE DISTAL TIP OF THE SEP8 BECAME LODGED IN THE CHRONIC, ORGANIZED CLOT IN THE TARGET VESSEL. WHILE THE SEP8 WAS BEING RETRACTED, THE SOFT WIRE DISTAL TO THE BULB STRETCHED. THE PHYSICIAN DID NOT MENTION RESISTANCE BUT THE SEP8 TIP COULD BE SEEN BUCKLING AGAINST THE THROMBUS. THE SEP8 WAS REMOVED AND THE PHYSICIAN CONTINUED THE PROCEDURE USING A NEW SEP8. WHILE REMOVING THE NEW SEP8 AFTER COMPLETING A PASS, THE BULB OF THE SEP8 WAS PULLED OFF THE WIRE AND REMAINED WITHIN THE ROTATING HEMOSTASIS VALVE (RHV). THE PHYSICIAN DID NOT MENTION RESISTANCE WHILE REMOVING THE SEP8. THE CAT8 WAS THEN REMOVED TO BE FLUSHED. WHILE AN ANGIOGRAM WAS BEING PERFORMED, THE NURSE WAS LOOPING THE CAT8 TO STORE ON THE TROLLEY AND INADVERTENTLY KINKED THE CAT8 AT THE MID-SHAFT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A COMBINATION OF DIRECT ASPIRATION AS WELL AS A SELECTION OF WIRES TO AGITATE THE THROMBUS THROUGH A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449598 ↗
• MalfunctionMar 31, 2017Entrapment of Device; Stretched; Deformation Due to Compressive Stress; Entrapment of Device; Stretched; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON FEMORAL VEIN USING INDIGO SYSTEM SEPARATOR 8 (SEP8) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) DEVICES. DURING THE PROCEDURE, WHILE IN USE WITH A CAT8, THE DISTAL TIP OF THE SEP8 BECAME LODGED IN THE CHRONIC, ORGANIZED CLOT IN THE TARGET VESSEL. WHILE THE SEP8 WAS BEING RETRACTED, THE SOFT WIRE DISTAL TO THE BULB STRETCHED. THE PHYSICIAN DID NOT MENTION RESISTANCE BUT THE SEP8 TIP COULD BE SEEN BUCKLING AGAINST THE THROMBUS. THE SEP8 WAS REMOVED AND THE PHYSICIAN CONTINUED THE PROCEDURE USING A NEW SEP8. WHILE REMOVING THE NEW SEP8 AFTER COMPLETING A PASS, THE BULB OF THE SEP8 WAS PULLED OFF THE WIRE AND REMAINED WITHIN THE ROTATING HEMOSTASIS VALVE (RHV). THE PHYSICIAN DID NOT MENTION RESISTANCE WHILE REMOVING THE SEP8. THE CAT8 WAS THEN REMOVED TO BE FLUSHED. WHILE AN ANGIOGRAM WAS BEING PERFORMED, THE NURSE WAS LOOPING THE CAT8 TO STORE ON THE TROLLEY AND INADVERTENTLY KINKED THE CAT8 AT THE MID-SHAFT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A COMBINATION OF DIRECT ASPIRATION AS WELL AS A SELECTION OF WIRES TO AGITATE THE THROMBUS THROUGH A NEW CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449553 ↗
• MalfunctionMar 31, 2017Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY USED THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) TO REMOVE THROMBUS. WHILE RETRACTING THE SEP8, THE TECHNOLOGIST ENCOUNTERED RESISTANCE AS THERE WAS CLOT ALL AROUND THE SEP8 BULB AND INTO THE ROTATING HEMOSTASIS VALVE (RHV). AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE SEP8 BULB WAS MISSING YET THE WIRE WAS INTACT. IT WAS BELIEVED THAT THE SEP8 BULB WAS ASPIRATED. THERE WAS STILL A SMALL AMOUNT OF CLOT REMAINING IN THE PATIENT. THEREFORE, THE PHYSICIAN COMPLETED THE PROCEDURE USING JUST THE CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6449392 ↗
• MalfunctionMar 28, 2017Break; Entrapment of Device; Material Separation; Break; Entrapment of Device; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, WHILE IN USE WITH ANOTHER MANUFACTURER¿S SHEATH AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), THE WIRE DISTAL TO THE SEP8 BULB BECAME DETACHED AND BROKE OFF IN THE PATIENT. CONSEQUENTLY, THE DETACHED WIRE BECAME LODGED IN THE CLOT. THE PHYSICIAN REMOVED REMAINDER OF THE SEP8 AND THEN ATTEMPTED TO ASPIRATE THE DETACHED WIRE USING THE CAT8 BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN LEFT THE WIRE IN THE PATIENT AND DOES NOT BELIEVE THAT IT WILL CAUSE HARM 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 6441486 ↗
• MalfunctionFeb 22, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Defective Device; Device Damaged Prior to Use; Out-Of-Box Failure; Defective Device

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP OF THE INDIGO SYSTEM (B)(4) WAS "DEFECTIVE". THE DEFECTIVE (B)(4) WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 6349543 ↗
• MalfunctionDec 13, 2016Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TREATING A PULMONARY EMBOLISM USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN USED A SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER (CAT8) FOR OVER TWO HOURS TO SUCCESSFULLY REMOVE THROMBUS. AFTER REMOVING THE SEP8 IN ORDER TO DE-CLOG THE CAT8, THE PHYSICIAN NOTICED THAT THE SEP8 BULB HAD SHEARED OFF. THEREFORE, THE PHYSICIAN OPENED A NEW SEP8 AND COMPLETED THE PROCEDURE USING THE SAME CAT8. AFTER COMPLETING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE SEP8 BULB WAS LODGED INTO A DISTAL PULMONARY BRANCH OF THE PATIENT'S LUNG. THE SEP8 BULB WAS LEFT IN THE PATIENT SINCE THE PHYSICIAN DOESN¿T BELIEVE THAT LEAVING THE SEP8 IN THE PATIENT¿S LUNG WOULD CAUSE ANY HARM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6172126 ↗
• InjuryNov 22, 2016Break; Entrapment of Device; Material Separation; Break; Entrapment of Device; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN OCCLUDED GRAFT USING AN INDIGO SEPARATOR SEPARATOR 8 (SEP8). IT WAS REPORTED THAT THE GRAFT WAS OCCLUDED AFTER A STENT DEVICE HAD BEEN PLACED IN THE PATIENT DURING A PREVIOUS PROCEDURE AND A BARE METAL STENT WAS PLACED NEAR THE PROXIMAL ANASTOMOSIS OF THE GRAFT; HOWEVER, THE STENT HAD MIGRATED DURING TO THE DISTAL ANASTOMOSIS. DURING THE CURRENT PROCEDURE TO TREAT THE OCCLUDED GRAFT, THE PHYSICIAN USED THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) TO SUCCESSFULLY REMOVED LOT OF THROMBUS FROM THE GRAPH BY WORKING PROXIMAL TO DISTAL. THE PHYSICIAN WAS ADVANCING AND RETRACTING THE SEP8 IN AND OUT OF THE CAT8 TOWARDS THE DISTAL END OF THE GRAFT NEAR WHERE THE BARE METAL STENT HAD MIGRATED TO CLEAR THROMBUS. DURING THIS PROCESS, THE SEP8 BULB APPEARED TO HAVE CAUGHT ONTO THE BARE METAL STENT AND CAME OFF WHEN THE PHYSICIAN PULLED THE SEP8 WIRE BACK. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE THE DETACHED BULB OUT BUT WAS UNSUCCESSFULLY. THEREFORE, THE PHYSICIAN REMOVED THE SEP8 FROM THE PATIENT AND THE DETACHED SEP8 BULB STAYED LODGED IN THE STENT DEVICE IN THE PATIENT. NEXT, THE PHYSICIAN PLACED A STENT GRAFT O

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

  MAUDE report 6122641 ↗
• MalfunctionNov 17, 2016Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ILIO-FEMORAL DEEP VEIN THROMBOSIS (DVT) USING INDIGO SYSTEM SEPARATORS 8 (SEP8) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, WHILE IN USE WITH THE CAT8, A SEP8 BULB BROKE OFF AFTER BEING USED DURING MULTIPLE PASSES. THE PHYSICIAN NOTICED THAT THE SEP8 BULB BROKE OFF WITHIN THE CAT8 UNDER FLUOROSCOPY AND THEREFORE THE SEP8 WAS REMOVED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN SEP8 BULB BY REMOVING THE CAT8. UPON INSPECTION OF THE CAT8 AFTER REMOVAL, THE PHYSICIAN NOTICED THE CAT8 TIP WAS KINKED AND STRETCHED DUE TO EXTENSIVE CLOT BURDEN. THE PHYSICIAN THEN DECIDED TO USE A NEW CAT8 WITH A NEW SEP8. HOWEVER, THE NEW SEP8 BULB BROKE OFF WHILE BEING USED TO CLEAR THE TIP OF THE CAT8 AS WELL. THE PHYSICIAN NOTICED THE BROKEN SEP8 BULB UNDER FLUOROSCOPY THEREFORE THE SEP8 WAS REMOVED AND THE PHYSICIAN THEN REMOVED THE CAT8 IN ORDER TO REMOVE THE BROKEN SEP8 BULB WITHIN IT. THE PHYSICIAN THEN RE-INSERTED THE SAME CAT8 INTO THE PATIENT¿S BODY AND COMPLETED THE PROCEDURE 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 6109931 ↗
• MalfunctionNov 17, 2016Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ILIO-FEMORAL DEEP VEIN THROMBOSIS (DVT) USING INDIGO SYSTEM SEPARATORS 8 (SEP8) AND INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, WHILE IN USE WITH THE CAT8, A SEP8 BULB BROKE OFF AFTER BEING USED DURING MULTIPLE PASSES. THE PHYSICIAN NOTICED THAT THE SEP8 BULB BROKE OFF WITHIN THE CAT8 UNDER FLUOROSCOPY AND THEREFORE THE SEP8 WAS REMOVED. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN SEP8 BULB BY REMOVING THE CAT8. UPON INSPECTION OF THE CAT8 AFTER REMOVAL, THE PHYSICIAN NOTICED THE CAT8 TIP WAS KINKED AND STRETCHED DUE TO EXTENSIVE CLOT BURDEN. THE PHYSICIAN THEN DECIDED TO USE A NEW CAT8 WITH A NEW SEP8. HOWEVER, THE NEW SEP8 BULB BROKE OFF WHILE BEING USED TO CLEAR THE TIP OF THE CAT8 AS WELL. THE PHYSICIAN NOTICED THE BROKEN SEP8 BULB UNDER FLUOROSCOPY THEREFORE THE SEP8 WAS REMOVED AND THE PHYSICIAN THEN REMOVED THE CAT8 IN ORDER TO REMOVE THE BROKEN SEP8 BULB WITHIN IT. THE PHYSICIAN THEN RE-INSERTED THE SAME CAT8 INTO THE PATIENT¿S BODY AND COMPLETED THE PROCEDURE 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 6109921 ↗
• MalfunctionNov 11, 2016Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SEP8 THROUGH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND THE BULB DETACHED FROM THE PUSHER WIRE AND WAS ASPIRATED. THE PHYSICIAN REMOVED THE SEP8, AND THEN ATTEMPTED TO CONTINUE WITH A NEW SEP8; HOWEVER, THE BULB BROKE OFF AND WAS ASPIRATED AGAIN. THE PROCEDURE WAS COMPLETED USING A DIFFERENT TREATMENT METHOD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6096296 ↗