Indigo System SEP6Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00814548016146), received between Oct 8, 2015 and Mar 16, 2026 — classified as 2 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A PULMONARY EMBOLISM (PE) USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, AFTER COMPLETING TWO PASSES IN THE TARGET LOCATION USING THE SEP6 AND THE CAT8, THE PHYSICIAN REPORTED THAT THE SEP6 FELT DIFFERENT AND WAS NOT BREAKING APART THE THROMBUS AS EFFECTIVELY. AFTER REMOVING THE SEP6, THE BULB WAS FOUND FRACTURED. THE PHYSICIAN PERFORMED A CLINICAL ASSESSMENT AND A CONTRAST INJECTION UNDER FLUOROSCOPY AND WAS UNABLE TO LOCATE THE BULB OF THE SEP6 WITHIN THE PULMONARY VASCULATURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PATIENT REMAINED STABLE POST-PROCEDURE. IT WAS ALSO REPORTED THAT THE BULB OF THE SEP6 WAS NOT VISIBLY IDENTIFIED IN THE PENUMBRA ENGINE CANISTER (CANISTER) OR THE CAT8. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8.

  Patient problems: Insufficient Information

  MAUDE report 24612930 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND AN INTRODUCER SHEATH (6F). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET VESSEL USING THE CAT6 AND SEP6. THE PHYSICIAN THEN OBSERVED UNDER FLUOROSCOPY THAT THE BULB OF THE SEP6 HAD FRACTURED IN THE FEMORAL ARTERY AND USED THE CAT6 TO ASPIRATE FRACTURED BULB. A SECOND SEP6 AND THE SAME CAT6 WERE THEN USED TO CONTINUE THE PROCEDURE. AFTER THREE PASSES WITH THE SECOND SEP6, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE BULB OF THE SEP6 HAD FRACTURED IN THE FEMORAL ARTERY. IT WAS REPORTED THAT THE BULB OF THE SEP6 REMAINED IN THE PATIENT'S VESSEL FOR APPROXIMATELY 30 MINUTES BEFORE A CORONARY BALLOON WAS USED TO GUIDE THE BULB INTO THE CAT6, ALLOWING IT TO BE SUCCESSFULLY ASPIRATED FROM THE PATIENT. ARTERIAL FLOW WAS RESTORED AT THIS POINT AND THE PROCEDURE WAS DEEMED COMPLETE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858005 ↗
• MalfunctionDec 19, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND AN INTRODUCER SHEATH (6F). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET VESSEL USING THE CAT6 AND SEP6. THE PHYSICIAN THEN OBSERVED UNDER FLUOROSCOPY THAT THE BULB OF THE SEP6 HAD FRACTURED IN THE FEMORAL ARTERY AND USED THE CAT6 TO ASPIRATE FRACTURED BULB. A SECOND SEP6 AND THE SAME CAT6 WERE THEN USED TO CONTINUE THE PROCEDURE. AFTER THREE PASSES WITH THE SECOND SEP6, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE BULB OF THE SEP6 HAD FRACTURED IN THE FEMORAL ARTERY. IT WAS REPORTED THAT THE BULB OF THE SEP6 REMAINED IN THE PATIENT'S VESSEL FOR APPROXIMATELY 30 MINUTES BEFORE A CORONARY BALLOON WAS USED TO GUIDE THE BULB INTO THE CAT6, ALLOWING IT TO BE SUCCESSFULLY ASPIRATED FROM THE PATIENT. ARTERIAL FLOW WAS RESTORED AT THIS POINT AND THE PROCEDURE WAS DEEMED COMPLETE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858004 ↗
• MalfunctionOct 15, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY AND THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE USING THE SEP6; HOWEVER, REMOVAL OF THROMBUS WAS DEEMED SUCCESSFUL. BOTH THE CAT6 AND SEP6 WERE THEN REMOVED. UPON REMOVAL, THE SEP6 BULB WAS NOTED TO BE MISSING, AND WAS LATER FOUND IN THE RHV CONNECTED TO THE CAT6, WITH NO MATERIAL REMAINING IN THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294184 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE AFTER SEVERAL PASSES, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SEP6 BULB HAD FRACTURED. THEREFORE, THE SEP6 WAS REMOVED. THE SEP6 BULB WAS LATER FOUND INSIDE THE CANISTER. IT WAS REPORTED THAT NO MATERIAL WAS LEFT IN THE PATIENT. THERE WAS NO CALCIFICATION OR STENT IN THE LESION, AND THE SEP6 HAD BEEN USED FOR AN EXTENDED PERIOD. THE PROCEDURE WAS COMPLETED USING THE CAT6 ONLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293245 ↗
• MalfunctionMay 16, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER USING THE SEP6, IT WAS REPORTED THAT THE SEP6 BULB FRACTURED. THE PHYSICIAN THEN ASPIRATED THE SEP6 BULB FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039080 ↗
• MalfunctionMay 16, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT6 AND SEP6 TO THE TARGET VESSEL VIA FEMORAL ACCESS AND SUCCESSFULLY PERFORMED A PASS. IT WAS REPORTED THAT LARGE CLOTS WERE ASPIRATED EFFECTIVELY. HOWEVER, AS THE PROCEDURE PROGRESSED, THE PHYSICIAN NOTICED THAT THE SEP6 WAS NO LONGER EFFECTIVE AND DECIDED TO REMOVE IT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE BULB OF THE SEP6 WAS PARTIALLY FRACTURED AND ONLY 1/8 OF THE BULB REMAINED. IT WAS REPORTED THAT NO FRAGMENTS OF THE SEP6 BULB COULD BE LOCATED, AND THAT THE FRAGMENTS MAY HAVE BEEN FLUSHED OUT. THE PHYSICIAN THEN USED A SECOND SEP6 WITH THE SAME CAT6 TO CONTINUE THE PROCEDURE. AFTER COMPLETING TWO PASSES IN THE TARGET VESSEL USING THE SEP6 AND CAT6, THE BULB OF THE SEP6 FRACTURED WITHIN THE CAT6. THEREFORE, THE SEP6 AND CAT6 WERE REMOVED FROM THE PATIENT, AND THE BULB OF THE SEP6 WAS FLUSHED OUT OF THE CAT6. THE PROCEDURE WAS COMPLETED USING THE SAME CAT6 AND THE FIRST SEP6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038039 ↗
• MalfunctionMay 16, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT6 AND SEP6 TO THE TARGET VESSEL VIA FEMORAL ACCESS AND SUCCESSFULLY PERFORMED A PASS. IT WAS REPORTED THAT LARGE CLOTS WERE ASPIRATED EFFECTIVELY. HOWEVER, AS THE PROCEDURE PROGRESSED, THE PHYSICIAN NOTICED THAT THE SEP6 WAS NO LONGER EFFECTIVE AND DECIDED TO REMOVE IT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE BULB OF THE SEP6 WAS PARTIALLY FRACTURED AND ONLY 1/8 OF THE BULB REMAINED. IT WAS REPORTED THAT NO FRAGMENTS OF THE SEP6 BULB COULD BE LOCATED, AND THAT THE FRAGMENTS MAY HAVE BEEN FLUSHED OUT. THE PHYSICIAN THEN USED A SECOND SEP6 WITH THE SAME CAT6 TO CONTINUE THE PROCEDURE. AFTER COMPLETING TWO PASSES IN THE TARGET VESSEL USING THE SEP6 AND CAT6, THE BULB OF THE SEP6 FRACTURED WITHIN THE CAT6. THEREFORE, THE SEP6 AND CAT6 WERE REMOVED FROM THE PATIENT, AND THE BULB OF THE SEP6 WAS FLUSHED OUT OF THE CAT6. THE PROCEDURE WAS COMPLETED USING THE SAME CAT6 AND THE FIRST SEP6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038038 ↗
• MalfunctionSep 18, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY (CFA) AND THE ANTERIOR TIBIAL ARTERY (ATA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM SEPARATOR 6 (SEP6), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN USED A CONTRALATERAL APPROACH AND EXPERIENCED RESISTANCE WHILE USING THE SEP6 IN THE CFA DUE TO ORGANIZED THROMBUS AND TORTUOSITY OF THE ILIAC ARTERY. IT WAS REPORTED THAT THE THROMBUS IN THE CFA COULD NOT BE ASPIRATED. THE PHYSICIAN CHANGED TO AN IPSILATERAL APPROACH AND PERFORMED ONE TO TWO PASSES IN THE ATA USING THE CAT6 AND SEP6. HOWEVER, THE PHYSICIAN ALSO EXPERIENCED RESISTANCE WHILE USING THE SEP6 IN THE ATA AND DECIDED TO REMOVE THE SEP6 FROM THE PATIENT. UPON REMOVAL OF THE SEP6, THE PHYSICIAN FOUND THAT THE SEP6 BULB WAS MISSING. THE PHYSICIAN COULD NOT LOCATE THE SEP6 BULB IN THE PATIENT'S BODY UNDER FLUOROSCOPY OR WITHIN THE CAT6 OR THE PENUMBRA ENGINE CANISTER (CANISTER). THE PROCEDURE WAS COMPLETED USING THE SAME 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 17769465 ↗
• MalfunctionMay 26, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PROXIMAL TIBIAL VESSELS USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), INDIGO SYSTEM SEPARATOR 6 (SEP6), INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY MADE APPROXIMATELY ONE TO TWO PASSES USING THE CATRX. IT WAS REPORTED THAT THE PHYSICIAN THEN DECIDED TO SWITCH TO THE CAT6. THERE WAS NO DAMAGE NOTED ON THE CATRX. THE PHYSICIAN INSERTED THE CAT6 AND THEN EXPERIENCED RESISTANCE WHILE INTRODUCING THE SEP6 THROUGH THE CAT6; THEREFORE, THE CAT6 WAS REMOVED AND FLUSHED. THE PHYSICIAN REINSERTED THE CAT6 AND THEN REINSERTED THE SEP6; HOWEVER, THE PHYSICIAN STILL EXPERIENCED RESISTANCE ADVANCING THE SEP6 THROUGH THE CAT6. SUBSEQUENTLY, THE PHYSICIAN MADE APPROXIMATELY TWO PASSES. WHILE MAKING THE NEXT PASS, THE PHYSICIAN WAS ADVANCING THE CAT6, AND THE HOSPITAL TECHNOLOGIST WAS ADVANCING AND RETRACTING THE SEP6 WHEN THE HOSPITAL TECHNOLOGIST NOTICED THE BULB OF THE SEP6 BROKE OFF AND WAS LODGED WITHIN THE CAT6. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER CONTAINING THE BROKEN BULB OF THE SEP6 UNDER ASPIRATION AND THE BULB WAS FLUSHED OUT. THE PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518954 ↗
• MalfunctionMar 1, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A BILATERAL CRITICAL ISCHEMIA OF THE EXTERNAL ILIAC ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND AN INDIGO SYSTEM SEPARATOR 6 (SEP6). DURING THE PROCEDURE THE PHYSICIAN COMPLETED APPROXIMATELY TEN PASSES USING THE CAT6 AND SEP6. UPON REMOVAL OF THE CAT6 AND THE SEP6, IT WAS NOTICED THAT THE BULB OF THE SEP6 WAS MISSING. IT WAS REPORTED THAT THE PHYSICIAN COULD NOT LOCATE THE BULB OF THE SEP6 BY SIGHT OR VIA FLUOROSCOPY. THE PHYSICIAN CONTINUED THE PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). IT WAS REPORTED THAT ALTHOUGH THE INDIGO SYSTEM ASPIRATION CATHETERS UNCLOGGED THE ARTERIES, THE ARTERIES RE-CLOGGED JUST AS QUICKLY DUE TO AN ALREADY ORGANIZED THROMBUS. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THE PATIENT WAS THEN PUT ON A CURATIVE HEPARIN THERAPY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636712 ↗
• MalfunctionSep 9, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE POPLITEAL AND TIBIAL ARTERIES USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND AN INDIGO SYSTEM SEPARATOR 6 (SEP6). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT6 AND SEP6. WHILE RETRACTING THE SEP6 OUT OF THE CAT6, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE DISTAL END OF THE SEP6 PROXIMAL TO THE BULB HAD BROKEN OFF IN THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE PHYSICIAN REMOVED THE BROKEN END OF THE SEP6 BY FLUSHING THE RHV. THE PHYSICIAN ATTEMPTED AN ADDITIONAL PASS USING THE SAME CAT6 AND RHV; HOWEVER, THE PHYSICIAN THEN DECIDED TO DRIP THROMBOLYTICS OVERNIGHT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450331 ↗
• InjuryJun 1, 2021Break; Break

  DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 03-MAY-2021, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "A SIMPLE RESCUE MANEUVER TO RETRIEVE INTRAVASCULAR FOREIGN BODY - THE TRIPLE WIRE TWISTING TECHNIQUE (GALZERANO ET AL. 2021). THE ARTICLE WAS RECEIVED ON 31-JAN-2021; HOWEVER, THE PROCEDURE DATE IS UNKNOWN. THIS ARTICLE DOCUMENTS TWO CASES OF RETRIEVAL OF FRACTURED DEVICES DURING PERIPHERAL LOWER LIMB PROCEDURES USING THREE GUIDEWIRES. IN ONE CASE, AN INDIGO SYSTEM SEPARATOR 6 (SEP6) WAS USED. DURING THE PROCEDURE, AFTER SEVERAL PASSES OF THE SEP6, APPROXIMATELY 15 MM OF THE DISTAL WIRE FRACTURED INSIDE THE MIDDLE OF THE POSTERIOR TIBIAL ARTERY. SUBSEQUENTLY, THE FRACTURED WIRE WAS RECAPTURED INSIDE AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) USING THREE GUIDEWIRES TO PERFORM THE TRIPLE WIRE TWISTING TECHNIQUE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917225 ↗
• MalfunctionNov 6, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR POPLITEAL ARTERY AND THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM SEPARATOR 6 (SEP6), A NON-PENUMBRA GUIDING SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CAT6 OVER THE GUIDEWIRE, THROUGH THE SHEATH AND INTO THE TARGET LOCATION. THE GUIDEWIRE WAS THEN REMOVED AND THE SEP6 WAS ADVANCED THROUGH THE CAT6 AND INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN COMPLETED THE FIRST PASS. DURING THE SECOND PASS, THE PHYSICIAN NOTICED VIA AN ANGIOGRAPHY THAT WHILE THE SEP6 WAS BEING ADVANCED IN AND OUT OF THE CAT6, THE SEP6 WAS UNABLE TO ADVANCE THROUGH THE OCCLUSION AND SUBSEQUENTLY, THE SEP6 FOLDED ON ITSELF INSIDE THE CAT6. THEREFORE, THE SEP6 AND CAT6 WERE REMOVED TOGETHER. AFTER THE REMOVAL, IT WAS NOTICED THAT THE BULB OF THE SEP6 BROKE BUT REMAINED ATTACHED TO THE PUSHER WIRE. AFTERWARDS, THE PHYSICIAN ADVANCED A NEW SEP6 WITH THE CAT6 TO ATTEMPT TO ENGAGE THE THROMBUS; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE SEP6 AND CAT6 WERE REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE BY PERFORMING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USING

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

  MAUDE report 10801973 ↗
• MalfunctionAug 29, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES USING THE SEP6 AND CAT6. UPON REMOVAL OF THE SEP6, THE PHYSICIAN NOTICED THAT THE BULB OF THE SEP6 WAS MISSING. UNDER X-RAY, THE PHYSICIAN NOTICED THAT THE BULB WAS INSIDE THE VESSEL; THEREFORE, THE BROKEN BULB OF THE SEP6 WAS ASPIRATED OUT USING THE CAT6. THE PROCEDURE WAS COMPLETED USING THE SAME CAT6 AND SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10469565 ↗
• MalfunctionAug 28, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES USING THE SEP6 AND CAT6. UPON REMOVAL OF THE SEP6, THE PHYSICIAN NOTICED THAT THE BULB OF THE SEP6 WAS MISSING. UNDER X-RAY, THE PHYSICIAN NOTICED THAT THE BULB WAS INSIDE THE VESSEL; THEREFORE, THE BROKEN BULB OF THE SEP6 WAS ASPIRATED OUT USING THE CAT6. THE PROCEDURE WAS COMPLETED USING THE SAME CAT6 AND SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10466481 ↗
• MalfunctionAug 25, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6). DURING THE PROCEDURE, THE BULB OF THE SEP6 BROKE OFF. IT IS UNKNOWN HOW 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 10451667 ↗
• MalfunctionAug 25, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED FOUR PASSES USING THE SEP6 AND CAT6. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE SEP6 THROUGH THE CAT6. SUBSEQUENTLY, WHILE REMOVING THE SEP6 OUT FROM THE CAT6, THE PHYSICIAN NOTICED THE DISTAL BULB OF THE SEP6 HAD BROKEN OFF UNDER FLUOROSCOPY. THE PHYSICIAN, THEREFORE, REMOVED THE CAT6 AND FOUND THE BROKEN BULB OF THE SEP6 UPON FLUSHING THE CAT6. THE PROCEDURE WAS COMPLETED USING A NEW SEP6 AND THE SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451340 ↗
• InjuryAug 24, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL TRUNK USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL PASSES WITH THE SEP6. AFTER THE SEP6 WAS REMOVED FROM THE SHEATH, THE PHYSICIAN REALIZED THAT THE BULB HAD BROKEN OFF IN THE PATIENT'S VESSEL. IT WAS ALSO NOTED THAT AN X-RAY CONFIRMED THE SEP6 BULB WAS LODGED IN THE PATIENT'S VESSEL. SUBSEQUENTLY, THE PHYSICIAN ASPIRATED THE BROKEN BULB USING THE CAT6. THE PROCEDURE WAS COMPLETED USING THE SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445469 ↗
• MalfunctionAug 7, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT FEMORAL ARTERY AND POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND A ROTATING HEMOSTASIS VALVE (RHV) ADAPTOR. DURING THE PROCEDURE, WHILE RETRACTING THE SEP6 FROM THE CAT6 TO CHECK IF THE CAT6 WAS CLOGGED, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE TIP OF THE SEP6 BROKE OFF AND WAS MISSING. TEN MINUTES LATER, THE PHYSICIAN FOUND THE BROKEN SEP6 TIP IN THE RHV ADAPTOR AND REMOVED IT. THE PROCEDURE WAS COMPLETED USING ANOTHER SEP6 AND THE SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382913 ↗
• MalfunctionJul 10, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT SUBCLAVIAN AND AXILLARY VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), INDIGO SYSTEM SEPARATOR 6 (SEP6) AND, A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT WAS BROUGHT BACK AFTER A ROUND OF INFUSION AND THE PHYSICIAN WANTED TO UTILIZE THE EXISTING ACCESS AND DID NOT WANT TO UPSIZE EXISTING SHEATH IN THE RIGHT UPPER ARM. IT WAS ALSO NOTED THAT THE ACCESS TO THE LESION WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE MULTIPLE PASSES USING THE CAT6 AND SEP6. WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE SEP6. AFTER SOME TIME, THE PHYSICIAN NOTICED THAT THERE WAS NO FLOW IN THE ASPIRATION TUBING; THEREFORE, THE CAT6 AND SEP6 WERE REMOVED AS A UNIT. UPON REMOVAL, IT WAS NOTICED THAT THE CAT6 WAS OVALIZED AROUND THE DISTAL END. THE PHYSICIAN THEN REMOVED THE SEP6 FROM THE CAT6 AND NOTICED THAT THE DISTAL BULB OF THE SEP6 WAS MISSING. THE CAT6 WAS SUBSEQUENTLY FLUSHED AND THE BROKEN DISTAL BULB OF THE SEP6 WAS EJECTED FROM THE CAT6. THE PROCEDURE WAS COMPLETED USING A BALLOON CATHETER AND BALLOON ANGIOPLASTY. THERE WAS NO REP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256664 ↗
• MalfunctionJun 11, 2020Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE CAT6, SEP6 AND SHEATH. DURING THE THIRD PASS, THE PHYSICIAN ADVANCED THE CAT6 OVER THE GUIDEWIRE, THEN REMOVED THE GUIDEWIRE. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE SEP6 THROUGH THE CAT6; HOWEVER, THE SEP6 BECAME STUCK AND WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE CAT6. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CAT6 AND SEP6. UPON REMOVAL, IT WAS NOTICED THAT THE CAT6 DISTAL TIP WAS STRETCHED AND THE DISTAL END OF THE SEP6 WAS BENT. THE PROCEDURE WAS COMPLETED USING A BALLOON ANGIOPLASTY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141557 ↗
• MalfunctionApr 29, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUBCLAVIAN ARTERIES USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6), INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY 20 TO 25 CYCLES IN THE TARGET VESSEL USING THE SEP6 WITH THE CAT6 AND SHEATH. UPON REMOVAL OF ALL THE DEVICES FROM THE SHEATH, THE BULB OF THE SEP6 UNWOUND. 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 10012368 ↗
• MalfunctionMar 27, 2020Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR TIBIAL ARTERY (AT) USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS CALCIFIED. DURING THE PROCEDURE, AFTER COMPLETING A FEW PASSES, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING AND RETRACTING THE SEP6 WITHIN THE CAT6. SUBSEQUENTLY, THE PHYSICIAN REALIZED THAT THE SEP6 WAS STRETCHED AT THE DISTAL END AND KINKED IN A FEW LOCATIONS. THEREFORE, THE SEP6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SEP6 AND THE SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892410 ↗
• MalfunctionMar 27, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR ARTERY USING AN INDIGO SYSTEM SEPARATOR 6 (SEP6) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). IT WAS REPORTED THAT THERE WAS A STENOSIS AT THE TARGET LOCATION. DURING THE PROCEDURE, THE PHYSICIAN ENGAGED THE CAT6 THROUGH THE STENOSIS WITH FORCE, THEN EXPERIENCED RESISTANCE WHILE ADVANCING THE SEP6 THROUGH THE CAT6. WHILE ADVANCING THE SEP6 IN AND OUT OF THE CAT6, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP6 WAS MISSING; THEREFORE, THE SEP6 WAS REMOVED. IT WAS REPORTED THAT THE BROKEN WIRE OF THE SEP6 WAS FOUND ON THE STERILIZED TABLE, AND IT IS UNKNOWN HOW IT ENDED UP ON THE STERILIZED TABLE. IT WAS ALSO REPORTED THE CAT6 KINKED WHILE ADVANCING THROUGH THE STENOSIS. THE PROCEDURE WAS COMPLETED USING A NEW SEP6 AND SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892273 ↗