Indigo System SEP8-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00815948022980), received between Sep 12, 2021 and Nov 15, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON ILIAC VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY IMAGING THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD FRACTURED INSIDE THE TARGET VESSEL. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE WIRE OF THE SEP8 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A THROMBOLYTIC CATHETER AND THE SAME CAT8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565036 ↗
• MalfunctionOct 30, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT PULMONARY EMBOLISM (PE) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, AFTER ASPIRATING FOR APPROXIMATELY ONE HOUR USING THE CAT8 AND SEP8, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE SEP8 BULB HAD FRACTURED WITHIN THE LEFT LOWER PULMONARY ARTERY. THE PHYSICIAN THEN USED THE CAT8 TO SUCCESSFULLY ASPIRATE THE WIRE OF THE SEP8 OUT OF THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426006 ↗
• MalfunctionJun 2, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE SEP8 DURING THE FIRST PASS AND DECIDED TO REMOVE IT. AFTER RETRACTING THE SEP8 OUT OF THE PATIENT, THE PHYSICIAN FOUND THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 WAS FRACTURED BUT STILL CONNECTED BY A WIRE. 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

  MAUDE report 22128541 ↗
• InjuryMay 21, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  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 WAS USING THE SEP8 AND THE CAT8 IN THE PATIENT AND REPORTED THAT NO RESISTANCE WAS EXPERIENCED. WHILE ASPIRATING UNDER FLUOROSCOPY, THE PHYSICIAN OBSERVED THAT A PIECE OF THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD FRACTURED IN THE RIGHT PULMONARY ARTERY. THE PHYSICIAN THEN USED A SNARE DEVICE TO ATTEMPT TO REMOVE THE PIECE OF THE SEP8 WIRE, WITHOUT SUCCESS. THE PHYSICIAN THEN DECIDED TO LEAVE THE PIECE OF THE WIRE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT8. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). A PATIENT STATUS UPDATE WAS REQUESTED. IT WAS REPORTED THAT AS OF ON (B)(6) 2025, THERE WAS NO FURTHER ADVERSE EFFECT OR CLINICAL IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22061239 ↗
• MalfunctionApr 22, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). IT WAS REPORTED THAT THE CLOT WAS NOT CALCIFIED BUT HAD WHITE OLD THROMBUS. DURING THE PROCEDURE, WHILE PERFORMING THE FIRST PASS USING THE CAT8 AND SEP8, THE PHYSICIAN FELT STUCK AND DECIDED TO REMOVE THE SEP8 FROM THE PATIENT. UPON REMOVAL OF THE SEP8, THE PHYSICIAN FOUND THAT THE BULB OF THE SEP8 HAD FRACTURED IN THE FEMORAL VEIN. THE CAT8 WAS THEN USED TO ASPIRATE THE SEP8 BULB. 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

  MAUDE report 21882288 ↗
• MalfunctionFeb 13, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON FEMORAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12) AND A INDIGO SYSTEM SEPARATOR 8 (SEP8). IT WAS NOTED THAT THE THROMBUS WAS CHRONIC. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES WITH THE CAT12 AND SEP8. AFTER ADVANCING AND RETRACTING THE SEP8 TO BREAKUP THE THROMBUS, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE SEP8 HAD FRACTURED AND WAS IMBEDDED WITHIN THE THROMBUS UNDER FLUOROSCOPY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE FRACTURED PORTION OF THE SEP8. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378664 ↗
• MalfunctionDec 8, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VEINS IN THE LOWER EXTREMITY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, WHILE REMOVING A CAT8 FROM THE PACKAGING, THE PHYSICIAN FOUND THAT THE CAT8 WAS OVALIZED AT THE DISTAL LENGTH. THE DAMAGE TO THE CAT8 WAS FOUND PRIOR TO USE AND THEREFORE, THE CAT8 WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN OPENED A NEW CAT8 AND COMPLETED THREE PASSES USING THE CAT8 AND SEP8. WHILE MAKING THE NEXT PASS, THE PHYSICIAN VISUALIZED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 FRACTURED. THEREFORE, THE SEP8 WAS REMOVED FROM THE PATIENT AND A SNARE DEVICE WAS USED TO REMOVE THE SEP8 WIRE. 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

  MAUDE report 20874867 ↗
• MalfunctionDec 5, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE TARGET LOCATION USING THE SEP8 AND THE CAT8. WHILE ADVANCING THE SEP8 AGAIN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY FOUND THAT THE CAT8 WAS OBSTRUCTED WITH THROMBUS DURING USE. THE PHYSICIAN THEN REMOVED THE CAT8 AND SEP8 FROM THE PATIENT FOR FLUSHING AND FOUND THAT THE BULB AT THE DISTAL END OF THE SEP8 HAD FRACTURED INSIDE THE PATIENT. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE BULB OF THE SEP8 FROM THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20859420 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT LOWER LIMB DEEP VEIN THROMBOSIS (DVT) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, IT WAS REPORTED THAT THE BULB OF THE SEP8 FRACTURED INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE SEP8 AND ASPIRATED THE SEP8 BULB USING THE CAT8. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644187 ↗
• InjuryFeb 9, 2024Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT POPLITEAL VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THREE PASSES IN THE TARGET LOCATION USING THE SEP8 AND THE CAT8 AND EXPERIENCED RESISTANCE WHILE USING THE SEP8 DURING ALL THREE PASSES. WHILE MAKING THE NEXT PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SEP8 AND SUBSEQUENTLY VISUALIZED UNDER FLUOROSCOPY THAT A PIECE OF THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD FRACTURED AND REMAINED IN THE TARGET LOCATION. THE PHYSICIAN ALSO OBSERVED THAT THE REMAINING WIRE DISTAL TO THE BULB OF THE SEP8 WAS KINKED. THE PHYSICIAN THEN USED THE CAT8 AND MADE SEVERAL ATTEMPTS TO ASPIRATE THE WIRE; HOWEVER, THE PIECE OF THE WIRE DISTAL TO THE BULB OF THE SEP8 COULD NOT BE REMOVED AND WAS STUCK IN THE PATIENT''S VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO ALLOW THE PIECE OF THE WIRE DISTAL TO THE BULB OF THE SEP8 TO REMAIN IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8.

  Patient problems: Foreign Body In Patient

  MAUDE report 18681934 ↗
• MalfunctionJan 5, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE CAT8 WAS KINKED. IT WAS ALSO REPORTED THAT THE BULB OF THE SEP8 FRACTURED. THEREFORE, THE CAT8 AND THE SEP8 WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH A SECOND SEP8. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE SECOND BULB OF THE SEP8. THE PROCEDURE WAS COMPLETED USING A NEW CAT8 AND A NEW SEP8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460327 ↗
• MalfunctionOct 19, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT DEEP VEIN THROMBOSIS (DVT) IN THE LEFT POPLITEAL TO ILIAC VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), AND NON-PENUMBRA SHEATHS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SEP8 AND WHILE RETRACTING THE SEP8 DURING THE FIRST PASS. SUBSEQUENTLY, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD FRACTURED IN THE LEFT FEMO-ILIAC VEIN. THE CAT8 WAS ADVANCED TOWARD THE SEP8 WIRE IN AN ATTEMPT TO ASPIRATE THE WIRE, WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO LEAVE THE SEP8 WIRE IN THE PATIENT AND DID NOT MAKE A PLAN TO REMOVE IT. THE PROCEDURE WAS COMPLETED USING THE SAME CAT8 AND THE SAME SHEATHS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17971138 ↗
• MalfunctionOct 16, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY (LPA) AND RIGHT PULMONARY ARTERY (RPA) USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES IN THE TARGET LOCATION USING THE SEP8 AND CAT8. WHILE REMOVING THE SEP8, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD FRACTURED. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE THE FRACTURED PART OF THE SEP8 USING THE CAT8, WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT8. THE FINAL ANGIOGRAM REVEALED THAT THE FRACTURED PART OF THE SEP8 REMAINED IN THE DISTAL LPA. THE PHYSICIAN PLANNED A LATER DATE FOR AN ECHOCARDIOGRAM AND ANGIOGRAM MONITORING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940896 ↗
• MalfunctionSep 11, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT SUPERIOR FEMORAL ARTERY (SFA) AND THE POPLITEAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A STENT, AND A .035 GUIDEWIRE. IT WAS NOTED THAT THE STENT WAS IMPLANTED INTO THE RIGHT SFA. DURING THE PROCEDURE, THE GUIDEWIRE WAS ADVANCED THROUGH THE LESION OF THE TARGET VESSEL AND ASPIRATION WAS TURNED ON. AFTER ADVANCING THE CAT8 INTO THE TARGET LOCATION, THE PHYSICIAN ADVANCED THE SEP8 APPROXIMATELY ONE AND A HALF CENTIMETERS OUT OF THE CAT8. WHILE MANIPULATING THE SEP8 BACK AND FORTH USING A TORQUE DEVICE WITHIN THE THROMBUS, THE PHYSICIAN OBSERVED VIA FLUOROSCOPY THAT THE DISTAL END OF THE SEP8 HAD FRACTURED OFF. AFTER REMOVING THE PROXIMAL PART OF THE SEP8, THE CAT8 CONTAINING THE FRACTURED SEP8 WAS REMOVED UNDER ASPIRATION. IT WAS REPORTED THAT THE SEP8 WAS FLUSHED OUT OF THE CAT8 ON THE BACK TABLE. 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

  MAUDE report 17724512 ↗
• MalfunctionAug 31, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILIC VEIN USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8) AND AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY FIVE PASSES USING THE SEP8 AND CAT7. SUBSEQUENTLY, THE DISTAL END OF THE SEP8 BROKE OFF WHILE RETRACTING IT THROUGH THE CAT7. THEREFORE, THE PHYSICIAN REMOVED THE SEP8 AND THE BROKEN PIECE OF THE SEP8 WAS ASPIRATED OUT USING THE CAT7. 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 15332081 ↗
• MalfunctionMar 4, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE POPLITEAL AND THE TIBIO PERONEAL TRUNK USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A LIGHTNING ASPIRATION TUBING (LIGHTNING) AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED MULTIPLE PASSES USING THE CAT7 AND SEP8. NEXT, THE SEP8 BULB WAS NOTICED TO BE SHEARED OFF IN THE PATIENT BASED ON FLUOROSCOPIC IMAGING. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ASPIRATE THE SEP8; HOWEVER, THE SEP8 COULD NOT BE REMOVED. THEREFORE, THE SEP8 WAS REMOVED VIA OPEN SURGICAL EMBOLECTOMY. IT WAS REPORTED THAT THE SURGICAL EMBOLECTOMY WAS REQUIRED REGARDLESS OF THE SEP8 BULB BREAKING OFF BECAUSE THE ENTIRE CLOT BURDEN COULD NOT BE ASPIRATED WITH THE CAT7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13672620 ↗
• InjurySep 12, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12), AN INDIGO SYSTEM SEPARATOR 12 (SEP12), AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO INSERT THE SEP12 THROUGH THE RHV ON THE FIRST ATTEMPT; HOWEVER, UPON REMOVING THE SEP12 AND ATTEMPTING TO REINSERT IT THROUGH THE RHV AGAIN, THE SEP12 WOULD NOT GO INTO THE RHV. SUBSEQUENTLY, THE PHYSICIAN REMOVED AND REPLACED THE RHV WITH A NEW RHV FROM ANOTHER LIGHTNING KIT; HOWEVER, WHEN ATTEMPTING TO INSERT THE SEP12 THROUGH THE RHV, THE SAME ISSUE OCCURRED. THEREFORE, THE RHV AND SEP12 WERE REMOVED. NEXT, THE PHYSICIAN OPENED A NEW LIGHTNING 8 KIT TO OBTAIN A SMALLER RHV AND COMPLETED ONE PASS USING THE SMALLER RHV AND AN INDIGO SYSTEM SEPARATOR 8 (SEP8). WHILE USING THE SEP8 DURING THE SECOND PASS, THE PHYSICIAN NOTICED THAT THE WIRE DISTAL TO THE BULB OF THE SEP8 HAD BROKEN OFF IN THE RIGHT PULMONARY ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN SEP8. THE PROCEDURE WAS COMPLETED USING A NEW SEP8 AND THE SAME CAT12 FROM THE FIRST LIGHTNING KIT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457855 ↗