Penumbra System 5MAXACE132-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00814548017426), received between Jun 24, 2016 and Jan 16, 2026 — classified as 2 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A GUIDE CATHETER, AND A MICROCATHETER. THE PHYSICIAN WAS ADVANCING THE ACE60 AND THE MICROCATHETER TOGETHER THROUGH THE GUIDE CATHETER. THE ACE60 WAS FRACTURED WHILE ADVANCING AT THE HUB OF THE GUIDE CATHETER. THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098949 ↗
• InjuryMay 16, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE RETRACTING THE ACE60, THE PHYSICIAN FRACTURED THE DISTAL LENGTH OF THE ACE60 WITHIN THE PATIENT. THE PHYSICIAN THEN USED A STENT DEVICE AND A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT OF THE ACE60, WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED PART OF THE ACE60 IN THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) BUT WAS THEN DISCHARGED IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22035013 ↗
• MalfunctionApr 22, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A STENT RETRIEVER. DURING THE PROCEDURE, WHEN THE PHYSICIAN REMOVED THE ACE60 AND THE STENT RETRIEVER TOGETHER FROM THE PATIENT, IT WAS FOUND THAT THE DISTAL LENGTH OF THE ACE60 WAS FRACTURED. 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 19152819 ↗
• MalfunctionFeb 22, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO TO THREE PASSES IN THE TARGET LOCATION USING THE ACE60. WHILE ADVANCING THE ACE60 DURING THE NEXT PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY FOUND THAT THE PROXIMAL END OF THE ACE60 WAS FRACTURED. THEREFORE, THE ACE60 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758183 ↗
• MalfunctionJun 30, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A LONG SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE60 INTO THE TARGET LOCATION. BEFORE A PASS COULD BE COMPLETED, THE PHYSICIAN RETRACTED THE ACE60 AND NOTICED THAT THE PROXIMAL END OF THE ACE60 WAS FRACTURED. THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 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 17240922 ↗
• MalfunctionApr 3, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS IN THE TARGET VESSEL AND SUBSEQUENTLY RETRACTED THE THROMBUS AND THE ACE60 TOGETHER. UPON REMOVAL FROM THE PATIENT, THE PHYSICIAN FOUND THAT THE ACE60 WAS FRACTURED AT THE PROXIMAL END AND REMAINED CONNECTED BY AN INNER WIRE. THEREFORE, THE ACE60 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE60, THE SAME NEURON MAX, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665934 ↗
• MalfunctionNov 16, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE60 THROUGH THE NEURON MAX INTO THE TARGET LOCATION. THE PHYSICIAN THEN INITIATED ASPIRATION; HOWEVER, IT WAS NOTICED THAT NO THROMBUS COULD BE ASPIRATED OUT. SUBSEQUENTLY, IT WAS NOTICED THAT THE ACE60 WAS KINKED AT THE MID-SHAFT. THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824441 ↗
• MalfunctionSep 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE ACE60 TO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE ACE60 REACHED THE CAVERNOUS SINUS SEGMENT. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE ACE60. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE ACE60 WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493460 ↗
• MalfunctionJul 28, 2021Material Deformation; Suction Failure; Material Deformation; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NON-PENUMBRA LONG SHEATH. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE OPHTHALMIC ARTERY WHILE USING AN ACE60. HOWEVER, THE PHYSICIAN WAS ABLE TO PLACE THE ACE60 INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN INITIATED ASPIRATION BUT AFTER 3 AND A HALF MINUTES UNDER ASPIRATION, IT WAS NOTICED THAT NO THROMBUS WAS RETRIEVED AND THE PHYSICIAN DECIDED TO REMOVE THE ACE60. UPON REMOVAL, IT WAS NOTICED THAT THE ACE60 WAS DEFORMED AT APPROXIMATELY SEVEN CENTIMETERS FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER AND THE SAME LONG SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242591 ↗
• MalfunctionJun 29, 2021Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE MICROCATHETER AND THEN THE ACE60 WAS FOLLOWED IN PLACE. NEXT, CONTRAST WAS INJECTED AND AFTER THE ANGIOGRAPHY WAS PERFORMED, IT WAS NOTICED THAT THE CONTRAST WAS LEAKING AT THE PROXIMAL END AND THE ACE60 WAS BROKEN. THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086596 ↗
• MalfunctionJun 8, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE BASILAR ARTERY OCCLUSION USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A MICRO GUIDEWIRE (0.014). DURING THE PROCEDURE, THE PHYSICIAN RETRACTED THE ACE60 TO FLUSH IT AND NOTICED THAT NO THROMBUS WAS COLLECTED. AN ANGIOGRAPHY WAS PERFORMED WHICH INDICATED THAT THE BLOOD VESSEL WAS NOT RECANALIZED. THEREFORE, THE PHYSICIAN COMPLETED TWO ADDITIONAL PASSES IN THE TARGET LOCATION; HOWEVER, THE VESSEL REMAINED OCCLUDED. THE ACE60 WAS DELIVERED TO THE OCCLUSION SEGMENT USING THE VELOCITY AND MICRO GUIDEWIRE. A STENT RETRIEVER WAS THEN RELEASED TO COVER THE OCCLUSION POSITION. AN ANGIOGRAPHY CONFIRMED BLOOD FLOW WAS RESTORED. AFTER WAITING FIVE MINUTES, THE PHYSICIAN ADVANCED THE VELOCITY PROXIMAL TO THE STENT RETRIEVER TO RETRACT THE STENT BUT WAS UNSUCCESSFUL. THEREFORE, THE STENT RETRIEVER AND VELOCITY WERE RETRACTED INTO THE ACE60 OUT OF THE PATIENT¿S BODY. WHILE PASSING THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) OF THE ACE60, THE RHV SEPARATED. THE RHV WAS REMOVED AND IT WAS REPORTED THAT THE DISTAL END OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958654 ↗
• MalfunctionMay 25, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE MICROCATHETER THROUGH AN ACE60, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE MICROCATHETER THROUGH THE DISTAL END OF THE ACE60. CONSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE ACE60 AND NEURON MAX. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE ACE60 WAS DEFORMED. THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60, THE SAME NEURON MAX AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879112 ↗
• MalfunctionMay 25, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE ACE60 INTO THE CAVERNOUS SINUS SEGMENT. THE PHYSICIAN THEN DECIDED TO REMOVE THE ACE60. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE ACE60 WAS KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60 AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879010 ↗
• MalfunctionMay 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE ACE60 THROUGH THE NEURON MAX AND INTO THE CAVERNOUS SINUS SEGMENT; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE ACE60 AND NEURON MAX. SUBSEQUENTLY, UPON REMOVAL, THE PHYSICIAN NOTICED THE DISTAL END OF THE ACE60 AND NEURON MAX TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852491 ↗
• MalfunctionMay 8, 2021Material Frayed; Material Frayed

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER ADVANCING THE ACE60 TO THE TARGET VESSEL, THE PHYSICIAN FOUND A WIRE EXPOSED AT THE PROXIMAL END (HUB) OF THE ACE60 PRIOR TO CONNECTING IT TO THE PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING). THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 11795418 ↗
• MalfunctionApr 6, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, THE PHYSICIAN FINISHED AN ANGIOGRAPHY INSPECTION. THEN, WHILE INSERTING AN ACE60 INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE ACE60 WAS FRACTURED. THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11621554 ↗
• MalfunctionJun 25, 2020Stretched; Material Deformation; Suction Failure; Stretched; Material Deformation; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, ASPIRATION WAS INITIATED; HOWEVER, THROMBUS COULD NOT BE REMOVED. AFTER TWO ATTEMPTS. THE PHYSICIAN REMOVED THE ACE60 FROM THE PATIENT. UPON REMOVAL OF THE ACE60, IT WAS NOTED THAT IT WAS OVALIZED AND STRETCHED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 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 10196980 ↗
• MalfunctionApr 16, 2020Suction Problem; Material Deformation; Suction Problem; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA SHORT SHEATH AND A NON-PENUMBRA LONG SHEATH. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO SUCCESSFUL PASSES IN THE TARGET VESSEL USING THE ACE60, SHORT SHEATH AND LONG SHEATH. THEN, DURING THE THIRD PASS, IT WAS NOTICED THAT NO THROMBUS WAS BEING ASPIRATED OUT AFTER SOME TIME; THEREFORE, PHYSICIAN DECIDED TO REMOVE THE ACE60. AFTER THE REMOVAL OF THE ACE60, IT WAS NOTICED THAT 5-10 CENTIMETERS FROM THE DISTAL END OF THE ACE60 WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60, THE SAME SHORT SHEATH AND THE SAME LONG SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9966332 ↗
• MalfunctionMar 13, 2020Break; Suction Failure; Break; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE ACE60 WAS NOT ASPIRATING DURING THE FIRST PASS. UPON REMOVAL, THE PHYSICIAN DISCOVERED AN EXPOSED WIRE AT THE DISTAL TIP OF THE ACE60. THEREFORE, THE ACE60 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60 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 9831034 ↗
• MalfunctionDec 16, 2019Collapse; Collapse

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), NON-PENUMBRA MICROCATHETER AND GUIDEWIRE. DURING THE PROCEDURE, THE ACE60 WAS ADVANCED WITH THE MICROCATHETER OVER THE GUIDEWIRE TO THE TARGET LOCATION. NEXT, ASPIRATION WAS INITIATED, BUT NO THROMBUS WAS BEING ASPIRATED AFTER THREE ATTEMPTS. THEREFORE, THE ACE60 WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE TIP OF THE ACE60 HAD COLLAPSED. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9477572 ↗
• MalfunctionDec 16, 2019Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), NON-PENUMBRA 6F LONG SHEATH, NON-PENUMBRA MICROCATHETER, AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT HAD A TORTUOUS VESSEL AND A TYPE III AORTIC ARCH. DURING THE PROCEDURE, WHILE ADVANCING AN ACE60 WITH THE MICROCATHETER OVER THE GUIDEWIRE, THE ACE60 WOULD NOT ADVANCE PAST THE OPHTHALMIC ARTERY. THE PHYSICIAN THEN ADVANCED THE MICROCATHETER AND GUIDEWIRE FURTHER AND ADJUSTED THE ACE60. AFTER A FEW ATTEMPTS, THE ACE60 WAS IN POSITION. NEXT, ASPIRATION WAS INITIATED BUT NO THROMBUS WAS BEING ASPIRATED; THEREFORE, THE ACE60 WAS REMOVED. UPON REMOVAL, THE ACE60 WAS NOTICED TO BE KINKED IN THE MIDDLE SHAFT. THE PROCEDURE WAS COMPLETED USING A NAVIEN CATHETER AND A STENT RETRIEVER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9477473 ↗
• MalfunctionDec 12, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING AN ACE60 WITH A MICROCATHETER OVER A GUIDEWIRE, THE ACE60 WOULD NOT ADVANCE PAST THE OPHTHALMIC ARTERY; THEREFORE, IT WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE ACE60 HAD A CREASE MARK APPROXIMATELY 50 MM FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60, THE SAME MICROCATHETER AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9458054 ↗
• MalfunctionOct 18, 2019Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETERS (ACE60S). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AN ACE60 THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) TO ACCESS THE C6 SEGMENT OF THE TARGET VESSEL; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE ACE60 WOULD NOT ADVANCE BEYOND THE C1 SEGMENT. THEREFORE, THE PHYSICIAN RETRACTED THE ACE60 AND STEAM-SHAPED THE DISTAL TIP. NEXT, THE PHYSICIAN PUT THE ACE60 IN PLACE FOR ASPIRATION; HOWEVER, NO THROMBUS WAS BEING ASPIRATED; THEREFORE, THE ACE60 WAS RETRACTED. UPON REMOVAL, THE DISTAL END OF THE ACE60 WAS NOTICED TO BE BROKEN. A SECOND ACE60 WAS OPENED, AND THE DISTAL TIP OF THE ACE60 WAS STEAM-SHAPED. NEXT, THE PHYSICIAN ATTEMPTED ANOTHER TWO PASSES IN THE TARGET VESSEL USING A STENT RETRIEVER DEVICE, THE ACE60, AND THE SAME NEURON MAX. HOWEVER, NO THROMBUS WAS BEING ASPIRATED, AND THE VESSEL REMAINED OCCLUDED. THE PHYSICIAN DECIDED NOT TO ATTEMPT ADDITIONAL PASSES, 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 9208779 ↗
• MalfunctionJul 30, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE ACE60 THROUGH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). THE PHYSICIAN CONTINUED TO USE THE ACE60 DESPITE THE RESISTANCE ENCOUNTERED AND WAS ABLE TO COMPLETE THE PROCEDURE USING THE SAME 3MAXC AND VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843708 ↗
• MalfunctionJul 1, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE60 AND A NON-PENUMBRA MICROCATHETER TO THE M1 SEGMENT AND TURNED ON ASPIRATION FOR APPROXIMATELY 90 SECONDS AND ATTEMPTED TO ASPIRATE THE THROMBUS SEVERAL TIMES; HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE ACE60 AND FOUND THE MID SHAFT TO BE OVALIZED. THE PROCEDURE WAS THEN COMPLETED USING A NEW ACE60 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750205 ↗