ACE 5MAXACE068KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00814548016603), received between Aug 23, 2016 and Dec 6, 2021 — classified as 12 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (49 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 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER, A GUIDEWIRE, AND A NON-PENUMBRA HEMOSTASIS VALVE. WHILE PREPARING THE ACE68 ON THE BACK TABLE, THE PHYSICIAN REPORTED THAT THE ACE68 WAS KINKED AT THE DISTAL END. HOWEVER, THE PHYSICIAN PROCEEDED TO USE A HEAT GUN TO SHAPE THE ACE68 ONE CENTIMETER FROM THE DISTAL TIP. DURING THE PROCEDURE, AFTER COMPLETING ONE PASS, THE ACE68 WAS RETRACTED UNDER NEGATIVE PRESSURE. WHILE RE-ADVANCING THE ACE68 INTO THE HEMOSTASIS VALVE TO MAKE ANOTHER PASS, RESISTANCE WAS ENCOUNTERED. THE ACE68 WAS ADVANCED AND RETRACTED SEVERAL TIMES IN THE HEMOSTASIS VALVE BEFORE IT WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE ACE68 WAS BROKEN AND CONNECTED BY A WIRE TO THE PROXIMAL SHAFT. HOWEVER, THE PROCEDURE WAS COMPLETED AT THIS POINT AND NO ADDITIONAL PASSES WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12945808 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDING CATHETER, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, AFTER THE ACE68 PASSED THROUGH THE LESION SIX TIMES, AN INTRACEREBRAL HEMORRHAGE WAS NOTICED. THE PHYSICIAN DECIDED TO STOP THE THROMBECTOMY PROCEDURE AT THIS POINT. IT WAS REPORTED THAT NO ADDITIONAL ACTION WAS TAKEN TO TREAT THE HEMORRHAGE. THERE WAS NO ADDITIONAL ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12819715 ↗
• MalfunctionNov 11, 2021Fracture; Fracture

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA MICROCATHETER, A STENT RETRIEVER, AND A GUIDEWIRE. WHILE RETRACTING THE STENT RETRIEVER AFTER THE SECOND PASS, RESISTANCE WAS ENCOUNTERED. AFTER REMOVING THE ACE68, THE PHYSICIAN FOUND THAT THE DISTAL END OF THE ACE68 HAD A FINE FRACTURE. RECANALIZATION WAS SUCCESSFULLY ACHIEVED AT THIS POINT; THEREFORE, NO ADDITIONAL PASSES WERE REQUIRED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800129 ↗
• MalfunctionAug 11, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL AND POSTERIOR TIBIAL USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE INSERTING A CAT6 USING A PEEL-AWAY SHEATH INTO THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN STRETCHED AND OVALIZED THE DISTAL TIP OF THE CAT6; THEREFORE, THE CAT6 WAS REMOVED. THE PHYSICIAN THEN COMPLETED ONE PASS USING A NEW CAT6 THAT REMOVED SOME CLOT. AFTERWARDS, WHILE RE-INSERTING THE CAT6 THROUGH THE PEEL-AWAY SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE CAT6. SUBSEQUENTLY, THE PHYSICIAN KINKED THE CAT6; THEREFORE, THE CAT6 WAS REMOVED. THEN, WHILE ATTEMPTING TO ADVANCE A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN OVALIZED THE DISTAL END OF THE ACE68. THEREFORE, THE ACE68 AND SHEATH WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT6 AND A NEW NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307588 ↗
• MalfunctionJul 22, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE ACE68 AND VELOCITY. DURING THE SECOND PASS, THE PHYSICIAN ADVANCED THE ACE68 OVER THE VELOCITY. NEXT, THE PHYSICIAN PERFORMED AN ANGIOGRAPHY AND NOTICED A CHANGE IN THE SHAPE OF THE ACE68. THEREFORE, THE ACE68 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS STRETCHED AT THE DISTAL END. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME VELOCITY AND NEW ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211381 ↗
• MalfunctionJul 16, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE ACE68 AND THE NEURON MAX. AFTER COMPLETION OF THE FIRST PASS, THE PHYSICIAN PERFORMED A CONTRAST RUN AND NOTICED AN ADDITIONAL OCCLUSION IN THE M1 SEGMENT. THE PHYSICIAN THEN DECIDED TO DO A SECOND PASS. WHILE RETRACTING THE ACE68 UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT THE TIP OF THE ACE68 WAS NOT MOVING. THEREFORE, THE PHYSICIAN REMOVED THE ACE68 AND THE NEURON MAX. UPON REMOVAL, IT WAS NOTICED THE ACE68 WAS STRETCHED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 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 12185855 ↗
• MalfunctionJun 15, 2021Break; Leak/Splash; Break; Leak/Splash

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE ACE68 AND BLOOD FLOW WAS RESTORED TO THE VESSEL. THE ACE68 WAS THEN REMOVED AND WHILE FLUSHING ON THE BACK TABLE, THE PHYSICIAN NOTICED A LEAK APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL TIP AND THE ACE68 TO BE BROKEN. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001223 ↗
• MalfunctionMay 30, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING APPROXIMATELY TWO CENTIMETERS OF AN ACE68 THROUGH THE DISTAL TIP OF THE NEURON MAX, THE ACE68 BECAME STUCK. THEREFORE, THE NEURON MAX AND THE ACE68 WERE REMOVED TOGETHER. AFTERWARDS, IT WAS NOTICED THAT THE DISTAL END OF THE ACE68 WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), THE SAME NEURON MAX AND A NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE ACE68 WAS FLUSHED, AND IT WAS NOTICED THAT THE OVALIZED AREA OF THE ACE68 WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905888 ↗
• MalfunctionMay 27, 2021Break; Migration; Physical Resistance/Sticking; Break; Migration; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA CATHETER, NON-PENUMBRA MICROCATHETERS, AND A GUIDEWIRE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CATHETER REACHED AS FAR AS THE INTERNAL CAROTID ARTERY (ICA). WHEN THE DISTAL TIP OF THE ACE68 REACHED THE C4 SEGMENT OF THE ICA, THE PATIENT DEVELOPED A VASOSPASM IN THE ICA AND MCA. THE RELATIONSHIP BETWEEN THE VASOSPASM AND THE ACE68 IS UNKNOWN. IT WAS ALSO REPORTED THAT THE ACE68 COULD NOT BE CONTROLLED AFTER PASSING THROUGH THE GUIDE CATHETER; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE ACE68 CONTAINING THE NON-PENUMBRA MICROCATHETER. UPON REMOVAL OF THE ACE68, RESISTANCE WAS ENCOUNTERED. WHEN THE ACE68 WAS OUTSIDE OF THE PATIENT, THE PHYSICIAN NOTICED THAT THE DISTAL TIP WAS BROKEN OFF IN THE MCA. THE PHYSICIAN DECIDED TO LEAVE THE ACE68 TIP INSIDE THE PATIENT; THEREFORE, NO ATTEMPTS WERE MADE TO REMOVE IT. NEXT, THE PHYSICIAN ATTEMPTED TO USE THE SAME NON-PENUMBRA MICROCATHETER TO ADVANCE A STENT RETRIEVER INTO THE TARGET LOCATION BUT WAS UNABLE TO REACH THE OCCLUSION SITE. THEREFORE, THE DEVICES WERE WITHDRAW

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

  MAUDE report 11895080 ↗
• MalfunctionMay 5, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN FLUSHED A ACE68. WHILE ADVANCING THE ACE68 THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE ACE68. UPON REMOVAL, THE PHYSICIAN NOTICED APPROXIMATELY FOUR CENTIMETERS OF THE DISTAL TIP OF THE ACE68 WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68, THE SAME NEURON MAX, AND A NON-PENUMBRA STENT RETRIEVER. IT WAS REPORTED THAT A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 3 WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780562 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA MICROCATHETER, AND A STENT RETRIEVER. AFTER ONE PASS USING THE ACE68 AND STENT RETRIEVER, RECANALIZATION WAS SUCCESSFULLY ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE OF 2B. NO PROCEDURAL COMPLICATIONS WERE REPORTED. ON (B)(6) 2021, THE PATIENT DEVELOPED SUBARACHNOID HEMORRHAGE (SAH) CAUSED BY DISSECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA). NO FURTHER TREATMENT WAS CONDUCTED PER WISHES OF THE PATIENT'S FAMILY AND THE PATIENT LATER EXPIRED. IT WAS REPORTED THAT THE ACE68 AND STENT RETRIEVER WERE RELATED TO THE VESSEL DISSECTION. THE CAUSE OF THE DEATH IS UNKNOWN.

  Patient problems: Vascular Dissection

  MAUDE report 11704563 ↗
• MalfunctionApr 12, 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 68 REPERFUSION CATHETER (ACE68), NON-PENUMBRA GUIDING CATHETER, MICROCATHETER AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE ACE68 WITH A FEW CENTIMETERS OF THE MICROCATHETER OUT. THE PHYSICIAN ALSO ENCOUNTERED RESISTANCE WHEN RETRIEVING THE MICROCATHETER. IT WAS REPORTED THERE WAS A SLIGHT KINK 85 MILLIMETERS FROM THE HUB OF MICROCATHETER. THE PROXIMAL SHAFT OF ACE68 WAS OVALIZED. THE PROCEDURE WAS COMPLETED BY USING A NON-PENUMBRA ASPIRATION CATHETER, MICROCATHETER AND STENT RETRIEVER AND THE SAME GUIDING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649836 ↗
• MalfunctionApr 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), VELOCITY DELIVERY MICROCATHETER (VELOCITY), PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), NON-PENUMBRA SHEATH AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN REACHED THE TARGET LOCATION WITH THE ACE68. WHEN ASPIRATION WAS TURNED ON, THE ACE69 DID NOT APPEAR TO BE ASPIRATING PROPERLY, BUT THERE WAS OCCASIONAL BLOOD COMING BACK. THE PHYSICIAN THEN REMOVED THE ACE68 TO SEE IF THE CLOT WAS INGESTED. AT THIS POINT, THE PHYSICIAN NOTICED THE ACE68 HAD ALMOST BROKE ABOUT 10IN FROM THE DISTAL TIP BUT WAS HANGING. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620503 ↗
• MalfunctionMar 23, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A SUCCESSFUL THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA MICROCATHETER. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE ACE68 FROM THE GUIDE CATHETER. AFTER THE ACE68 WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE MID-SHAFT OF THE ACE68 WAS BROKEN AND ONLY CONNECTED BY WIRES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556240 ↗
• MalfunctionMar 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), USING A PENUMBRA SYSTEM (B)(4) REPERFUSION CATHETER ((B)(4)) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE (B)(4) AND GUIDE CATHETER FOR FLUSHING. WHILE RE-ADVANCING THE (B)(4) APPROXIMATELY TWO-THIRDS OF THE WAY INTO THE GUIDE CATHETER ON THE BACK TABLE, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE (B)(4) WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485498 ↗
• MalfunctionFeb 14, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, ON THE SECOND PASS UNDER ASPIRATION, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE WHEN PULLING BACK THE ACE68. AS THE PHYSICIAN CONTINUED TO PULL BACK UNDER ASPIRATION, THE ACE68 STRETCHED DISTALLY. THE PHYSICIAN WAS ABLE TO REMOVE THE ACE68. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME SHEATH. 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 11326014 ↗
• MalfunctionDec 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE ACE68 AND VELOCITY TOGETHER THROUGH THE CATHETER BEFORE ANY PASSES WERE MADE. THE PHYSICIAN DECIDED TO CONTINUE ADVANCEMENT AND SUBSEQUENTLY, THE ACE68 AND VELOCITY BECAME STUCK INSIDE THE CATHETER. THEREFORE, THE ACE68 AND VELOCITY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) AND THE SAME VELOCITY. 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 10950530 ↗
• MalfunctionNov 19, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (LMCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE ACE68 WOULD NOT ADVANCE ALL THE WAY THROUGH THE OTHER CATHETER. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER. 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 10872048 ↗
• MalfunctionOct 23, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BALLOON GUIDE CATHETER IN THE HIGH CERVICAL. THEN, WHILE ADVANCING THE ACE68 PASS THE DISTAL TIP OF THE BALLOON GUIDE CATHETER, THE ACE68 WOULD NOT ADVANCE FURTHER. WHILE RETRACTING THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE DISTAL TIP OF THE ACE68 STAYED IN THE SAME PLACE BUT THE ACE68 WAS RETRACTING. UPON REMOVAL OF THE ACE68, IT WAS NOTICED THAT THE MID-SHAFT OF THE ACE68 UNRAVELED. THE PROCEDURE WAS COMPLETED USING A ANOTHER CATHETER AND THE SAME BALLOON GUIDE 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 10731254 ↗
• MalfunctionOct 16, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETERS (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE NEURON MAX, ACE68 AND 3MAXC. DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE ACE68 AND SUBSEQUENTLY, THE ACE68 SEPARATED AT THE MIDSHAFT; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE68, THE SAME 3MAXC AND NEURON MAX. 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 10690677 ↗
• MalfunctionSep 10, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS REPORTED THAT THE PATIENT HAD AN ANGIOPLASTY AND STENT PLACED IN THE INTERNAL CAROTID ARTERY (ICA). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX NORTH OF THE STENT, ADVANCED THE ACE68 THROUGH THE NEURON MAX, AND PERFORMED ASPIRATION USING THE ACE68. THE PHYSICIAN THEN OBSERVED THAT THERE WAS NO FLOW COMING OUT OF THE ACE68 AND PULLED BACK THE ACE68. WHILE RETRACTING THE ACE68, THE PHYSICIAN NOTICED A COIL WIND COMING OUT OF THE DISTAL END OF THE ACE68; THEREFORE, THE NEURON MAX WAS REMOVED WITH THE ACE68. THE ACE68 WAS THEN PULLED OUT OF THE NEURON MAX ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED AFTER THE REMOVAL OF THE ACE68 AS THE VESSEL WAS OPENED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513200 ↗
• MalfunctionSep 9, 2020Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE ACE68. WHILE RETRACTING THE ACE68 THROUGH THE NEURON MAX ON THE NEXT PASS TO REMOVE THE CLOT, THE MID-SHAFT OF THE ACE68 UNRAVELED. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME NEURON MAX. A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10512187 ↗
• MalfunctionSep 9, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), NEURON SELECT CATHETER 6F, VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND NON-PENUMBRA STENT RETRIEVER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS ONLY ABLE TO ADVANCE THE NEURON MAX TO THE COMMON CAROTID ARTERY DUE TO THE TORTUOUS ANATOMY. THE FIRST PASS WAS COMPLETED USING THE ACE68, VELOCITY AND, STENT RETRIEVER (6MM X 40MM). THE ACE68 AND STENT RETRIEVER WERE THEN REMOVED; SUBSEQUENTLY, THE PHYSICIAN NOTICED THE STENT RETRIEVER AND THE DISTAL END OF THE ACE68 WERE DAMAGED ON THE BACK TABLE. THE PHYSICIAN USED A NEW ACE68, NEW STENT RETRIEVER (4MM X 40MM), AND THE SAME VELOCITY TO MAKE ANOTHER PASS. WHILE ADVANCING THE TRIAXIAL SYSTEM CONSISTING OF THE ACE68, STENT RETRIEVER, AND VELOCITY INTO THE INTERNAL CAROTID ARTERY, THE PHYSICIAN NOTICED A RADIO-OPAQUE MARKER IN THE EXTERNAL CAROTID ARTERY. CONSEQUENTLY, THE DISTAL TIP FROM THE FIRST ACE68 HAD BROKEN OFF AND WAS LODGED IN THE EXTERNAL CAROTID ARTERY. NO ATTEMP

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

  MAUDE report 10511593 ↗
• MalfunctionSep 7, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS IN THE TARGET VESSEL USING THE ACE68 WITH ADAPT TECHNIQUE. UPON REMOVAL, THE ACE68 WAS OBSERVED TO BE KINKED. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE68, THE SAME NEURON MAX, AND NON-PENUMBRA STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10499450 ↗
• MalfunctionJul 7, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA INTRODUCER SHEATH AND STENT RETRIEVER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE NEURON MAX, INTRODUCER SHEATH, ACE68 AND THE STENT RETRIEVER. WHILE RETRACTING THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON REMOVAL OF THE ACE68, THE PHYSICIAN NOTICED THE MID-SHAFT OF THE ACE68 WAS BROKEN. IT WAS REPORTED THAT THE REST OF THE ACE68 WAS REMOVED BY CONTINUOUS PULLING. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC) AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10242755 ↗