ACE 5MAXACE068Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00814548016535), received between Jan 11, 2017 and Jun 16, 2023 — classified as 2 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (28 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2023Fracture; Difficult to Advance; Physical Resistance/Sticking; Fracture; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN STEAM SHAPED THE DISTAL END OF THE ACE68. NEXT, WHILE ADVANCING THE ACE68 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND AFTER PARTIALLY ADVANCING THE ACE68 OUT OF THE DISTAL END OF THE SHEATH, THE ACE68 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE ACE68. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS FRACTURED AT THE DISTAL END AND CONNECTED BY A WIRE. THEREFORE, THE ACE68 WAS NO LONGER USED IN THE PROCEDURE. 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

  MAUDE report 17144595 ↗
• MalfunctionApr 4, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX IN THE PATIENT. WHILE ADVANCING THE ACE68 INTO THE NEURON MAX, THE PHYSICIAN FRACTURED THE ACE68 AT THE PROXIMAL END NEAR THE HUB. SUBSEQUENTLY, THE ACE68 WAS LEAKING AT THE FRACTURED PART OUTSIDE OF THE PATIENT, JUST BEFORE CONNECTION WITH THE ASPIRATION SYSTEM. THEREFORE, THE ACE68 WAS REMOVED. 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 16677731 ↗
• MalfunctionJun 30, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE68 THROUGH THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN KINKED AND BROKE THE ACE68 ON THE PROXIMAL END, FIVE CENTIMETERS FROM THE HUB. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881109 ↗
• MalfunctionMar 8, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE68 THROUGH THE SHEATH. IT WAS REPORTED THAT THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE THE ACE68 THROUGH THE SHEATH BUT THE ATTEMPTS WERE UNSUCCESSFUL. THEREFORE, THE ACE68 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE ACE68 WAS FRACTURED APPROXIMATELY 20 CENTIMETERS FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691052 ↗
• MalfunctionNov 30, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), 8F SHEATH, AND A 8F BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 INTO THE TARGET LOCATION AND USED A 40CC SYRINGE TO ASPIRATE CLOT. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT FEELING TYPICAL CLOT ASPIRATION THROUGH THE ACE68 AFTER SEVERAL ATTEMPTS. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE ACE68 AND FOUND THE DISTAL END TO BE STRETCHED. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA CATHETER WITH THE SAME SHEATH AND BALLOON GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12903498 ↗
• MalfunctionAug 20, 2021Suction Problem; Material Twisted/Bent; Suction Problem; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA SHEATH, A PENUMBRA ENGINE (ENGINE), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 INTO THE TARGET VESSEL, CONNECTED THE ACE68 TO THE ENGINE AND INITIATED ASPIRATION. THE PHYSICIAN THEN NOTICED THAT THE ASPIRATION WAS LOW AND DECIDED TO RETRACT THE ACE68. AFTER RETRACTING THE ACE68, THE PHYSICIAN NOTICED THE DISTAL END OF THE ACE68 WAS OVALIZED. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE REPERFUSION 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 12351433 ↗
• MalfunctionJul 21, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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), A NON-PENUMBRA BALLOON GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE68 THROUGH THE BALLOON GUIDE CATHETER AND SUBSEQUENTLY THE PHYSICIAN BENT THE ACE68 AT APPROXIMATELY FIVE CENTIMETERS FROM THE HUB. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 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

  MAUDE report 12208046 ↗
• MalfunctionJun 30, 2021Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA BALLOON GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING AN ACE68 THROUGH A BALLOON GUIDE CATHETER AROUND THE INTERNAL CAROTID ARTERY (ICA), THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE ACE68 AND BALLOON GUIDE CATHETER. UPON REMOVAL, IT WAS NOTICED THAT THE ACE68 WAS BROKEN AT APPROXIMATELY TWENTY CENTIMETERS FROM THE DISTAL END, BUT REMAINED CONNECTED BY THE BRAIDED INNER WIRES. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 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

  MAUDE report 12095961 ↗
• MalfunctionApr 5, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A CENTRAL VENOUS THROMBOSIS (CVT) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE ACE68 THROUGH THE NEURON MAX. SUBSEQUENTLY, THE ACE68 WAS RETRACTED AND THE PHYSICIAN ATTEMPTED TO READVANCE THE ACE68 THROUGH THE NEURON MAX; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PHYSICIAN KINKED THE DISTAL END OF THE ACE68. THEREFORE, THE ACE68 WAS REMOVED. 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 11615673 ↗
• MalfunctionApr 5, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A 6F NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING AN ACE68 THROUGH THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE ACE68. UPON REMOVAL, IT WAS NOTICED THAT THE ACE68 WAS BROKEN IN HALF BUT REMAINED CONNECTED BY BRAIDED WIRES. 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

  MAUDE report 11615284 ↗
• MalfunctionMar 18, 2021Flaked; Flaked

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). AFTERWARDS, THE PHYSICIAN NOTICED SOME LIGHT SPOTS VIA A COMPUTED TOMOGRAPHY SCAN (CT SCAN), POSSIBLY DUE TO SOME SCRAPS PEELED OFF FROM THE DISTAL MARKERBAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11519941 ↗
• MalfunctionMar 8, 2021Positioning Problem; Positioning Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE RADIOPAQUE MARKER OF THE ACE68 WAS NOT VISIBLE ON THE MONITOR UNDER FLUOROSCOPY; THEREFORE, THE PHYSICIAN COULD NOT DETERMINE THE POSITIONING OF THE DISTAL TIP OF THE ACE68. THE ACE68 WAS THEREFORE REMOVED. 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 11434472 ↗
• MalfunctionMar 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE THE PHYSICIAN ADVANCED AN ACE68 WITH A BALLOON CATHETER AT THE RIGHT COMMON CAROTID ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE ACE68 AND BALLOON CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND A NEW BALLOON 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 11399015 ↗
• MalfunctionJan 20, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), NON-PENUMBRA SHEATH, BALLOON GUIDE CATHETER, AND PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 INTO THE TARGET LOCATION AND TURNED ON THE PUMP MAX TO INITIATE ASPIRATION; HOWEVER, IT WAS NOTICED THAT THE ASPIRATION WAS LOW. THEREFORE, THE ACE68 WAS REMOVED AND THE PHYSICIAN FOUND THE ACE68 TO BE OVALIZED APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 WITH THE SAME SHEATH, GUIDE CATHETER, AND PUMP 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 11201377 ↗
• MalfunctionJan 7, 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) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN TRACKING THE ACE68 THROUGH THE NEURON MAX TO THE TARGET LOCATION. THEREFORE, THE ACE68 WAS REMOVED FROM THE PATIENT. ON THE BACK TABLE, THE PHYSICIAN OBSERVED KINKING AT THE DISTAL TIP OF THE ACE68 AND WHILE FLUSHING, THE DISTAL TIP EXPANDED. 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; No Consequences Or Impact To Patient

  MAUDE report 11132435 ↗
• MalfunctionDec 16, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING THE ACE68. WHILE ADVANCING THE ACE68 THROUGH THE BALLOON GUIDE CATHETER TO MAKE ANOTHER PASS, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE INTERNAL CAROTID ARTERY (ICA); CONSEQUENTLY, THE ACE68 BECAME KINKED AT A STEEP ANGLE AND THE ACE68 WOULD NOT ADVANCE ANY FURTHER. SUBSEQUENTLY, THE PHYSICIAN CONFIRMED THE ACE68 WAS STILL INTACT AND DECIDED TO REMOVE IT; HOWEVER, AFTER REMOVING THE ACE68, THE PHYSICIAN NOTICED THE MIDDLE TO HIGHER DISTAL PORTION OF THE ACE68 HAD BROKEN OFF AND DETACHED INSIDE THE BALLOON GUIDE CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE BALLOON GUIDE CATHETER CONTAINING THE DETACHED PORTION OF THE ACE68. THE PROCEDURE WAS COMPLETED USING 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 11015993 ↗
• MalfunctionSep 4, 2020Break; Suction Problem; Break; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE NEURON MAX AND ACE68 INTO THE PATIENT, THEN CONNECTED A SYRINGE TO THE ACE68; HOWEVER, NO ASPIRATION WAS OBSERVED. SUBSEQUENTLY, THE PHYSICIAN REALIZED THAT THERE WAS NO NEGATIVE PRESSURE. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT, BUT SAME ISSUE OCCURRED. THEREFORE, THE ACE68 WAS REMOVED AND FLUSHED ON THE BACK TABLE. WHILE FLUSHING THE ACE68, THE PHYSICIAN FOUND A LEAK APPROXIMATELY 1-2 CENTIMETERS NEAR THE DISTAL TIP. THEREFORE, THE ACE68 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68, THE SAME NEURON MAX, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497243 ↗
• MalfunctionJul 30, 2020Stretched; Stretched

  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 PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, WHILE THE PUMP MAX WAS POWERED ON, THE PHYSICIAN FELT SOME SHAKING WHEN THE DISTAL END OF THE ACE68 MOVED ON THE MONITOR AND SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE ACE68. UPON REMOVAL OF THE ACE68, IT WAS NOTICED THAT THE DISTAL END OF THE ACE68 WAS STRETCHED. THEREFORE, THE ACE68 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10346043 ↗
• MalfunctionJul 24, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, WHILE INSERTING THE ACE68 TO MAKE AN INITIAL PASS, THE PHYSICIAN NOTICED THE PROXIMAL END OF THE ACE68 TO BE KINKED. THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10320302 ↗
• MalfunctionJun 19, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE ACE68 TOWARD THE LESION. AS THE ACE68 WAS INTRODUCED TO THE TARGET SITE, THE PHYSICIAN REALIZED THAT THE CLOT WAS ACTUALLY INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) AND VESSEL STENOSIS, WHICH CANNOT BE TREATED WITH THE ACE68. UPON REMOVAL OF THE ACE68, THE PHYSICIAN ENCOUNTERED RESISTANCE AND A CRACK WAS FOUND APPROXIMATELY THIRTY CENTIMETERS FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH AND A 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 10176890 ↗
• MalfunctionApr 29, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE ACE68 INTO THE RIGHT M1 SEGMENT. THE PHYSICIAN DECIDED TO REMOVE THE ACE68 AND FOUND THAT IT WAS KINKED AT THE PROXIMAL PART. THEREFORE, THE ACE68 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10011352 ↗
• MalfunctionMar 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE ACE68 APPROXIMATELY 5-10 CENTIMETERS THROUGH THE GUIDE CATHETER, THE PHYSICIAN EXPERIENCE RESISTANCE; THEREFORE, THE ACE68 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795844 ↗
• MalfunctionMar 4, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN STEAMED-SHAPED THE TIP OF THE ACE68 AND NOTICED THAT THE ACE68 SEEMED DAMAGED; HOWEVER, THE PHYSICIAN CONTINUED TO PROCEED WITH ADVANCING THE ACE68 INTO THE VESSEL. WHILE ADVANCING THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE; AND THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE ACE68. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE ACE68 WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A NEW ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786731 ↗
• MalfunctionJan 24, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND AN 8F NON-PENUMBRA BALLOON GUIDE CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE ACE68 THROUGH THE 8F BALLOON GUIDE CATHETER; THEREFORE, THE ACE68 WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE ACE68 WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME 8F BALLOON GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9625556 ↗
• MalfunctionJan 7, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE ACE68 INTO THE NON-PENUMBRA GUIDING SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE ACE68 WOULD NOT ADVANCE INTO THE SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE68 AND THE SAME GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9561140 ↗