Penumbra System 5MAXACE132KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00814548017433), received between May 25, 2016 and Oct 6, 2021 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Kinked” (6 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE THE BENCHMARK MAX TO THE HIGH CERVICAL. THEREFORE, THE BENCHMARK MAX WAS PLACED IN THE COMMON CAROTID. NEXT, WHILE ADVANCING THE ACE60 WITH THE VELOCITY USING A GUIDEWIRE TO THE TARGET VESSEL, THE MID-SHAFT OF THE ACE60 KINKED DUE TO PATIENT¿S TORTUOUS ANATOMY. CONSEQUENTLY, THE VELOCITY KINKED AT MID-SHAFT. THEREFORE, THE ACE60 AND VELOCITY WERE REMOVED. THE PHYSICIAN THEN USED THE 4MAXC IN PLACE OF ACE60 WITH THE SAME VELOCITY. HOWEVER, THE 4MAXC KINKED DUE TO THE KINK IN THE VELOCITY. THEREFORE, THE 4MAXC AND VELOCITY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER ASPIRATION CATHETER AND ANOTHER MICROCATHETER. IT WAS ALSO REPORTED THAT NO VISIBLE KINK WAS NOTICED ON THE 4MAXC BY THE PENUMBRA SALES REPRESENTATIVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587001 ↗
• InjuryMay 4, 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 RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA GUIDE CATHETER, AND A STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES WITH THE ACE60 AND GUIDE CATHETER AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A WAS ACHIEVED. NO PROCEDURAL COMPLICATIONS NOR DEVICE DEFICIENCIES WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE. HOWEVER, A CONTRAST RUN REVEALED SLIGHT INTRACRANIAL HEMORRHAGE. THE RELATIONSHIP BETWEEN THE ACE60 AND THE INTRACRANIAL HEMORRHAGE IS UNKNOWN. IT WAS REPORTED THAT NO ADDITIONAL ACTION WAS TAKEN TO TREAT THE HEMORRHAGE; HOWEVER, THE PATIENT WAS IN STABLE CONDITION AND WAS TRANSFERRED TO ANOTHER HOSPITAL.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11767936 ↗
• MalfunctionNov 13, 2020Material Puncture/Hole; Material Puncture/Hole

  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 VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER COMPLETING THE FIRST PASS, THE ACE60 WAS REMOVED. WHILE FLUSHING THE ACE60 IN PREPARATION FOR THE SECOND PASS, THE TECHNOLOGIST NOTICED A SMALL HOLE IN THE PROXIMAL PART OF THE ACE60. THEREFORE, THE ACE60 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60 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 10839803 ↗
• MalfunctionDec 26, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEREBRAL ARTERY USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND BALLOON GUIDE CATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE ACE60 THROUGH THE BALLOON GUIDE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN PASSING THE HUB; THEREFORE, THE ACE60 WAS REMOVED. UPON REMOVAL, THE DISTAL TIP OF THE ACE60 WAS NOTICED TO BE FLATTENED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60 AND THE SAME BALLOON GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521126 ↗
• MalfunctionDec 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE MICROCATHETER THROUGH THE ACE60 IN THE TARGET VESSEL. NEXT, WHILE ADVANCING THE STENT RETRIEVER THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE MICROCATHETER TO INCREASE ASPIRATION POWER WITHIN THE ACE60, BUT THE MICROCATHETER BECAME STUCK INSIDE THE ACE60; THEREFORE, THE PHYSICIAN REMOVED THE ACE60, MICROCATHETER, AND STENT RETRIEVER AS A UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60 AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS THEN ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490904 ↗
• MalfunctionSep 18, 2019Stretched; Failure to Advance; Physical Resistance/Sticking; Stretched; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 HI-FLOW KIT. IT WAS NOTED THAT THE PATIENT¿S OPHTHALMIC ARTERY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA BALLOON GUIDE CATHETER IN THE INTERNAL CAROTID PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND A NON-PENUMBRA MICROCATHETER OVER THE TIP OF THE BALLOON GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE PHYSICIAN ADVANCED THE ACE60 CONTAINING THE MICROCATHETER A FEW TIMES WITHIN THE GUIDE CATHETER; HOWEVER, IT WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE ACE60 WAS REMOVED AND FOUND TO BE STRETCHED APPROXIMATELY TWO TO THREE CENTIMETERS AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 WITH THE SAME MICROCATHETER AND GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082887 ↗
• MalfunctionAug 13, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE CEREBRAL ARTERY USING A PENUMBRA SYSTEM ACE 60 KIT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) WITH A NON-PENUMBRA SHEATH INTO THE PATIENT¿S BODY. WHILE ATTEMPTING TO INSERT A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) INTO THE ACE60 AND THE SHEATH, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE ACE60 WAS KINKED; THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER ACE60 AND THE SAME 3MAXC AND SHEATH. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8890536 ↗
• MalfunctionJul 17, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 KIT AND A UNKNOWN PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN MADE A SUCCESSFUL PASS USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND THE UNKNOWN PENUMBRA MICROCATHETER WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE MICROCATHETER THROUGH THE ACE60 AND, THEREFORE, THE ACE60 AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER 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 8798404 ↗
• MalfunctionMay 30, 2019Difficult to Advance; Difficult to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A PENUMBRA SYSTEM ASPIRATION 3MAX REPERFUSION CATHETER (3MAXC) INTO THE ACE60 ON THE BACK TABLE. DURING ADVANCEMENT, IT WAS REPORTED THAT THE 3MAXC WAS ONLY ABLE TO ADVANCE APPROXIMATELY 15 CM OUT FROM THE TIP OF THE ACE60 AND WOULD NOT ADVANCE FURTHER. THE PHYSICIAN THEN DECIDED TO REMOVE THE ACE60 AND NOTED THAT SOMETHING WAS WITHIN THE INNER DIAMETER, PREVENTING THE 3MAXC FROM ADVANCING FURTHER. THE ISSUE WITH THE ACE60 WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) AND THE SAME 3MAXC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656620 ↗
• InjuryMay 3, 2019Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE60 OVER A GUIDEWIRE AND A NON-PENUMBRA MICROCATHETER WITHIN A NON-PENUMBRA SHEATH TO THE TARGET LOCATION AT THE BASE OF THE CLOT. THE PHYSICIAN ADVANCED THE GUIDEWIRE THROUGH THE CLOT BUT WAS UNABLE TO ADVANCE THE MICROCATHETER PAST THE BASE OF THE CLOT. THE PHYSICIAN ASPIRATED FOR 90 SECONDS WITH THE ACE60, AND THEN ATTEMPTED TO RETRACT THE ACE60. WHILE RETRACTING, THE PHYSICIAN FELT MINIMAL RESISTANCE AND THE ACE60 STRETCHED AND BROKE INTO TWO PIECES. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DISTAL END OF THE ACE60 AND THEN DISCONTINUED THE THROMBECTOMY PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580002 ↗
• MalfunctionDec 28, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 HI-FLOW KIT. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), THROUGH THE CROSS CUT VALVE OF A NON-PENUMBRA SHEATH AND, CONSEQUENTLY, THE TIP OF THE ACE60 BECAME OVALIZED. THEREFORE, THE ACE60 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW CATHETER 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 8203079 ↗
• MalfunctionSep 20, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) AND A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) WERE KINKED AT THE HUB AND BEGAN TO UNRAVEL UPON REMOVAL FROM THEIR PACKAGING. THE DAMAGE TO THE 5MAX ACE AND THE ACE64 OCCURRED PRIOR TO USE AND, THEREFORE, THE DEVICES WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE64.

  Patient problems: No Patient Involvement

  MAUDE report 7894796 ↗
• MalfunctionAug 6, 2018Defective Device; Defective Device

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL FOUND THAT THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) COULD NOT BE FLUSHED IN A PROPER WAY FOR UNKNOWN REASONS. THE REPORTED ISSUE WAS FOUND PRIOR TO USE. THEREFORE, THE ACE60 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE60.

  Patient problems: No Patient Involvement

  MAUDE report 7754441 ↗
• MalfunctionJul 30, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, THE ACE60 BROKE WHILE BEING RETRACTED FROM THE ROTATING HEMOSTASIS VALVE (RHV) AFTER TWO PASSES HAD BEEN MADE. THE PHYSICIAN WAS ABLE TO PULL OUT THE TWO PIECES OF THE ACE60, AND THE PROCEDURE WAS COMPLETED USING THE SAME CATHETER AND A NEW ACE60. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732896 ↗
• MalfunctionMar 9, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M3 SEGMENT OF MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM ACE 60 HIGH-FLOW KIT (KIT). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND THE 3MAXC. WHILE REMOVING THE 3MAXC FROM THE ACE60, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON REMOVAL OF THE 3MAXC, THE PHYSICIAN NOTICED THAT THE END OF THE 3MAXC WAS FRAYED AND THAT THE DISTAL TIP OF THE 3MAXC WAS MISSING. THE PHYSICIAN THEN DECIDED TO REMOVE ACE60. UPON REMOVING AND FLUSHING THE ACE60 WITH SALINE, THE MISSING PIECE OF THE 3MAXC CAME OUT OF THE ACE60 ALONG WITH CLOT. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING A NEW ACE60 AND 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327900 ↗
• MalfunctionJan 3, 2018Material Frayed; Device Operates Differently Than Expected; Material Frayed; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 HI-FLOW KIT (ACE60). DURING THE PROCEDURE, ON THE THIRD PASS USING THE ACE60 WITHIN A NEURON MAX, THE PHYSICIAN REMOVED AND FLUSHED THE ACE60, HOWEVER AS THE PHYSICIAN WAS FLUSHING THE ACE60 OUTSIDE OF THE PATIENT, A BALLOON FORMED IN THE SHAFT OF THE ACE60. THE PROCEDURE WAS THEREFORE COMPLETED USING THE SAME NEURON MAX AND A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7161303 ↗
• MalfunctionDec 19, 2017Retraction Problem; Material Deformation; Mechanical Jam; Retraction Problem; Material Deformation; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 HI-FLOW KIT (KIT). DURING THE PROCEDURE, WHILE USING THE SOLUMBRA TECHNIQUE, THE PHYSICIAN RETRACTED THE STENT RETRIEVER BACK INTO THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60); HOWEVER, THE STENT RETRIEVER BECAME STUCK AFTER RETRACTING A FEW CENTIMETERS INTO THE ACE60. THE PHYSICIAN THEN ATTEMPTED TO RETRACT AND REMOVE THE ACE60 AND THE STENT RETRIEVER TOGETHER BUT BOTH BECAME STUCK INSIDE THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). SUBSEQUENTLY, THE PHYSICIAN REMOVED THE NEURON MAX WITH BOTH THE ACE60 AND STENT RETRIEVER FROM THE PATIENT'S BODY. UPON FLUSHING THE ACE60 OUTSIDE OF THE PATENT'S BODY, A BALLOON FORMED IN THE DISTAL SHAFT OF THE ACE60. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX, A NEW ACE60, AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129284 ↗
• MalfunctionOct 19, 2017Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM ACE 60 HI-FLOW KITS (ACE60S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS USING A NON-PENUMBRA MICROCATHETER AND STENT RETRIEVER. THE PHYSICIAN THEN ATTEMPTED TO MAKE A SECOND PASS USING THE MICROCATHETER AND STENT RETRIEVER, HOWEVER THE PHYSICIAN FELT RESISTANCE ADVANCING JUST PAST THE PROXIMAL HUB OF THE ACE60. UPON INSPECTION OF THE ACE60, A SPLIT NEAR THE PROXIMAL END OF THE CATHETER WAS FOUND AND THEREFORE, THE ACE60 WAS REMOVED. THE PHYSICIAN THEN ADVANCED A SECOND ACE60 AND THE SAME MICROCATHETER, GUIDE WIRE, AND STENT RETRIEVER INTO THE MCA, HOWEVER AT THAT MOMENT THE PATIENT BEGAN MOVING VIGOROUSLY ON THE TABLE. THE PHYSICIAN ADMINISTERED MORE ANESTHESIA AND PROCEEDED WITH THE CASE, HOWEVER THE ACE60, THE MICROCATHETER, AND THE GUIDE WIRE WERE NOW CURLED UP IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) AND WERE KINKED; THEREFORE, THE DEVICES WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60, A NEW MICROCATHETER, A NEW GUIDE WIRE, AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963745 ↗
• MalfunctionOct 19, 2017Split; Physical Resistance; Split; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM ACE 60 HI-FLOW KITS (ACE60S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS USING A NON-PENUMBRA MICROCATHETER AND STENT RETRIEVER. THE PHYSICIAN THEN ATTEMPTED TO MAKE A SECOND PASS USING THE MICROCATHETER AND STENT RETRIEVER, HOWEVER THE PHYSICIAN FELT RESISTANCE ADVANCING JUST PAST THE PROXIMAL HUB OF THE ACE60. UPON INSPECTION OF THE ACE60, A SPLIT NEAR THE PROXIMAL END OF THE CATHETER WAS FOUND AND THEREFORE, THE ACE60 WAS REMOVED. THE PHYSICIAN THEN ADVANCED A SECOND ACE60 AND THE SAME MICROCATHETER, GUIDE WIRE, AND STENT RETRIEVER INTO THE MCA, HOWEVER AT THAT MOMENT THE PATIENT BEGAN MOVING VIGOROUSLY ON THE TABLE. THE PHYSICIAN ADMINISTERED MORE ANESTHESIA AND PROCEEDED WITH THE CASE, HOWEVER THE ACE60, THE MICROCATHETER, AND THE GUIDE WIRE WERE NOW CURLED UP IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) AND WERE KINKED; THEREFORE, THE DEVICES WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60, A NEW MICROCATHETER, A NEW GUIDE WIRE, AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6963740 ↗
• MalfunctionSep 14, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR AN ISCHEMIC STROKE USING A PENUMBRA SYSTEM ACE 60 HI-FLOW KIT (KIT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) THROUGH A NEURON MAX WITH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC); HOWEVER, AFTER SIGNIFICANT MANIPULATION, THE PHYSICIAN NOTICED THE ACE60 WAS KINKED NEAR THE HUB. UPON FURTHER MANIPULATION, THE STRAIN RELIEF BEGAN TO SEPARATE NEAR THE KINK; THEREFORE, THE ACE60 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED WITH A NEW ACE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6865665 ↗
• MalfunctionAug 23, 2017Kinked; Failure to Advance; Kinked; Failure to Advance

  THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM ACE 60 HIGH FLOW KITS (KITS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) OF A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE 5MAX ACE BECAME KINKED AT THE MID-SHAFT. THE PHYSICIAN DID NOT MENTION EXPERIENCING RESISTANCE; HOWEVER, IT WAS REPORTED THAT THE RHV WAS TIGHTENED TOO TIGHTLY. THEREFORE, THE 5MAX ACE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER KIT 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 6815127 ↗
• MalfunctionJul 17, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, A PENUMBRA SYSTEM ACE 60 HI-FLOW KIT (ACE60) WAS KINKED AT THE HUB UPON REMOVAL FROM THE PACKAGING TRAY. THE DAMAGE TO THE ACE60 OCCURRED PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE60.

  Patient problems: No Patient Involvement

  MAUDE report 6719963 ↗
• MalfunctionJan 13, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE TECHNICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) WAS KINKED UPON OPENING THE PACKAGING OF THE PENUMBRA SYSTEM ACE 60 HI-FLOW KIT (KIT). THE KINKED ACE 60 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6251743 ↗
• MalfunctionJan 4, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE LAB STAFF NOTICED A KINK IN THE MID-SHAFT OF THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) UPON OPENING THE PENUMBRA SYSTEM ACE 60 HI-FLOW KIT (KIT) AND REMOVING THE TUBING COVER FROM THE ACE 60 PACKAGING. SUBSEQUENTLY, THE ACE 60 WAS REMOVED FROM THE PACKAGING AND THE PHYSICIAN THEN ATTEMPTED TO FIX THE KINK BUT FURTHER DAMAGED THE ACE 60 INSTEAD. THE KINKED ACE 60 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW KIT.

  Patient problems: No Patient Involvement

  MAUDE report 6224092 ↗
• MalfunctionOct 26, 2016Crack; Device Damaged Prior to Use; Out-Of-Box Failure; Crack; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE 68) AND A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60). DURING THE PROCEDURE, UPON OPENING THE ACE 68 AND ACE 60 PRODUCT BOXES, THE HOSPITAL STAFF NOTICED THEY WERE CRACKED WITHIN THEIR PRODUCT PACKAGINGS. THE CRACKED ACE 68 AND ACE 60 WERE FOUND PRIOR TO USED AND THEREFORE WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 60.

  Patient problems: No Patient Involvement

  MAUDE report 6057989 ↗