Penumbra System 5MAXACE132Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00814548012803), received between Aug 20, 2015 and Dec 7, 2018 — classified as 3 deaths, 23 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Kinked” (38 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 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2018Collapse; Stretched; Failure to Advance; Collapse; Stretched; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 5MAX ACE INTO THE TARGET VESSEL THROUGH THE NEURON MAX, BUT FELT RESISTANCE. THE PHYSICIAN THEN NOTICED THAT THE NEURON MAX HAD BECOME BENT. AS A RESULT, THE 5MAX ACE HAD STRETCHED AND COLLAPSED. THEREFORE, THE PHYSICIAN REMOVED BOTH THE NEURON MAX AND THE 5MAX ACE. RESISTANCE WAS EXPERIENCED WHILE RETRACTING THE DEVICES FOR REMOVAL. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE CATHETER AND A NEW REPERFUSION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144683 ↗
• MalfunctionSep 5, 2018Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, THE PHYSICIAN USED A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) TO ADVANCE THE 5MAX ACE AND A NON-PENUMBRA STENT RETRIEVER TO THE TARGET LOCATION. THE PHYSICIAN REPORTED FEELING SLIGHT RESISTANCE WHILE ADVANCING THE 5MAX ACE BUT WAS ABLE TO ENGAGE THE THROMBUS USING THE STENT RETRIEVER. THE PHYSICIAN THEN BEGAN ASPIRATION, HOWEVER, WHILE RETRACTING, THE 5MAX ACE BROKE INTO TWO PIECES AT THE DISTAL END. THE PHYSICIAN WAS ABLE TO REMOVE BOTH PIECES OF THE 5MAX ACE BECAUSE THE GUIDEWIRE WAS STILL WITHIN BOTH PIECES. THE PROCEDURE ENDED AT THIS POINT BECAUSE THE THROMBUS WAS ABLE TO BE REMOVED WITH THE STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846671 ↗
• MalfunctionMay 23, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THE KINK ON THE PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) SHAFT AT 25CM FROM THE HUB WHEN FLUSHING THE 5MAX ACE. THE DAMAGE TO THE 5MAX ACE WAS FOUND PRIOR TO USE. THEREFORE, THE 5MAX ACE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 7538399 ↗
• MalfunctionJan 9, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE DISTAL RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ASPIRATE THE THROMBUS USING THE 5MAX ACE; HOWEVER, COMPLETE REVASCULARIZATION WAS NO ACHIEVED. THEREFORE, THE PHYSICIAN ATTEMPTED TO COAXIALLY ADVANCE A NON-PENUMBRA MICROCATHETER THROUGH THE 5MAX ACE; HOWEVER, THE CATHETERS WOULD NOT ADVANCE AFTER REACHING THE OPHTHALMIC ARTERY. IT WAS REPORTED THAT STRONG TORQUE AND FORCE WAS LOADED ONTO THE 5MAX ACE. THE PHYSICIAN THEN SIMULTANEOUSLY ADVANCED ANOTHER MICROCATHETER AND STENT RETRIEVER DEVICE THROUGH THE 5MAX ACE IN ORDER TO CAPTURE THE THROMBUS. UPON DEPLOYING THE STENT RETRIEVER, THE PHYSICIAN WAS ABLE TO PASS THE 5MAX ACE OVER THE OPHTHALMIC ARTERY AND INTO THE TREATMENT SITE IN M1. SUBSEQUENTLY, THE THROMBUS WAS COMPLETELY ASPIRATED AND THE 5MAX ACE WAS REMOVED. UPON REMOVING THE 5MAX ACE, IT WAS NOTED THAT THE 5MAX ACE WAS DEFORMED. IT IS UNKNOWN IF THE 5MAX ACE BECAME KINKED, STRETCHED OR TWISTED, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7176612 ↗
• DeathJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING A NON-PENUMBRA GUIDING CATHETER, A NON-PENUMBRA MICROCATHETER, A 5MAX ACE AND A NON-PENUMBRA STENT RETRIEVER DEVICE. THE PATIENT¿S THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE WAS IIA. AFTER REMOVING THE STENT RETRIEVER DEVICE, THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE PATIENT¿S FINAL THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE WAS III. HOWEVER, SEVEN HOURS AFTER THE PROCEDURE, SYMPTOMATIC INTRACRANIAL HEMORRHAGE WAS OBSERVED IN THE RIGHT MIDDLE CEREBRAL ARTERY (PH2 / PHR2). THE PATIENT SUFFERED FROM CEREBRAL EDEMA, CONSCIOUSNESS DISTURBANCE, AND RESPIRATORY DISTURBANCE, BUT IT IS NOT IDENTIFIED WHETHER AN ADDITIONAL TREATMENT WAS PERFORMED OR NOT. THE PATIENT EXPIRED ON (B)(6) 2017 DUE TO CEREBRAL HEMORRHAGE.THE PHYSICIAN STATED THAT IT IS UNCLEAR WHICH DEVICE (PENUMBRA¿S OR THE OTHER MANUFACTURES¿) DIRECTLY CAUSED THE REPORTED CEREBRAL HEMORRHAGE AND SUBSEQUENT PATIENT DEATH BECAUSE THREE DIFFERENT DEVICES WERE USED

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 7175729 ↗
• MalfunctionJan 5, 2018Kinked; Occlusion Within Device; Kinked; Occlusion Within Device

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA BALLOON GUIDE CATHETER TOWARDS THE INTERNAL CAROTID ARTERY (ICA), THEN ADVANCED A NON-PENUMBRA MICROCATHETER AND THE 5MAX ACE COAXIALLY TOWARDS THE TARGET LOCATION. THE PHYSICIAN DID NOT MENTION FEELING RESISTANCE WHILE ADVANCING THE 5MAX ACE. WHILE INITIATING ASPIRATION WITH THE PENUMBRA SYSTEM PUMP MAX 110V (PUMP MAX), THE PHYSICIAN NOTICED THAT THE SHAFT OF THE 5MAX ACE BECAME OCCLUDED AND KINKED. THEREFORE, THE 5MAX ACE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169759 ↗
• InjuryDec 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE-STAGE CEREBRAL INFARCTION USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAXACE) AND A NON-PENUMBRA STENT RETRIEVER DEVICE. FIFTEEN HOURS AFTER THE PROCEDURE, A HEMORRHAGIC TRANSFORMATION (PH2 LEVEL) OCCURRED AT THE OCCLUSION SITE. IT IS UNKNOWN WHETHER OR NOT ADDITIONAL TREATMENT WAS PERFORMED AFTER THE ORIGINAL PROCEDURE, DUE TO INSUFFICIENT INFORMATION. THE INTRACRANIAL BLEEDING WAS DETERMINED TO HAVE A PROBABLE RELATIONSHIP WITH THE 5MAXACE. ON (B)(6) 2016, THE PATIENT ALSO SUFFERED PARALYSIS ON THE RIGHT SIDE OF THE BODY AND WAS CONFIRMED TO HAVE APHASIA. ON (B)(6) 2016, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. ON (B)(6) 2016, THE PATIENT EXPIRED DUE TO DETERIORATED GENERAL CONDITION. THE PATIENT''S DEATH WAS DETERMINED TO BE UNRELATED TO THE 5MAXACE.

  Patient problems: Intracranial Hemorrhage; Neurological Deficit/Dysfunction; Paralysis

  MAUDE report 7127738 ↗
• MalfunctionNov 8, 2017Physical Resistance; Patient-Device Incompatibility; Material Deformation; Physical Resistance; Patient-Device Incompatibility; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS FROM THE AORTIC ARCH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE COAXIALLY ADVANCING THE 5MAX ACE WITH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). NEXT, THE PHYSICIAN REMOVED THE 3MAX AND TURNED ON THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). THE PHYSICIAN WAS ABLE TO REMOVE PARTS OF THE CLOT; HOWEVER, AFTER A COUPLE OF PASSES, THE ASPIRATION STOPPED AND THE PHYSICIAN DECIDED TO REMOVE THE 5MAX ACE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE 5MAX ACE WAS OVALIZED ABOUT THIRTY CENTIMETERS FROM ITS DISTAL END. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NON-PENUMBRA STENT RETRIEVER DEVICE WITH A NON-PENUMBRA MICROCATHETER THROUGH A NEURON DELIVERY CATHETER 070 (NEURON 070); HOWEVER, IT TOOK ABOUT TWENTY MINUTES TO REACH THE MIDDLE CEREBRAL ARTERY (MCA). UPON REACHING THE TREATMENT SITE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT RETRIEVER DEVICE BUT IT BECAME STUCK IN THE MICROCATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011774 ↗
• MalfunctionOct 5, 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 USING PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETERS (5MAX ACES), THE PHYSICIAN NOTICED A KINK ON THE PROXIMAL SHAFT OF THE 5MAX ACE UPON REMOVAL FROM THE PACKAGING HOOP. THEREFORE, THE 5MAX ACE WAS SET ASIDE AND DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6918343 ↗
• InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) ON (B)(6) 2017 USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE TWO NON-PENUMBRA DEVICES, HOWEVER WAS UNABLE TO REMOVE THE THROMBUS; THEREFORE, THE PHYSICIAN ATTEMPTED TO USE THE 5MAX ACE. THE PHYSICIAN WAS THEN UNABLE TO REMOVE THE THROMBUS AND, THEREFORE, THE 5MAX ACE WAS REMOVED. DURING THE FINAL ANGIOGRAPHY, IT WAS FOUND THAT THERE WAS BLEEDING INSIDE THE PATIENT FROM THE OCCLUDED LOCATION; THEREFORE, THE PATIENT UNDERWENT A CRANIOTOMY, AND THE PROCEDURE THEN ENDED. AS OF (B)(6) 2017, THE PATIENT'S MRS WAS 5. AS OF (B)(6) 2017, THE PATIENT'S CONDITION IS UNKNOWN. THE 5MAX ACE HAS AN UNCERTAIN RELATIONSHIP TO THE INTRACRANIAL HEMORRHAGE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 6812078 ↗
• MalfunctionAug 17, 2017Fracture; Physical Resistance; Fracture; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). IT WAS NOTED THAT THE PATIENT WAS OCCLUDED FROM THE VERTEBRAL ARTERY TO THE BASILAR ARTERY. IN ADDITION, IT WAS NOTED THAT THE PATIENT HAD A VERY EXCESSIVE TORTUOUS VERTEBRAL ARTERY. DURING THE PROCEDURE, THE PHYSICIAN DID NOT MENTION RESISTANCE WHILE ADVANCING A 5MAX ACE IN THE TARGET VESSEL USING A NON-PENUMBRA 16F GUIDING CATHETER. THE PHYSICIAN THEN COMPLETED TWO PASSES WITH THE 5MAX ACE USING THE ADAPT TECHNIQUE. AFTER COMPLETION OF THE SECOND PASS, THE PHYSICIAN DECIDED TO PULL THE 5MAX ACE BACK INTO THE GUIDE CATHETER AND INFLATED THE NON-PENUMBRA BALLOON CATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN PULLED THE 5MAX ACE BACK DESPITE THE RESISTANCE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE 5MAX WAS FRACTURED AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED AFTER THE REMOVAL OF THE 5MAX ACE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6800978 ↗
• MalfunctionAug 3, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  WHILE PREPARING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN OPENED THE 5MAX ACE PACKAGING AND FLUSHED THE PACKAGING HOOP AND 5MAX ACE. UPON REMOVING THE 5MAX ACE FROM ITS DISPENSER HOOP AFTER THE FLUSH, THE PHYSICIAN CONFIRMED A KINK APPROXIMATELY 60 CM FROM THE PROXIMAL END OF THE 5MAX ACE. THE DAMAGED 5MAX ACE WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6764695 ↗
• MalfunctionJul 27, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ACUTE-STAGE CEREBRAL INFARCTION (OCCLUDED M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA)) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, POST CAROTID ARTERY STENTING (CAS) AND PRIOR TO USE, THE PHYSICIAN NOTICED THAT THE 5MAX ACE WAS KINKED AT THE STAIN RELIEF UPON REMOVAL FROM THE PACKAGING. THE DAMAGED 5MAX ACE WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6749211 ↗
• MalfunctionJul 20, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA SHEATH TOWARDS THE TARGET VESSEL AND THEN ADVANCED THE 5MAX ACE HALF WAY THROUGH THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE 5MAX ACE ANY FURTHER. THEREFORE, THE 5MAX ACE WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A NON-PENUMBRA BALLOON CATHETER TOWARDS THE ICA AND THEN ATTEMPTED TO ADVANCE THE SAME 5MAX ACE INTO THE BALLOON CATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE 5MAX ACE WOULD NOT ADVANCE INTO THE BALLOON CATHETER. AT THAT POINT, THE PROXIMAL SHAFT OF THE 5MAX ACE BECAME KINKED. THEREFORE, THE 5MAX ACE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER DEVICE. HOWEVER, THE PATIENT WAS BLEEDING FROM THE CAROTID-CAVERNOUS SINUS FISTULA (CCF). NO MEDICATION WAS GIVEN TO TREAT THE BLEEDING. THE PHYSICIAN ATTRIBUTED THE BLEEDING TO THE NON-PENUMBRA STENT DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT RELATED TO THE PENUMBRA DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6727944 ↗
• MalfunctionJul 12, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, PRIOR TO USE, THE PHYSICIAN NOTICED THAT THE 5MAX ACE WAS KINKED AT THE STRAIN RELIEF AND BECAME "WEAK" UPON REMOVAL FROM THE PACKAGING. HOWEVER, THE PHYSICIAN DID NOT HAVE ANOTHER 5MAX ACE TO USE RIGHT AWAY AND DECIDED TO USE THE KINKED 5MAX ACE. WHILE IN USE WITH THE PATIENT, BLOOD LEAKED OUT OF THE 5MAX ACE. THEREFORE, THE 5MAX ACE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6707110 ↗
• MalfunctionJul 7, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS (3MAXC) AND PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETERS (5MAX ACE). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA BALLOON CATHETER IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A NON-PENUMBRA GUIDEWIRE THROUGH A 3MAXC, THEN ATTEMPTED TO ADVANCE THE 3MAXC INTO THE 5MAX ACE; HOWEVER, THE PHYSICIAN FELT THAT IT WAS NOT SMOOTH BUT SOMEHOW WAS ABLE TO ADVANCE THE 3MAXC THROUGH THE 5MAX ACE. WHILE ATTEMPTING TO CO-AXIALLY ADVANCE THE 5MAX ACE THROUGH THE NON-PENUMBRA BALLOON CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE 3MAXC AND 5MAX ACE WOULD NOT ADVANCE. THEREFORE, THE PHYSICIAN REMOVED THE 3MAXC AND THE 5MAX ACE. THE PROCEDURE WAS THEN COMPLETED USING A NEW 3MAXC AND THE 5MAX ACE AND THE SAME BALLOON CATHETER WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6694761 ↗
• MalfunctionJul 5, 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 PHYSICIAN NOTICED THAT A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) WAS KINKED NEAR THE HUB UPON OPENING THE PACKAGING. THE DAMAGE TO THE 5MAX ACE WAS NOTICED PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6686293 ↗
• MalfunctionJul 3, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, WHILE ADVANCING THE 5MAX ACE THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE TIP OF THE 5MAX ACE REACHED THE DISTAL PORTION OF THE RIGHT ICA AND WAS UNABLE TO ADVANCE THE 5MAX ACE FURTHER. THEREFORE, THE 5MAX ACE WAS REMOVED. UPON INSPECTION, A KINK WAS OBSERVED ON THE PROXIMAL SHAFT OF THE 5MAX ACE. THE PROCEDURE WAS THEN COMPLETED USING THE SAME MICROCATHETER AND A STENT-RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684673 ↗
• MalfunctionJun 23, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  WHILE PREPARING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) FOR THE THROMBECTOMY PROCEDURE, THE PHYSICIAN OPENED THE PACKAGE AND FLUSHED THE 5MAX ACE THROUGH ITS HOOP WITH SALINE. UPON REMOVAL FROM THE PACKAGING HOOP, THE PHYSICIAN CONFIRMED THAT THE 5MAX ACE WAS KINKED AT THE SHAFT, APPROXIMATELY ONE CENTIMETER FROM THE HUB. THE KINKED 5MAX ACE WAS FOUND PRIOR TO ITS USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE WITHOUT FURTHER ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 6663228 ↗
• MalfunctionMay 30, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  WHILE PREPARING FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE SHAFT OF THE PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) WAS KINKED APPROXIMATELY FIFTY CENTIMETERS FROM THE PROXIMAL END UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGED 5MAX ACE WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6599715 ↗
• InjuryMay 16, 2017Adverse 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 M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS EXCESSIVELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA BALLOON GUIDING CATHETER IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). NEXT, THE PHYSICIAN COAXIALLY ADVANCED A 5MAX ACE WITH A NON-PENUMBRA CATHETER IN THE RIGHT M1 SEGMENT OF THE MCA. THE PHYSICIAN THEN COMPLETED TWO PASSES USING A NON-PENUMBRA STENT RETRIEVER DEVICE; HOWEVER, LITTLE IMPROVEMENT WAS OBSERVED. THEREFORE, THE PHYSICIAN DECIDED TO ASPIRATE THE THROMBUS USING A 3MAX. WHILE ADVANCING THE 3MAX THROUGH THE 5MAX ACE ALONG WITH THE STENT RETRIEVER DEVICE, RESISTANCE WAS EXPERIENCED WHEN THE 3MAX REACHED THE RIGHT M2. SUBSEQUENTLY, THE 3MAX BECAME STUCK AND WOULD NOT ADVANCE FURTHER. WHILE USING THE 3MAX WITH THE STENT RETRIEVER, THE PHYSICIAN WAS ABLE TO REMOVE THE THROMBUS BEFORE PULLING BACK THE 3MAX THEN REMOVED HIS HAND. IT WAS REPORTED THAT AFTER REMOVING HIS HAND, THE 3MAX RETURNED TO THE ORIGINAL POSITION. THE PHYSIC

  Patient problems: Extravasation

  MAUDE report 6569422 ↗
• MalfunctionApr 7, 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 PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) WAS KINKED AT THE HUB UPON REMOVAL FROM THE PACKAGING. THE DAMAGED 5MAX ACE WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6472412 ↗
• MalfunctionMar 8, 2017Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) WAS FRACTURED APPROXIMATELY FORTY CENTIMETERS FROM ITS TIP UPON REMOVAL FROM THE PACKAGING HOOP. THE FRACTURED 5MAX ACE WAS NOTICED PRIOR TO USE, AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6389644 ↗
• MalfunctionJan 31, 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 PHYSICIAN NOTICED THE PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE ACE 60 WAS NOTICED PRIOR TO USE AND THEREFORE, IT WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 60.

  Patient problems: No Patient Involvement

  MAUDE report 6291506 ↗
• MalfunctionJan 24, 2017Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THE PROXIMAL END OF THE PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE) WAS FRACTURED PRIOR TO FLUSHING IT. THE DAMAGE TO THE 5MAX ACE WAS NOTICED PRIOR TO USE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE.

  Patient problems: No Patient Involvement

  MAUDE report 6273010 ↗