Neuron PNML6F088904Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00814548012179), received between Nov 20, 2015 and May 20, 2022 — classified as 9 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (24 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.

• MalfunctionMay 20, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT VERTEBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AN 8F NON-PENUMBRA SHEATH, AND A NON-PENUMBRA GUIDING CATHETER. IT WAS REPORTED THAT THE PATIENT¿S RIGHT VERTEBRAL ARTERY WAS STENOTIC. DURING THE PROCEDURE, THE PHYSICIAN USED THE 8F SHEATH TO PUNCTURE THE PATIENT¿S FEMORAL ARTERY AND THEN ADVANCED THE NEURON MAX. ONCE THE NEURON MAX REACHED THE ABDOMINAL AORTA, AN ANGIOGRAPHY TUBE WAS INSERTED TO GUIDE THE NEURON MAX INTO THE TARGET VESSEL. WHILE ADVANCING THE NEURON MAX INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE; AND SUBSEQUENTLY, THE PHYSICIAN BROKE THE NEURON MAX TOWARDS THE MID TO DISTAL END INSIDE THE PATIENT. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME 8F SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458968 ↗
• InjuryJun 26, 2021Material Fragmentation; Material Fragmentation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A GUIDEWIRE, A NON-PENUMBRA CAROTID DISTAL PROTECTION FILTER, A NON-PENUMBRA CAROTID STENT AND A NON-PENUMBRA STENT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON MAX INTO THE PATIENT BY DIRECT PUNCTURE USING A DILATOR AND GUIDEWIRE. THEN, AFTER REMOVING THE DILATOR AND GUIDEWIRE, IT WAS NOTICED THAT THE MARKERBAND OF THE NEURON MAX HAD DETACHED AT THE CAROTID STENOSIS. AFTERWARDS, THE PHYSICIAN PLACED A CAROTID DISTAL PROTECTION FILTER AND RELEASED A CAROTID STENT. SUBSEQUENTLY, THE DETACHED MARKERBAND WAS CAPTURED INSIDE THE FILTER AFTER MANIPULATION. THE PROCEDURE WAS COMPLETED BY PERFORMING A CAROTID ANGIOPLASTY, USING THE SAME NEURON MAX, THE SAME CAROTID DISTAL PROTECTION FILTER, AND THE SAME CAROTID STENT. AFTER TREATMENT OF THE CAROTID STENOSIS, THE PHYSICIAN PERFORMED A THROMBECTOMY USING THE NON-PENUMBRA STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT AFTER REMOVING THE NEURON MAX POST-PROCEDURE, IT WAS NOTICED THAT THE HYDROPHILIC COVER OF THE DISTAL END OF THE NEURON MAX WAS PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072416 ↗
• MalfunctionJan 5, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND EXCHANGE WIRE. DURING THE PROCEDURE, WHILE REMOVING THE EXCHANGE WIRE FROM THE NEURON MAX TO SWITCH TO A NEW EXCHANGE WIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AND DAMAGED THE NEURON MAX PROXIMALLY. THEREFORE, THE NEURON MAX WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A 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 11117227 ↗
• MalfunctionDec 1, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE NEURON MAX INTO THE PATIENT AND ATTEMPTED TO FLUSH WITH SALINE TO CLEAR IT. HOWEVER, THE NEURON MAX BROKE WHERE THE CATHETER WOULD CONNECT TO THE HUB. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 10927155 ↗
• MalfunctionJun 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE NEURON MAX INTO THE PATIENT, THE NEURON MAX KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141588 ↗
• MalfunctionFeb 14, 2020Fracture; Fracture

  THE PATIENT UNDERWENT A MEDICAL PROCEDURE TO PLACE A STENT USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA SHEATH. AFTER THE PROCEDURE WAS COMPLETED, THE PHYSICIAN HAD DIFFICULTY REMOVING THE NEURON MAX. UPON REMOVAL OF THE NEURON MAX, IT WAS NOTICED ON THE BACK TABLE THAT THE NEURON MAX HAD EXPOSED WIRE. IT WAS REPORTED THAT THE NEURON MAX MAY HAVE BEEN FRACTURED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9711912 ↗
• MalfunctionJan 8, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE JET7 BROKE WHILE BEING ADVANCED THROUGH THE NEURON MAX. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9566095 ↗
• MalfunctionJan 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND, VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON MAX IN THE LEFT INTERNAL CAROTID ARTERY (ICA), A VELOCITY WAS THEN USED TO BRING UP THE JETD THROUGH THE NEURON MAX AND INTO THE TARGET VESSEL. AFTERWARD, THE PHYSICIAN REMOVED VELOCITY; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE RETRACTING THE VELOCITY OUT FROM THE JETD. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THERE MIGHT BE SOMETHING WRONG WITH THE JETD; THEREFORE, IT WAS REMOVED. HOWEVER, WHILE RETRACTING THE JETD OUT OF THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JETD PROXIMAL END BEGAN TO COLLAPSE. THE PHYSICIAN ALSO THOUGHT THERE MIGHT SOMETHING WRONG WITH THE NEURON MAX DISTALLY; THEREFORE, THE NEURON MAX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JETD, NEURON MAX AND THE SAME VELOCITY. IT WAS ALSO REPORTED THAT AFTER THE PROCEDURE, THE FIRST NEURON MAX WAS EXAMINED, AND THE DISTAL END WAS FOUND TO BE KINKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539336 ↗
• MalfunctionNov 26, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VERTEBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE NEURON MAX INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON MAX KINKED AT THE DISTAL ONE THIRD PORTION; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW NEURON MAX; HOWEVER, RESISTANCE WAS EXPERIENCED AGAIN AND THE SAME ISSUE OCCURRED. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379325 ↗
• MalfunctionNov 26, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VERTEBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE NEURON MAX INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON MAX KINKED AT THE DISTAL ONE THIRD PORTION; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW NEURON MAX; HOWEVER, RESISTANCE WAS EXPERIENCED AGAIN AND THE SAME ISSUE OCCURRED. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379299 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), A PENUMBRA SYSTEM JET7 KIT (KIT) AND, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE MAKING AN INITIAL PASS USING THE PSR3D WITH THE JET7, NEURON MAX AND, A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT THE PSR3D INTO A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE PSR3D WAS RETRACTED BACK INTO THE DELIVERY SHEATH. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SAME PSR3D, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE PSR3D AND FOUND THE LEADING EDGE OF THE DISTAL TIP TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D WITH THE SAME JET7, NEURON MAX AND MICROCATHETER. AFTER THE PROCEDURE, MODERATE VASOSPASM WAS PRESENT IN THE DISTAL LEFT INTERNAL CAROTID ARTERY. IT WAS ALSO REPORTED THAT THE VASOSPASM OCCURRED UPON PLACING THE NEURON MAX. THE VASOSPASM WAS CONSIDERED RESOLVED AS OF (B)(6) 2019.

  Patient problems: Vasoconstriction

  MAUDE report 9328841 ↗
• MalfunctionNov 6, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT (KIT) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON MAX IN THE RADIAL ARTERY TO THE CERVICAL INTERNAL CAROTID ARTERY (ICA). NEXT, THE PHYSICIAN ADVANCED A TRIAXIAL SYSTEM CONSISTING OF A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA GUIDEWIRE THROUGH THE NEURON MAX. THE PATIENT BEGAN COUGHING AND THRASHING UNCONTROLLABLY AND THE PHYSICIAN CONVERTED FROM A MONITORED ANESTHESIA CARE (MAC) TO A GENERAL ANESTHESIA. AFTER THE PATIENT WAS INTUBATED, THE PHYSICIAN REMOVED THE MICROCATHETER AND GUIDEWIRE BUT NOT WITHOUT DIFFICULTY. IT WAS DISCOVERED THAT THE METAL RADIOPAQUE MARKER BAND FROM THE MICROCATHETER HAD PINCHED OFF AND EMBOLIZED DISTALLY INTO THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA). THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE JET7 FROM THE PATIENT; HOWEVER, IT WAS DISCOVERED THAT THE NEURON MAX HAD KINKED CAUSING THE JET7 TO FRACTURE. THEREFORE, A NON-PENUMBRA BALLOON CATHETER WAS ADVANCED INTO THE NEURON MAX ALONG THE SIDE OF THE FRACTUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9288232 ↗
• MalfunctionNov 4, 2019Failure 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 M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A 8FR NON-PENUMBRA SHEATH WAS UTILIZED FOR A RAPID PRIMARY ACCESS. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON MAX OVER A 5FR NON-PENUMBRA SELECT CATHETER AND A GLIDEWIRE INTO THE HIGH CERVICAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN THEN INSERTED THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND, A GUIDEWIRE AS A SYSTEM INTO THE NEURON MAX; HOWEVER, IT WOULD ONLY ADVANCE APPROXIMATELY THREE TO FOUR INCHES. IT WAS ALSO REPORTED THAT THE PHYSICIAN CONTINUED TO ADVANCE THE NEURON MAX AGAINST RESISTANCE; CONSEQUENTLY, THE NEURON MAX BECAME KINKED PROXIMALLY CLOSE TO THE HUB. THEREFORE, A DILATOR WAS USED TO REPLACE THE NEURON MAX OVER THE EXCHANGE WIRE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX WITH THE SAME JET7, VELOCITY AND, GUIDEWIRE RESULTING IN A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9271869 ↗
• MalfunctionOct 8, 2019Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE TORQUING THE NEURON MAX INTO THE COMMON CAROTID ARTERY, THE NEURON MAX BROKE AT THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169862 ↗
• MalfunctionOct 2, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE NEURON MAX KINKED AT THE HUB UPON INSERTION INTO THE DIAGNOSTIC SHEATH. THE NEURON MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146838 ↗
• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE NEURON MAX, A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). UPON COMPLETION OF THE FIRST PASS, THE 3MAXC WAS RETRIEVED UNDER SECONDARY ASPIRATION AND A FOLLOW UP ANGIOGRAM WAS PERFORMED THROUGH THE JETD. THE ANGIOGRAM SHOWED RECANALIZATION OF THE PREVIOUSLY OCCLUDED M2 SEGMENT OF THE MCA. THERE WAS A PERSISTENT STENOSIS OF THE M2, BUT GOOD DISTAL FLOW WAS NOTED. IT WAS ALSO NOTED THAT THERE WAS PROPAGATION OF EMBOLUS INTO THE DISTAL M2 SEGMENT OF THE MCA. THEREFORE, THE PHYSICIAN MADE THE DECISION TO PROCEED WITH ANOTHER PASS OF THE OCCLUDED DISTAL BRANCH USING THE SAME NEURON MAX, JETD AND 3MAXC. GIVEN THE PERSISTENT SUB-OCCLUSIVE STENOSIS, AN INTRA-ARTERIAL VERAPAMIL (5MG) WAS INJECTED INTO THE LEFT INTERNAL CAROTID (ICA). SUBSEQUENT ANGIOGRAPHIC RUNS SHOWED IMPROVEMENT IN THE SUPERIOR DIVISION M2 BRANCH STENOSIS. HOWEVER, THE DISTAL M2 BRANCH REMAINS OCCLUDED. AFTER REMOVAL OF THE JETD AND 3MAX

  Patient problems: Vasoconstriction

  MAUDE report 8984335 ↗
• MalfunctionAug 9, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO RE-ADVANCE THE NON-PENUMBRA CATHETER INTO THE NEURON MAX. THE NEURON MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881409 ↗
• MalfunctionMay 22, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL TECHNICIAN FOUND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) TO BE BROKEN NEAR THE PROXIMAL END UPON REMOVAL FROM THE PACKAGING. THE DAMAGE WAS FOUND PRIOR TO USE AND, THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8634420 ↗
• MalfunctionMay 7, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A JET7 THROUGH A NEURON MAX AND, THEREFORE, THE JET7 AND NEURON MAX WERE REMOVED. IT WAS REPORTED THAT THE JET7 WAS FOUND TO BE KINKED. THE PROCEDURE WAS THEN COMPLETED USING A NEW NEURON MAX AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8588263 ↗
• MalfunctionApr 12, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN FOUND THAT THE NEURON MAX HAD BECOME KINKED AT THE PROXIMAL SECTION AFTER CLEANING. THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8511063 ↗
• MalfunctionApr 3, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE NEURON MAX BECAME KINKED. THE NEURON MAX WAS THEN REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478004 ↗
• MalfunctionMar 5, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE, AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8392728 ↗
• MalfunctionFeb 22, 2019Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET7 KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO NEURON MAXS WITH A NON-PENUMBRA CATHETER THROUGH A DIFFICULT TURN FROM THE AORTIC ARCH TO THE LEFT COMMON CAROTID ARTERY (LCC), THE NEURON MAXS BENT AND SNAPPED AROUND THEIR DISTAL ENDS; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN WAS THEN ABLE TO ADVANCE A THIRD NEURON MAX TO THE TARGET VESSEL USING ANOTHER CATHETER. NEXT, THE PHYSICIAN COMPLETED FOUR PASSES USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). HOWEVER, UPON REMOVAL OF THE JET7 AFTER A TOUGH FOURTH PASS IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE PHYSICIAN NOTICED THAT THE JET7 WAS ¿ACCORDIONED¿ AND HAD COLLAPSED ON ITSELF. THE PROCEDURE WAS THEN COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA STENT RETRIEVER DEVICE. THERE WAS NO NOTED DAMAGE OR ALLEGED DEFICIENCY WITH THE PSR3D. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363428 ↗
• MalfunctionFeb 22, 2019Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET7 KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO NEURON MAXS WITH A NON-PENUMBRA CATHETER THROUGH A DIFFICULT TURN FROM THE AORTIC ARCH TO THE LEFT COMMON CAROTID ARTERY (LCC), THE NEURON MAXS BENT AND SNAPPED AROUND THEIR DISTAL ENDS; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN WAS THEN ABLE TO ADVANCE A THIRD NEURON MAX TO THE TARGET VESSEL USING ANOTHER CATHETER. NEXT, THE PHYSICIAN COMPLETED FOUR PASSES USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). HOWEVER, UPON REMOVAL OF THE JET7 AFTER A TOUGH FOURTH PASS IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE PHYSICIAN NOTICED THAT THE JET7 WAS ¿ACCORDIONED¿ AND HAD COLLAPSED ON ITSELF. THE PROCEDURE WAS THEN COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA STENT RETRIEVER DEVICE. THERE WAS NO NOTED DAMAGE OR ALLEGED DEFICIENCY WITH THE PSR3D. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363420 ↗
• MalfunctionFeb 20, 2019Material Deformation; Material Deformation

  DURING A THROMBECTOMY PROCEDURE, IT WAS REPORTED THAT A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) KINKED UPON WITHDRAWAL. IT IS UNKNOWN IF THE NEURON MAX KINKED UPON REMOVAL FROM THE PACKAGING OR AFTER USE WITH THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8355836 ↗