Neuron PNML6F088904MRecalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00814548012162), received between Aug 20, 2015 and Oct 15, 2021 — classified as 12 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (67 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 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2021Material Deformation; Material Deformation

  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 ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE ACE68. AFTER REMOVING THE ACE68 FROM THE NEURON MAX, THE PHYSICIAN VISUALIZED A KINK IN THE NEURON MAX. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE OUTER LAYER OF THE NEURON MAX HAD COME OFF. THEREFORE, THE NEURON MAX WAS NO LONGER USED IN THE PROCEDURE. NEXT, THE SAME ACE68 WAS USED WITH A NEW NEURON MAX TO MAKE TWO ADDITIONAL PASSES. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, THE PHYSICIAN FOUND THAT THE OUTER LAYER OF THE NEURON MAX WAS PEELED OFF. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642861 ↗
• MalfunctionOct 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT A NEURON MAX WAS OVALIZED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE AND, THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME ACE60.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583511 ↗
• MalfunctionAug 10, 2021Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING A DILATOR INTO A NEURON MAX AND DECIDED TO REMOVE THE NEURON MAX. UPON REMOVAL, IT WAS NOTICED THAT THE NEURON MAX WAS STRETCHED AT THE DISTAL END AND KINKED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303684 ↗
• MalfunctionMay 19, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE ACE60 THROUGH THE NEURON MAX AND INTO THE CAVERNOUS SINUS SEGMENT; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE ACE60 AND NEURON MAX. SUBSEQUENTLY, UPON REMOVAL, THE PHYSICIAN NOTICED THE DISTAL END OF THE ACE60 AND NEURON MAX TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW ACE60 AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852495 ↗
• InjuryApr 29, 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 NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON MAX TO THE ILIAC ARTERY. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO FURTHER ADVANCE THE NEURON MAX TO THE CERVICAL ARTERY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE NEURON MAX. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE NEURON MAX WAS KINKED. AFTERWARDS, THE PHYSICIAN INJECTED CONTRAST AND NOTICED THERE WAS DISTAL EMBOLIZATION AND DISSECTION IN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, THE SAME ACE68, THE SAME 3MAXC. IT WAS ALSO REPORTED THAT THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE NEURON MAX AND THE DISTAL EMBOLIZATION AND DISSECTION. LATER, TWO DAYS POST-PROCEDURE, THE PATIENT WAS SEEN AT THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED WITHOUT ANY TREATMENT FOR THE DISTAL EMBOLIZATION AND DISSECTION.

  Patient problems: Thromboembolism; Vascular Dissection

  MAUDE report 11745892 ↗
• MalfunctionApr 19, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A NEURON MAX TO THE CERVICAL ARTERY, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE NEURON MAX WAS UNSTABLE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE NEURON MAX. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL TIP OF THE NEURON MAX WAS BROKEN BUT INTACT. 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

  MAUDE report 11691085 ↗
• MalfunctionAug 5, 2020Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT THE NEURON MAX INTO THE PATIENT AND SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO INSERT THE NEURON MAX INTO THE PATIENT. NEXT, THE PHYSICIAN ENLARGED THE ENTRY PUNCTURE WITH A BLADE AND ATTEMPTED TO RE-INSERT THE NEURON MAX INTO THE PATIENT; HOWEVER, IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370944 ↗
• MalfunctionJul 24, 2020Difficult to Insert; Difficult to Insert

  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, AFTER THE PHYSICIAN ADVANCED THE NEURON MAX, IT WAS NOTICED THAT THE CROSS-CUT VALVE WAS UNABLE TO BE FIXED INTO THE HUB OF THE MICROCATHETER. THEREFORE, THE NEURON MAX 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 10324179 ↗
• MalfunctionJul 16, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A VELOCITY AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE NEURON MAX, ACE60 AND VELOCITY. UPON REMOVAL OF THE ACE60, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE ACE60 WAS STRETCHED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) 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 10281261 ↗
• MalfunctionJun 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2020, 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), A NEURON SELECT CATHETER 6F, A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SHEATH WITH THE NEURON MAX AND 6F SELECT. THEN, THE PHYSICIAN ADVANCED THE JETD OVER THE VELOCITY THROUGH THE NEURON MAX AND EXPERIENCED RESISTANCE AT THE DISTAL END OF THE NEURON MAX; THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. AFTER THE REMOVAL OF THE ENTIRE SYSTEM, IT WAS NOTICED THAT THE NEURON MAX WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NEW NEURON MAX, AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2020, A POST-PROCEDURE IMAGING WAS PERFORMED, AND IT INDICATED THAT THERE WAS AN UNKNOWN ITEM REMAINING IN THE PATIENT¿S BRAIN. IT WAS REPORTED THAT THE ITEM HAD BROKEN OFF AND MIGRATED INTO THE OPEN M2 SEGMENT OF THE MCA DUE TO THE OTHER BRANCH OF M2 BEING OCCLUDED. NO INTERVENTION WAS PERFORMED. PATIENT¿S S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215426 ↗
• MalfunctionMar 12, 2020Break; Break

  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 UP THE AORTIC ARCH, THE PROXIMAL HUB OF THE NEURON MAX BROKE; 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 Consequences Or Impact To Patient

  MAUDE report 9826563 ↗
• MalfunctionFeb 21, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE TORQUING THE NEURON MAX, THE DISTAL TIP APPEARED DAMAGED ON THE ANGIOGRAM; THEREFORE, IT WAS REMOVED. UPON REMOVAL, THE DISTAL END OF THE NEURON MAX WAS OBSERVED TO BE BROKEN. 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 9740168 ↗
• MalfunctionNov 11, 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 ACE 64 REPERFUSION CATHETER (ACE64) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE INTERNAL CAROTID ARTERY (ICA) FOLLOWED BY THE ACE64. UPON ADVANCEMENT OF THE ACE64, THE PHYSICIAN MET UNUSUAL RESISTANCE. AN ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN VISUALIZED THAT THE DIAMETER OF THE ACE64 WAS TOO SMALL AND THAT THE NEURON MAX MAY HAVE KINKED MID-SHAFT. THE PHYSICIAN DECIDED TO REMOVE THE ACE64 AND REPLACE IT WITH A LARGER CATHETER; HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE ACE64 WAS RETRACTED A FEW CENTIMETERS BACK INTO THE NEURON MAX. SUBSEQUENTLY, THE ACE64 BECAME STUCK AND BROKE IN THE NEURON MAX. THE DISTAL PART OF THE ACE64 REMAINED IN THE NEURON MAX, THEREFORE, THE NEURON MAX AND BROKEN ACE64 WERE REMOVED TOGETHER FROM THE PATIENT. IT WAS REPORTED THAT, UPON REMOVAL OF THE NEURON MAX, NO KINK WAS FOUND. HOWEVER, THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). THERE WAS NO REPORT OF AN ADVERSE EFFE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9303023 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, A NEURON MAX WAS ADVANCED THROUGH A NON-PENUMBRA SHEATH IN THE RIGHT ICA. A COAXIAL SYSTEM OF A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) WERE THEN ADVANCED OVER A GUIDEWIRE AND THROUGH THE NEURON MAX. SEVERAL PASSES WERE COMPLETED USING A JET 7 AND A 3MAX ACHIEVING A TICI SCORE 2A. AFTER REMOVAL OF THE JET7, A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS OBTAINED THROUGH THE NEURON MAX IN THE PROXIMAL RIGHT ICA SHOWING VASOSPASM, INVOLVING THE CERVICAL SEGMENT OF THE RIGHT ICA; THEREFORE, 10 MG OF INTRA-ARTERIAL VERAPAMIL WAS INFUSED USING A SLOW HAND BOLUS TECHNIQUE THROUGH THE NEURON MAX. POST-VERAPAMIL INFUSION ANGIOGRAPHY SHOWED THE VASOSPASM WAS RESOLVED. THE VASOSPASM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND NEURON MAX.

  Patient problems: Vasoconstriction

  MAUDE report 9285180 ↗
• MalfunctionNov 3, 2019Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE HEMOSTASIS VALVE ADAPTOR (HVA) WAS LEAKING AND WAS NOT TIGHTENING PROPERLY; 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 9270629 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). AFTER THE PROCEDURE, THE CONTROL ANGIOGRAM IMAGING INDICATED THAT A VASOSPASM HAD OCCURRED. THE PATIENT WAS SUBSEQUENTLY TREATED WITH A VASODILATOR (NIMODIPINE) AND HEPARIN. FOLLOWING TREATMENT WITH THE INTRAVENOUS FLUIDS, THE PATIENT'S CONDITION IMPROVED AND RESOLVED ON THE SAME DAY. THE PATIENT WAS DISCHARGED TO ANOTHER HOSPITAL ON (B)(6) 2019. THE VASOSPASM WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE NEURON MAX AND INDEX PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 9192662 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM IN THE LEFT COMMON CAROTID ARTERY (CCA) AND LEFT CERVICAL INTERNAL CAROTID ARTERY (ICA). THEREFORE, THE PHYSICIAN ADMINISTERED VERAPAMIL TO TREAT THE VASOSPASM. THIS EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2019. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT DEFINITELY RELATED TO THE INDEX PROCEDURE, PROBABLY RELATED TO THE NEURON MAX AND POSSIBLY RELATED TO THE JET7.

  Patient problems: Vasoconstriction

  MAUDE report 8809394 ↗
• MalfunctionJul 3, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN NOTED THAT THE GREEN DILATOR LOOKED SIGNIFICANTLY DIFFERENT AND ALSO APPEARED TO HAVE A PIECE BROKEN OFF. THE ISSUE WITH 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 8758342 ↗
• MalfunctionJun 20, 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 ITS 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 A NEW CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8720445 ↗
• MalfunctionJun 20, 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 ITS 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 A NEW CATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 8720440 ↗
• MalfunctionMay 20, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE HOSPITAL STAFF MEMBER FOUND THAT THE NEURON MAX WAS KINKED. THE DAMAGE TO THE NEURON MAX 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 8624004 ↗
• InjuryMay 3, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE NEURON MAX WITH A NON-PENUMBRA ACCESS SHEATH THROUGH THE BASILAR ARTERY, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE AND THE TIP OF THE NEURON MAX BROKE OFF INSIDE OF THE PATIENT. THEREFORE, THE PHYSICIAN USED A STENT RETRIEVER TO SUCCESSFULLY REMOVE THE BROKEN TIP OF THE NEURON MAX AND DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579846 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) INTO THE NEURON MAX. THE PHYSICIAN THEN FOUND THAT THE NEURON MAX WAS KINKED APPROXIMATELY 40 CM FROM THE PROXIMAL END. THE NEURON MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN FOUND THAT THREE ADDITIONAL NEURON MAXS WERE KINKED IN THE SAME LOCATION UPON REMOVAL FROM THE PACKAGING AND DURING VISUAL INSPECTION, RESPECTIVELY. THESE NEURON MAXS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8574023 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) INTO THE NEURON MAX. THE PHYSICIAN THEN FOUND THAT THE NEURON MAX WAS KINKED APPROXIMATELY 40 CM FROM THE PROXIMAL END. THE NEURON MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN FOUND THAT THREE ADDITIONAL NEURON MAXS WERE KINKED IN THE SAME LOCATION UPON REMOVAL FROM THE PACKAGING AND DURING VISUAL INSPECTION, RESPECTIVELY. THESE NEURON MAXS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8574020 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) INTO THE NEURON MAX. THE PHYSICIAN THEN FOUND THAT THE NEURON MAX WAS KINKED APPROXIMATELY 40 CM FROM THE PROXIMAL END. THE NEURON MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN FOUND THAT THREE ADDITIONAL NEURON MAXS WERE KINKED IN THE SAME LOCATION UPON REMOVAL FROM THE PACKAGING AND DURING VISUAL INSPECTION, RESPECTIVELY. THESE NEURON MAXS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8574008 ↗