Neuron PNML6F088804MRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00814548012209), received between Oct 23, 2015 and Oct 14, 2022 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (32 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE COMMON CAROTID ARTERY (CCA) AND INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AN EMBOLIC PROTECTION SYSTEM, AND A STENT DEVICE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE EMBOLIC PROTECTION SYSTEM THROUGH THE NEURON MAX TO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED THE STENT DELIVERY SYSTEM OVER THE GUIDEWIRE OF THE EMBOLIC PROTECTION SYSTEM AND THROUGH THE NEURON MAX TO THE TARGET VESSEL. NEXT, THE PHYSICIAN DEPLOYED THE STENT DEVICE IN THE TARGET LOCATION AND THEN REMOVED THE EMBOLIC PROTECTION SYSTEM AND STENT DELIVERY SYSTEM. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE NEURON MAX AND UPON REMOVAL THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE NEURON MAX WAS DAMAGED. IT WAS REPORTED THAT THE OUTER LAYER OF THE DISTAL END OF THE NEURON MAX WAS DAMAGED AND THAT THE INNER BRAIDING OF THE NEURON MAX WAS EXPOSED. A SUBSEQUENT ANGIOGRAPHY SHOWED THAT NO DAMAGED PIECE OF THE NEURON MAX WAS LEFT IN THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15602756 ↗
• MalfunctionOct 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA INTERMEDIATE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON MAX IN THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE AN INTERMEDIATE CATHETER INTO THE NEURON MAX, BUT THE INTERMEDIATE CATHETER WOULD NOT ADVANCE PAST THE HUB OF THE NEURON MAX. THEREFORE, THE INTERMEDIATE CATHETER WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER INTERMEDIATE CATHETER INTO THE NEURON MAX, BUT THE SAME ISSUE OCCURRED. THE INTERMEDIATE CATHETER WOULD NOT ADVANCE THROUGH THE NEURON MAX. THEREFORE, THE NEURON MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME SECOND INTERMEDIATE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677816 ↗
• MalfunctionOct 2, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA GUIDING CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE NEURON MAX IN THE COMMON CAROTID ARTERY. THEREFORE, THE PHYSICIAN PLACED A GUIDING SHEATH INSIDE THE NEURON MAX FOR SUPPORT. THE PHYSICIAN THEN ADVANCED THE GUIDING SHEATH AND NEURON MAX IN THE COMMON CAROTID ARTERY AND DOWN THE AORTA. WHILE ADVANCING THE GUIDING SHEATH AND NEURON MAX TO THE BRACHIOCEPHALIC ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PHYSICIAN COULD NOT NAVIGATE THE GUIDING CATHETER. THEREFORE, THE NEURON MAX AND GUIDING CATHETER WERE REMOVED TOGETHER. AFTER THE REMOVAL OF THE NEURON MAX AND GUIDING CATHETER, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE NEURON MAX WAS KINKED, AND THE OUTER LAYER WAS PEELED OFF. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME GUIDING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566300 ↗
• MalfunctionMar 16, 2021Break; Break

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A HOSPITAL STAFF NOTICED THAT THE DISTAL TIP OF A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS BROKEN PRIOR TO INSERTION INTO A NON-PENUMBRA SHORT SHEATH. THE DAMAGE TO THE NEURON MAX OCCURRED PRIOR TO USE AND, THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496945 ↗
• InjuryFeb 18, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA CATHETER AND A STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON MAX INTO THE INTERNAL CAROTID ARTERY WITHOUT ANY ISSUE, THEN ADVANCED A CATHETER WITH A STENT RETRIEVER INTO THE TARGET LOCATION. AFTER A SUCCESSFUL THROMBECTOMY, AN ANGIOGRAPHY WAS PERFORMED, THE STENT RETRIEVER AND THE CATHETER WERE RETRACTED INTO THE NEURON MAX, AND A DETACHED MARKERBAND WAS NOTICED AT THE LEVEL OF THE M2 BIFURCATION OF THE LEFT MCA. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE MARKERBAND USING A NON-PENUMBRA DEVICE, THEN ASPIRATION; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. SUBSEQUENTLY, SEVERAL PASSES WERE MADE WITH COMBINED USE OF AN ASPIRATION CATHETER AND A STENT RETRIEVER, AND THE MARKERBAND WAS SUCCESSFULLY REMOVED. A TRANSIENT M2 VESSEL OCCLUSION WAS SUCCESSFULLY TREATED USING TIROFIBAN INFUSION. THE FINAL ANGIOGRAM NOTED NO ANGIOGRAPHIC SIGN OF ANY REMAINING VESSEL OCCLUSION. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11343382 ↗
• MalfunctionAug 20, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEURON MAX THROUGH THE FEMORAL ARTERY DUE TO ATHEROSCLEROSIS. SUBSEQUENTLY, THE DISTAL TIP OF THE NEURON MAX KINKED AND, 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 10431485 ↗
• MalfunctionFeb 21, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA INTRACRANIAL SUPPORT CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE INTRACRANIAL SUPPORT CATHETER OVER THE GUIDEWIRE THROUGH THE NEURON MAX; THEREFORE, THE NEURON MAX WAS REMOVED. UPON REMOVAL OF THE NEURON MAX, IT WAS NOTICED THAT THE NEURON MAX WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME INTRACRANIAL SUPPORT CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9740842 ↗
• MalfunctionOct 10, 2019Peeled/Delaminated; Material Deformation; Physical Resistance/Sticking; Peeled/Delaminated; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE NEURON MAX ACROSS THE AORTIC ARCH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PROXIMAL ZONE BECAME KINKED. IT WAS ALSO REPORTED THAT THE SURFACE COATING OF THE NEURON MAX WAS OBSERVED TO BE PEELING. THE NEURON MAX WAS REMOVED, AND 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 9177199 ↗
• MalfunctionFeb 22, 2019Device Damaged Prior to Use; Physical Resistance/Sticking; Device Damaged Prior to Use; Physical Resistance/Sticking

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN FOUND THAT THE TIP OF THE NEURON MAX COULD NOT BE REMOVED FROM THE MANDREL. THE NEURON MAX WAS THEN SET ASIDE AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8364562 ↗
• MalfunctionFeb 12, 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 HOSPITAL STAFF FOUND THAT THE TIP OF THE NEURON MAX WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8333843 ↗
• MalfunctionFeb 8, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A HOSPITAL STAFF MEMBER OPENED A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) PACKAGE AND BEGAN PREPPING THE NEURON MAX. IT WAS THEN NOTICED THAT THE TIP OF THE NEURON MAX APPEARED TO BE STUCK TO THE PACKAGING MANDREL AND LOOKED DAMAGED. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8323820 ↗
• MalfunctionFeb 6, 2019Accessory Incompatible; Accessory Incompatible

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, A NON-PENUMBRA CATHETER WOULD NOT FIT INTO THE NEURON MAX HEMOSTASIS VALVE ADAPTOR (HVA). THEREFORE, THE NEURON MAX WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8311219 ↗
• MalfunctionDec 6, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE TIP OF THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS STUCK TO THE PACKAGING MANDREL AND WHILE REMOVING THE NEURON MAX, THE TIP OF THE NEURON MAX BROKE OFF. THE DAMAGE TO THE NEURON MAX OCCURRED 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 8138912 ↗
• MalfunctionOct 4, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) TIP WAS DAMAGED WHILE REMOVING FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7936469 ↗
• MalfunctionOct 3, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE DISTAL TIP OF THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7932629 ↗
• MalfunctionSep 28, 2018Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS RIPPED OFF WHILE REMOVING FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7919698 ↗
• MalfunctionSep 27, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS BROKEN 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.

  Patient problems: No Patient Involvement

  MAUDE report 7916615 ↗
• MalfunctionSep 19, 2018Break; 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 REMOVED THE NEURON MAX FROM THE STERILE PACKAGE AND NOTICED THAT A PIECE OF THE TIP HAD BROKEN OFF. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7891966 ↗
• MalfunctionSep 12, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT TWO NEURON MAX 6F 088 LONG SHEATHS (NEURON MAXS) TIP WERE RIPPED OFF WHILE REMOVING FROM THEIR PACKAGINGS. THE DAMAGE TO THE NEURON MAXS WERE FOUND PRIOR TO USE. THEREFORE, THE NEURON MAXS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7870504 ↗
• MalfunctionSep 12, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT TWO NEURON MAX 6F 088 LONG SHEATHS (NEURON MAXS) TIP WERE RIPPED OFF WHILE REMOVING FROM THEIR PACKAGINGS. THE DAMAGE TO THE NEURON MAXS WERE FOUND PRIOR TO USE. THEREFORE, THE NEURON MAXS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7870501 ↗
• MalfunctionSep 11, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT EACH TIP OF THREE NEURON MAX 6F 088 LONG SHEATH (NEURON MAXS'') WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAXS'' WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAXS'' WERE NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7864906 ↗
• MalfunctionSep 11, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT EACH TIP OF THREE NEURON MAX 6F 088 LONG SHEATH (NEURON MAXS'') WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAXS'' WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAXS'' WERE NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7864864 ↗
• MalfunctionSep 11, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT EACH TIP OF THREE NEURON MAX 6F 088 LONG SHEATH (NEURON MAXS'') WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE NEURON MAXS'' WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAXS'' WERE NOT USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7864848 ↗
• InjuryAug 24, 2018Break; Migration; Physical Resistance/Sticking; Break; Migration; 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, THE PHYSICIAN ADVANCED A NEURON MAX TO THE TARGET LOCATION USING A NON-PENUMBRA SHEATH. AFTER SUCCESSFULLY ASPIRATED THE THROMBUS USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITHIN THE NEURON MAX, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING THE NEURON MAX TO REMOVE IT. CONSEQUENTLY, THE RADIOPAQUE MARKER BAND AT THE DISTAL END OF THE NEURON MAX DISLODGED WHILE THE DEVICES WERE BEING REMOVED. THE MARKER BAND MIGRATED AND REMAINED STUCK IN THE DISTAL PORTION OF THE EXTERNAL CAROTID ARTERY (ECA) AND THE PHYSICIAN WAS UNABLE TO REMOVE IT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 7813727 ↗
• MalfunctionAug 3, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE TIP OF THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) HAD A BURR ON IT AND THE INNER MATERIAL WAS VISIBLE UPON UNPACKING AND FLUSHING THE NEURON MAX. THE DAMAGE TO THE NEURON MAX WAS FOUND PRIOR TO USE. THEREFORE, THE NEURON MAX WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 7747705 ↗