Neuron PNML6F088804Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00814548012216), received between Sep 17, 2015 and Sep 25, 2020 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (14 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE BY FLOW DIVERSION IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A NEURON 070 THROUGH THE NEURON MAX AND SUBSEQUENTLY, THE NEURON 070 WAS UNABLE TO ADVANCE THROUGH THE NEURON MAX. THEREFORE, THE NEURON MAX WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SAME NEURON 070 INTO A NEW NEURON MAX; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE NEURON 070 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON 070 AND THE SAME SECOND 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 10586364 ↗
• MalfunctionMay 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), NON-PENUMBRA CATHETER, AND NON-PENUMBRA STENT RETRIEVER DEVICE. DURING THE PROCEDURE, THE NEURON MAX WAS PLACED IN THE VERTEBRAL ARTERY. NEXT, THE CATHETER WAS ADVANCED THROUGH THE NEURON MAX AND INTO THE BASILAR ARTERY, BUT THE NEURON MAX WAS KICKED OUT OF THE VESSEL; SUBSEQUENTLY, THE CATHETER WAS REMOVED. THE PHYSICIAN THEN ADVANCED A JET7 THROUGH THE SAME NEURON MAX, BUT THE SAME ISSUE OCCURRED. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRACT THE JET7, BUT THE TIP OF THE JET7 BECAME STUCK IN THE NEURON MAX. UPON PULLING ON THE JET7, THE TIP BROKE/ UNRAVELED; THEREFORE, THE PHYSICIAN REMOVED THE NEURON MAX WITH THE BROKEN JET7 TIP. THE PHYSICIAN MADE ONE MORE PASS USING THE NON-PENUMBRA CATHETER AND STENT RETRIEVER DEVICE VIA THE RADIAL ARTERY BUT WAS NOT ABLE TO REVASCULARIZE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10075424 ↗
• MalfunctionApr 4, 2020Material 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). DURING THE PROCEDURE, WHILE ADVANCING THE NEURON MAX AND DILATOR FROM THE BRACHIOCEPHALIC ARTERY INTO THE CAROTID ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON MAX BECAME KINKED. THEREFORE, THE NEURON MAX WAS REMOVED. IT WAS REPORTED THAT THE NEURON MAX BECAME BENT ON THE TURN AROUND THE SUBCLAVIAN ARTERY. 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 9926163 ↗
• InjurySep 20, 2019Material Deformation; 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, AFTER PLACING THE NEURON MAX IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THERE WAS POOR ASPIRATION WHILE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN FOUND THE DISTAL END OF THE NEURON MAX TO BE KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX WITH THE SAME JET7 AND MICROCATHETER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED VASOSPASM IN THE ICA AND WAS TREATED WITH 100 MICROGRAM OF INTRA-ARTERIAL NITROGLYCERIN; HOWEVER, THE VASOSPASM IS UNRELATED TO ANY PENUMBRA DEVICES USED IN THE INDEX PROCEDURE. SUBSEQUENTLY, THE PHYSICIAN PERFORMED AN ANGIOGRAM THAT REVEALED A SMALL FILLING THROMBUS IN THE PROXIMAL PETROUS PORTION OF THE ICA. WHILE MAKING THE FINAL PASS, THE PHYSICIAN ADVANCED THE JET7 TO THE LEVEL OF THE FILLING OF THROMBUS AND ADDITIONAL ASPIRATION WAS PERFORMED. ANOTHER ANGIOGRAM WAS PERFORMED AND REVEALED A CLEARING OF FILLING DEFECT BUT A RESIDUAL NONFLOW LIMITING DISSECTION WAS IDENTIFIED. IT WAS

  Patient problems: No Consequences Or Impact To Patient; Vascular Dissection

  MAUDE report 9099004 ↗
• MalfunctionMay 1, 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 DAMAGED UPON OPENING OF 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 A NEW NEURON MAX.

  Patient problems: No Patient Involvement

  MAUDE report 8569222 ↗
• MalfunctionApr 4, 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 NEURON MAX WAS FOUND TO BE BROKEN AT 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 8484197 ↗
• MalfunctionMar 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN FOUND THAT A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS SLIGHTLY KINKED MID-SHAFT UPON REMOVAL FROM THE PACKAGING. 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 8384352 ↗
• MalfunctionFeb 22, 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 AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN REPORTED FEELING RESISTANCE WHILE ADVANCING THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) THROUGH THE NEURON MAX. ADDITIONALLY, THE JET7 WAS UNABLE TO ADVANCE THROUGH THE NEURON MAX INTO THE TARGET VESSEL. THE PHYSICIAN THEN DECIDED TO REMOVE THE JET7 AND COMPLETED THE PROCEDURE USING A SMALLER CATHETER AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. UPON EXAMINATION OF THE DEVICES AFTER THE CASE, THE PHYSICIAN FOUND THAT THE DISTAL END OF THE NEURON MAX HUB HAD BECOME KINKED, AND HAD PREVENTED THE JET7 FROM ADVANCING. IT WAS ALSO REPORTED THAT THE KINK IN THE NEURON MAX LIKELY OCCURRED DURING POSITIONING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361420 ↗
• MalfunctionDec 27, 2018Break; Break

  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 PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE NEURON MAX WAS BROKEN AFTER INSERTING THE NEURON MAX INTO THE FEMORAL ARTERY; 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 8199437 ↗
• MalfunctionDec 7, 2018Material 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). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE INSERTING A NEURON MAX INTO THE PATIENT'S BODY, THE NEURON MAX BECAME KINKED AND 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 8144292 ↗
• MalfunctionOct 30, 2018Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN USED THE NEURON MAX WITH NO ISSUE. HOWEVER, UPON COMPLETION OF THE PROCEDURE, WHILE REMOVING THE NEURON MAX THE RADIO-OPAQUE MARKER CAME OFF. THEREFORE, THE PHYSICIAN PINNED THE RADIO-OPAQUE MARKER TO THE INTERNAL GREEN INTRODUCER AND REMOVED THE NEURON MAX CONTAINING THE RADIO-OPAQUE MARKER FROM THE PATIENT¿S BODY WITHOUT INCIDENT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8022265 ↗
• MalfunctionSep 21, 2018Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Damaged Prior to Use; Contamination /Decontamination Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED A "GLUE LIKE SUBSTANCE" MID WAY UP THE SHAFT THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE SUBSTANCE 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 7900296 ↗
• MalfunctionJun 29, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE TIP OF A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) BECAME KINKED AS THE PHYSICIAN ATTEMPTED TO ADVANCE IT THROUGH A 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 AND THE SAME SHEATH.

  Patient problems: No Patient Involvement

  MAUDE report 7652758 ↗
• MalfunctionMay 22, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE NEURON MAX BECAME KINKED DURING USE AND WAS THEREFORE 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 7534148 ↗
• MalfunctionApr 6, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, IT WAS NOTICED THAT A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS KINKED AFTER FLUSHING IT AND ATTEMPTING TO PUT A NEURON SELECT 5F SELECT CATHETER (5F SELECT) THROUGH IT. THEREFORE, THE NEURON MAX WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX AND THE SAME 5F SELECT.

  Patient problems: No Patient Involvement

  MAUDE report 7404708 ↗
• InjuryMar 29, 2018Break; Break

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) ON (B)(6) 2018. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX OVER A NON-PENUMBRA DIAGNOSTIC CATHETER, AND THEN EXCHANGED THE DIAGNOSTIC CATHETER FOR A BENCHMARK DELIVERY CATHETER (BENCHMARK) BECAUSE THE PHYSICIAN NEEDED TO ADVANCE PAST A 360 DEGREE LOOP IN THE PATIENT¿S ANATOMY AND NEEDED MORE DISTAL ACCESS TO REACH THE ANEURYSM. THE PHYSICIAN THEN ADVANCED A BALLOON CATHETER AND A NON-PENUMBRA MICROCATHETER THROUGH THE BENCHMARK AND PAST THE NECK OF THE ANEURYSM INTO THE LEFT A2. THE PHYSICIAN SUCCESSFULLY PLACED FIVE COILS AND TWO PENUMBRA SMART COILS. AN ANGIOGRAM PERFORMED POST-PROCEDURE REVEALED NOTHING OUT OF THE ORDINARY. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED APPROXIMATELY 2 HOURS AFTER THE COIL EMBOLIZATION HAD BEEN COMPLETED, AND DURING THE CT, THE PATIENT SUDDENLY BECAME HEMIPLEGIC AND DEVELOPED APHASIA. THE PATIENT, THEREFORE, WAS RETURNED TO THE ANGIO SUITE, AND THE ANGIOGRAM REVEALED A RADIO-OPAQUE RING IN THE DISTAL LEFT M1 OF THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN ATTEMPTED TO REMOVE THE RADIO-OPA

  Patient problems: Death

  MAUDE report 7383361 ↗
• MalfunctionMar 8, 2018Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT A NEURON SELECT CATHETER 6F (6F SELECT) INTO A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) ON THE BACK TABLE; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE 6F SELECT DID NOT FIT INTO THE NEURON MAX. IT WAS ALSO REPORTED THAT THE PHYSICIAN ALSO HAD DIFFICULTY ADVANCING THE NEURON MAX THROUGH AN 8F SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW 6F SELECT, THE SAME NEURON MAX AND SAME 8F SHEATH.

  Patient problems: No Patient Involvement

  MAUDE report 7325673 ↗
• MalfunctionFeb 27, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED UPON ADVANCING INTO THE GROIN OF THE PATIENT THAT THE TIP OF THE NEURON MAX WAS OVALIZED. THE NEURON MAX WAS THEREFORE 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 7299105 ↗
• InjuryFeb 2, 2018Break; Detachment Of Device Component; Entrapment of Device; Migration or Expulsion of Device; Material Separation; Break; Detachment Of Device Component; Entrapment of Device; Migration or Expulsion of Device; Material Separation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT HAD NO TORTUOSITY OR COMPROMISED ARTERIES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX PASS THE INTERNAL AND EXTERNAL CAROTID BIFURCATION AND THEN ADVANCED THE TIP OF THE NEURON MAX INTO THE RIGHT COMMON CAROTID ARTERY (CCA) WITHOUT ANY RESISTANCE. THE PHYSICIAN THEN NOTICED THAT THE MARKER BAND OF THE NEURON MAX WAS DETACHED AND CAUGHT AT THE BIFURCATION. AFTER REMOVING THE DIAGNOSTIC CATHETER, THE PHYSICIAN PRESSED ON THE FLUOROSCOPY AND NOTICED THAT THE MARKER BAND HAD MIGRATED UP TO THE MIDDLE CEREBRAL ARTERY (MCA). THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE THE MARKER BAND THROUGH ASPIRATION USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), TWO NON-PENUMBRA CATHETERS AND NON-PENUMBRA STENT RETRIEVERS BUT ENDED UP PERFORATING THE RIGHT MCA WITH THE STENT RETRIEVER. THEREFORE, THE PROCEDURE WAS ABORTED AND THE MARKER BAND WAS LEFT IN THE MCA. THE PATIENT WAS EXTUBATED BUT COULD NOT MOVE HER LEFT SIDE. AS OF (B)(6) 2018, THE PATIENT IS STILL IN THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Paralysis

  MAUDE report 7238221 ↗
• MalfunctionJan 31, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE NEURON MAX THROUGH THE VESSEL AND INTO THE INTERNAL ILIAC ARTERY (IIA) BECAUSE THE TIP WAS TOO SOFT. THE NEURON MAX WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232712 ↗
• MalfunctionOct 26, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE TARGET VESSEL WAS CALCIFIED. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE NEURON MAX INTO THE FEMORAL ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON MAX WOULD NOT ADVANCE. IT WAS REPORTED THAT THE TIP OF THE NEURON MAX GETS HUNG UP PRIOR TO ENTERING THE FEMORAL ARTERY. THEREFORE, THE NEURON MAX WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6981998 ↗
• 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 MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS KINKED UPON OPENING 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 6918709 ↗
• MalfunctionSep 5, 2017Fracture; Device Damaged Prior to Use; Out-Of-Box Failure; Fracture; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN NOTICED THAT THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS FRACTURED AROUND THE STRAIN RELIEF UPON REMOVAL FROM THE PACKAGING. THE DAMAGED 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 6842615 ↗
• MalfunctionAug 24, 2017Entrapment of Device; Failure to Advance; Physical Resistance; Entrapment of Device; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE NEURON MAX OVER THE DILATOR, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE NEURON MAX INTO THE FEMORAL ARTERY. THE PHYSICIAN THEN TRIED TO USE A STIFFER WIRE BUT THE NEURON MAX WOULD NOT ADVANCE. IT WAS REPORTED THAT THE TIP OF THE NEURON MAX WAS SOFT AND WOULD GET CAUGHT UP. THEREFORE, THE NEURON MAX WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6818921 ↗
• MalfunctionAug 23, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE NEURON MAX OVER THE DILATOR, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE NEURON MAX INTO THE FEMORAL ARTERY. IT WAS ALSO REPORTED THAT THE PHYSICIAN TRIED TO USE A STIFFER WIRE BUT THE SOFT TIP OF THE NEURON MAX GOT WEDGED CAUSING IT NOT TO ADVANCE. THEREFORE, THE NEURON MAX WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6814010 ↗