Neuron PNS5F130SIMRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00814548010236), received between Jan 8, 2016 and Mar 20, 2026 — classified as 1 death, 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 reports).

1 other recall cover devices cleared under the same FDA submission (K083125); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NON-PENUMBRA SHEATH (6F), AND A GUIDEWIRE (0.038). THE PHYSICIAN GAINED RIGHT RADIAL ACCESS AND ADVANCED THE BENCHMARK AND THE 5F SELECT THROUGH THE SHEATH OVER THE GUIDEWIRE TO THE AORTIC ARCH. THE BENCHMARK WAS THEN PLACED IN THE SUBCLAVIAN ARTERY. WHILE SELECTING THE ICA USING THE 5F SELECT, THE PHYSICIAN OBSERVED THAT THE 5F SELECT APPEARED TO BE DAMAGED UNDER FLUOROSCOPY. THE PHYSICIAN DECIDED TO REMOVE 5F SELECT. WHILE RETRACTING THE 5F SELECT, THE 5F SELECT FRACTURED AT THE DISTAL END IN THE AORTIC ARCH. THE 5F SELECT WAS REMOVED AND THE FRACTURED PORTION REMAINED IN THE AORTIC ARCH WHILE THE PHYSICIAN CONTINUED THE COIL EMBOLIZATION PROCEDURE USING ANOTHER 5F SELECT. AFTER COMPLETION OF THE COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN GAINED RIGHT FEMORAL ACCESS AND A 9F SHEATH WAS PLACED. THE PHYSICIAN ADVANCED A SNARE DEVICE TO RETRIEVE THE FRACTURED 5F SELECT SEGMENT. WHILE RETRACTING INTO THE SHEATH, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT FRACTURED AT THE DISTAL

  Patient problems: Foreign Body In Patient

  MAUDE report 24654851 ↗
• MalfunctionNov 13, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE NEURON MAX OVER THE AORTIC ARCH, THE PHYSICIAN EXPERIENCED RESISTANCE AND OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT WAS FRACTURED ON THE DISTAL LENGTH. THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE FRACTURED PART OF THE 5F SELECT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675504 ↗
• MalfunctionOct 25, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A GUIDEWIRE (0.035 INCH) VIA A TRANSRADIAL APPROACH. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THERE WAS NO MOVEMENT OF THE 5F SELECT UNDER FLUOROSCOPY. THE PHYSICIAN THEN NOTICED THAT THE 5F SELECT WAS FRACTURED AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENT OF THE 5F SELECT WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. THE PHYSICIAN THEN ADVANCED A SECOND 5F SELECT INTO THE TARGET LOCATION. AFTER ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT WAS FRACTURED INTO THREE PIECES AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENTS OF THE 5F SELECT WERE REMOVED FROM THE PATIENT USING THE SAME SNARE DEVICE. AT THIS POINT, THE PROCEDURE WAS CONVERTED INTO FEMORAL ACCESS USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534421 ↗
• MalfunctionOct 25, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A GUIDEWIRE (0.035 INCH) VIA A TRANSRADIAL APPROACH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THERE WAS NO MOVEMENT OF THE 5F SELECT UNDER FLUOROSCOPY. THE PHYSICIAN THEN NOTICED THAT THE 5F SELECT WAS FRACTURED AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENT OF THE 5F SELECT WAS REMOVED FROM THE PATIENT USING A SNARE DEVICE. THE PHYSICIAN THEN ADVANCED A SECOND 5F SELECT INTO THE TARGET LOCATION. AFTER ADVANCING THE 5F SELECT TO THE TARGET LOCATION, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT WAS FRACTURED INTO THREE PIECES AT THE DISTAL LENGTH. THEREFORE, THE FRACTURED SEGMENTS OF THE 5F SELECT WERE REMOVED FROM THE PATIENT USING THE SAME SNARE DEVICE. AT THIS POINT, THE PROCEDURE WAS CONVERTED INTO FEMORAL ACCESS USING A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534217 ↗
• MalfunctionSep 6, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO PERFORM ANGIOGRAPHY USING A NEURON SELECT CATHETERS 5F (5F SELECT) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE 5F SELECT THROUGH THE RIGHT COMMON CAROTID ARTERY (CCA) TO PERFORM AN ANGIOGRAPHY VIA RADIAL ACCESS, THE PHYSICIAN FRACTURED THE 5F SELECT AT THE DISTAL LENGTH IN THE RIGHT SUBCLAVIAN ARTERY. THEREFORE, THE PHYSICIAN REMOVED THE 5F SELECT AND USED A SNARE DEVICE TO REMOVE THE FRACTURED SEGMENT OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157120 ↗
• MalfunctionApr 19, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A CAROTID STENTING PROCEDURE IN THE CAROTID ARTERY USING A NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE NEURON MAX, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE DISTAL SEGMENT OF THE 5F SELECT FRACTURED. THE PROXIMAL SEGMENT OF THE 5F SELECT WAS THEN REMOVED. THE PHYSICIAN THEN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DISTAL SEGMENT OF THE 5F SELECT. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE AND POSTPONED IT FOR ANOTHER DATE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149652 ↗
• MalfunctionMar 21, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT TO TARGET ANATOMY, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE 5F SELECT HAD FRACTURED. THEREFORE, THE PHYSICIAN REMOVED IT FROM THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18954033 ↗
• InjuryMar 14, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT TO THE BRAIN, THE PHYSICIAN OBSERVED UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) THAT THE DISTAL END OF THE 5F SELECT FRACTURED IN THE SUBCLAVIAN ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE TO REMOVE THE 5F SELECT. THE PROCEDURE WAS ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18909449 ↗
• InjuryMar 14, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT), A BALLOON GUIDE CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED 5F SELECT THROUGH THE RIGHT FEMORAL ARTERY DURING THE FIRST PASS AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL LENGTH OF THE 5F SELECT HAD FRACTURED AND WAS LODGED IN THE ILIAC ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE TO SUCCESSFULLY REMOVE THE FRACTURED SEGMENT OF THE 5F SELECT. THERE WAS NO ADDITIONAL ADVERSE EFFECT TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEURON SELECT CATHETER 6F (6F SELECT) AND THE BALLOON CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18909425 ↗
• DeathMar 7, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A DIAGNOSTIC PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH INTRODUCER (6F PRELUDE) AND GUIDEWIRE (0.035" TERUMO). DURING THE PROCEDURE, THE PHYSICIAN CATHETERIZED THE RIGHT COMMON CAROTID ARTERY VIA RADIAL ACCESS USING THE 5F SELECT, SHEATH INTRODUCER AND GUIDEWIRE. WHILE REMOVING THE GUIDEWIRE TO INJECT CONTRAST, THE PHYSICIAN NOTICED THE DISTAL LENGTH OF THE 5F SELECT FRACTURED. WHILE ATTEMPTING TO REMOVE THE FRACTURED 5F SELECT WITH A SNARE DEVICE, THE PHYSICIAN FURTHER FRACTURED THE DISTAL LENGTH OF THE 5F SELECT. A FRACTURED PIECE OF THE 5F SELECT MIGRATED TO THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WHICH THEN BEGAN TO THROMBOSE. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRACTURED PIECE USING DIFFERENT TECHNIQUES BUT WAS UNSUCCESSFUL. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WITH A MALIGNANT INFARCTION IN THE RIGHT MCA. DUE TO THE POOR PROGNOSIS, A DECOMPRESSIVE CRANIECTOMY WAS OFFERED; HOWEVER, THE FAMILY REJECTED IT DUE TO THE SERIOUS DISABILITY IN WHICH THE PATIENT WOULD BE LEFT IN. THE PATIENT LATER EXPIRED. THE PATIENT¿S CAUSE OF DEATH WAS RE

  Patient problems: Foreign Body Embolism; Ischemia Stroke

  MAUDE report 18857416 ↗
• MalfunctionMar 31, 2023Break; Break

  PENUMBRA RECEIVED ADDITIONAL INFORMATION VIA A POST-OPERATIVE REPORT ON APRIL 4, 2023. A DIAGNOSTIC PROCEDURE WAS PERFORMED TO VISUALIZE A CEREBELLAR AVM USING A NEURON SELECT CATHETER 5F (5F SELECT). THE 5F SELECT WAS ADVANCED TO THE TARGET ANATOMY VIA RADIAL ACCESS THROUGH A SHORT SHEATH WITH USE OF A 0.035 GUIDEWIRE. THE 5F SELECT WAS NAVIGATED TO THE LVA, LCCA, LECA, AND LICA AND ANGIOGRAMS WERE PERFORMED IN EACH VESSEL RESPECTIVELY. THE 5F SELECT WAS VISUALIZED FOR REMOVAL FROM THE LICA WHEN IT WAS NOTICED THE 5F SELECT HAD FRACTURED RESULTING IN TWO LOOSE SEGMENTS. AT THIS POINT, A SNARE WAS INTRODUCED THROUGH THE 5F SELECT. DURING ADVANCEMENT OF THE SNARE TO THE LICA IN ATTEMPT TO SNARE THE LARGER SEGMENT, THE SMALLER SEGMENT DISLODGED AND MIGRATED TO THE M2/M3. THE SNARE AND 5F SELECT WERE REMOVED FROM THE RADIAL ACCESS SITE. THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS THEN ACCESSED AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96) AND 5 FRENCH NON-PENUMBRA CATHETER WERE INTRODUCED INTO THE LEFT COMMON CAROTID ARTERY (LCCA). A SNARE WAS INTRODUCED THROUGH THE DIAGNOSTIC CATHETER TO SNARE THE LARGER SEGMENT. THE LARGER SEGMENT WAS RETRACTED INTO THE RCFA BUT COULD NOT BE REMOVED. A

  Patient problems: Foreign Body In Patient

  MAUDE report 16659269 ↗
• MalfunctionFeb 2, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE SHEATH INTO THE ILIAC ARTERY, THEN ADVANCED THE 5F SELECT INTO THE SHEATH. WHILE ADVANCING THE 5F SELECT THROUGH THE DISTAL END OF THE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE DISTAL END OF THE 5F SELECT KINKED DUE TO TORTUOSITY IN THE PELVIS AXIS. AFTER ADVANCING THE 5F SELECT APPROXIMATELY FOUR CENTIMETERS OUT OF THE DISTAL END OF THE SHEATH IN THE ILIAC ARTERY, THE PHYSICIAN ATTEMPTED TO ADVANCE THE GUIDEWIRE THROUGH THE 5F SELECT; HOWEVER, THE GUIDEWIRE WOULD NOT ADVANCE OUT THE DISTAL END OF THE 5F SELECT. IT WAS THEN NOTICED THAT THE GUIDEWIRE HAD PERFORATED THE DISTAL END OF THE 5F SELECT AND SUBSEQUENTLY, THE DISTAL END OF THE 5F FRACTURED AT THE KINK LOCATION. NEXT, THE PHYSICIAN MADE ACCESS THROUGH THE OPPOSITE SIDE OF THE GROIN AND PERFORMED A SUCCESSFUL INTRACRANIAL THROMBECTOMY OF THE RIGHT MCA. AFTERWARDS, THE PHYSICIAN REMOVED THE FRACTURED DISTAL END OF THE 5F SELECT USING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16288067 ↗
• MalfunctionDec 30, 2022Break; Break

  THE PATIENT WAS UNDERGOING A CEREBRAL ARTERIOGRAM OF THE RIGHT COMMON CAROTID ARTERY (CCA) TO CHECK THE RIGHT CAROTID ARTERY OF A PREVIOUSLY TREATED UNRUPTURED ANEURYSM USING A NEURON SELECT CATHETER 5F (5F SELECT), A GUIDEWIRE, AND A NON-PENUMBRA SHORT INTRODUCER SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 5F SELECT OVER THE GUIDEWIRE THROUGH THE SHORT SHEATH AND INTO THE PATIENT VIA RADIAL APPROACH. THE PHYSICIAN THEN ADMINISTERED TWO CONTRAST INJECTIONS. AFTERWARDS, BETWEEN THE SECOND INJECTION OF CONTRAST AND THE 3D SEQUENCE, THE QUALITY OF THE IMAGE HAD DECREASED, AND THE PHYSICIAN NOTICED THAT THE GUIDEWIRE WOULD NOT PASS THROUGH THE DISTAL END OF THE 5F SELECT. THE PHYSICIAN ALSO NOTICED THAT THE DISTAL END OF THE 5F SELECT WAS BROKEN BUT REMAINED CONNECTED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 5F SELECT. WHILE RETRACTING THE 5F SELECT, THE DISTAL END OF THE 5F SELECT BROKE OFF IN THE RADIAL ARTERY. THE PHYSICIAN THEN USED A NON-PENUMBRA LONG INTRODUCER SHEATH AND A SNARE DEVICE TO REMOVE THE BROKEN DISTAL END OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED WITH A BOLUS INJECTION. IT WAS REPORTED THAT A FINAL CONTROL OF THE RADIAL ARTERY WAS ACHIEVED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16077674 ↗
• MalfunctionJul 25, 2022Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER ADVANCING THE BENCHMARK OVER THE 5F SELECT TO THE TARGET VESSEL, THE PHYSICIAN BROKE THE 5F SELECT AT THE DISTAL END UPON REMOVING IT. IT WAS REPORTED THAT THE DISTAL TIP OF THE 5F SELECT WAS STILL PARTIALLY ATTACHED TO THE PROXIMAL SEGMENT OF THE CATHETER BY A THREAD. THE PROCEDURE WAS COMPLETED USING THE SAME BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099451 ↗
• MalfunctionNov 22, 2021Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL ARTERY USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A NON-PENUMBRA SHORT SHEATH. IT WAS NOTED THAT THE PATIENT ANATOMY WAS CALCIFIED AND TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE SHORT SHEATH, THE PHYSICIAN KINKED THE DISTAL END OF THE 5F SELECT. THE PHYSICIAN THEN DECIDED TO REMOVE THE 5F SELECT. WHILE RETRACTING THE 5F SELECT WITH DIFFICULTY, THE DISTAL END OF THE 5F SELECT BROKE OFF WITHIN THE SHORT SHEATH. THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE THE BROKEN DISTAL END OF THE 5F SELECT USING MANUAL ASPIRATION WITH A SYRINGE BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE SHORT SHEATH CONTAINING THE BROKEN DISTAL END OF THE 5F SELECT. THE PROCEDURE WAS COMPLETED USING A NEW SELECT AND A NEW SHORT SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850485 ↗
• MalfunctionSep 14, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, IT WAS REPORTED THE 5F SELECT BECAME KINKED UPON PULLING OUT FROM THE PATIENT. THEREFORE, THE 5F SELECT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471810 ↗
• MalfunctionJun 3, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA SHORT SHEATH AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, WHILE ADVANCING A 5F SELECT HALFWAY THROUGH A SHORT SHEATH, THE 5F SELECT BECAME STUCK AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE 5F SELECT AND THE SHORT SHEATH WERE REMOVED. NEXT, WHILE ADVANCING A NEURON MAX HALFWAY THROUGH A LONG SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE NEURON MAX BECAME STUCK AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE NEURON MAX WAS REMOVED. AFTERWARDS, THE PHYSICIAN PERFORMED ANOTHER DIAGNOSTIC TEST AND DECIDED THAT THE PATIENT DID NOT NEED INTERVENTION. 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 11932550 ↗
• InjuryMay 25, 2021Material Too Rigid or Stiff; Physical Resistance/Sticking; Material Too Rigid or Stiff; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VERTEBRAL ARTERY USING NEURON SELECT CATHETER 5F (5F SELECT), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE 5F SELECT THROUGH THE NEURON MAX OVER THE GUIDEWIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AND, SUBSEQUENTLY, NOTICED THERE WAS A DISSECTION IN THE VERTEBRAL ARTERY. THEREFORE, THE 5F SELECT, THE NEURON MAX, AND THE GUIDEWIRE WERE REMOVED. IT WAS REPORTED BY THE PHYSICIAN THAT THE 5F SELECT WAS ¿STIFFER¿ THAN USUAL UPON REMOVAL. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED BY THE PHYSICIAN THAT THE VESSEL DISSECTION WAS RELATED TO THE 5F SELECT AND NEURON MAX. IT SHOULD BE NOTED THAT THERE WAS NO CLINICAL OUTCOME RELATED TO THE VESSEL DISSECTION AND NO ACTION WAS TAKEN TO TREAT THE DISSECTION OF THE VERTEBRAL ARTERY. POST-PROCEDURE, A THROMBUS FORMATION WAS NOTED IN THE RIGHT FEMORAL ARTERY AND WAS REPORTED TO BE RELATED TO THE NEURON MAX.

  Patient problems: Vascular Dissection

  MAUDE report 11874785 ↗
• InjuryJan 8, 2021Break; Device Dislodged or Dislocated; Physical Resistance/Sticking; Break; Device Dislodged or Dislocated; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE VESSEL WITH THE NEURON MAX AND SUBSEQUENTLY ENCOUNTERED RESISTANCE WHILE ADVANCING THE 5F SELECT FOR THE FIRST PASS. NEXT, ANGIOGRAM VISUALIZATION REVEALED THAT THE 5F SELECT TIP WAS BROKEN AND HAD DISLODGED IN THE CAROTID ARTERY. THE 5F SELECT WAS REMOVED AND A SNARE DEVICE WAS USED TO EXTRACT THE BROKEN TIP FROM THE VESSEL. THE PROCEDURE WAS COMPLETED USING THE SAME 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 11142992 ↗
• InjuryJan 5, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ACCESSING THE BRACHIOCEPHALIC ARTERY, THE 5F SELECT FRACTURED. THEREFORE, THE PHYSICIAN USED A GOOSE NECK SNARE TO REMOVE THE BROKEN PIECE OF THE 5F SELECT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11118184 ↗
• MalfunctionApr 17, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, PRIOR TO ADVANCEMENT INTO THE PATIENT, THE PHYSICIAN FLUSHED THE 5F SELECT AND ATTEMPTED TO ADVANCE A GUIDEWIRE. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE GUIDEWIRE AND REPORTED THAT IT WAS UNABLE TO ADVANCE THROUGH THE 5F SELECT. THE 5F SELECT WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 5F SELECT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525024 ↗
• InjuryNov 7, 2017Break; Entrapment of Device; Material Separation; Break; Entrapment of Device; Material Separation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE TO PLACE A STENT IN THE CAROTID ARTERY USING A NEURON SELECT 5F SELECT CATHETER (5F SELECT). DURING THE PROCEDURE, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE USING THE 5F SELECT; HOWEVER, WHILE TORQUING THE 5F SELECT TO CONFORM TO THE AORTIC ARCH, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE 5F SELECT CAME OFF IN THE PATIENT¿S BODY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED TIP AFTER HOURS OF TRYING. THE CAROTID STENT WAS THEN SUCCESSFULLY PLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006202 ↗
• MalfunctionJul 15, 2016Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON 5F SELECT CATHETER (5F SELECT). DURING THE PROCEDURE, WHILE THE 5F SELECT WAS BEING LOADED INTO THE ROTATING HEMOSTASIS VALVE (RHV) FOR THE SECOND TIME, THE TIP OF THE 5F SELECT SNAPPED OFF. THEREFORE, THE 5F SELECT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 5F SELECT AND THE SAME RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5799875 ↗
• InjuryJan 8, 2016Entrapment of Device; Fracture; Entrapment of Device; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A NEURON SELECT 5F SELECT CATHETER (5F SELECT). DURING THE PROCEDURE, THE 5F SELECT FRACTURED WHILE BEING USED IN THE PATIENT. AFTER AN UNSUCCESSFUL ATTEMPT TO RETRIEVE THE BROKEN PIECE OF THE 5F SELECT USING A SNARE DEVICE, THE PHYSICIAN DECIDED TO LEAVE IT IN THE PATIENT'S EXTERNAL CAROTID ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 5354810 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083125. One submission often covers many models, so check the product and lot details in each record.

• Z-2049-2009 · Jul 2, 2009 · Terminated
  Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional