Penumbra System 4MAXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00814548012414), received between Oct 8, 2015 and Jun 30, 2023 — classified as 1 death, 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE 4MAXC TOWARDS THE TARGET VESSEL. AFTER REACHING THE TARGET VESSEL, THE PHYSICIAN ATTEMPTED TO ASPIRATE USING THE 4MAXC, BUT NO THROMBUS WAS ASPIRATED. THE PHYSICIAN THEN VISUALIZED UNDER FLUOROSCOPY THAT THE 4MAXC WAS FRACTURED. THEREFORE, THE 4MAXC WAS REMOVED. UPON REMOVAL, THE PHYSICIAN CONFIRMED THAT THE 4MAXC WAS FRACTURED BUT REMAINED CONNECTED BY THE INNER WIRES. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243081 ↗
• MalfunctionMay 12, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENTS ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES WITH THE 4MAXC. NEXT, WHILE ADVANCING THE 4MAXC OVER THE GUIDEWIRE TOWARDS THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE 4MAXC. UPON REMOVAL OF THE 4MAXC, THE PHYSICIAN FOUND THAT THE 4MAXC WAS FRACTURED AT THE MID-SHAFT AND CONNECTED BY THE INNER WIRE BRAIDING. THEREFORE, THE 4MAXC WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC, A NEW GUIDEWIRE, 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 16921588 ↗
• MalfunctionSep 20, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX IN THE PATIENT. NEXT, WHILE ADVANCING THE 4MAXC INTO THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 4MAXC. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE MID-SHAFT OF THE 4MAXC WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457681 ↗
• MalfunctionNov 30, 2021Break; Suction Problem; Break; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ASPIRATED CLOT IN THE LEFT MIDDLE CEREBRAL ARTERY USING THE ACE68. AFTER PERFORMING AN ANGIOGRAPHY, THE PHYSICIAN FOUND THAT THERE WAS THROMBUS IN THE P1 SEGMENT OF THE DISTAL POSTERIOR CEREBRAL ARTERY AND DECIDED TO USE A 4MAXC FOR ASPIRATION. THE PHYSICIAN FLUSHED THE 4MAXC WITH WATER, ADVANCED THE 4MAXC TO THE TARGET LOCATION, AND INITIATED ASPIRATION TWICE; HOWEVER, IT WAS REPORTED THE SUCTION FORCE WAS LOW AND THE IMAGE WAS NOT CLEAR. UPON REMOVAL OF THE 4MAXC, THE PHYSICIAN INJECTED WATER INTO IT AND NOTICED THERE WAS A BREAK AT THE DISTAL END. THE PHYSICIAN TOOK A PHOTO, AND 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 12903324 ↗
• MalfunctionOct 22, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, WHILE ADVANCING THE 4MAXC THROUGH THE INTERNAL CAROTID ARTERY, THE PHYSICIAN FRACTURED THE TRANSITION SECTION OF THE 4MAXC. THEREFORE, THE 4MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683596 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 4MAXC THROUGH THE SHEATH INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN INITIATED MANUAL ASPIRATION USING A 30CC SYRINGE. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THERE WAS NO FLUID BEING ASPIRATED INTO THE SYRINGE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 4MAXC. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE 4MAXC WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER, 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 12530558 ↗
• MalfunctionSep 13, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, WHILE INSERTING THE 4MAXC INTO THE GUIDING SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PROXIMAL END OF THE 4MAXC; THEREFORE, THE 4MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465496 ↗
• InjuryAug 11, 2021Fracture; Difficult to Advance; Fracture; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), NON-PENUMBRA SHEATH AND MICROCATHETER. IT WAS REPORTED THAT PATIENT HAD A VERY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN TRACKED THE 4MAXC TO THE CLOT AND STARTED ASPIRATION. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE 4MAXC DURING THE FIRST PASS, THEY EXPERIENCED RESISTANCE. UPON REMOVAL OF THE 4MAXC IT WAS REPORTED THAT IT BROKE AND THE DISTAL END OF THE 4MAXC REMAINED IN THE PATIENT. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE BROKEN 4MAXC. 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 12309366 ↗
• MalfunctionMay 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, WHILE CO-AXIALLY ADVANCING THE 4MAXC WITH THE VELOCITY, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE VELOCITY. WHILE RETRACTING THE VELOCITY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TIP OF THE VELOCITY WAS NOT MOVING. THE PHYSICIAN THEN REALIZED THAT THE VELOCITY BROKE AT THE PROXIMAL ONE THIRD WITHIN THE 4MAXC; THEREFORE, THE PHYSICIAN ADVANCED A MICROWIRE THROUGH THE 4MAXC AND TWISTED THE MICROWIRE SEVERAL TIMES TO SUCCESSFULLY CAPTURE AND REMOVE THE BROKEN PIECE OF THE VELOCITY. SUBSEQUENTLY, THE 4MAXC WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837661 ↗
• MalfunctionMay 4, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), A NON-PENUMBRA GUIDING SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INSERTING A 4MAXC OVER A GUIDEWIRE INTO THE GUIDING SHEATH, THE PHYSICIAN KINKED THE PROXIMAL END OF THE 4MAXC. THEREFORE, THE 4MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC AND THE SAME GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11771401 ↗
• MalfunctionApr 20, 2021Fracture; Failure to Advance; Physical Resistance/Sticking; Fracture; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 4MAXC INTO THE M1 SEGMENT OF THE MCA AND COMPLETED A PASS THAT REMOVED THE THROMBUS. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 4MAXC INTO THE M2 SEGMENT OF THE MCA TO PERFORM A SECOND PASS AND EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE 4MAXC WOULD NOT ADVANCE INTO THE M2 SEGMENT OF THE MCA. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 4MAXC. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE 4MAXC WAS FRACTURED. THE PROCEDURE WAS COMPLETED BY ADMINISTERING ALTEPLASE TO THE PATIENT SINCE THE HOSPITAL DID NOT HAVE ANOTHER 4MAXC TO USE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693639 ↗
• MalfunctionDec 26, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), NON-PENUMBRA SHEATH, AND NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH AND THE GUIDE CATHETER. WHILE ATTEMPTING TO INSERT THE 4MAXC INTO GUIDE CATHETER, THE PROXIMAL END OF THE 4MAXC KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC, THE SAME SHEATH AND GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9521432 ↗
• MalfunctionAug 6, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE, USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, THE 4MAXC BROKE AT THE HUB; THEREFORE, IT WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866250 ↗
• MalfunctionJul 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, WHILE ADVANCING THE 4MAXC OVER THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED AFTER ADVANCING THE 4MAXC APPROXIMATELY 20 TO 30 CENTIMETERS. THE PHYSICIAN THEN REMOVED THE GUIDEWIRE AND COMPLETED THE PROCEDURE USING THE SAME 4MAXC, A VELOCITY DELIVERY MICROCATHETER AND A STENT RETRIEVER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781393 ↗
• MalfunctionMay 7, 2019Break; Fracture; Break; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, PRIOR TO ADVANCEMENT INTO THE PATIENT, THE PHYSICIAN BEGAN FLUSHING THE 4MAXC WITH A CONTINUOUS FLUSH OF SALINE AND IT WAS REPORTED THAT THE 4MAXC WAS LEAKING AT A PROXIMAL PORTION OF THE 4MAXC, JUST PAST THE HUB. THE PHYSICIAN THEN NOTICED THAT THE 4MAXC WAS BROKEN INTO TWO PIECES AND CONNECTED BY A WIRE, JUST PAST THE HUB. THE 4MAXC WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 4MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8589109 ↗
• MalfunctionFeb 27, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, TWO PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERS (4MAXCS) BROKE IN TWO PARTS UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE TWO 4MAXCS OCCURRED PRIOR TO USE AND, THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 8376390 ↗
• MalfunctionFeb 27, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, TWO PENUMBRA SYSTEM 4MAX REPERFUSION CATHETERS (4MAXCS) BROKE IN TWO PARTS UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE TWO 4MAXCS OCCURRED PRIOR TO USE AND, THEREFORE, WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 8376383 ↗
• MalfunctionNov 28, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER IN THE VERTEBRAL ARTERY (VA). THE PHYSICIAN THEN OPENED A 4MAXC AND NOTICED THAT IT WAS FRACTURED UPON REMOVAL FROM THE PACKAGING; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME CATHETER, NEW 4MAXC AND A STENT DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8111033 ↗
• MalfunctionMay 8, 2018Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY/RIGHT POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 4MAXC THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) OVER A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN THEN BROUGHT THE GUIDEWIRE BACK INTO THE 4MAXC TO TORQUE IT AND ADVANCE INTO THE RIGHT PCA. HOWEVER, THE GUIDEWIRE WENT THROUGH THE SIDE OF THE 4MAXC AND WAS NO LONGER COMING OUT OF THE DISTAL END OF THE 4MAXC; THEREFORE, THE 4MAXC AND GUIDEWIRE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 4MAXC, THE SAME NEURON MAX AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7494931 ↗
• MalfunctionJan 11, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAXACE) TOWARDS THE OCCLUDED PORTION OF THE RIGHT M1 SEGMENT AND THEN PERFORMED ASPIRATION THROUGH THE 5MAXACE. THE ANGIOGRAPHY REVEALED THAT THE M2 SEGMENT WAS ALSO OCCLUDED. SINCE THE 5MAXACE WAS NOT THE APPROPRIATE SIZE FOR THE TARGET VESSEL DIAMETER, THE PHYSICIAN DECIDED TO USE THE 4MAXC INSTEAD. WHILE ATTEMPTING TO ADVANCE A PX SLIM INTO THE 4MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE PROXIMAL PART OF THE 4MAXC. ALTHOUGH RESISTANCE WAS ENCOUNTERED, THE PHYSICIAN WAS ABLE TO ADVANCE THE 4MAXC INTO THE TARGET VESSEL AND SUCCESSFULLY COMPLETED THE PROCEDURE USING THE SAME 4MAXC. IT WAS REPORTED THAT THERE WERE NO OBSERVED KINKS ON THE PX SLIM OR 4MAXC. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7184349 ↗
• MalfunctionJul 31, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) BECAME KINKED AT THE MID-SHAFT. THE 4MAX WAS DAMAGED PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 4MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6755752 ↗
• MalfunctionNov 29, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA REPERFUSION 4MAX REPERFUSION CATHETER (4MAX). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO INSERT THE 4MAX INTO THE ROTATING HEMOSTASIS VALVE (RHV); HOWEVER,THE 4MAX WOULD NOT ADVANCE BEYOND THE FIRST FEW CENTIMETERS. THEREFORE, THE PHYSICIAN OPENED THE RHV AS LARGE AS IT COULD BE OPENED; HOWEVER THE 4MAX WAS STILL UNABLE TO ADVANCE. THE PHYSICIAN REPORTED THAT THE 4MAX SEEMED VISUALLY A BIT LARGE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA SYSTEM 4MAX DISTAL DELIVERY CATHETER (4MAXDDC) 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 6133838 ↗
• MalfunctionNov 9, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) WAS KINKED UPON REMOVAL FROM ITS DISPENSER HOOP. THE KINKED 4MAX WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 4MAX.

  Patient problems: No Patient Involvement

  MAUDE report 6090699 ↗
• MalfunctionOct 12, 2016Kinked; Failure to Advance; Kinked; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 4MAX THROUGH A NON-PENUMBRA SHEATH AND THEN ATTEMPTED TO ADVANCE A VELOICTY DELIVERY MICROCATHETER (VELOCITY) THROUGH THE 4MAX. HOWEVER, THE VELOCITY WAS UNABLE TO ADVANCE THROUGH THE 4MAX. THEREFORE, THE PHYSICIAN REMOVED THE 4MAX AND VELOCITY FROM THE PATIENT AND NOTICED THAT THE 4MAX WAS KINKED UPON INSPECTION. THE PROCEDURE WAS THEN COMPLETED USING A NEW 4MAX, THE SAME VELOCITY AND THE SAME NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6024801 ↗
• DeathOct 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A CARDIOGENIC CEREBRAL INFARCTION IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE), A PENUMBRA SYSTEM 5MAX SEPARATOR (5MAX SEPARATOR), A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAX) AND A PENUMBRA SYSTEM 4MAX SEPARATOR (4MAX SEPARATOR). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ASPIRATE THE THROMBUS USING THE 5MAX ACE AND 5MAX SEPARATOR BUT WAS UNSUCCESSFUL BECAUSE THE THROMBUS WAS TOO STIFF. THEREFORE, THE PHYSICIAN DECIDED TO USE ANOTHER MANUFACTURER'S RETRIEVAL DEVICE TO REMOVE THE THROMBUS; HOWEVER, WHILE USING THE RETRIEVAL DEVICE, THE PHYSICIAN NOTICED THAT A PIECE OF THE THROMBUS MIGRATED TO THE DISTAL M2 SEGMENT OF THE MCA. THE PHYSICIAN THEN SWITCHED TO THE 4MAX AND 4MAX SEPARATOR TO REMOVE THE THROMBUS IN THE M2 SEGMENT. THE PROCEDURE WAS COMPLETED AND THE PHYSICIAN WAS ABLE TO REMOVE ALL THE THROMBUS FROM THE PATIENT. THERE WERE NO ALLEGED MALFUNCTIONS WITH THE PENUMBRA DEVICES. FOLLOWING THE PROCEDURE, THE PATIENT'S THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE IMPROVED FROM A ZERO TO A THREE, INDICATING COMPLETE PERFUSION. HOWEVER, WITHIN TWENT

  Patient problems: Death, Intrauterine Fetal; Intracranial Hemorrhage

  MAUDE report 6011780 ↗