Penumbra System 3MAXC-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00814548019956), received between Dec 23, 2019 and Jul 24, 2025 — classified as 2 deaths, 10 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Break” (39 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE 3MAXC FRACTURED. THE PHYSICIAN PERFORMED SURGICAL INTERVENTION TO REMOVE THE 3MAXC. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591485 ↗
• MalfunctionJul 24, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX IN THE LEFT INTERNAL CAROTID ARTERY (ICA), AND THE GUIDEWIRE WAS POSITIONED DISTALLY. WHILE ADVANCING THE 3MAXC THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE 3MAXC FURTHER. THE PHYSICIAN THEN DECIDED TO REMOVE THE 3MAXC, AND UPON REMOVAL, IT WAS NOTED THAT THE DISTAL LENGTH HAD BECOME DAMAGED. THE 3MAXC WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 3MAXC 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 22589962 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913048 ↗
• MalfunctionJul 8, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA SHEATH, A STENT RETRIEVER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED PASSES IN THE TARGET LOCATION USING THE RED68 AND 3MAXC. THE PHYSICIAN THEN RE-ADVANCED THE RED68 AND 3MAXC TO THE CLOT AND ATTEMPTED TO ADVANCE THE STENT RETRIEVER THROUGH THE RED68. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN PLACING THE RED68 AND STENT RETRIEVER DUE TO THE PATIENT¿S ANATOMY, CAUSING THE PHYSICIAN TO USE ADDITIONAL FORCE. AFTER SEVERAL ATTEMPTS TO ADVANCE THE STENT RETRIEVER, THE PHYSICIAN DECIDED TO REMOVE IT WITH THE RED68 AND 3MAXC AND AGAIN EXPERIENCED RESISTANCE. UPON REMOVAL, IT WAS NOTED THAT BOTH THE RED68 AND THE 3MAXC FRACTURED INTO TWO PIECES APPROXIMATELY FIVE CENTIMETERS FROM THE PROXIMAL END. THEREFORE, THE RED68 AND THE 3MAXC WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ASPIRATION CATHETER AND THE SAME SHEATH. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697172 ↗
• DeathJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE ANTERIOR CIRCULATION OF THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON SELECT CATHETER 5F (5F SELECT), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT RECEIVED 18 MG OF THROMBOLYTIC THERAPY AND SINGLE ANTIPLATELET MEDICATION PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE LEFT M2 SEGMENT USING THE RED62. THE RED62 WAS RETRACTED TO PERFORM AN ANGIOGRAM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). ADDITIONAL CLOT WAS NOTICED IN THE RIGHT PERICALLOSAL ARTERY. THE PHYSICIAN THEN ADVANCED A RED43 INTO THE DISTAL RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND INTO THE RIGHT PERICALLOSAL ARTERY AND COMPLETED ONE PASS USING THE RED43. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 WAS ACHIEVED. POST-THROMBECTOMY, IT WAS REPORTED THE PATIENT CONTINUED TO HAVE PE

  Patient problems: Cerebral Edema; Ischemia Stroke

  MAUDE report 18481438 ↗
• DeathJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE ANTERIOR CIRCULATION OF THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON SELECT CATHETER 5F (5F SELECT), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT RECEIVED 18 MG OF THROMBOLYTIC THERAPY AND SINGLE ANTIPLATELET MEDICATION PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES IN THE LEFT M2 SEGMENT USING THE RED62. THE RED62 WAS RETRACTED TO PERFORM AN ANGIOGRAM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). ADDITIONAL CLOT WAS NOTICED IN THE RIGHT PERICALLOSAL ARTERY. THE PHYSICIAN THEN ADVANCED A RED43 INTO THE DISTAL RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND INTO THE RIGHT PERICALLOSAL ARTERY AND COMPLETED ONE PASS USING THE RED43. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 WAS ACHIEVED. POST-THROMBECTOMY, IT WAS REPORTED THE PATIENT CONTINUED TO HAVE PE

  Patient problems: Cerebral Edema; Ischemia Stroke

  MAUDE report 18481437 ↗
• MalfunctionJan 8, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENOUS SINUS USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS WITH THE 3MAXC. NEXT, WHILE ADVANCING THE 3MAXC TO TAKE MEASUREMENTS, THE PHYSICIAN MET RESISTANCE AND KINKED THE 3MAXC. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 3MAXC. WHILE EXAMINING ON THE BACK TABLE, THE 3MAXC FRACTURED AT THE KINKED LOCATION. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466456 ↗
• MalfunctionDec 18, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE 3MAXC AFTER COMPLETION OF THE SECOND PASS. AFTER REMOVING THE 3MAXC FROM THE PATIENT, THE PHYSICIAN FOUND THAT IT WAS FRACTURED AT THE DISTAL LENGTH. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE FRACTURED PART OF THE 3MAXC FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC 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 18346843 ↗
• InjuryDec 12, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A RED 68 REPERFUSION CATHETER (RED68), A NON-PENUMBRA BALLOON GUIDE CATHETER, A PENUMBRA ENGINE (ENGINE), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS AND ASPIRATED THE THROMBUS USING THE BALLOON GUIDE CATHETER. AFTER FLUSHING THE 3MAXC, RED68, AND THE BALLOON GUIDE CATHETER, THE PHYSICIAN ADVANCED THE 3MAXC AND RED68 OVER THE GUIDEWIRE FOR A SECOND PASS TO OPEN THE OCCLUDED M1 BRANCH. AFTER REACHING THE SURFACE OF THE CLOT, THE PHYSICIAN ATTEMPTED TO RETRACT THE 3MAXC AND GUIDEWIRE TO START ASPIRATION. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND COULD NOT RETRACT THE 3MAXC AND GUIDEWIRE. THE PHYSICIAN THEN TIGHTENED HIS GRIP AND, FELT THE 3MAXC AND GUIDEWIRE BECOME LOOSE, AND RETRACTED THE 3MAXC AND GUIDEWIRE THROUGH THE BALLOON GUIDE CATHETER. UPON REMOVAL OF THE 3MAXC, THE PHYSICIAN PERFORMED AN ANGIOGRAM AND NOTICED THAT THE DISTAL LENGTH OF THE 3MAXC FRACTURED AND WAS PUSHED BACK INTO THE ICA AND THE ANTERIOR CEREBRAL ARTERY (ACA) W

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18312787 ↗
• MalfunctionNov 8, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE 3MAXC BECAME STUCK AND THE DISTAL END OF THE 3MAXC FRACTURED WITHIN THE RED72. THE PHYSICIAN THEN USED A SNARE DEVICE WITH THE RED72 TO RETRIEVE THE FRACTURED SEGMENT OF THE 3MAXC. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, A NEW RED72 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 18097435 ↗
• MalfunctionJul 20, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68). DURING THE PROCEDURE, THE PHYSICIAN USED A 3MAXC TO ADVANCE A RED68 TO THE TARGET LOCATION. WHILE ATTEMPTING TO REMOVE THE 3MAXC TO INITIATE ASPIRATION WITH THE RED68, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE DISTAL END OF THE 3MAXC INTO TWO SEPARATE PIECES. THEREFORE, THE RED68 WAS REMOVED CONTAINING THE BROKEN PIECES OF THE 3MAXC. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43) AND THE SAME RED68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367871 ↗
• MalfunctionApr 25, 2023Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, THE 3MAXC WAS ADVANCED OVER THE GUIDEWIRE TO THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE THE RED72 OVER THE 3MAXC TO THE TARGET LOCATION, WITHOUT SUCCESS. WHILE REMOVING THE RED72 AND 3MAXC TOGETHER, THE PHYSICIAN EXPERIENCED RESISTANCE AND APPLIED FORCE TO REMOVE THE DEVICES. UPON REMOVAL, THE PHYSICIAN OBSERVED THAT THE PROXIMAL END OF THE RED72 WAS STRETCHED AND THE 3MAXC WAS FRACTURED AT THE DISTAL END. THEREFORE, THE RED72 AND THE 3MAXC WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), THE SAME BENCHMARK MAX, A NON-PENUMBRA MICROCATHETER, AND A STENT RETRIEVER TO PERFORM A COMBINED TECHNIQUE OF ASPIRATION AND CLOT RETRIEVAL USING THE STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811527 ↗
• MalfunctionFeb 3, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), AND A GUIDEWIRE. DURING THE PROCEDURE, IT WAS REPORTED A 3MAXC BROKE INSIDE OF A RED62. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO SEPARATE THE 3MAXC FROM THE RED62. IT WAS ALSO NOTED THE GUIDEWIRE WAS STUCK IN THE 3MAXC AND RED62. THEREFORE, THE 3MAXC, RED62 AND GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16300318 ↗
• MalfunctionJan 20, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING THE 3MAXC OVER A GUIDEWIRE THROUGH RED72 AND UP THE ICA. SUBSEQUENTLY, WHEN THE 3MAXC REACHED THE DISTAL MIDDLE CEREBRAL ARTERY (MCA), THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE 3MAXC WAS BROKEN. THEREFORE, THE RED72 WAS REMOVED CONTAINING THE BROKEN 3MAXC AND GUIDEWIRE. IT WAS ALSO REPORTED THAT THE RED72 WAS BENT AT THE PROXIMAL END CLOSE TO THE HUB. THE 3MAXC AND RED72 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW 3MAXC AND A NEW RED72; HOWEVER, THE PHYSICIAN WAS UNABLE TO TRACK THE RED72 UP TO THE TARGET LOCATION USING THE 3MAXC. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 3MAXC. THERE WAS NO DAMAGE NOTED ON THE 3MAXC. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA CATHETER, SAME RED72, AND THE SAME GUIDEWIRE TO ACHIEVE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. THERE WAS NO REPORT OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215492 ↗
• InjuryJan 11, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), BENCHMARK BMX96 ACCESS SYSTEM (BMX96), PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A PENUMBRA ENGINE CANISTER (CANISTER), AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 THROUGH THE BMX96 AND MADE THE FIRST PASS IN THE TARGET VESSEL USING THE RED72. NEXT, THE PHYSICIAN ADVANCED THE RED72 OVER THE 3MAXC AND THEN REMOVED THE 3MAXC TO MAKE THE SECOND PASS USING THE RED72. SUBSEQUENTLY, UPON INSPECTING THE CANISTER FOR CLOT, THE PHYSICIAN NOTICED THE DISTAL END OF THE 3MAXC HAD BROKEN OFF AND WAS ASPIRATED WITH THE RED72 AND INTO THE CANISTER. THEREFORE, THE 3MAXC WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS ALSO REPORTED THAT THE CLOT MIGRATED FROM THE ICA TO THE M2 SEGMENT OF THE MCA, AND THE PHYSICIAN DECIDED TO REMOVE THE RED72 AND SWITCH TO A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). THE PROCEDURE WAS COMPLETED USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND RED62.

  Patient problems: Thromboembolism

  MAUDE report 16141857 ↗
• InjuryJan 6, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT PRESENTED WITH MOTOR DEFICIT, LANGUAGE ALTERATION AND THE CRANIAL TOMOGRAPHY SHOWED MILD LEFT TEMPORAL ISCHEMIA. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE BMX96 INTO THE PATIENT. THE PHYSICIAN THEN ADVANCED THE RED72 THROUGH THE BMX96 AND INTO THE TARGET VESSEL USING THE 3MAXC AND GUIDEWIRE. AFTER THAT, THE 3MAXC AND GUIDEWIRE WERE REMOVED. NEXT, WHILE ATTEMPTING TO ADVANCE THE RED72 AGAINST THE THROMBUS, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE 3MAXC HAD FRACTURED AND A FRAGMENT OF THE 3MAXC REMAINED WITHIN THE RED72. THE PHYSICIAN THEN DECIDED TO USE THE SOLUMBRA TECHNIQUE TO CAPTURE THE THROMBUS AND THE FRAGMENT OF THE 3MAXC. HOWEVER, WHILE ATTEMPTING TO POSITION A MICROCATHETER AND THE GUIDEWIRE INTO THE M2 SEGMENT OF THE MCA TO DELIVER THE STENT RETRIEVER, THE DISTAL END OF THE 3MAXC FRAGMENT STARTED TO CONCOMITANTLY ADVANCE TOWARDS THE M2 SEGMENT OF THE MCA.

  Patient problems: Foreign Body Embolism; Foreign Body In Patient

  MAUDE report 16117014 ↗
• MalfunctionDec 30, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RED68 THROUGH THE BMX96 IN THE TARGET LOCATION USING THE 3MAXC. SUBSEQUENTLY, THE 3MAXC WAS REMOVED. UPON REMOVAL, THE DISTAL END OF THE 3MAXC WAS NOTICED TO BE BROKEN. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE 3MAXC WAS IN THE PATIENT. AT THIS POINT A NEW 3MAXC WAS OPENED AND ADVANCED THROUGH THE RED68 TO ASPIRATE THE BROKEN DISTAL END OF THE FIRST 3MAXC, HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SECOND 3MAXC. WHILE ATTEMPTING TO RETRACT THE SECOND 3MAXC, THE 3MAXC BECAME STRETCHED; HOWEVER, THE PHYSICIAN WAS ABLE TO REMOVE IT. THE PHYSICIAN THEN DECIDED TO USE A SNARE DEVICE AND REMOVED THE DISTAL END OF THE FIRST 3MAXC. AFTER REMOVING THE 3MAXC, THE PHYSICIAN DECIDED TO USE A VELOCITY DELIVERY MICROCATHETER (VELOCITY) WITH A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). WHILE ATTEMPTING TO REMOVE THE VELOCITY FROM T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080815 ↗
• MalfunctionOct 13, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE NEURON MAX INTO THE PATIENT AND THEN ADVANCED THE 3MAXC INTO THE TARGET VESSEL. THE PHYSICIAN THEN COMPLETED THE FIRST PASS USING THE 3MAXC. WHILE REMOVING THE 3MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE AND CONSEQUENTLY, THE DISTAL END OF THE 3MAXC BROKE OFF. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN PART OF THE 3MAXC FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC 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 15598856 ↗
• MalfunctionSep 14, 2022Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A GUIDE CATHETER, AND A 0.035¿ GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS TO THE TARGET VESSEL VIA RIGHT RADIAL ARTERY USING THE GUIDE CATHETER. THEN, THE PHYSICIAN COMPLETED ONE PASS IN THE TARGET VESSEL USING THE RED72, 3MAXC, AND GUIDE CATHETER. WHILE RETRACTING THE RED72 AND 3MAXC THROUGH THE GUIDE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE RED72 AND 3MAXC AT THE MID-SHAFT. IT WAS ALSO REPORTED THAT BOTH DEVICES BECAME UNRAVELED AT THE MID-SHAFT AND THE GUIDE CATHETER BECAME KINKED. THE PHYSICIAN THEN ADVANCED THE GUIDEWIRE INTO THE 3MAXC AND RED72 AND REMOVED BOTH DEVICES SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, A 6FR NON-PENUMBRA CATHETER, AND A NEW GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420396 ↗
• MalfunctionAug 18, 2022Stretched; Unraveled Material; Failure to Advance; Stretched; Unraveled Material; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND A GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE ACE68 OVER THE 3MAXC THROUGH THE GUIDE CATHETER TO THE TARGET VESSEL. HOWEVER, THE 3MAXC WOULD NOT ADVANCE PAST A SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 3MAXC AND SWITCH TO A STENT RETRIEVER. UPON REMOVAL OF THE 3MAXC, THE PHYSICIAN NOTICED THAT THE 3MAXC WAS STRETCHED AND UNRAVELED. THE PROCEDURE WAS COMPLETED USING THE STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254966 ↗
• MalfunctionJun 21, 2022Break; Break

  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 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND AN ASPIRATION CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX IN THE PATIENT. WHILE ADVANCING THE 3MAXC INTO THE ASPIRATION CATHETER, THE PHYSICIAN BROKE THE MID-SHAFT OF THE 3MAXC. THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761352 ↗
• MalfunctionJun 2, 2022Break; Break

  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 (6F SELECT), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX IN THE PATIENT USING THE 6F SELECT. THEN, THE PHYSICIAN USED THE 3MAXC TO BRING THE ACE68 TO THE FRONT OF THE THROMBUS. AFTER REMOVING THE 3MAXC, THE PHYSICIAN NOTICED THAT APPROXIMATELY THREE CENTIMETERS FROM THE DISTAL END OF THE 3MAXC WAS MISSING. IT WAS THEN NOTICED THAT THE BROKEN DISTAL END OF THE 3MAXC WAS NEAR THE SITE OF THE OCCLUSION. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO START ASPIRATING THE THROMBUS USING THE ACE68 AND STENT RETRIEVER. AFTER SUCCESSFUL RECANALIZATION OF THE VESSEL, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO REMOVE THE BROKEN DISTAL END OF THE 3MAXC USING TWO DIFFERENT NON-PENUMBRA STENT RETRIEVERS BUT WAS UNSUCCESSFUL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14575838 ↗
• MalfunctionApr 26, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS WITH TWO 360-DEGREE LOOPS AND HAD HARD PLAQUE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS IN THE TARGET VESSEL USING THE 3MAXC, CATHETER, AND SHEATH. WHILE RETRACTING THE 3MAXC TO REMOVE IT FROM THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE 3MAXC BROKE NEAR THE OPHTHALMIC VESSEL WHILE THE DISTAL TIP WAS IN THE M1. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE PROXIMAL PIECE OF THE 3MAXC AND ASPIRATED THE BROKEN DISTAL PIECE OF THE 3MAXC OUT OF THE PATIENT USING THE CATHETER. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT AS THE PHYSICIAN WAS UNABLE TO GET PAST THE PLAQUE USING THE 3MAXC. IT WAS ALSO REPORTED THAT THE PATIENT¿S FAMILY DID NOT WANT INTRAVENOUS (IV) TISSUE PLASMINOGEN ACTIVATOR (TPA) ADMINISTERED TO THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215241 ↗
• MalfunctionMar 12, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), AND A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE BENCHMARK MAX, RED72 AND 3MAXC. WHILE RETRACTING THE 3MAXC, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON REMOVAL, THE PHYSICIAN FOUND THE 3MAXC BROKEN AT THE DISTAL END AND HANGING BY A THREAD. THEREFORE, THE 3MAXC WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, THE SAME BENCHMARK MAX AND THE SAME RED72. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13744879 ↗
• MalfunctionJan 31, 2022Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A NON-PENUMBRA GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE RED72. DURING THE THIRD PASS, THE PHYSICIAN ADVANCED THE RED72 TO THE FACE OF THE CLOT WITH ASPIRATION AND THEN REMOVED THE 3MAXC. UPON REMOVAL OF THE 3MAXC, IT WAS NOTICED THAT THE DISTAL PART OF THE 3MAXC WAS MISSING. THE RED72 APPEARED TO BE KINKED ON THE FLUOROSCOPY. THEREFORE, THE RED72 WAS ALSO REMOVED FROM THE PATIENT. THE BROKEN PIECE OF THE 3MAXC WAS FOUND INSIDE THE RED72; HOWEVER, THE RED72 WAS NOT DAMAGED. SUBSEQUENTLY, THE PHYSICIAN USED A SYRINGE TO REMOVE THE BROKEN PIECE OF 3MAXC ON THE BACK TABLE. THEN, THE PHYSICIAN COMPLETED TWO ADDITIONAL PASSES USING A NEW 3MAXC, THE SAME RED72 AND THE SAME NEURON MAX. THE THROMBECTOMY WAS NOT SUCCESSFUL DUE TO LOW TICI SCORE; HOWEVER, THIS WAS NOT DUE TO ANY PENUMBRA DEVICES USED IN THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404969 ↗