RED 72 RED72KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00815948023932), received between Oct 15, 2021 and Jun 11, 2025 — classified as 2 deaths, 6 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (29 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 57 reports, in the reporter's own words as published by the FDA.

• DeathJun 11, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A LARGE VESSEL OCCLUSION (LVO) IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, AFTER PERFORMING A DIRECT ASPIRATION FIRST-PASS TECHNIQUE (ADAPT) FOR APPROXIMATELY NINETY SECONDS, THE PHYSICIAN RETRACTED THE RED72 UNDER ASPIRATION AND NOTICED THAT A DISTAL SEGMENT OF THE RED72 FRACTURED WITHIN THE RIGHT ICA. THE PHYSICIAN DECIDED NOT TO REMOVE THE FRACTURED SEGMENT OF THE RED72 AND CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RED72, THE SAME BMX96, AND A NON-PENUMBRA MICROCATHETER WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A+. THE PHYSICIAN THEN STARTED A DOUBLE ANTI-AGGREGATION THERAPY. IT WAS REPORTED THAT THE CAROTID BRANCH THAT PREVIOUSLY HAD SLOWER FLOW, HAD INCREASED FLOW DUE TO THE IMPLANTED PART OF THE RED72. THE PART OF THE RED72 WAS NOT REMOVED DUE TO THE PATIENT'S DELICATE MEDICAL CONDITION. IT WAS ALSO REPORTED THAT THE BRANCH OF THE RIGHT ICA WHERE THE PART OF THE RED72 REMAINED, LATER BECAME RE-OCCLUDED. THE PATIENT WAS ALSO TRANSFERRED TO THE INTENSI

  Patient problems: Foreign Body Embolism

  MAUDE report 22191148 ↗
• InjuryFeb 4, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) A NON-PENUMBRA BASE CATHETER, AND A GUIDEWIRE VIA THE RIGHT RADIAL ARTERY. IT WAS NOTED THAT THE PATIENT HAD A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE RED72 WAS ADVANCED THROUGH THE NON-PENUMBRA CATHETER BUT THE PHYSICIAN ENCOUNTERED RESISTANCE IN THE INTERNAL CAROTID ARTERY (ICA). THEREFORE, THE PHYSICIAN DECIDED TO REMOVE BOTH CATHETERS. A GUIDEWIRE WAS INSERTED FOR REMOVAL SUPPORT. THE RED72 FRACTURED AND THE DISTAL PORTION OF THE RED72 REMAINED IN THE PATIENT. MULTIPLE SNARE DEVICES WERE USED TO TRY AND RETRIEVE THE FRACTURED PIECE OF THE RED72; HOWEVER, IT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY FOR AN OPEN CAROTID ENDARTERECTOMY WHERE THE FRACTURED PIECE OF THE RED72 WAS REMOVED. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). ON 13-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS RECOVERING IN A SKILLED NURSING FACILITY AND ABLE TO PERFORM BASIC FUNCTIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21305500 ↗
• MalfunctionJan 7, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA STENT RETRIEVER, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. THE PHYSICIAN THEN ADVANCED THE RED72 TO THE TARGET LOCATION AND DEPLOYED THE STENT RETRIEVER THROUGH IT. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING AND RETRACTING THE RED72. AFTER THE STENT RETRIEVER WAS DEPLOYED, AN ANGIOGRAM WAS PERFORMED AND REVEALED THAT THE DISTAL END OF THE RED72 FRACTURED IN THE PATIENT¿S COMMON CAROTID ARTERY. THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE THE FRACTURED SEGMENT OF THE RED72. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED62 REPERFUSION CATHETER (RED62), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21097396 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  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 RED 72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA SHEATH (8F TERUMO), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. WHILE ATTEMPTING TO REMOVE THE RED72 FROM THE BMX96 AFTER COMPLETION OF THE FIRST PASS, THE PHYSICIAN NOTICED THAT THE RED72 UNRAVELED AND FRACTURED AT THE DISTAL END UNDER FLUOROSCOPY. IT WAS REPORTED THAT THE BMX96 WAS HERNIATING INTO THE EXTERNAL CAROTID ARTERY (ECA) DUE TO THE PATIENT¿S ANATOMY. THE BMX96 CONTAINING THE FRACTURED DISTAL PORTION OF THE RED72 WAS REMOVED AND THE FRACTURED PORTION OF THE RED72 WAS THEN REMOVED FROM THE BMX96 ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER RED72, THE SAME RED 43, THE SAME BMX96, THE SAME SHEATH, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652628 ↗
• MalfunctionMay 23, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), AND A GUIDEWIRE. IT WAS NOTED THAT THERE WAS SIGNIFICANT PLAQUE AND CALCIFICATION WITHIN THE VESSELS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 TO THE TARGET VESSEL AND COMPLETED ONE PASS. NEXT, WHILE RETRACTING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE RED72 WAS STUCK IN THE VESSEL. THE PHYSICIAN RETRACTED THE RED72 AGAINST RESISTANCE AND SUBSEQUENTLY FRACTURED THE RED72. THEREFORE, THE RED72 WAS SNARED FROM THE PATIENT. THE PROCEDURE WAS CONSIDERED COMPLETED RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2C. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388802 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A STENT RETRIEVER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED ONE PASS USING THE RED72 AND THE STENT RETRIEVER. UPON REMOVAL OF THE RED72 AND STENT RETRIEVER, THE PHYSICIAN NOTICED THAT THE RED72 WAS FRACTURED AT THE MID-SHAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080840 ↗
• InjuryMar 26, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A LARGE VESSEL OCCLUSION (LVO) IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA STENT RETRIEVER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE STENT RETRIEVER AND COMPLETED ONE PASS USING THE RED72. AFTER COMPLETION OF THE FIRST PASS, THE PHYSICIAN RETRACTED THE STENT RETRIEVER THROUGH THE RED72. WHILE RETRACTING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE RED72 WAS FRACTURED AT THE DISTAL LENGTH. THE PHYSICIAN THEN ATTEMPTED TO ASPIRATE THE FRACTURED DISTAL SEGMENT OF THE RED72 USING A NEW RED72 BUT WAS UNABLE TO RETRIEVE IT. THE PROCEDURE ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18984188 ↗
• MalfunctionNov 20, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN USED RADIAL APPROACH AND COMPLETED THE FIRST PASS WITH ASPIRATION USING THE RED72 AND STENT RETRIEVER. WHILE REMOVING THE RED72 AFTER THE FIRST PASS ASPIRATION, THE PHYSICIAN NOTICED UNWINDING OF THE RED72 AT THE DISTAL END. THE PHYSICIAN REMOVED ALL THE CATHETERS AND SWITCHED TO FEMORAL ACCESS. THE PROCEDURE WAS COMPLETED WITH TWO MORE PASSES USING A NON-PENUMBRA SHEATH, A NON-PENUMBRA CATHETER, THE SAME MICROCATHETER AND THE SAME STENT RETRIEVER. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B WAS ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172484 ↗
• MalfunctionNov 6, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. AFTER COMPLETION OF THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE RED72. UPON REMOVAL OF THE RED72, THE PHYSICIAN NOTICED THAT THE RED72 WAS FRACTURED ON THE DISTAL END. THE FRACTURED PORTION OF THE RED72 WAS WITHIN THE NEURON MAX. THE NEURON MAX CONTAINING THE FRACTURED PORTION OF THE RED72 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 18074945 ↗
• MalfunctionSep 1, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, A NON-PENUMBRA STENT RETRIEVER, A NON-PENUMBRA CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET VESSEL USING THE NON-PENUMBRA CATHETER. NEXT, THE PHYSICIAN COMPLETED THE SECOND PASS USING THE RED72. WHILE RETRACTING THE RED72 WITH THE STENT RETRIEVER, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE RED72 WAS BROKEN. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE RED72 WAS IN THE RIGHT VERTEBRAL ARTERY AND EXTENDED TO THE SUBCLAVIAN ARTERY. THE PHYSICIAN COMPLETED THE PROCEDURE USING A NON-PENUMBRA CATHETER AND THE SAME SHEATH BY GOING THROUGH THE LEFT VERTEBRAL ARTERY AND THEN SNARED THE DISTAL END OF THE RED72 BY GOING THROUGH THE RIGHT VERTEBRAL ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671231 ↗
• MalfunctionAug 18, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT CAROTID ARTERY AND MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET VESSEL USING THE RED72. AFTER THE PASS, THE PHYSICIAN NOTICED THERE WAS CLOT INSIDE OF THE RED72 AND DECIDED TO REMOVE THE RED72 FOR FLUSHING. WHILE REMOVING THE RED72, THE PHYSICIAN NOTICED MAJORITY OF THE RED72 WAS BEING PULLED OUT FROM THE SHEATH. THE PHYSICIAN PERFORMED A FLUOROSCOPY AND NOTICED THE RED72 APPEARED TO BE FRACTURED IN THE VESSEL. THE PROXIMAL RED72 WAS REMOVED WITH THE BMX96. THE PHYSICIAN THEN PLACED A NEURON MAX AND SNARED THE DISTAL RED72. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA ASPIRATION CATHETER AND A NON-PENUMBRA GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577646 ↗
• MalfunctionAug 7, 2023Fracture; Stretched; Physical Resistance/Sticking; Fracture; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA SHORT SHEATH. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH TANDEM OCCLUSION. DURING THE PROCEDURE, THE RED72 WAS ADVANCED THROUGH THE NEURON MAX AND THE SHORT SHEATH. THE PHYSICIAN THEN ADVANCED THE RED43 THROUGH THE RED72 TO THE TARGET LOCATION AND COMPLETED THE FIRST PASS WITH THE RED43. IN ORDER TO PERFORM THE SECOND PASS, THE RED72 WAS ADVANCED WITHOUT THE RED43 TO THE TARGET LOCATION. WHILE RETRACTING THE RED72 UNDER ASPIRATION FROM THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE DISTAL MID-SHAFT OF THE RED72 HAD BECOME STRETCHED AND FRACTURED. THEREFORE, THE RED72 AND THE NEURON MAX WERE REMOVED TOGETHER. IT WAS REPORTED THAT NO ISSUE WAS NOTED WITH THE NEURON MAX. THE PHYSICIAN THEN OPENED A NEW NEURON MAX AND ATTEMPTED TO ADVANCE INTO THE SAME SHORT SHEATH; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE NEURON MAX WOULD NOT FIT INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477046 ↗
• MalfunctionJul 27, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA GUIDE SHEATH, A ROTATING HEMOSTASIS VALVE (RHV), AND A MICROWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 AND THE VELOCITY OVER THE MICROWIRE AND THROUGH THE GUIDE SHEATH TO THE TARGET LOCATION. THE PHYSICIAN THEN REMOVED THE VELOCITY AND THE MICROWIRE AND RETRACTED THE RED72 FOR REPOSITIONING. WHILE ATTEMPTING TO COMPLETE A FIRST PASS, THE PHYSICIAN HEARD A SOUND AND NOTICED THAT THE RED72 WAS FRACTURED AT THE PROXIMAL LOCATION. IT WAS REPORTED THAT THE HOSPITAL TECHNOLOGIST MAY HAVE OVERTIGHTENED THE RHV PRIOR TO RETRACTING THE RED72. THE RED72 AND THE RHV WERE REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), THE SAME VELOCITY, THE SAME GUIDE SHEATH, ANOTHER RHV, AND THE SAME MICROWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410277 ↗
• MalfunctionJul 14, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 BIFURCATION SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE RED72. WHILE RETRACTING THE RED72 TO FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RED72 FRACTURED AT THE MIDSHAFT WITHIN THE NEURON MAX. THEREFORE, THE NEURON MAX CONTAINING THE FRACTURED RED72 WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE RED72 WAS STILL CONNECTED BY THE COIL WINDS OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW RED72, A NEW NEURON MAX, AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17326522 ↗
• MalfunctionJun 28, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A BENCHMARK BMX96 ACCESS SYSTEM (BMX96). DURING THE PROCEDURE, WHILE ATTEMPTING TO MAKE THE FIRST PASS USING THE RED72, THE PHYSICIAN NOTICED THAT AIR WAS LEAKING AT THE PROXIMAL END, UNDER THE HUB. SUBSEQUENTLY, THE PHYSICIAN APPLIED PRESSURE ON THE HUB AND THE AMOUNT OF AIR WAS REDUCED. THEREFORE, THE RED72 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), THE SAME VELOCITY, AND THE SAME BMX96. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214621 ↗
• MalfunctionJun 23, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, AFTER THE RED72 WAS ADVANCED IN THE PATIENT FOR THE FIRST PASS AND HOOKED UP FOR ASPIRATION, THE PHYSICIAN NOTICED THAT THE RED72 WAS ASPIRATING AIR. SUBSEQUENTLY, THE RED72 WAS FOUND TO BE FRACTURED AT THE HUB. THEREFORE, THE RED72 WAS REMOVED. 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 17195473 ↗
• MalfunctionJun 21, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN TURNED ON THE ENGINE AND THE RED72 WAS ASPIRATING AIR. IT WAS NOTED THE RED72 WAS FRACTURED AT THE HUB. THEREFORE, THE RED72 WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING 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 17177942 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NEURON SELECT CATHETER 5F (5F SELECT), A NON-PENUMBRA SHEATH, A NON-PENUMBRA WALL STENT, AND GUIDEWIRES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 OVER THE VELOCITY AND GUIDEWIRE THROUGH THE SHEATH TO THE TARGET LOCATION. NEXT, THE VELOCITY WAS RETRACTED AND UPON REMOVAL, THE MID-SHAFT OF THE VELOCITY WAS NOTICED TO BE FRACTURED. THE VELOCITY WAS REMOVED IN ITS ENTIRETY AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN PERFORMED A CRANIAL ANGIOGRAPHY AND NOTICED THE CLOT MIGRATED FROM THE M1 SEGMENT TO THE RIGHT M2 SEGMENT. AFTER THE ANGIOGRAPHY WAS PERFORMED, A NEW VELOCITY ALONG WITH THE RED72 AND GUIDEWIRE WERE ADVANCED TO THE M2 SEGMENT. THE VELOCITY AND GUIDEWIRE WERE THEN REMOVED AND THE RED72 WAS USED TO ASPIRATE TO COMPLETE THE FIRST PASS. A CERVICAL ANGIOGRAPHY REVEALED DISSECTION OF THE CERVICAL SEGMENT OF THE ICA. NEXT, A GUIDEWIRE WAS ADVANCED ACROSS THE CERVICAL DISSECTION AND INTO THE VESSEL. T

  Patient problems: Vascular Dissection

  MAUDE report 16839289 ↗
• MalfunctionMar 27, 2023Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE BMX96 INTO THE PATIENT. WHILE ADVANCING THE RED72 OVER THE MICROCATHETER AND GUIDEWIRE THROUGH THE BMX96, THE PHYSICIAN EXPERIENCED RESISTANCE. THE RED72 WOULD NOT ADVANCE PAST THE CAROTID SIPHON. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT THE RED72 REACHED THE FACE OF THE CLOT. THE PHYSICIAN THEN REMOVED THE MICROCATHETER AND GUIDEWIRE AND INITIATED ASPIRATION. HOWEVER, IT WAS NOTICED THAT NO THROMBUS WAS BEING REMOVED AND AFTER TWO MINUTES UNDER ASPIRATION THE PHYSICIAN BEGAN TO RETRACT THE RED72. SUBSEQUENTLY, RESISTANCE WAS ENCOUNTERED, BUT THEN THE PHYSICIAN FELT A REDUCTION IN RESISTANCE AND WAS ABLE TO REMOVE THE RED72. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE RED72 WAS UNRAVELED BUT REMAINED INTACT. THEREFORE, THE RED72 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), THE SAME BM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624823 ↗
• MalfunctionMar 21, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), THE MIDDLE CEREBRAL ARTERY (MCA), AND THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE RED72. WHILE RETRACTING THE RED72 AFTER COMPLETION OF THE SECOND PASS, THE RED72 BROKE IN HALF. IT WAS REPORTED THAT THE RED72 MAY HAVE BECOME WEDGED BETWEEN THE PLAQUE AND THE TIP OF THE BMX96. SUBSEQUENTLY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THE DISTAL END OF THE RED72 REMAINED IN THE PATIENT. THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE DISTAL PIECE OF THE RED72. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583078 ↗
• MalfunctionMar 3, 2023Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72). DURING THE PROCEDURE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RED72 HAD BROKEN INSIDE THE PATIENT. THE PHYSICIAN PULLED THE RED72 OUT AND THEN USED A SNARE DEVICE TO REMOVE THE DISTAL PART OF THE RED72. IT WAS REPORTED THAT THE RED72 WAS ALSO NOTICED TO BE UNRAVELED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETED 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 16482957 ↗
• MalfunctionFeb 27, 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 RED 72 REPERFUSION CATHETER (RED72), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON MAX INTO THE PATIENT. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RED72 WITH THE VELOCITY THROUGH THE NEURON MAX. THE PHYSICIAN WAS STILL ABLE TO ADVANCE THE RED72 TO THE FACE OF THE CLOT. ASPIRATION WAS THEN INITIATED; HOWEVER, THE PHYSICIAN NOTICED THAT THE BLOOD COMING INTO THE PENUMBRA ENGINE CANISTER (CANISTER) WAS FOAMY AND DECIDED TO REMOVE THE RED72. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE RED72 WAS BROKEN AROUND THE MID TO DISTAL END BUT REMAINED CONNECTED BY THE INTERNAL COIL WINDS. THEREFORE, THE RED72 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, THE SAME NEURON MAX, AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16450173 ↗
• MalfunctionJan 30, 2023Leak/Splash; Unraveled Material; Physical Resistance/Sticking; Leak/Splash; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA STENT RETRIEVER, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RED72 INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED A MICROCATHETER THROUGH THE RED72 AND SUBSEQUENTLY, DELIVERED THE STENT RETRIEVER USING THE MICROCATHETER. THE PHYSICIAN THEN COMPLETED THE FIRST PASS USING THE RED72 AND THE STENT RETRIEVER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE REMOVING THE RED72 AND THE STENT RETRIEVER FOR THE NEXT PASS. WHILE FLUSHING THE RED72 THE PHYSICIAN NOTICED THAT THE RED72 WAS UNWOUND AND WAS FOUND TO BE LEAKING ONE THIRD AWAY FROM THE DISTAL TIP. THEREFORE, THE RED72 WAS NOT USED. THE THROMBECTOMY WAS SUCCESSFUL 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 16269025 ↗
• MalfunctionJan 6, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; 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 NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, AFTER THE PHYSICIAN ADVANCED THE CATHETER THROUGH THE NEURON MAX, THE CATHETER WOULD NOT ADVANCE INTO THE HIGH CERVICAL SEGMENT. THEREFORE, THE CATHETER WAS REMOVED. THE PHYSICIAN THEN ADVANCED THE RED72 THROUGH THE NEURON MAX; HOWEVER, THE RED72 WOULD ALSO NOT ADVANCE INTO THE HIGH CERVICAL SEGMENT. IT WAS REPORTED THAT WHILE PUSHING THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE, THEN KINKED AND SUBSEQUENTLY, BROKE THE PROXIMAL END OF THE RED72 THAT WAS OUTSIDE THE PATIENT. THEREFORE, THE RED72 WAS PULLED OUT OF THE NEURON MAX BY HAND. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER 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 16114308 ↗
• MalfunctionJan 4, 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 RED72 REPERFUSION CATHETER (RED72), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE RED72. SUBSEQUENTLY, WHILE ADVANCING THE RED72 PAST THE CAROTID T TO MAKE THE NEXT PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RED72. HOWEVER, UPON RETRACTING, THE PHYSICIAN NOTICED THE MIDSHAFT TOWARDS THE DISTAL END OF THE RED72 HAD BROKEN OFF UNDER ANGIOGRAPHY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN PIECE OF THE RED72 OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, NON-PENUMBRA STENT RETRIEVER, 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 16092696 ↗