Penumbra System 5MAXJET7KIT-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 00815948020962), received between Jul 19, 2019 and Mar 1, 2021 — classified as 14 deaths, 26 injuries, 181 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (83 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 15, 2020Terminated

   The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.

   Z-0849-2021 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 221 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE JET7 INTO THE NEURON MAX, THE JET7 BECAME FRACTURED NEAR THE HUB. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND 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 11396756 ↗
• MalfunctionJan 23, 2021Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VERTEBRAL ARTERY USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), AN ASPIRATION TUBING (TUBING), A NON-PENUMBRA SHORT SHEATH AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, PRIOR TO ANY PASSES, THE PHYSICIAN KINKED THE PROXIMAL PART OF THE JET7 THAT CONNECTS TO THE TUBING AND IT FRACTURED. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7, THE SAME SHORT SHEATH, AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11220288 ↗
• MalfunctionJan 8, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE JET7, VELOCITY AND NEURON MAX THROUGH THE PATIENT¿S VESSEL PRIOR TO ANY PASSES, THE PHYSICIAN NOTICED THE PROXIMAL END NEXT TO THE HUB OF THE JET7 APPEARED TO BE STRETCHED AND WAS LEAKING SALINE. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND 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 11143278 ↗
• MalfunctionJan 7, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID ARTERY USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN USED THE 3MAXC AND NEURON MAX TO ADVANCE THE JET7 TO THE TARGET VESSEL. THE PHYSICIAN THEN MADE TWO PASSES USING THE JET7. UPON ATTEMPTING TO REMOVE THE JET7, THE TIP OF THE JET7 DID NOT MOVE, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN REALIZED THE JET7 HAD STRETCHED 8 INCHES FROM THE PROXIMAL END AND SUCCESSFULLY REMOVED THE JET7. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC), PENUMBRA SYSTEM MAX 4 SEPARATOR (4MAXS), AND THE SAME SHEATH. 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 11136350 ↗
• MalfunctionJan 7, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, PRIOR TO THE FIRST PASS, THE PHYSICIAN INJECTED CONTRAST THROUGH THE JET7 AND NOTICED THAT CONTRAST WAS COMING OUT INSIDE THE 3MAXC. SUBSEQUENTLY, THE PHYSICIAN FOUND A HOLE IN THE PROXIMAL SHAFT OF THE JET7 WHICH WAS INSIDE THE 3MAXC. THEREFORE, THE JET7 WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 11135395 ↗
• MalfunctionJan 5, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN USED A 3MAXC, GUIDEWIRE AND GUIDE CATHETER TO BRING THE JET7 TO THE TARGET VESSEL. NEXT, THE PHYSICIAN COMPLETED TWO PASSES USING THE JET7. AFTERWARDS, THE JET7 WAS REMOVED AND WHILE FLUSHING THE JET7 ON THE BACK TABLE, IT WAS NOTICED THAT APPROXIMATELY THREE CENTIMETERS FROM THE DISTAL TIP OF THE JET7 WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING A NEW JET7, THE SAME GUIDE CATHETER AND A STENT RETRIEVER. 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 11120712 ↗
• MalfunctionDec 31, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE TECHNICIAN KINKED THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) NEAR THE HUB. THE ISSUE OCCURRED PRIOR TO USE; THEREFORE, THE JET7 WAS NOT USED IN THE PROCEDURE. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY USING A JET7, A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), PENUMBRA 5F SELECT CATHETER (5F SELECT), AND NON-PENUMBRA SHORT SHEATH. THE PROCEDURE STARTED WITH A MICROPUNCTURE, FOLLOWED BY THE SHORT SHEATH. A BENCHMARK MAX AND 5F SELECT WERE USED IN THE LEFT COMMON CAROTID. THE CLOT WAS IDENTIFIED IN THE LEFT M2 SEGMENT. SUBSEQUENTLY, THE PHYSICIAN PLACED THE BENCHMARK MAX IN THE COMMON CAROTID ARTERY AND ADVANCED THE JET7 TO THE TARGET VESSEL WITHOUT A MICROWIRE AND/OR AN IMMEDIATE CATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE AND BEGAN TO REMOVE THE JET7 BACK PROXIMALLY. AT THIS POINT, THE PHYSICIAN NOTICED THE JET7 WAS FRACTURED AT THE INTERNAL CAROTID ARTERY (ICA)/ EXTERNAL CAROTID ARTERY (ECA) BIFURCATION, AND THE JET7 WOULD NOT RETRACT BACK INTO THE BENCHMARK MAX. THE PHYSICIAN BEGAN TO REMOVE THE BENCHMARK MAX AND THE PROXIMAL SEGMENT OF THE JET7 AND NOTI

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11101989 ↗
• MalfunctionDec 21, 2020Material Deformation; Physical Resistance/Sticking; 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 JET7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE JET7. WHILE RETRACTING THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE JET7. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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; No Consequences Or Impact To Patient

  MAUDE report 11051470 ↗
• MalfunctionDec 16, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE JET7 THROUGH THE NEURON MAX USING THE VELOCITY AND GUIDEWIRE, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE JET7 BROKE AT THE MIDSHAFT APPROXIMATIVELY HALFWAY INTO THE NEURON MAX. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ONE PASS USING A NEW JET7, THE SAME VELOCITY, GUIDEWIRE AND 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 11023948 ↗
• MalfunctionDec 12, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE JET7 BROKE AT THE PROXIMAL END AFTER BEING INSERTED INTO THE NEURON MAX. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND 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 10996581 ↗
• MalfunctionDec 8, 2020Stretched; Material Deformation; Stretched; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE DIRECT ASPIRATION FIRST PASS (ADAPT) WITH THE JET7 AND SUBSEQUENTLY REMOVED IT. UPON REMOVAL, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE JET7 HAD LOOSE COIL WINDS. WHILE FLUSHING ON THE BACK TABLE WITH SALINE USING A 10 CC SYRINGE, THE DISTAL PORTION OF THE JET7 EXPANDED. THEREFORE, THE JET7 WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND THE SAME MICROCATHETER. 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 10969873 ↗
• MalfunctionDec 7, 2020Stretched; Stretched

  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 JET 7 REPERFUSION CATHETER (JET7), VELOCITY DELIVERY MICROCATHETER (VELOCITY), NON-PENUMBRA STENT RETRIEVER, AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED SEVERAL PASSES USING THE JET7, VELOCITY, AND NON-PENUMBRA STENT RETRIEVER. SUBSEQUENTLY, THE JET7, VELOCITY, AND STENT RETRIEVER WERE REMOVED TO BE FLUSHED. HOWEVER, THE PHYSICIAN NOTICED THE DISTAL END OF THE JET7 TO BE STRETCHED WITH SLIGHT DISCOLORATION ON THE BACK TABLE. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) WITH THE SAME VELOCITY, STENT RETRIEVER, AND SHEATH. 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 10963181 ↗
• MalfunctionDec 5, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES IN THE TARGET LOCATION USING THE JET7 WITH A STENT RETRIEVER. IT WAS REPORTED THAT THE HOSPITAL TECHNOLOGISTS RAN THEIR FINGERS ACROSS THE DISTAL 10CM OF THE JET7 AFTER EACH PASS. AFTER THE SECOND PASS, A CHANGE TO THE FEEL OF THE JET7 WAS FELT AND IT WAS NOTICED THAT THE JET7 APPEARED "WORN." THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND 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 10953138 ↗
• MalfunctionDec 5, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE JET7 WAS PLACED IN THE TARGET VESSEL, AND THE SHEATH WAS ADVANCED AROUND A SIGNIFICANT TURN AND OVER THE JET7. WHILE REMOVING THE JET7 AFTER THE FIRST PASS, THE PHYSICIAN EXPERIENCED TENSION, AND THE JET7 WAS OBSERVED TO BE STRETCHED 15-20CM FROM THE DISTAL TIP. THEREFORE, THE JET7 NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME SHEATH, RESULTING IN A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B. 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 10951086 ↗
• MalfunctionDec 1, 2020Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), AN ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE) AND A NON-PENUMBRA SHEATH. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 THROUGH A SHEATH TO THE FACE OF THE CLOT THEN CONNECTED THE TUBING TO THE ENGINE AND INITIATED ASPIRATION. NEXT, THE PHYSICIAN COMPLETED ONE PASS USING THE JET7 AND DURING THE SECOND PASS, AFTER TURNING THE FLOW SWITCH TO ON, THE PHYSICIAN NOTICED THERE WAS INSUFFICIENT SUCTION. THEREFORE, THE JET7 WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE JET7 WAS FRACTURED APPROXIMATELY 20 CENTIMETERS FROM THE HUB SIDE OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW JET7, THE SAME ENGINE AND THE SAME SHEATH. 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 10931153 ↗
• MalfunctionNov 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A MICROCATHETER, AND A GREEN CROSS CUT VALVE. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS WITH THE JET7 AND REMOVED IT FOR FLUSHING. WHILE ATTEMPTING TO RE-ADVANCE THE JET7 AND MICROCATHETER THROUGH THE PEEL-AWAY SHEATH, THE JET7 WOULD NOT PASS THROUGH IT. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), THE SAME NEURON MAX, AND THE SAME MICROCATHETER. 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 10919222 ↗
• DeathNov 26, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), VELOCITY DELIVERY MICROCATHETER (VELOCITY), NON-PENUMBRA STENT RETRIEVER (TREVO), AN OCCLUSION BALLOON (STRYKER 3MM TRANSFORM OCCLUSION BALLOON), AND WIRE (SYNCHRO 14). DURING THE PROCEDURE, THE PHYSICIAN MADE A FIRST PASS IN THE TARGET VESSEL WITH THE JET7 AND A STENT RETRIEVER USING COMBINATION TECHNIQUE. THE JET7 WAS NAVIGATED OVER A WIRE AND TO THE M1 SEGMENT. THE VELOCITY WAS THEN PASSED THROUGH THE CLOT, AND THE WIRE WAS REMOVED. NEXT, THE STENT RETRIEVER WAS PASSED THROUGH THE VELOCITY UNDER CONTINUOUS SALINE FLUSH AND DEPLOYED INTO THE CLOT. AFTER A DWELL TIME OF FIVE MINUTES, THE STENT RETRIEVER WAS PULLED TOWARDS THE JET7 TO TRAP THE CLOT BETWEEN THE JET7 AND STENT RETRIEVER. FOLLOWING A SUCCESSFUL TRAP AND PULL OF THE CLOT, THE PHYSICIAN WAS REMOVING THE JET7 AND THE STENT RETRIEVER AS A SYSTEM. HOWEVER, AS THE STENT RETRIEVER WAS COMPLETELY RETRACTED INTO THE JET7, THE PHYSICIAN DECIDED TO RETRACT THE STENT RETRIEVER THROUGH THE LENGTH OF THE JET7. AFTER THE STENT RETRIEVER WAS REMOVED, THE PHYSICIAN ASPIRAT

  Patient problems: Death; Fistula

  MAUDE report 10909735 ↗
• MalfunctionNov 26, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A NON-PENUMBRA REVASCULARIZATION DEVICE. DURING THE PROCEDURE, THE JET7 BECAME STRETCHED AND FRACTURED ON THE DISTAL SHAFT WHILE USING THE REVASCULARIZATION DEVICE. THEREFORE, THE JET7 WAS NO LONGER USED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE HAS BEEN PROVIDED. 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 10907528 ↗
• MalfunctionNov 25, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ASPIRATE THROUGH THE BENCHMARK MAX WITH A 10CC SYRINGE BUT WAS UNABLE TO ASPIRATE FLUID. THEREFORE, THE PHYSICIAN DID NOT ATTEMPT TO INJECT CONTRAST THROUGH THE BENCHMARK MAX AROUND THE JET7. THE JET7 WAS SUBSEQUENTLY REMOVED. UPON REMOVAL, THE DISTAL END OF THE JET7 WAS OBSERVED TO BE KINKED. THE PROCEDURE ENDED AT THIS POINT. A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS ACHIEVED WITH TWO PASSES USING THE JET7. 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 10907118 ↗
• MalfunctionNov 25, 2020Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA SHEATH AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED APPROXIMATELY TWO TO THREE PASSES USING THE JET7 AND FOR THE LAST PASS A STENT RETRIEVER WAS USED. AFTERWARDS, THE JET7 WAS REMOVED AND WHILE THE TECHNICIAN FLUSHED THE JET7 ON THE BACK TABLE, IT WAS NOTICED THAT THE DISTAL TIP OF THE JET7 EXPANDED. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THE SAME SHEATH. 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 10903547 ↗
• MalfunctionNov 25, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), STENT RETRIEVER, AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE JET7 THROUGH THE NEURON MAX. UPON REACHING THE THROMBUS, THE PHYSICIAN PERFORMED THE SOLUMBRA TECHNIQUE ON THE FIRST PASS USING THE JET7 AND STENT RETRIEVER BUT COULD NOT ACHIEVE REPERFUSION. ON THE SECOND PASS, THE PHYSICIAN NOTICED NO BLOOD WAS GOING INTO THE CANISTER AND REMOVED THE JET7. UPON REMOVAL, THE DISTAL TIP OF THE JET7 WAS OBSERVED TO BE KINKED AND EXPANDED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND THE SAME NEURON MAX AND STENT RETRIEVER. 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 10901927 ↗
• MalfunctionNov 19, 2020Stretched; Physical Resistance/Sticking; 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 JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), MICROCATHETER, AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DELIVERING THE JET7 TO THE OCCLUDED M1 SEGMENT DUE TO CHALLENGING ANATOMY. AFTER WORKING FOR SOME TIME, THE PHYSICIAN DID A HAND INJECTION THROUGH THE JET7 TO BETTER VISUALIZE THE VESSEL. SHORTLY AFTERWARDS, THE PHYSICIAN REMOVED THE JET7 IN ORDER TO REMOVE THE NEURON MAX. UPON REMOVAL OF THE JET7, THE PHYSICIAN NOTICED SOME SLIGHT EXPANSION NEAR THE DISTAL END OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. 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 10872374 ↗
• MalfunctionNov 19, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, WHILE RETRACTING THE STENT RETRIEVER BACK INTO THE JET7, THE DISTAL TIP OF THE JET7 DETACHED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 10869089 ↗
• DeathNov 17, 2020Unraveled Material

  DOCTOR NOTED THAT PATIENT HAD A LEFT MIDDLE CEREBRAL ARTERY (M1 SEGMENT) REOCCLUSION DEMONSTRATED VIA CEREBRAL ANGIOGRAPHY. USING THE PENUMBRA JET¿ 7 REPERFUSION CATHETER + PENUMBRA HI-FLOW TUBING ( MODEL: 5MAXJET7KIT-B), DOCTOR MADE 3 PASSES AND WAS UNABLE TO OPEN THE ARTERY. WHEN DOCTOR REMOVED THE CATHETER, HE FOUND THAT THE CATHETER HAD UNRAVELED. THE INTERNAL METAL OF THE CATHETER WAS UNRAVELED NEAR THE END OF THE CATHETER AND EXPOSED, BUT THE ACTUAL TIP WAS INTACT. USING ANOTHER CATHETER, HE EXAMINED THE ARTERY AND THE UNRAVELED CATHETER HAD CAUSED A CAROTID CAVERNOUS FISTULA, AND BLEEDING FROM THE CAROTID ARTERY. TO STOP THE BLEEDING, HE PERFORMED A LEFT CAROTID TAKE DOWN WITH COILS WHICH ESSENTIALLY CUT OFF BLOOD FLOW TO THE LEFT SIDE OF THE BRAIN. LEFT HEMISPHERIC ISCHEMIC STROKE PROGRESSED AND EVENTUALLY CAUSED A MIDLINE SHIFT. PATIENT WAS GIVEN COMFORT CARE AND ALLOWED TO PASS PEACEFULLY. PATIENT DIED TWO DAYS LATER.

  Patient problems: Death; Fistula; Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke

  MAUDE report 10850869 ↗
• MalfunctionNov 16, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SYSTEM JET 7 REPERFUSION CATHETERS (JET7)S AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE JET7 WAS LEAKING JUST BEYOND THE HUB ON THE BACK TABLE. THEREFORE, THE JET7 WAS NOT USED IN THE PROCEDURE. ANOTHER JET7 WAS USED TO CONTINUE THE PROCEDURE; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS ALSO REPORTED THAT WHILE THE NEURON MAX WAS STILL INSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS KINKED; THE NEURON MAX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND ANOTHER 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 10847225 ↗