Penumbra System 5MAXJET7BKIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00815948023246), received between Feb 5, 2021 and Dec 8, 2021 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2021Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). DURING THE PROCEDURE, WHILE ADVANCING THE JET7 THROUGH THE CAVERNOUS SEGMENT OF THE ICA TO THE MAKE THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE JET7. SUBSEQUENTLY, UPON RETRACTION, THE JET7 HAD FRACTURED. THEREFORE, THE BENCHMARK MAX CONTAINING THE FRACTURED JET7 WERE REMOVED. THE PROCEDURE HAD ENDED AT THIS POINT AND THE PHYSICIAN WAS ABLE TO ACHIEVE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964867 ↗
• InjuryNov 11, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A JET7 OVER A VELOCITY THROUGH THE BENCHMARK MAX TO THE FACE OF THE CLOT AND THEN REMOVED VELOCITY. THE PHYSICIAN THEN CONNECTED THE JET7 TO THE ENGINE AND INITIATED ASPIRATION. AFTER THREE MINUTES UNDER ASPIRATION, THE PHYSICIAN DECIDED TO REMOVE THE JET7. WHILE PULLING BACK THE JET7, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE JET7 WAS NOT MOVING. IT WAS REPORTED THAT THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE. THE PHYSICIAN CONTINUED TO PULL THE JET7 AND THE DISTAL END OF THE JET7 WAS STILL NOT MOVING; HOWEVER, THE JET7 WAS BEING PULLED OUT OF THE HUB OF THE BENCHMARK MAX. AFTER THE REMOVAL OF THE JET7, IT WAS NOTICED THAT APPROXIMATELY TEN CENTIMETERS FROM THE DISTAL END OF THE JET7 HAD BROKEN OFF INTRACRANIALLY. NEXT, THE BENCHMARK MAX WAS REMOVED AND IT WAS NOTICED THAT THERE WAS A SLIT ON THE DISTAL END OF THE BENCHMARK MAX. AFTERWARDS, THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12799845 ↗
• MalfunctionNov 7, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ASPIRATED CLOT USING THE JET7 AND THE VELOCITY. UPON REMOVAL OF THE JET7, THE PHYSICIAN NOTICED THE JET7 WAS STRETCHED. 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 12760125 ↗
• MalfunctionOct 28, 2021Fracture; Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716099 ↗
• MalfunctionOct 12, 2021Material 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) AND BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS IN THE TARGET VESSEL USING THE JET7. WHEN REMOVING THE JET7 AFTER THE PASS, IT STRETCHED AS THE PHYSICIAN PULLED THE JET7 FROM THE BENCHMARK MAX. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND THE SAME BENCHMARK MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619432 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND GUIDEWIRE. DURING THE PROCEDURE, AFTER MAKING THE FIRST PASS USING THE JET7, THE MIDSHAFT OF THE JET7 BECAME KINKED. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND ACHIEVE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12524293 ↗
• MalfunctionSep 14, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE DISTAL END OF THE JET7 BROKE INSIDE THE PATIENT'S BODY. IT WAS REPORTED THAT THE NEURON MAX USED WITH THE JET7 WAS KINKED WHICH MAY HAVE CAUSED DAMAGE TO THE JET7. THE PHYSICIAN WAS ABLE TO RETRIEVE ALL THE PIECES OF THE JET7 FROM THE PATIENT'S BODY. 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 12469123 ↗
• MalfunctionAug 18, 2021Break; 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), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST PASS WITH THE ADAPT TECHNIQUE USING A JET7 AND A VELOCITY. WHILE RETRACTING THE JET7 WITH CLOT, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE JET7 INTO TWO PIECES AT THE MID-SHAFT. THEREFORE, THE PHYSICIAN REMOVED THE JET7 BY PULLING IT OUT OF THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER 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 12339768 ↗
• MalfunctionAug 5, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE JET7 AND NEURON MAX. AFTER REMOVING THE JET7 FROM THE PATIENT''S BODY DURING THE SECOND PASS, THE PHYSICIAN NOTICED THE JET7 TO BE OVALIZED FROM DISTAL END TO MID-SHAFT WITH THE CLOT CORKED IN THE JET7. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ACE68, JETD 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 12284687 ↗
• MalfunctionJul 6, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE JET7 BECAME FRACTURED. 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 12125263 ↗
• InjuryJun 29, 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), BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), AND VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE VELOCITY AND JET7 TO THE FACE OF THE CLOT, THE VELOCITY WAS THEN REMOVED AND THE PHYSICIAN-INITIATED ASPIRATION USING THE JET7. AFTER APPROXIMATELY TWO MINUTES, THE CLOT WAS OBSERVED TO BE COMING THROUGH THE JET7. THE PHYSICIAN THEN PERFORMED A CONTRAST RUN RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3. SUBSEQUENTLY, WHILE RETRACTING THE JET7, THE PHYSICIAN NOTICED THE JET7 BECAME STUCK AND COULD NOT BE RETRACTED. THE PHYSICIAN CONTINUED TO PULL THE JET7 AND CONSEQUENTLY, THE DISTAL END OF THE JET7 BROKE OFF IN THE M1. IT WAS ALSO REPORTED THAT PRIOR TO REMOVING THE JET7, THE PHYSICIAN NOTICED THAT THE JET7 WAS SLIGHTLY HERNIATING INTO THE EXTERNAL ARTERY AND THE JET7 BECAME BROKEN AT THE JUNCTION OF THE INTERNAL AND EXTERNAL ARTERY. AFTER APPROXIMATELY AN HOUR AND MULTIPLE ATTEMPTS USING A SNARE DEVICE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN DISTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089794 ↗
• MalfunctionJun 7, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A MICROCATHETER. DURING THE PROCEDURE, THE JET7 WAS PLACED DISTALLY. WHILE USING THE JET7, THE PHYSICIAN NOTICED THERE WAS A SEPARATION NEAR THE PROXIMAL HUB. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND THE SAME BENCHMARK MAX AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952325 ↗
• MalfunctionMay 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND VELOCITY DELIVERY MICROCATHETER (VELOCITY). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE PASS USING THE JET7. THE JET7 WAS THEN REMOVED AND WHILE FLUSHING ON THE BACK TABLE, THE PHYSICIAN NOTICED DISTAL TIP OF THE JET7 TO BE OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 WITH THE SAME VELOCITY AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787724 ↗
• MalfunctionApr 22, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, AFTER LOADING THE JET7 ONTO THE WIRE, THE TECH NOTICED FLUSH WAS COMING OUT FROM THE HUB OF THE JET7 AND THE JET7 WAS BROKEN AT THE HUB. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11709185 ↗
• MalfunctionApr 16, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INJECTING CONTRAST THROUGH THE JET7 DURING THE FIRST PASS, THE PHYSICIAN NOTICED A SMALL PIN HOLE NEAR THE DISTAL ONE THIRD OF THE JET7; THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 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 11682674 ↗
• MalfunctionApr 13, 2021Material 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) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE JET7 TO THE TARGET LOCATION TO MAKE THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE MIDDLE TO PROXIMAL PORTION OF THE JET7 BECAME KINKED. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) 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 11660520 ↗
• MalfunctionMar 24, 2021Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX), AND A GLIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE JET7 THROUGH THE BENCHMARK MAX OVER THE GLIDEWIRE. AFTER THE JET7 WAS POSITIONED, THE GLIDEWIRE WAS ADVANCED FURTHER INTO THE PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE JET7 WAS THEN ADVANCED OVER THE GLIDEWIRE BUT BECAME STUCK IN THE OPTHALMIC ARTERY WHERE THE PHYSICIAN ENCOUNTERED MORE RESISTANCE. THE PHYSICIAN DECIDED TO REMOVE THE JET7 FROM THE PATIENT BUT NOTICED THAT THE JET7 WAS NOT TRACKING IN TANDEM WITH THE ATTEMPTS TO PULL IT BACK. WHEN THE JET7 BEGAN EMERGING FROM THE BENCHMARK MAX, THE PHYSICIAN NOTICED THAT THE DISTAL TIP WAS FRACTURED AND ONLY REMAINED CONNECTED TO THE JET7 BY A SINGLE WIRE. OVER A PERIOD OF SEVEN MINUTES, THE JET7 WAS CAREFULLY RETRACTED AND SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, THE SAME BENCHMARK MAX, AND THE SAME GLIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566221 ↗
• MalfunctionFeb 26, 2021Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WENT UP USING THE JET7 AND THE VELOCITY. DUE TO TORTUOSITY, THE VELOCITY WAS REMOVED, AND THE PHYSICIAN USED A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WITH A GUIDEWIRE TO COMPLETE TWO PASSES. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE JET7 IN THE CAROTID. AFTER REMOVING THE 3MAXC, THE PHYSICIAN ATTEMPTED TO PULL BACK THE JET7 AND REPORTED THAT THE DISTAL TIP WAS NOT MOVING. AFTER REMOVING THE JET7 AND BENCHMARK MAX TOGETHER, THE PHYSICIAN NOTICED THE JET7 TIP WAS FRACTURED AND CONNECTED BY A WIRE. THEREFORE, THE JET7 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY RE-POSITIONING THE BENCHMARK MAX AND USING THE SAME VELOCITY WITH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NON-PENUMBRA STENT DEVICE. 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 11387130 ↗
• MalfunctionFeb 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, A JET7 BECAME KINKED; THEREFORE, THE JET7 WAS REMOVED. LATER, THE SAME ISSUE OCCURRED WITH A SECOND JET7; THEREFORE, THE SECOND JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME 3MAXC AND THE SAME NEURON MAX. IT IS UNKNOWN WHETHER ANOTHER JET7 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11362087 ↗
• MalfunctionFeb 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A GUIDEWIRE. DURING THE PROCEDURE, A JET7 BECAME KINKED; THEREFORE, THE JET7 WAS REMOVED. LATER, THE SAME ISSUE OCCURRED WITH A SECOND JET7; THEREFORE, THE SECOND JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME 3MAXC AND THE SAME NEURON MAX. IT IS UNKNOWN WHETHER ANOTHER JET7 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11362077 ↗
• MalfunctionFeb 18, 2021Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE HUB OF THE JET7 FRACTURED ON THE WAY OUT AFTER MAKING THREE PASSES. THE HOSPITAL TECHNOLOGIST BELIEVES THE ROTATING HEMOSTASIS VALVE (RHV) WAS TOO TIGHT. NO ADDITIONAL INFORMATION HAS BEEN 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; No Consequences Or Impact To Patient

  MAUDE report 11345772 ↗
• MalfunctionFeb 9, 2021Fracture; Physical Resistance/Sticking; Fracture; 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), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS NOTED THAT THE PATIENT¿S ACCESS VESSEL WAS CALCIFIED. DURING THE PROCEDURE, WHILE INITIALLY ADVANCING THE NEURON MAX THROUGH THE ACCESS VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE; HOWEVER, THE PHYSICIAN SUCCESSFULLY PLACED THE NEURON MAX. THEN, WHILE ADVANCING THE JET7 THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE JET7 FURTHER AND DECIDED TO REMOVE THE JET7. WHILE RETRACTING THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, UNDER FLUOROSCOPY THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE JET7 WAS FRACTURED AND REMAINED INSIDE THE PROXIMAL END OF THE NEURON MAX. THEREFORE, THE JET7 AND NEURON MAX WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND THE SAME 3MAXC. 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 11301496 ↗
• MalfunctionFeb 5, 2021Fracture; 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), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND NON-PENUMBRA HEMOSTASIS VALVE (HV). DURING THE PROCEDURE, WHILE ADVANCING THE 3MAXC AND JET7 THROUGH THE HV, THE 3MAXC BECAME FRACTURED NEAR THE HUB. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRACT THE 3MAXC TOGETHER WITH THE JET7 OUT FROM THE HV TO REMOVE THEM; HOWEVER, THE JET7 BECAME FRACTURED. THEREFORE, BOTH THE 3MAXC AND JET7 WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11287790 ↗