Penumbra System 5MAXJET7KITRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00814548019925), received between Aug 2, 2019 and Feb 13, 2024 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT 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), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A STENT RETRIEVER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT HAD ELONGATED AND CALCIFIED VESSELS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED68 WITH THE STENT RETRIEVER USING THE NEURON MAX TO THE TARGET LOCATION. HOWEVER, DUE TO THE DIFFICULTY AND UNSUCCESSFUL PLACEMENT OF THE RED68, THE PHYSICIAN DECIDED TO SWITCH THE RED68 FOR A JET7. THE PHYSICIAN SUCCESSFULLY ADVANCED THE JET7 USING THE NEURON MAX TO THE TARGET LOCATION ON THE SECOND ATTEMPT. THE PHYSICIAN THEN INITIATED ASPIRATION FOR APPROXIMATELY THREE TO FOUR MINUTES. THE JET7 WAS THEN RETRACTED UNDER ASPIRATION. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL LENGTH OF THE JET7 WAS FRACTURED. THE PHYSICIAN THEN USED THE GUIDEWIRE AND THE NEURON MAX TO REMOVE THE FRACTURED JET7. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. IT WAS REPORTED THAT THE PATIENT EXPIRED ON 14JAN2024 DUE TO A MEDIA INFARCTION. THE PHYSICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696653 ↗
• MalfunctionJun 12, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VENOUS SINUS USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA SHEATH, A MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER COMPLETING APPROXIMATELY TEN PASSES USING THE JET7, THE PHYSICIAN REMOVED THE JET7 FOR FLUSHING. WHILE RE-ADVANCING THE JET7 OVER THE MICROCATHETER AND GUIDEWIRE THROUGH THE SHEATH, THE JET7 BECAME STUCK AT APPROXIMATELY TEN TO FIFTEEN CENTIMETERS FROM THE DISTAL END OF THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ADVANCE AND RETRACT THE JET7 BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE MICROCATHETER ALSO BECAME STUCK WITHIN THE SHEATH. THEREFORE, THE SHEATH CONTAINING THE JET7, MICROCATHETER AND GUIDEWIRE WAS REMOVED. AFTER REMOVAL OF THE SHEATH, THE PHYSICIAN NOTICED THAT THE DISTAL PORTION OF THE JET7 HAD FRACTURED BUT REMAINED CONNECTED BY AN INNER WIRE WITHIN THE SHEATH. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH TEN ADDITIONAL PASSES USING NEW DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107463 ↗
• MalfunctionApr 10, 2023Break; Physical Resistance/Sticking; Break; 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 JET7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S CERVICAL CAROTID ARTERY WAS CURVED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SHEATH TO THE PROXIMAL CERVICAL CAROTID ARTERY CURVE. THE PHYSICIAN THEN STEAMED SHAPED THE JET7 AND ADVANCED IT OVER THE GUIDEWIRE THROUGH THE SHEATH AND INTO THE LEVEL OF THE CLOT. AFTER INITIATION OF THE ASPIRATION DURING THE FIRST PASS, THE PHYSICIAN NOTICED THAT NO CLOTS WERE BEING RETRIEVED AND DECIDED TO REMOVE THE JET7. WHILE RETRACTING THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JET7 WOULD NOT MOVE AT ALL. IT WAS REPORTED THAT JET7 WAS KINKED DURING THE INITIAL ADVANCEMENT THROUGH THE CURVE OF THE CERVICAL CAROTID ARTERY BUT THE PHYSICIAN DID NOT NOTICE THE KINK. THE PHYSICIAN THEN APPLIED MORE FORCE TO PULL THE JET7 OUT AND CONSEQUENTLY, FRACTURED THE JET7. SUBSEQUENTLY, ONLY THE PROXIMAL END OF THE JET7 WAS REMOVED AND THE DISTAL SEGMENT OF THE JET7 REMAINED AT THE LEVEL OF THE CLOT. AFTERWARDS, THE PHYSICIAN RETRACTED THE SHEATH AND THE DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710375 ↗
• MalfunctionMar 16, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, HE PHYSICIAN ADVANCED THE JET7 OVER THE 3MAXC AND THROUGH THE NEURON MAX TO THE TARGET LOCATION. THE PHYSICIAN THEN REMOVED THE 3MAXC AND COMPLETED THE FIRST PASS. SUBSEQUENTLY, WHILE RETRACTING THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE MID-SHAFT OF THE JET7 WITHIN THE NEURON MAX. IT WAS REPORTED THAT PART OF THE DISTAL SEGMENT OF THE JET7 WAS IN THE NEURON MAX AND THE OTHER PART WAS IN THE PATIENT. THEREFORE, THE PHYSICIAN REMOVED THE NEURON MAX CONTAINING THE DISTAL SEGMENT OF THE JET7. THE PROCEDURE WAS COMPLETED USING A NEW JET7, A NEW 3MAXC, AND A NEW NEURON MAX. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED MALFUNCTION AND OR DEFICIENCY AGAINST THE FIRST 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16558417 ↗
• MalfunctionSep 28, 2021Break; Material Frayed; Break; Material Frayed

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, AFTER USING THE JET7 UNDER ASPIRATION FOR APPROXIMATELY TEN MINUTES, THE PHYSICIAN DECIDED TO REMOVE THE JET7. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE JET7 WAS PARTIALLY FRAYED. 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 12542574 ↗
• MalfunctionSep 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM JET7 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, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A 3MAXC TO THE TARGET LOCATION USING A JET7 AND GUIDEWIRE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE 3MAXC. WHILE REMOVING THE 3MAXC FROM THE JET7, IT WAS NOTICED THAT A LONG METAL SPIRAL WAS COMING OUT. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE WHOLE SYSTEM. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, 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

  MAUDE report 12425040 ↗
• MalfunctionJul 15, 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) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE JET7 AND NEURON MAX. AFTER COMPLETION OF THE FIRST PASS, THE PHYSICIAN REMOVED THE JET7 TO FLUSH IT AND NOTICED THE PROXIMAL END OF THE JET7 WAS OVALIZED. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE68 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 12173360 ↗
• MalfunctionJun 22, 2021Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE JET7. THEN, AFTER ADVANCING TWO THIRDS OF THE DISTAL END OF THE JET7 THROUGH THE NEURON MAX FOR A THIRD PASS, THE PHYSICIAN NOTICED THAT APPROXIMATELY SEVEN CENTIMETERS OF THE PROXIMAL END OF JET7 THAT WAS NEAR TO THE ROTATING HEMOSTASIS VALVE (RHV) CURVED. SUBSEQUENTLY, THE PHYSICIAN BROKE THE JET7 AT THE PROXIMAL ONE THIRD. THEREFORE, THE JET7 WAS REMOVED. IT WAS REPORTED THAT THE JET7 BROKE BUT REMAINED CONNECTED BY THE INNER WIRE. 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

  MAUDE report 12042759 ↗
• MalfunctionJun 4, 2021Break; Break

  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), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE JET7; HOWEVER, NO CLOT WAS REMOVED. THE PHYSICIAN THEN REMOVED THE JET7 TO FLUSH. THEN, UPON FLUSHING, IT WAS NOTICED THAT THERE WAS A SMALL HOLE ON THE DISTAL PART OF THE JET7. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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

  MAUDE report 11938503 ↗
• MalfunctionMay 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 JET7 REPERFUSION CATHETER (JET7) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TREATMENT IN THE EXTRACRANIAL CAROTID AREA USING A JET7 UNDER ASPIRATION. UPON REMOVAL OF THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE PROXIMAL END OF THE JET7. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ASPIRATION 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 11842082 ↗
• MalfunctionMar 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), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE THE PHYSICIAN INSERTED A JET7 INTO THE PATIENT, THE PHYSICIAN BROKE THE PROXIMAL END BELOW THE HUB OF THE JET7. SUBSEQUENTLY, BLOOD LEAKAGE WAS OBSERVED. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ASPIRATION CATHETER, THE SAME VELOCITY, AND THE SAME SHEATH. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440545 ↗
• MalfunctionJan 20, 2021Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE JET7 INTO THE NEURON MAX AFTER FLUSHING, IT WAS NOTICED THAT THE METAL STRAIN RELIEF NEAR THE HUB WAS BROKEN. THEREFORE, THE JET7 WAS REMOVED. THE PHYSICIAN THEN USED A 3MAXC THROUGH THE NEURON MAX TO BRING A NEW JET7 TO THE TARGET VESSEL. AFTER COMPLETING SEVERAL PASSES, THE JET7 WAS NOTICED TO BE LEAKING AND THE MID-SHAFT OF THE JET7 WAS FOUND TO BE KINKED. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION CATHETER, THE SAME 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; No Consequences Or Impact To Patient

  MAUDE report 11202824 ↗
• MalfunctionJan 20, 2021Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE JET7 INTO THE NEURON MAX AFTER FLUSHING, IT WAS NOTICED THAT THE METAL STRAIN RELIEF NEAR THE HUB WAS BROKEN. THEREFORE, THE JET7 WAS REMOVED. THE PHYSICIAN THEN USED A 3MAXC THROUGH THE NEURON MAX TO BRING A NEW JET7 TO THE TARGET VESSEL. AFTER COMPLETING SEVERAL PASSES, THE JET7 WAS NOTICED TO BE LEAKING AND THE MID-SHAFT OF THE JET7 WAS FOUND TO BE KINKED. THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION CATHETER, THE SAME 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; No Consequences Or Impact To Patient

  MAUDE report 11202799 ↗
• MalfunctionNov 4, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; 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 JET 7 REPERFUSION CATHETER (JET7), NON-PENUMBRA STENT RETRIEVERS, A NON-PENUMBRA SHEATH, A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THERE WAS DISSECTION IN THE CAROTID ARTERY, WHICH MADE ACCESS TO THE TARGET VESSEL DIFFICULT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7, MICROCATHETER AND STENT RETRIEVER DEVICE THROUGH THE PARENT CATHETER AND INTO THE TARGET VESSEL. AFTER COMPLETION OF A PASS, THE PHYSICIAN REMOVED THE MICROCATHETER AND PULLED THE STENT RETRIEVER DEVICE THROUGH THE JET7. THE PHYSICIAN DID NOT WANT TO LOSE ACCESS AND THEREFORE, LEFT THE JET7 IN PLACE. WHILE ADVANCING ANOTHER STENT RETRIEVER DEVICE THROUGH THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER COMPLETION OF ANOTHER PASS, THE PHYSICIAN WAS UNABLE TO REMOVE THE STENT RETRIEVER DEVICE AND THEREFORE, REMOVED THE JET7 AND STENT RETRIEVER DEVICE AS A UNIT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE JET7 ACCORDIONED. IT WAS ALSO REPORTED THAT A CONTRAST RUN WAS PERFORMED THROUGH THE JET7 AT SOME POINT. THE PROCEDURE WAS

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

  MAUDE report 10788921 ↗
• MalfunctionOct 30, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA MICROCATHETER, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A GUIDEWIRE AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 AND MICROCATHETER OVER THE GUIDEWIRE THROUGH THE NEURON MAX AND INTO THE TARGET VESSEL TO ASPIRATE THE CLOT WITH NO REPORTED RESISTANCE. DURING ASPIRATION WHILE RETRACTING THE JET7, THE CATHETER FRACTURED DISTALLY. THEREFORE, THE PHYSICIAN REMOVED THE JET7 AND THE FRACTURED TIP REMAINED IN THE PATIENT. UPON REMOVAL, IT WAS NOTICED THAT THE PROXIMAL END OF THE JET7 WAS KINKED. THE PROCEDURE WAS COMPLETED USING AN ACE68, THE SAME NEURON MAX AND MICROCATHETER. HOWEVER, THE FRACTURED DISTAL TIP OF THE JET7 WAS DISPLACED INTO THE ANTERIOR CEREBRAL ARTERY (ACA) AND WAS LEFT IN THE PATIENT¿S BODY AS IT WAS TOO DISTAL TO BE RETRIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AFTER THE PROCEDURE, THE JET7 FRACTURED AT THE MID-SHAFT OF WHILE IT WAS BEING PACKED INTO THE BOX.

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

  MAUDE report 10765488 ↗
• MalfunctionSep 24, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE JET7 WAS PLACED OVER THE MICROCATHETER AND WHILE ADVANCING THE JET7 INTO THE M1, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE CAVERNOUS SINUS. SUBSEQUENTLY, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE JET7 WITH ASPIRATION. HOWEVER, UPON REMOVAL AFTER THE FIRST PASS, THE PHYSICIAN NOTICED MULTIPLE PARTS OF THE JET7 DISTAL SEGMENT TO BE KINKED. THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, THE SAME NEURON MAX AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10584246 ↗
• MalfunctionJul 15, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT 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 PHYSICIAN COMPLETED ONE PASS USING THE JET7. WHILE ATTEMPTING TO MAKE ANOTHER PASS, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE JET7 WAS BROKEN DURING ASPIRATION; THEREFORE, THE PHYSICIAN PULLED TO REMOVE THE JET7. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, A STENT RETRIEVER DEVICE AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280317 ↗
• MalfunctionMay 19, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) 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, THE PHYSICIAN INSERTED THE NEURON MAX INTO THE PATIENT, THEN USED THE 3MAXC AND GUIDEWIRE TO BRING UP THE JET7 TO THE TARGET VESSEL. NEXT, THE PHYSICIAN COMPLETED TWO PASSES USING THE JET7. UPON REMOVAL OF THE JET7 AFTER COMPLETION OF THE SECOND PASS, THE PHYSICIAN FLUSHED THE JET7 WITH SALINE AND NOTICED THAT IT WAS BROKEN AT THE PROXIMAL END AND MID-SHAFT; THEREFORE, THE JET7 WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITH THE SAME 3MAXC AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10068445 ↗
• MalfunctionMay 13, 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), A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE PATIENT, THEN USED THE 3MAXC TO BRING UP THE JET7 TO THE TREATMENT SITE THROUGH THE NEURON MAX. THE PHYSICIAN THEN COMPLETED ONE PASS USING THE JET7. WHILE REMOVING THE JET7 FROM THE CROSSCUT VALVE OF THE NEURON MAX AFTER COMPLETION OF THE PASS, THE JET7 FRACTURED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10053510 ↗
• MalfunctionMar 19, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; 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 A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING THE JET7 THROUGH THE NEURON MAX, THE JET7 BECAME STUCK; 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 Consequences Or Impact To Patient

  MAUDE report 9857586 ↗
• MalfunctionFeb 21, 2020Break; Material Deformation; Break; Material Deformation

  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) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE INSERTING THE JET7 INTO THE NEURON MAX, THE PHYSICIAN NOTICED THAT THE JET7 WAS KINKED APPROXIMATELY FOUR INCHES FROM THE PROXIMAL HUB. IT WAS REPORTED THAT ADDITIONAL MANIPULATION OF THE KINKED AREA RESULTED WITH A FRACTURE. 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 Consequences Or Impact To Patient

  MAUDE report 9736958 ↗
• MalfunctionFeb 14, 2020Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A VELOCITY AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE NEURON MAX, ACE60 AND VELOCITY. UPON REMOVAL OF THE ACE60, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE ACE60 WAS STRETCHED. 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 Consequences Or Impact To Patient

  MAUDE report 9713200 ↗
• MalfunctionFeb 13, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PROXIMAL M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER, VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING IN THE TARGET VESSEL USING THE JET7, VELOCITY, AND SHEATH. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE JET7 WAS FLATTENED; THEREFORE, IT WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER JET7 AND THE SAME VELOCITY AND SHEATH. A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS THEN ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708899 ↗
• MalfunctionJan 24, 2020Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA)/A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE JET7 OVER THE GUIDEWIRE THROUGH THE NEURON MAX. IT WAS REPORTED THAT THE NEURON MAX DROPPED DOWN INTO THE AORTIC ARCH TWICE AND THE JET7 WOULD NOT ADVANCE BEYOND THE OPHTHALMIC ARTERY. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE JET7 WAS BROKEN; THEREFORE, THE JET7 WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE JET7 WAS BROKEN AROUND THE MID-SHAFT AND HELD TOGETHER BY A NITINOL WIRE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ASPIRATION CATHETER AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9629199 ↗
• MalfunctionDec 23, 2019Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; 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 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, WHILE ADVANCING THE 3MAXC THROUGH THE JET7, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JET7 WOULD NOT ADVANCE. SUBSEQUENTLY, THE JET7 BROKE AT THE HUB CAUSING THE 3MAXC TO ALSO BREAK. THEREFORE, THE JET7 AND 3MAXC WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511993 ↗