Penumbra System 5MAXJET7KIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00814548019918), received between Sep 21, 2018 and Feb 5, 2020 — classified as 1 death, 14 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (32 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 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 NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THAT NEURON MAX WITHIN THE COMMON CAROTID ARTERY. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE MICROCATHER AND THE STENT RETRIEVER THROUGH THE JET7 TO THE FACE OF THE CLOT. THEN, AFTER SUCCESSFULLY COMPLETING ONE PASS, THE PHYSICIAN DECIDED TO RETRACT THE JET7 TO REPOSITION IT BUT EXPERIENCED RESISTANCE WHILE RETRACTING. DURING THE RETRACTION OF THE JET7, THE PHYSICIAN NOTICED THAT THE TIP OF THE JET7 NO LONGER RETRACTED. SUBSEQUENTLY, THE JET7 SPLIT INTO TWO PIECES, WITH THE DISTAL HALF REMAINING INSIDE THE INTERNAL CAROTID ARTERY (ICA); THEREFORE, A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE IT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW JET7, NEW SOLITAIRE 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 9674244 ↗
• InjuryJan 9, 2020Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND THE CAROTID ARTERY USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE USING THE JET7 WITH THE NEURON MAX, THE PHYSICIAN NOTICED THAT THERE WAS A SIGNIFICANT SPASM OF THE ICA THAT CLAMPED ON THE JET7, AND THERE WAS NO FLOW IN THE TUBING; THEREFORE, THE JET7 WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE JET7. UPON REMOVAL OF THE JET7, IT WAS NOTED THAT THE JET7 WAS BROKEN AND HAD UNRAVELED APPROXIMATELY 20 CENTIMETERS FROM THE DISTAL TIP. IN ADDITION, A VASOSPASM WAS NOTED AND THE PATIENT WAS GIVEN VERAPAMIL TO TREAT THE SPASM. THE RELATIONSHIP BETWEEN THE VASOSPASM AND THE JET7 IS UNKNOWN. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), NON-PENUMBRA STENT RETRIEVER AND THE SAME NEURON MAX.

  Patient problems: Vasoconstriction

  MAUDE report 9571895 ↗
• MalfunctionDec 3, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), NON-PENUMBRA 8F SHEATH, AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE JET7 OVER THE GUIDEWIRE THROUGH THE 8F SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY NOTICED THAT BLOOD WAS LEAKING OUT. IT WAS REPORTED THAT THE JET7 BROKE AND BRAIDED MATERIAL WAS EXPOSED; THEREFORE, THE JET7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406515 ↗
• MalfunctionOct 24, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET7 KIT (KIT). IT WAS NOTED THAT THE PATIENT¿S AORTIC ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) THROUGH THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE JET7 PAST THE OPHTHALMIC ARTERY; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) 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 9234514 ↗
• MalfunctionOct 1, 2019Physical Resistance/Sticking; 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) FROM A PENUMBRA SYSTEM JET 7 KIT. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCEMENT OF THE JET7 THROUGH THE NON-PENUMBRA SHEATH. THE JET7 WAS UNABLE TO ADVANCE THROUGH THE SHEATH, AND THEREFORE, WAS REMOVED AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141616 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), A PENUMBRA SYSTEM JET7 KIT (KIT) AND, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE MAKING AN INITIAL PASS USING THE PSR3D WITH THE JET7, NEURON MAX AND, A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT THE PSR3D INTO A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE PSR3D WAS RETRACTED BACK INTO THE DELIVERY SHEATH. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SAME PSR3D, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE PSR3D AND FOUND THE LEADING EDGE OF THE DISTAL TIP TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D WITH THE SAME JET7, NEURON MAX AND MICROCATHETER. AFTER THE PROCEDURE, MODERATE VASOSPASM WAS PRESENT IN THE DISTAL LEFT INTERNAL CAROTID ARTERY. IT WAS ALSO REPORTED THAT THE VASOSPASM OCCURRED UPON PLACING THE NEURON MAX. THE VASOSPASM WAS CONSIDERED RESOLVED AS OF (B)(6) 2019.

  Patient problems: Vasoconstriction

  MAUDE report 9101319 ↗
• MalfunctionSep 11, 2019Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) UP TO THE CLOT. WHILE PULLING THE JET7 OUT FROM THE FIRST PASS, THE PHYSICIAN NOTICED THAT THE MID-SHAFT OF THE JET7 HAD FRACTURED; THEREFORE, IT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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 8997488 ↗
• MalfunctionAug 30, 2019Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET7 KIT (KIT). DURING THE PROCEDURE, WHILE RETRACTING THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) PROXIMALLY, IT BECAME STUCK AND, SUBSEQUENTLY, THE JET7 BECAME ¿UNRAVELED¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8949459 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) FROM A PENUMBRA SYSTEM JET 7 KIT AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, IT WAS REPORTED THAT THE FIRST AND SECOND PASSES USING THE PENUMBRA DEVICES RESULTED IN THE PATIENT'S MTICI FLOW BECOMING GRADE 1; ADDITIONALLY, AND THE THIRD PASS USING THE PENUMBRA DEVICES RESULTED IN THE PATIENT'S MTICI FLOW BECOMING GRADE 2A. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY WITH A NIHSS SCORE OF 8. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH LEFT SIDED FACIAL DROOP, COUGH, SLURRED SPEECH, AND LEFT SIDED WEAKNESS. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY SCAN (CTA) SHOWED HIGH GRADE STENOSIS OF THE PROXIMAL M2 BRANCH OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2019. THE EVENT WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO BOTH THE PENUMBRA DEVICES AND THE INDEX PROCEDURE.

  Patient problems: Stenosis; Weakness

  MAUDE report 8947390 ↗
• MalfunctionAug 27, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET7 KIT AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND TOUGH AORTIC ARCH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE VELOCITY WITH A NON-PENUMBRA STENT RETRIEVER DEVICE TO THE TARGET VESSEL USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). THE PHYSICIAN THEN COMPLETED THREE PASSES AND REMOVED THE SYSTEM. WHILE ATTEMPTING TO RE-ADVANCE THE JET7 USING THE STENT RETRIEVER DEVICE FOR ANCHORING, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE JET7 WOULD NOT ADVANCE. SUBSEQUENTLY, THE JET7 KINKED, AND THEREFORE, THE SYSTEM WAS REMOVED. THE PHYSICIAN THEN MADE AN ADDITIONAL PASS USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITH THE SAME VELOCITY AND STENT RETRIEVER DEVICE. WHILE ATTEMPTING TO RE-ADVANCE THE VELOCITY WITH THE ACE68 AND STENT RETRIEVER DEVICE TO COMPLETE ANOTHER PASS, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE VELOCITY AROUND THE OPHTHALMIC ARTERY, AND THE VELOCITY BECAME ¿UNRESPONSIVE.¿ THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935356 ↗
• MalfunctionAug 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT. AFTER THE FIRST AND FINAL PASS USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) HAD BEEN SUCCESSFULLY COMPLETED; THE PHYSICIAN RETRACTED THE JET7, AND NOTED RESISTANCE. ADDITIONALLY, IT WAS REPORTED THAT THE DISTAL TIP OF THE JET7 HAD BECOME STRETCHED APPROXIMATELY 1-2 CM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8885125 ↗
• MalfunctionAug 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 HI-FLOW KIT AND A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A JET 7 REPERFUSION CATHETER (JET7) AND AN PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE AORTIC ARCH KEPT KICKING THE NEURON MAX OUT OF THE COMMON CAROTID ARTERY, AND THE JET7 AND ACE68 WOULD NOT ADVANCE DUE TO THE TORTUOSITY. THEREFORE, THE JET7 AND ACE68 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), THE SAME NEURON MAX, AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857572 ↗
• DeathJul 25, 2019Fracture; Physical Resistance/Sticking; Fracture; 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 JET7 REPERFUSION CATHETER (JET7), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D). IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE JET7 AND VELOCITY THROUGH THE NEURON MAX. AFTER COMPLETING TWO PASSES, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING AND RETRACTING THE JET7 AND SUBSEQUENTLY THE JET7 FRACTURED. THE NEURON MAX CONTAINING THE BROKEN JET7 WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE NEURON MAX, A KINK WAS OBSERVED. THE PROCEDURE WAS CONCLUDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT THEN LATER EXPIRED; HOWEVER, THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 8829329 ↗
• MalfunctionJul 25, 2019Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, AS THE PHYSICIAN WAS REMOVING THE JET7, IT BEGAN TO UNRAVEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828850 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM IN THE LEFT MIDDLE CEREBRAL ARTERY. THEREFORE, THE PHYSICIAN ADMINISTERED 5MG OF VERAPAMIL TO TREAT THE VASOSPASM. A FOLLOW-UP ANGIOGRAPHY WAS PERFORMED AFTER 5 MINUTES WHICH SHOWED WORSENING VASOSPASM; THEREFORE, THE PHYSICIAN ADMINISTERED ANOTHER 5MG OF VERAPAMIL. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY (B)(6) 2019. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH PROBABLE RELATIONSHIP TO THE NEURON MAX, POSSIBLE RELATIONSHIP TO THE JET7 AND DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 8824171 ↗
• MalfunctionJul 24, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) KIT. DURING THE PROCEDURE, THE PHYSICIAN MADE ONE SUCCESSFUL PASS USING THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) WITH A NON-PENUMBRA SHEATH. WHILE ATTEMPTING TO MAKE A SECOND PASS, THE PHYSICIAN WAS UNABLE TO ADVANCE THE JET7; THEREFORE IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821368 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM IN THE LEFT COMMON CAROTID ARTERY (CCA) AND LEFT CERVICAL INTERNAL CAROTID ARTERY (ICA). THEREFORE, THE PHYSICIAN ADMINISTERED VERAPAMIL TO TREAT THE VASOSPASM. THIS EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2019. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT DEFINITELY RELATED TO THE INDEX PROCEDURE, PROBABLY RELATED TO THE NEURON MAX AND POSSIBLY RELATED TO THE JET7.

  Patient problems: Vasoconstriction

  MAUDE report 8809391 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE ON (B)(6) 2019 USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), HOWEVER, THERE WAS NO RECANALIZATION DUE TO EXTRAVASATION. THE PATIENT WAS THEN INTUBATED DUE TO DECLINING MENTAL STATUS. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2019 SHOWED AN EVOLVING INFARCT IN THE RIGHT MCA, AND CEREBRAL EDEMA WAS ALSO NOTED BY THE PRINCIPAL INVESTIGATOR (PI). THE CEREBRAL EDEMA WAS MEDICALLY MANAGED AT THAT TIME. THE CT SCAN ALSO REVEALED SUBARACHNOID CONTRAST WAS DECREASING AND, THEREFORE, A SMALL SUBARACHNOID COULD NOT BE EXCLUDED. THE PATIENT WAS TREATED WITH MEDICATION. AS OF (B)(6) 2019, THE EVENT IS STILL ONGOING. THESE EVENTS WERE ADJUDICATED TO BE SERIOUS ADVERSE EVENTS WITH A PROBABLE RELATIONSHIP TO THE INDEX STROKE, INDEX PROCEDURE, PSR3D, AND A POSSIBLE RELATIONSHIP TO THE JET7.

  Patient problems: Infarction, Cerebral

  MAUDE report 8753132 ↗
• MalfunctionJun 28, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT (KIT). DURING THE PROCEDURE, AFTER MAKING AN INITIAL PASS WITH THE PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN NOTICED THAT THE JET7 WAS NOT ABLE TO ACHIEVE PROPER ASPIRATION. THERE WERE EXCESSIVE BUBBLES IN THE TUBING AND THE PROXIMAL SHAFT OF THE JET7 WAS FOUND TO BE BROKEN AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745260 ↗
• MalfunctionJun 21, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) FROM A PENUMBRA SYSTEM JET 7 KIT. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE JET7 THROUGH THE OPHTHALMIC ARTERY AND IT WAS REPORTED THAT IT WOULD NOT ADVANCE FURTHER THROUGH THE ANATOMY. THE JET7 WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723494 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM IN THE SUPRACLINOID RIGHT INTERNAL CAROTID ARTERY (ICA) AND M1. THEREFORE, THE PHYSICIAN ADMINISTERED 10 MG OF VERAPAMIL TO TREAT THE VASOSPASM. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT DEFINITELY RELATED TO THE INDEX PROCEDURE, PROBABLY RELATED TO THE JET7, AND POSSIBLY RELATED TO THE 3MAXC.

  Patient problems: Vasoconstriction

  MAUDE report 8709122 ↗
• MalfunctionJun 14, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET7 KIT (KIT). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY MADE ONE PASS USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE ATTEMPTING TO ADVANCE JET7 OVER THE 3MAXC TO MAKE THE SECOND PASS, THE JET7 WAS KINKED, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), SAME 3MAXC AND SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701406 ↗
• MalfunctionJun 12, 2019Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CERVICAL INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE AN ACE68 AND A NON-PENUMBRA CATHETER; HOWEVER, REVASCULARIZATION WAS NOT ACHIEVED. THEREFORE, THE PHYSICIAN DECIDED TO USE A JET7 AFTER EXCHANGING THE NON-PENUMBRA CATHETER WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE ADVANCING THE JET7 OVER A GUIDEWIRE AND INTO A NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE. WHEN THE JET7 ADVANCED APPROXIMATELY 10 CM INTO THE NEURON MAX, THE JET7 BECAME STUCK AND THE TIP FOLDED OVER AND BROKE OFF INSIDE THE NEURON MAX. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE JET7 OUT OF THE NEURON MAX BUT REPORTED THAT UPON RETRACTION THE JET7 BROKE AND UNCOILED APPROXIMATELY 10 CM FROM THE DISTAL TIP. THE PIECES OF THE JET7 WERE THEN SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT RETRIEVER 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 8693858 ↗
• MalfunctionJun 6, 2019Stretched; Failure to Advance; Physical Resistance/Sticking; Stretched; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA), MIDDLE CEREBRAL ARTERY (MCA) AND THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SYSTEM JET7 KIT. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). WHILE ATTEMPTING TO INTRODUCE THE JET7 THROUGH THE NEURON MAX FOR THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JET7 WOULD NOT ADVANCE BEYOND 15-20 CENTIMETERS; THEREFORE, IT WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE JET7 APPEARED TO BE 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 8673231 ↗
• MalfunctionMay 28, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF OPENED A PENUMBRA SYSTEM JET7 KIT AND NOTICED THAT THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) APPEARED TO BE KINKED. THE DAMAGED JET7 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68).

  Patient problems: No Patient Involvement

  MAUDE report 8647079 ↗