JET 5MAXJETDKIT-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00814548019741), received between Oct 4, 2018 and May 15, 2020 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE JETD WOULD NOT ADVANCE THROUGH THE SHEATH; THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER 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 10063777 ↗
• InjuryFeb 14, 2020Adverse 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 M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE 3MAXC, JETD, AND NEURON MAX IN THE TARGET VESSEL AND USED THE JETD TO PERFORM ASPIRATION. A FOLLOW-UP ANGIOGRAM SHOWED RECANALIZATION OF OVER 50% OF THE OCCLUDED BRANCH. HOWEVER, MINIMAL CATHETER-INDUCED VASOSPASM WAS PRESENT. IT WAS NOT TREATED AS THE PATIENT SHOWED CONTINUED IMPROVEMENT. THE PHYSICIAN THEN ATTEMPTED TO CATHETERIZE THE OCCLUDED BRANCH, BUT THE PATIENT BEGAN TO EXPERIENCE EMESIS; THEREFORE, THE DEVICES WERE REMOVED. THE TWO EVENTS WERE CONSIDERED RESOLVED ON THE SAME DAY. THE PROCEDURE ENDED AT THIS POINT, AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS ACHIEVED. THE VASOSPASM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND JETD, AND THE EMESIS WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE AND JETD.

  Patient problems: Vasoconstriction; Vomiting

  MAUDE report 9712471 ↗
• MalfunctionJan 2, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND, VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON MAX IN THE LEFT INTERNAL CAROTID ARTERY (ICA), A VELOCITY WAS THEN USED TO BRING UP THE JETD THROUGH THE NEURON MAX AND INTO THE TARGET VESSEL. AFTERWARD, THE PHYSICIAN REMOVED VELOCITY; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE RETRACTING THE VELOCITY OUT FROM THE JETD. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THERE MIGHT BE SOMETHING WRONG WITH THE JETD; THEREFORE, IT WAS REMOVED. HOWEVER, WHILE RETRACTING THE JETD OUT OF THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JETD PROXIMAL END BEGAN TO COLLAPSE. THE PHYSICIAN ALSO THOUGHT THERE MIGHT SOMETHING WRONG WITH THE NEURON MAX DISTALLY; THEREFORE, THE NEURON MAX WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JETD, NEURON MAX AND THE SAME VELOCITY. IT WAS ALSO REPORTED THAT AFTER THE PROCEDURE, THE FIRST NEURON MAX WAS EXAMINED, AND THE DISTAL END WAS FOUND TO BE KINKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539354 ↗
• MalfunctionNov 15, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) FROM A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JETD THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND MADE ONE PASS. SUBSEQUENTLY, THE JETD WAS REMOVED FROM THE PATIENT FOR FLUSHING. WHILE FLUSHING THE JETD ON THE BACK TABLE, THE PHYSICIAN NOTICED THAT IT WAS FRACTURED APPROXIMATELY 10 CM FROM THE DISTAL TIP. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND A SOFIA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328952 ↗
• MalfunctionNov 1, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE A SUCCESSFUL PASS USING A JETD, A NON PENUMBRA STENT RETRIEVER, AND A NON PENUMBRA MICROCATHETER. BEFORE MAKING A SECOND PASS, THE PHYSICIAN NOTICED THE MICROCATHETER TO BE DAMAGED AND; THEREFORE, IT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO INSERT A NEW MICROCATHETER FOR A SECOND PASS; HOWEVER, WAS UNABLE TO ADVANCE THE MICROCATHETER AND GUIDEWIRE THROUGH THE JETD. IT WAS DISCOVERED THAT THE TIP OF THE INITIAL MICROCATHETER HAD BROKEN OFF AND TRAVELED DISTALLY. IT WAS REPORTED THAT THE PHYSICIAN DID NOT WANT TO LOSE ACCESS AND DECIDED TO ASPIRATE USING THE JETD. THE JETD WAS THEN REMOVED FROM THE PATIENT AND FOUND THE DISTAL END OF THE JETD TO BE KINKED. THE PROCEDURE WAS ENDED AT THIS POINT AND THE BROKEN TIP OF THE INITIAL MICROCATHETER WAS LEFT IN THE PATIENT AS IT WAS TOO DISTAL IN THE ANATOMY TO BE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269629 ↗
• MalfunctionOct 30, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE A PASS USING THE JETD WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). WHILE ATTEMPTING TO MAKING ANOTHER PASS, THE PHYSICIAN ADVANCED THE JETD AND APPROXIMATELY 20 TO 30 CENTIMETERS FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THE JETD WAS REMOVED AND A NEW JETD WAS THEN USED. THE PHYSICIAN ADVANCED THE JETD AND THE SAME ISSUE OCCURRED, IN THAT, APPROXIMATELY 20 TO 30 CM FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THE JETD WAS REMOVED AND THE PHYSICIAN USED ANOTHER JETD TO MAKE A PASS; HOWEVER, WHILE RETRACTING, APPROXIMATELY 20 TO 30 CENTIMETERS FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THIS JETD WAS REMOVED. THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE USING NON-PENUMBRA STENT RETRIEVERS WITH THE SAME NEURON MAX; HOWEVER, IT WAS UNSUCCESSFUL, AND THE PHYSICIAN WAS UNABLE TO COMPLETELY REMOVE THE REMAINING CLOT USING ANY OF THE DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258264 ↗
• MalfunctionOct 30, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE A PASS USING THE JETD WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). WHILE ATTEMPTING TO MAKING ANOTHER PASS, THE PHYSICIAN ADVANCED THE JETD AND APPROXIMATELY 20 TO 30 CENTIMETERS FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THE JETD WAS REMOVED AND A NEW JETD WAS THEN USED. THE PHYSICIAN ADVANCED THE JETD AND THE SAME ISSUE OCCURRED, IN THAT, APPROXIMATELY 20 TO 30 CM FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THE JETD WAS REMOVED AND THE PHYSICIAN USED ANOTHER JETD TO MAKE A PASS; HOWEVER, WHILE RETRACTING, APPROXIMATELY 20 TO 30 CENTIMETERS FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THIS JETD WAS REMOVED. THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE USING NON-PENUMBRA STENT RETRIEVERS WITH THE SAME NEURON MAX; HOWEVER, IT WAS UNSUCCESSFUL, AND THE PHYSICIAN WAS UNABLE TO COMPLETELY REMOVE THE REMAINING CLOT USING ANY OF THE DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258263 ↗
• MalfunctionOct 30, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE A PASS USING THE JETD WITH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). WHILE ATTEMPTING TO MAKING ANOTHER PASS, THE PHYSICIAN ADVANCED THE JETD AND APPROXIMATELY 20 TO 30 CENTIMETERS FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THE JETD WAS REMOVED AND A NEW JETD WAS THEN USED. THE PHYSICIAN ADVANCED THE JETD AND THE SAME ISSUE OCCURRED, IN THAT, APPROXIMATELY 20 TO 30 CM FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THE JETD WAS REMOVED AND THE PHYSICIAN USED ANOTHER JETD TO MAKE A PASS; HOWEVER, WHILE RETRACTING, APPROXIMATELY 20 TO 30 CENTIMETERS FROM THE DISTAL TIP BECAME KINKED; THEREFORE, THIS JETD WAS REMOVED. THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE USING NON-PENUMBRA STENT RETRIEVERS WITH THE SAME NEURON MAX; HOWEVER, IT WAS UNSUCCESSFUL, AND THE PHYSICIAN WAS UNABLE TO COMPLETELY REMOVE THE REMAINING CLOT USING ANY OF THE DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258261 ↗
• MalfunctionSep 27, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM JET D KIT. IT WAS NOTED THAT THE PATIENT HAD A MID-BASILAR UNDERLYING STENOSIS WITH AN ADJACENT BASILAR OCCLUSION. DURING THE PROCEDURE, WHILE ADVANCING THE PENUMBRA SYSTEM JET D REPERFUSION CATHETER (JETD) WITH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A GUIDEWIRE THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE JETD APPEARED TO KINK; HOWEVER, IT WAS ADVANCED TO THE CLOT AND AN ASPIRATION PASS WAS PERFORMED. IT WAS NOTED THAT THE CLOT WAS NOT COMPLETELY REMOVED AFTER THE FIRST PASS. UPON REMOVAL OF THE JETD AFTER THE FIRST PASS, IT WAS NOTICED THAT THE JETD APPEARED TO HAVE MULTIPLE KINKS; THEREFORE, IT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME NEURON MAX, A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), THE SAME 3MAXC, AND A STENT RETRIEVER DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131339 ↗
• MalfunctionSep 18, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A 3MAXC AND A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) WITH A MICROWIRE THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE 3MAXC AND JETD WOULD HARDLY ADVANCE AT ALL THROUGH THE NEURON MAX; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW 3MAXC AND JETD AND THE SAME MICROWIRE AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082319 ↗
• MalfunctionAug 8, 2019Material 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 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM JET D KIT. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) INTO THE PATIENT, THEN ATTEMPTED TO ADVANCE THE 3MAXC AND THE PENUMBRA SYSTEM JET D REPERFUSION CATHETER (JETD) INTO THE NEURON MAX. HOWEVER, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ADVANCING THE 3MAXC AND JETD AND SUBSEQUENTLY, THE 3MAXC AND JETD WERE DAMAGED. IT WAS REPORTED THAT THE DISTAL END OF THE 3MAXC STRETCHED AND THE PROXIMAL END OF THE JETD KINKED; THEREFORE, THEY WERE BOTH REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND ANOTHER 3MAXC AND JETD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875412 ↗
• MalfunctionJul 10, 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 M2 OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) OVER THE 3MAXC WITH A GUIDEWIRE TO THE TARGET LOCATION. IT WAS REPORTED THAT THE PATIENT¿S VESSELS WERE VERY TORTUOUS. THE PHYSICIAN THEN ATTEMPTED TO RETRACT AND REMOVE THE 3MAXC, HOWEVER, THE PHYSICIAN FELT RESISTANCE. THEREFORE, THE PHYSICIAN RETRACTED THE JETD TO RELEASE TENSION AND WAS THEN ABLE TO REMOVE THE 3MAXC AND THE GUIDEWIRE. HOWEVER, UPON REMOVAL, THE PHYSICIAN FOUND THAT THE 3MAXC WAS STRETCHED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ONE PASS OF THE JETD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777034 ↗
• MalfunctionJun 7, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, WHILE REMOVING THE JETD WITH A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE ((B)(4)), THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE JETD WAS SPLIT. THE THROMBUS WAS REMOVED WITH THE JETD AND (B)(4) AND, THEREFORE, THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679382 ↗
• MalfunctionJun 5, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, WHILE ADVANCING THE PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL P1 SEGMENT. CONSEQUENTLY, THE MID SHAFT OF THE JETD KINKED IN TRANSITION IN THE VERTEBRAL V3 SEGMENT. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 8670801 ↗
• MalfunctionMay 8, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET D KIT, THE HOSPITAL STAFF NOTICED THE PENUMBRA SYSTEM JET D REPERFUSION CATHETER (JET D) TO BE KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE JET D WAS FOUND PRIOR TO USE, AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER JET D.

  Patient problems: No Patient Involvement

  MAUDE report 8591844 ↗
• MalfunctionApr 17, 2019Collapse; Collapse

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) FROM A PENUMBRA SYSTEM JETD KIT. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE MANIPULATING THE 3MAXC INTO THE TARGET VESSEL THROUGH THE JETD AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). AS THE PHYSICIAN CONTINUED TO ADVANCE THE 3MAXC, IT WAS REPORTED THAT THE 3MAXC BROKE AT THE RHV OF THE JETD. THE PHYSICIAN THEN CLAMPED THE JETD USING A KELLY CLAMP AND EXTRACTED THE 3MAXC. IT WAS ALSO REPORTED THAT, UPON CLAMPING THE JETD, IT BECAME CRUSHED. THE RHV, 3MAXC, AND JETD WERE, THEREFORE, REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A PENUMBRA SYSTEM 3D REPERFUSION CATHETER (PSR3D), A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), 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 8524708 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ASYMPTOMATIC HI-1 SMALL PETECHIAL HEMORRHAGE IN THE LEFT INSULA. THIS EVENT WAS NOT CONSIDERED A SERIOUS ADVERSE EVENT. THIS EVENT WAS ADJUDICATED TO BE RELATED TO PENUMBRA CATHETERS, POSSIBLY RELATED TO THE JETD AND A 3MAXC, AND POSSIBLY RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL TREATMENT WAS DONE, AND THIS EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2018.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage

  MAUDE report 8489366 ↗
• MalfunctionMar 6, 2019Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JETD KIT (KIT). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) THROUGH A NON-PENUMBRA MICROCATHETER. AS THE JETD NEARED THE LEFT CIRCUMFLEX CORONARY ARTERY (LCCA), THE OUTER LAYER OF THE JETD BECAME "CRINKLED" OUTSIDE OF THE RHV, EXPOSING THE INNER WIRING OF THE JETD. THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE JETD, HOWEVER, THE JETD SEPARATED PROXIMALLY. THE PROCEDURE WAS THEN COMPLETED USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER, A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER, A NEW JETD, AND A NON-PENUMBRA STENT RETRIEVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8394808 ↗
• MalfunctionFeb 27, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A LESION IN THE P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM JETD KIT. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS AND WITH VERY THIN ARTERIES. DURING THE PROCEDURE, WHILE ADVANCING THE PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO TRACK THE JETD THROUGH THE NON-DOMINANT VERTEBRAL ARTERY DUE TO THE TORTUOSITY OF THE VESSEL. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME NEURON MAX. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8373849 ↗
• MalfunctionFeb 12, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) WAS STUCK ON THE PLASTIC INSERT DURING REMOVAL FROM THE PENUMBRA SYSTEM JETD KIT PACKAGING TRAY, THEN KINKED NEAR THE HUB. THE DAMAGE TO THE JETD OCCURRED PRIOR TO USE AND, THEREFORE, THE JETD WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D).

  Patient problems: No Patient Involvement

  MAUDE report 8332484 ↗
• MalfunctionFeb 1, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT A PENUMBRA SYSTEM JETD REPERFUSION CATHETER WAS BROKEN AT THE HUB UPON REMOVAL FROM THE PENUMBRA SYSTEM JETD KIT PACKAGING. IT WAS REPORTED THAT IT SEEMED LIKE THE JETD WAS STUCK IN THE HUB AND BROKE WHEN IT WAS PULLED OUT. THE DAMAGE TO THE JETD WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER JETD.

  Patient problems: No Patient Involvement

  MAUDE report 8298605 ↗
• MalfunctionJan 18, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET7 KIT. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) WITH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), THE JETD PROLAPSED INTO A BRANCH ARTERY AND KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261082 ↗
• MalfunctionJan 15, 2019Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, THE PHYSICIAN MADE AN INITIAL PASS USING A NON-PENUMBRA STENT RETRIEVER THROUGH THE PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE REMOVING THE STENT RETRIEVER, IT WAS ¿HUNG UP¿ INSIDE OF THE JETD, CAUSING THE JETD TO STRETCH; THEREFORE, THE JETD AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), WITH A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), THE SAME SHEATH, AND ANOTHER STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248282 ↗
• MalfunctionNov 16, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES USING THE JETD. AFTER THE SECOND PASS, THE PHYSICIAN NOTICED THAT THE JETD WAS KINKED. IT WAS REPORTED THAT THE PHYSICIAN HAD FELT RESISTANCE WHILE ADVANCING THE JETD WITHIN THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THEREFORE, THE JETD WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW JETD, THE SAME NEURON MAX, NON-PENUMBRA MICROCATHETER, AND STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8081767 ↗
• InjuryOct 4, 2018Fracture; Difficult to Remove; Fracture; Difficult to Remove

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1/A3 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY /ANTERIOR CEREBRAL ARTERY USING A PENUMBRA SYSTEM JETD KIT (KIT) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT HAD A TYPE III AORTIC ARCH. DURING THE PROCEDURE, WHILE ATTEMPTING TO REMOVE THROMBUS IN THE M1 SEGMENT, THE PHYSICIAN PLACED A NEURON MAX IN THE TARGET VESSEL, THEN SUCCESSFULLY ENGAGED THE CLOT WITH A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). HOWEVER, THE PHYSICIAN HAD DIFFICULTY WHILE ATTEMPTING TO WITHDRAW THE JETD AND UPON REMOVAL OF THE JETD, THE PHYSICIAN NOTICED THAT THE TIP OF THE JETD WAS NOT INTACT. UPON REVIEW OF THE PATIENT UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE JETD R/O MARKER WAS IN THE A3 SEGMENT. THE PHYSICIAN ALSO OBSERVED A KINK IN NEURON MAX IN AN AREA NEAR THE AORTIC ARCH AND FELT THAT THE JETD WAS CAUGHT IN THE KINK AND WHEN PULLED, IT BECAME FRACTURED. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE JETD DISTAL SEGMENT USING A SNARE DEVICE BUT ALL ATTEMPTS WERE UNSUCCESSFUL BECAUSE THE SNARE DEVICE WOULD NOT NAVIGATE TO THE A2/A3 SEGMENT. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 60 REPERFUSIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7936999 ↗