Penumbra System 3MAXC-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00814548019932), received between Apr 25, 2018 and Jan 21, 2021 — classified as 10 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1, M2, AND M3 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REMOVING THE 3MAXC FROM THE NEURON MAX AFTER A PASS. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A CONTRAST RUN AND NOTICED THE TIP OF THE 3MAXC WAS LEFT BEHIND. THE PHYSICIAN USED THE CATHETER TO ASPIRATE THE TIP OUT. THE PROCEDURE ENDED AT THIS POINT. 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 11210017 ↗
• InjuryJan 23, 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 M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D), PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND, PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). ON (B)(6) 2019, A FOLLOW UP 24-HOUR COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED EVIDENCE OF THE LEFT MCA INFARCTION WITH SUSPECT CONTRAST STAINING. THIS EVENT IS CONSIDERED RESOLVED WITH CLINICAL SEQUELAE AS OF (B)(6) 2019. THE PROGRESSION OF INDEX STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT RELATED TO THE PSR3D, JET7, 3MAXC AND, THE INDEX PROCEDURE.

  Patient problems: Infarction, Cerebral

  MAUDE report 9623597 ↗
• MalfunctionJan 22, 2020Physical Resistance/Sticking; 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 3D REVASCULARIZATION DEVICE (PSR3D). DURING THE PROCEDURE, WHILE ADVANCING THE PSR3D THROUGH THE 3MAXC IN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AS THE PSR3D WAS HALFWAY IN THE 3MAXC; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME PSR3D AND A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617268 ↗
• MalfunctionDec 11, 2019Break; Difficult to Advance; Break; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN PLACED A GUIDE CATHETER AND ATTEMPTED TO ADVANCE A NON-PENUMBRA REPERFUSION CATHETER TOGETHER WITH A 3MAXC; HOWEVER, THE PHYSICIAN HAD DIFFICULTY ADVANCING PAST THE OPHTHALMIC WITH THE REPERFUSION CATHETER. THEREFORE, THE 3MAXC WAS RETRACTED AND BECAME FRACTURED. THE PHYSICIAN PULLED THE COIL WIND AND SUCCESSFULLY REMOVED THE REMAINING PARTS OF THE 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453010 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS REPORTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAXC THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) IN THE TARGET VESSEL. WHILE UNDER ASPIRATION, THE 3MAXC ¿COLLAPSED;¿ THEREFORE, THE 3MAXC WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE 3MAXC WAS CRUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER 3MAXC 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 9252926 ↗
• MalfunctionOct 24, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS (3MAXCS). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT A 3MAXC WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE 3MAXC WAS THEN REMOVED AND THE PHYSICIAN USED ANOTHER 3MAXC TO CONTINUE THE PROCEDURE. WHILE USING THE NEXT 3MAXC IN THE PATIENT, THE PHYSICIAN REPORTED THAT IT BROKE AND WAS "SUCKED IN BY THE PENUMBRA VACUUM". THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9235859 ↗
• MalfunctionSep 24, 2019Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS (3MAXCS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED A 3MAXC THROUGH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) TO THE TARGET LOCATION. WHEN THE 3MAXC WAS BEING RETRACTED FROM THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON REMOVAL OF THE 3MAXC FROM THE TUOHY, THE 3MAXC FRACTURED INTO TWO PIECES. THE PHYSICIAN THEN USED HEMOSTAT FORCEPS TO REMOVE THE REMAINING PIECE OF 3MAXC FROM THE ACE68. THEREFORE, THE 3MAXC WAS COMPLETELY REMOVED FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING ANOTHER 3MAXC, HOWEVER, THE SAME ISSUE OCCURRED. THIS 3MAXC WAS ALSO REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A THIRD 3MAXC AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112531 ↗
• MalfunctionSep 24, 2019Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM 3MAX REPERFUSION CATHETERS (3MAXCS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED A 3MAXC THROUGH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) TO THE TARGET LOCATION. WHEN THE 3MAXC WAS BEING RETRACTED FROM THE ACE68, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON REMOVAL OF THE 3MAXC FROM THE TUOHY, THE 3MAXC FRACTURED INTO TWO PIECES. THE PHYSICIAN THEN USED HEMOSTAT FORCEPS TO REMOVE THE REMAINING PIECE OF 3MAXC FROM THE ACE68. THEREFORE, THE 3MAXC WAS COMPLETELY REMOVED FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING ANOTHER 3MAXC, HOWEVER, THE SAME ISSUE OCCURRED. THIS 3MAXC WAS ALSO REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A THIRD 3MAXC AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112518 ↗
• MalfunctionSep 20, 2019Unraveled Material; Material Deformation; Unraveled Material; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, WHILE ADVANCING THE 3MAXC INTO A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE 3MAXC COILED UP INSIDE OF THE JET7. THEREFORE, THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE 3MAXC; HOWEVER, WHILE RETRACTING, IT BECAME UNRAVELED UPON REMOVAL. THE PROCEDURE WAS THEN COMPLETED USING A NEW 3MAXC WITH THE SAME JET7 AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098518 ↗
• 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 9082346 ↗
• MalfunctionSep 10, 2019Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER 3MAXC. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REMOVE THE 3MAXC FROM THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER JET7 AND REPORTED THAT THE 3MAXC STRETCHED AND BECAME STUCK INSIDE THE JET7. THE JET7 AND 3MAXC WERE THEN REMOVED TOGETHER FROM THE PATIENT AND THE 3MAXC WAS RETRACTED OUT OF THE JET7. THE 3MAXC WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME JET7 AND ANOTHER 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8983861 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) FROM A PENUMBRA SYSTEM JET 7 KIT AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM AFTER RECANALIZATION OF THE MCA BRANCH AND DISTAL VASCULATURE. THE PHYSICIAN THEN ADMINISTERED 10 MG OF VERAPAMIL TO TREAT THE VASOSPASM. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY (B)(6) 2019. THE VASOSPASM WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH POSSIBLE RELATIONSHIP TO THE JET7 AND 3MAXC AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: Vasoconstriction

  MAUDE report 8893165 ↗
• InjuryAug 9, 2019Break; Fracture; Physical Resistance/Sticking; Break; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE 3MAXC, A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE REMOVING THE 3MAXC AFTER COMPLETION OF THE PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND A TIGHT TURN AND THE DISTAL TIP OF THE 3MAXC BROKE OFF. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN TIP. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC AND THE SAME ACE68 AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879882 ↗
• MalfunctionAug 8, 2019Stretched; Physical Resistance/Sticking; Stretched; 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 8875404 ↗
• MalfunctionJul 19, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JET D), AND A 3MAXC IN THE TARGET VESSEL. THE PHYSICIAN THEN EXPERIENCED RESISTANCE UPON REMOVAL OF THE 3MAXC. AS THE PHYSICIAN GOT TO THE CAROTID TERMINUS, UPON PULLING THE 3MAXC THE DISTAL PORTION CAME LOOSE AND REMAINED IN THE PATIENT'S BODY. THE PHYSICIAN REMOVED THE REST OF THE 3MAXC WHILE THE JETD REMAINED IN THE TARGET LOCATION. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE REMAINING PIECE OF THE 3MAXC FROM THE PATIENT'S BODY. THE PHYSICIAN FELT THAT THE ISSUE WAS CAUSED BY DIFFICULT ANATOMY. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, THE SAME NEURON MAX AND JET D. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808561 ↗
• MalfunctionJul 3, 2019Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) OVER A 3MAXC, OVER A NON-PENUMBRA GUIDEWIRE AND TRACKED INTO THE TARGET VESSEL. AS THE GUIDEWIRE WAS BEING RETRACTED, THE PHYSICIAN FELT RESISTANCE AND THE PHYSICIAN PULLED THE 3MAXC BACK DESPITE THE RESISTANCE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE 3MAXC WAS FRACTURED AT THE MID-SHAFT; THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME ACE68, GUIDEWIRE AND A NEW 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761252 ↗
• MalfunctionJun 27, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN USED THE 3MAXC TO DELIVER A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) TO THE TARGET VESSEL. THE PHYSICIAN THEN REMOVED THE 3MAXC AND FOUND IT TO BE BROKEN APPROXIMATELY THREE CENTIMETERS AT THE DISTAL TIP BUT REMAINED INTACT. THE PHYSICIAN THEN USED A NEW 3MAXC AND THE SAME JETD TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8740228 ↗
• MalfunctionJun 20, 2019Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CAROTID ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING INITIAL INTRODUCTION OF THE 3MAXC THROUGH THE TUOHY VALVE AND INTO THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), THE TECHNICIAN REPORTED THAT THE 3MAXC KINKED AND BROKE IN HALF MID-SHAFT. IT WAS ALSO REPORTED THAT THE 3MAXC BREAK OCCURRED IN THE PORTION OF THE CATHETER THAT HAD NOT BEEN ADVANCED INTO THE TUOHY VALVE; THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 3MAXC AND THE SAME JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716243 ↗
• 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 8709126 ↗
• MalfunctionJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT SUCCESSFULLY UNDERWENT A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). THERE WAS NO REPORTED COMPLICATION DURING THE PROCEDURE. A 24-HOUR FOLLOW UP MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED, WHICH REVEALED MINOR ASYMPTOMATIC HEMORRHAGIC TRANSFORMATION ON THE LEFT INSULA AND OPERCULUM. THE PATIENT WAS DISCHARGED ON (B)(6) 2019 IN STABLE CONDITION WITH A NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) OF 0. THIS EVENT WAS CONSIDERED UNRESOLVED. THE ASYMPTOMATIC HEMORRHAGIC TRANSFORMATION ON THE LEFT INSULA AND OPERCULUM WERE ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND THE INDEX PROCEDURE.

  Patient problems: Hemorrhage, Cerebral

  MAUDE report 8701301 ↗
• InjuryJun 12, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE 3MAXC BROKE WHILE BEING PULLED THROUGH A NON-PENUMBRA CATHETER THAT HAD KINKED. THEREFORE, THE PHYSICIAN USED A NEW 3MAXC AND A SNARE DEVICE TO RETRIEVE THE DISTAL TIP OF THE BROKEN 3MAXC. THE PROCEDURE WAS THEN COMPLETED USING A PENUMBRA SYSTEM ACE68 REPERFUSION CATHETER (ACE68) AND THE SECOND 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8691901 ↗
• MalfunctionMay 20, 2019Material Deformation; Material Deformation

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FLUSHED A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND HANDED IT TO THE PHYSICIAN. THE PHYSICIAN THEN NOTICED THAT IT WAS FRAYED. THE DAMAGE TO THE 3MAXC WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 8623686 ↗
• MalfunctionMay 13, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE 3MAXC WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 8604173 ↗
• MalfunctionMay 9, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) FROM A PENUMBRA SYSTEM JET7 KIT, AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO TRACK A JET7 OVER THE 3MAXC TO MAKE THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE JET7 WAS UNABLE TO ADVANCE ANY FURTHER. THE JET7 WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO TRACK ANOTHER JET7 OVER THE SAME 3MAXC AND THE SAME ISSUE OCCURRED. THIS JET7 WAS ALSO REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. IT WAS ALSO REPORTED THAT UPON RETRACTION OF THE 3MAXC DURING THE SECOND PASS THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE 3MAXC BECAME KINKED APPROXIMATELY 20 CM FROM THE DISTAL END. THE 3MAXC WAS THEREFORE REMOVED AND THE PROCEDURE WAS CONTINUED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND ANOTHER 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596223 ↗
• 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 3MAX REPERFUSION CATHETER (3MAXC), THE PHYSICIAN FOUND THAT THE TIP OF THE 3MAXC WAS KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE 3MAXC WAS FOUND PRIOR TO USE AND THEREFORE THE 3MAXC WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 3MAXC.

  Patient problems: No Patient Involvement

  MAUDE report 8592609 ↗