Penumbra System 3MAXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 241 adverse event reports that list this exact device (DI 00814548012490), received between Aug 28, 2015 and Apr 2, 2023 — classified as 1 death, 49 injuries, 191 malfunctions.

The most frequently reported specific device problem is “Break” (83 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 241 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2023Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE 3MAXC INTO THE NEURON MAX, THE PHYSICIAN NOTICED SOME ABNORMALITIES AND IMMEDIATELY STARTED TO PULL BACK THE 3MAXC. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE 3MAXC WAS FRACTURED BUT REMAINED CONNECTED BY THE INNER WIRE. THE 3MAXC WAS THEN REMOVED AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW 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

  MAUDE report 16660856 ↗
• MalfunctionJun 3, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NEURON MAX AND AN ACE68 INTO THE PATIENT. THEN THE PHYSICIAN USED A 3MAXC AS AN INTERMEDIATE CATHETER AND INJECTED CONTRAST THROUGH IT. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING A GUIDEWIRE OVER THE 3MAXC AND DECIDED TO REMOVE ALL DEVICES. UPON REMOVAL OF ALL DEVICES, IT WAS NOTICED THAT THE MID-SHAFT OF THE 3MAXC WAS STRETCHED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT CONTINUE TO USE THE ACE68 BECAUSE THE ACE68 COULD NOT PASS TO THE OPHTHALMIC ARTERY. ALSO, NO DAMAGE WAS NOTED ON THE ACE68 UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND STENTING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934814 ↗
• InjuryFeb 23, 2021Material Deformation; Suction Failure; Material Deformation; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTRACRANIAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAXC TO THE TARGET VESSEL. THEN, DURING THE FIRST PASS, THE PHYSICIAN USED A 20 ML SYRINGE TO MANUALLY ASPIRATE; HOWEVER, IT WAS NOTICED THAT THE 3MAXC WAS UNABLE ASPIRATE ANY THROMBUS. THEREFORE, THE PHYSICIAN REMOVED THE 3MAXC AND NOTICED THAT THE MARKERBAND WAS DEFORMED. THE PHYSICIAN THEN USED A PLASTIC NEEDLE TO RESTORE THE DEFORMED MARKERBAND. AFTERWARDS, THE PHYSICIAN RE-ADVANCED THE 3MAXC TO THE TARGET VESSEL AND USED A 10 ML SYRINGE TO MANUALLY ASPIRATE; HOWEVER, IT WAS NOTICED THAT THE 3MAXC WAS UNABLE TO ASPIRATE ANY THROMBUS. THEREFORE, THE 3MAXC WAS REMOVED AND IT WAS NOTICED THAT THE MARKERBAND WAS DEFORMED AGAIN. THE PROCEDURE ENDED AT THIS POINT. DUE TO THE PATIENT¿S AGE AND TORTUOUS ANATOMY, THE PHYSICIAN WANTED TO REDUCE THE RISK OF A HEMORRHAGE COMPLICATION. IT WAS ALSO REPORTED THAT A CT WAS PERFORMED IMMEDIATELY FOLLOWING THE PROCEDURE AND IT SHOWED INTRACRANIAL HEMORRHAGE LESIONS. THE INTRACRANIAL HEMORRHAGE WAS REPORTED

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

  MAUDE report 11369874 ↗
• MalfunctionJan 5, 2021Failure 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 3MAX REPERFUSION CATHETER (3MAXC), NON-PENUMBRA GUIDE CATHETER AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE GUIDE CATHETER AND GUIDEWIRE TO THE TARGET LOCATION. NEXT, WHILE ADVANCING THE 3MAXC THROUGH THE GUIDE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND 3MAXC BECAME STUCK IN THE DISTAL PORTION; APPROXIMATELY FIVE CENTIMETERS FROM EXITING THE GUIDE CATHETER. THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. 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 11120826 ↗
• MalfunctionDec 29, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE 3MAXC AND PLACED THE GUIDE CATHETER IN THE PATIENT. WHILE ADVANCING THE 3MAXC THROUGH THE GUIDE CATHETER, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE AND FOUND A KINK AT THE PROXIMAL END OF THE 3MAXC. THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC AND THE SAME GUIDE CATHETER. 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 11088988 ↗
• MalfunctionDec 18, 2020Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA GUIDE SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE 3MAXC WAS ADVANCED TO THE TARGET LOCATION TO MAKE THE FIRST PASS AND SUBSEQUENTLY, THE PHYSICIAN USED A SYRINGE TO MANUALLY ASPIRATE. IT WAS REPORTED THAT THE THROMBUS WAS STILL PRESENT AND THEREFORE, A SECOND PASS WAS ATTEMPTED. ON THE SECOND PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTICED THE 3MAXC WAS BROKEN APPROXIMATELY 315 MM FROM THE DISTAL TIP WHILE ADVANCING INTO THE GUIDE SHEATH, OUTSIDE OF THE PATIENT''S BODY. THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA DEVICES. 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 11041996 ↗
• MalfunctionDec 16, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), GUIDE CATHETER, AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED THE FIRST PASS USING THE 3MAXC AND JETD. WHILE ATTEMPTING TO MAKE THE SECOND PASS, THE PHYSICIAN REINSERTED THE JETD TO ACCESS THE VESSEL USING THE 3MAXC; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE ACCESS POINT. SUBSEQUENTLY, THE PHYSICIAN COMPLETED THE SECOND PASS AND WHILE REMOVING THE 3MAXC OUT FROM THE JETD, THE DISTAL TIP OF THE 3MAXC BROKE OFF. THEREFORE, THE PHYSICIAN PERFORMED ASPIRATION THROUGH THE JETD TO REMOVE THE BROKEN TIP OF THE 3MAXC AND THROMBUS TOGETHER. THE PROCEDURE HAD ENDED AT THIS POINT RESULTING IN THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 2B. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11015398 ↗
• MalfunctionNov 13, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, AFTER COMPLETING ONE PASS, THE 3MAXC WAS REMOVED FROM THE PATIENT FOR FLUSHING. WHILE FLUSHING THE 3MAXC, THE HOSPITAL TECHNOLOGIST NOTICED A KINK NEAR THE HUB. THEREFORE, THE 3MAXC WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10839719 ↗
• MalfunctionOct 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A NON-PENUMBRA COIL EXTRACTION PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO INSERT THE 3MAXC INTO THE CATHETER, THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 3MAXC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10621553 ↗
• MalfunctionJul 31, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE NEURON MAX, ACE68 AND 3MAXC. UPON REMOVAL OF THE 3MAXC, IT WAS NOTICED THAT THE DISTAL END OF THE 3MAXC WAS KINKED AND OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, THE SAME 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 10353802 ↗
• MalfunctionJul 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, IT WAS REPORTED THAT A GUIDEWIRE WOULD NOT ADVANCE THROUGH THE 3MAXC AND, THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10321777 ↗
• MalfunctionDec 19, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, WHILE ADVANCING THE 3MAXC AND THE ACE68 TO THE THROMBUS, IT WAS NOTICED THAT THE 3MAXC WAS BROKEN AND WAS HELD TOGETHER BY THE BRAID. THE PHYSICIAN HAD DIFFICULTY REMOVING THE 3MAXC. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9496656 ↗
• MalfunctionDec 9, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 18-DEC-2019, THERE WAS NO ALLEGED DEFICIENCY RELATED TO ANY PENUMBRA DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9439801 ↗
• MalfunctionNov 26, 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 PHYSICIAN MADE A PASS USING THE 3MAXC WITH A NON-PENUMBRA GUIDE CATHETER AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). WHILE RETRACTING, THE 3MAXC BROKE AT PROXIMAL END TOWARDS THE HUB; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC WITH THE SAME GUIDE CATHETER AND NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377766 ↗
• InjuryOct 23, 2019Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS NOTED THAT THE PATIENT CAME IN WITH APHASIA AND COMPLETE HEMIPLEGIA. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAXC THROUGH A PENUMBRA SYSTEM ACE REPERFUSION CATHETER TO THE TARGET VESSEL. THE PHYSICIAN COMPLETED ONE PASS, RETRIEVED A SMALL PIECE OF CLOT, THEN PARTIALLY RETRACTED THE 3MAXC. WHILE RETRACTING THE 3MAXC DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE, AND THE DISTAL TIP OF THE 3MAXC BROKE OFF IN THE MID-M1 SEGMENT. THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE THE BROKEN 3MAXC TIP USING A SNARE DEVICE; HOWEVER, THE TIP OF 3MAXC COULD NOT BE GRASPED AND REMOVED. THE BROKEN TIP OF THE 3MAXC WAS LEFT IN THE PATIENT. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT AND ADMINISTER AN ANTICOAGULANT TO TREAT THE APHASIA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9225813 ↗
• MalfunctionOct 22, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 68 HI-FLOW KIT AND A PENUMBRA SYSTEM 3MAXC REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND 3MAXC WERE PLACED INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THE ACE68 AND 3MAXC TO HAVE ROUGH SURFACES; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER CATHETERS. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221655 ↗
• MalfunctionOct 10, 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). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN RETRACTING THE 3MAXC OUT OF THE PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). THE PHYSICIAN CONTINUED TO RETRACT THE 3MAXC AND FOUND THAT THE DISTAL PART OF THE CATHETER WAS STRETCHED UPON REMOVAL FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9177421 ↗
• MalfunctionSep 26, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CEREBRAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN FLUSHED THE 3MAXC PRIOR TO INSERTION. WHILE ADVANCING THE 3MAXC THROUGH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE 3MAXC WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN NOTICED THERE WAS A KINK ON THE 3MAXC. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 9126484 ↗
• MalfunctionAug 14, 2019Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY FOR ACUTE CEREBRAL INFARCTION USING PENUMBRA SYSTEM MAX 3 REPERFUSION CATHETER (3 MAXC). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE INSERTING THE GUIDE WIRE INTO THE 3 MAXC AND THE 3 MAXC WAS NOT USED. IT WAS REPORTED THAT THE 3 MAXC COULD HAVE BEEN OVALIZED. THE PHYSICIAN THEN INSERTED THE GUIDEWIRE INTO ANOTHER 3 MAX; HOWEVER, HE COULD NOT CATCH THE CLOT WITH IT. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE BY USING THE SAME 3 MAXC AND 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 8895485 ↗
• MalfunctionAug 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) IN THE TARGET LOCATION. DURING ADVANCEMENT OF A NON-PENUMBRA DEVICE IN THE 3MAXC, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE 3MAXC WAS REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE USING THE ACE68 AND OTHER NON-PENUMBRA DEVICES. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8885809 ↗
• MalfunctionJul 11, 2019Physical 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 ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE 3MAXC INTO THE ACE68 AND THE 3MAXC GOT STUCK. THEREFORE, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 8780503 ↗
• MalfunctionJul 8, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE (PSR3D) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PSR3D THROUGH THE 3MAXC. IT WAS REPORTED THAT THE PSR3D FELT ¿STICKY¿ AND COULD NOT ADVANCE THROUGH THE 3MAXC; THEREFORE, THE 3MAXC AND PSR3D WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PSR3D 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 8768338 ↗
• MalfunctionJul 1, 2019Break; Break

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN FOUND THAT THE PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WAS BROKEN INTO TWO PIECES UPON REMOVAL FROM THE STERILE PACKAGING. 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 8750626 ↗
• MalfunctionJun 26, 2019Break; Fracture; Break; Fracture

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN A DISTAL BRANCH OF THE LEFT MIDDLE ARTERY USING A PENUMBRA SYSTEM 3 MAX REPERFUSION CATHETER (3MAXC) ON (B)(6) 2019. NO ISSUES WERE NOTED DURING THE PROCEDURE. THREE MONTHS AFTER THE PROCEDURE, THE HOSPITAL PERFORMED A DOPPLER ULTRASOUND FOLLOW UP AND NOTICED A FOREIGN MATERIAL IN THE CERVICAL PORTION OF THE CAROTID ARTERY INSIDE THE PATIENT. A COMPUTERIZED TOMOGRAPHY (CT) SCAN THEN CONFIRMED IT WAS A PIECE OF THE 3MAXC FROM THE PROCEDURE PERFORMED ON (B)(6) 2019. THE PIECE OF THE 3MAXC APPEARED TO BE COMPLETELY ENDOTHELIALIZED, AND THE PATIENT HAS NO SYMPTOMS RELATED TO THIS EVENT. THERE IS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8736733 ↗
• MalfunctionJun 21, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WAS BROKEN 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 8724687 ↗