Penumbra System 5MAXACE064-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00814548016207), received between Aug 13, 2015 and Nov 8, 2017 — classified as 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Out-Of-Box Failure” (11 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX), A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64) AND A NON-PENUMBRA STENT RETRIEVER. THERE WAS NO PROCEDURAL COMPLICATIONS. HOWEVER, THREE DAYS LATER, ON (B)(6) 2017, THE PATIENT HAD A GENERALIZED TONIC-CONIC SEIZURE WITH POST-SEIZURE BRACHIAL PARESIS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A SUBARACHNOID HEMORRHAGE IN THE RIGHT SYLVIAN FISSURE AND RIGHT CONVEXITY SULCI. THE CORE LAB ALSO IDENTIFIED THIS SUBARACHNOID HEMORRHAGE AND THE PATIENT WAS ADMINISTERED PROTAMINE SULFATE. THE PATIENT WAS STABILIZED AND DISCHARGED HOME ON (B)(6) 2017 WITH A MAGNETIC RESONANCE SPECTROSCOPY (MRS) SCORE OF 2 AND NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE OF 0. A FOLLOW-UP CT SCAN PERFORMED ON (B)(6) 2017, DEMONSTRATED PROGRESSION OF THE HEMATIC CONTENT DENSITY OF THE RIGHT SYLVIAN FISSURE WHICH WAS LESS EVIDENT IN THE FOLLOW UP STUDY, AND NO OTHER INTRACRANIAL ABNORMALITIES. THE INVESTIGATOR REPORTED THE EVENT AS A SERIOUS ADVERSE EVENT UNRELATED TO ACE64, OTHER PENUMBRA DEVICE (3MAX), NON-PENUMBRA DEVICE (STENT RETRIEVER) AND IV-RT-PA, AND PROBABLE RE

  Patient problems: Hemorrhage, Subarachnoid; Seizures

  MAUDE report 7011514 ↗
• MalfunctionMay 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO REMOVE THROMBUS EXTENDING FROM THE M1 SEGMENT TO THE M2 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS PLACED, EXTENDING TO THE HIGH CERVICAL SEGMENT OF THE ICA. NEXT, THE PHYSICIAN CO-AXIALLY ADVANCED A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WITH ANOTHER MANUFACTURER¿S CATHETER AND THE ACE 64 WAS NAVIGATED TO THE CLOT IN THE M1 SEGMENT. FOLLOWING THE SUCCESSFUL NAVIGATION OF THE ACE64, ANOTHER MANUFACTURER¿S MICRO-DELIVERY CATHETER WAS ADVANCED THROUGH THE CLOT TO DELIVER A STENT RETRIEVER DEVICE. THE PHYSICIAN THEN PERFORMED FIVE PASSES USING THE STENT RETRIEVER DEVICE AND THE ACE 64 BY USING THE COMBINATION THERAPY WITH NO EFFECT ON THE CLOT. FOLLOWING THE UNSUCCESSFUL COMBINATION THERAPY, THE PHYSICIAN USED ONLY THE ACE64 WITH THE ADAPT TECHNIQUE TO PARTIALLY CLEAR THE M1 SEGMENT. SOME PLAQUE AND ARTHOSCLEROTIC DISEASE REMAINED IN THE M1 SEGMENT, BUT THE M2 SEGMENT REMAINED OCCLUDED. IT WAS NOTED THAT THE ACE64 WOULD NOT PASS THROUGH THE DISEASED PORTION OF THE M1 SEGMENT; THEREFORE, T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6575345 ↗
• InjuryMay 9, 2017Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE ACE64 FRACTURED WITHIN THE PATIENT; THEREFORE THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE ACE64 FROM THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555748 ↗
• MalfunctionJan 31, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) KINKED UPON REMOVAL FROM ITS PROTECTIVE HOOP. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 6290170 ↗
• MalfunctionSep 30, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TREATING AN OCCLUDED BYPASS GRAFT USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA SHEATH ALONG WITH A GUIDEWIRE TO THE TARGET VESSEL. WHILE CROSSING THE PROXIMAL CAP OF THE GRAFT, THE PHYSICIAN EXPERIENCED DIFFICULTY BUT WAS ABLE TO SUCCESSFULLY ADVANCE THE GUIDEWIRE. HOWEVER, THE PHYSICIAN DID NOT WANT TO LOSE GUIDEWIRE ACCESS AND ADVANCED A SECOND GUIDEWIRE SO THAT A BUDDY SYSTEM COULD BE USED WHILE USING THE PENUMBRA SYSTEM. THE PHYSICIAN THEN ADVANCED THE ACE 64 THROUGH THE SHEATH; HOWEVER, WHILE ADVANCING THE ACE 64,THE PHYSICIAN EXPERIENCED RESISTANCE NOTICED THAT THE TIP OF THE CATHETER BECAME KINKED. IT IS UNCLEAR WHEN THE KINK OCCURRED. CONSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE A SEPARATOR WIRE THROUGH THIS KINKED ACE 64 AND THEREFORE THE ACE 64 WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED AN INDIGO SYSTEM ASPIRATION CATHETER 5(CAT5) OVER THE GUIDEWIRE THEN REMOVED THE GUIDEWIRE BEFORE ADVANCING THE SEP5 THROUGH THE CAT5. AS THE ASPIRATION WAS INITIATED, THE PHYSICIAN MENTIONED EXPERIENCING RESISTANCE WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5992115 ↗
• MalfunctionJul 6, 2016Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, AFTER THE SECOND PASS USING ANOTHER MANUFACTURER'S REVASCULARIZATION DEVICE THROUGH THE ACE 64, THE PHYSICIAN NOTICED THAT THE ACE 64 BROKE AT THE CATHETER AND HUB CONNECTION. THEREFORE, THE ACE 64 WAS REMOVED AND THE PROCEDURE WAS STOPPED SINCE THE PHYSICIAN HAD OBTAINED ADEQUATE REVASCULARIZATION. THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE, FRICTION OR DIFFICULTY WHILE USING THE ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5772406 ↗
• MalfunctionJun 24, 2016Unraveled Material; Material Integrity Problem; Unraveled Material; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE 60) AND A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE PHYSICIAN USED THE ACE 60 FOR THE FIRST PASS AND AFTER ASPIRATION, THE ACE 60 WAS REMOVED. AFTER REMOVAL, THE TIP OF THE ACE 60 WAS FOUND TO BE FRACTURED AND COULD NOT BE USED FOR THE SECOND PASS. THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE, FRICTION OR DIFFICULTY WHILE USING THE ACE 60. AN ACE 64 WAS THEN OPENED FOR THE PROCEDURE AND IT WAS NOTICED THAT THERE WAS AN UNWINDING OF COILED WIRE AT THE HUB OF THE ACE 64. THE PHYSICIAN ATTEMPTED TO ADVANCE A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX) THROUGH THE ACE 64; HOWEVER, THE WIRE WAS UNCOILING AGAIN AT THE HUB AND SUBSEQUENTLY, THE ACE 64 DID NOT ENTER THE PATIENT'S BODY. AGAIN, THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE OR FRICTION WHILE ATTEMPTING TO ADVANCE THE 3MAX THROUGH THE ACE 64. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING A NEW ACE 64 AND THE SAME 3MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749356 ↗
• MalfunctionJun 24, 2016Fluid/Blood Leak; Fluid/Blood Leak

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS LEAKING SALINE AT THE JUNCTION OF THE HUB AND THE CATHETER. THERE WAS NO OBSERVED DAMAGE TO THE ACE 64. HOWEVER, DUE TO THE OBSERVED LEAK, THE ACE 64 WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5749089 ↗
• MalfunctionJun 8, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) BECAME KINKED AT THE PROXIMAL HUB WHILE IT WAS BEING REMOVED FROM THE PACKAGING. THE ACE 64 BECAME KINKED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5707714 ↗
• MalfunctionMay 13, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED ACE 64 WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5654824 ↗
• MalfunctionApr 22, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5598696 ↗
• MalfunctionApr 14, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5577932 ↗
• MalfunctionApr 14, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED AT THE HUB UPON REMOVAL FROM THE DISPENSER HOOP. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5577147 ↗
• InjuryApr 4, 2016Break; Migration or Expulsion of Device; Retraction Problem; Break; Migration or Expulsion of Device; Retraction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) WAS INSERTED INTO THE LEFT ICA AND THEN THE ACE 64 WAS ADVANCED TO THE PROXIMAL SIDE OF THE M1 OCCLUSION OVER A VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND GUIDEWIRE. THE VELOCITY AND GUIDEWIRE WERE REMOVED AND ASPIRATION WAS INITIATED USING THE PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX). THE M1 CLOT WAS REMOVED UTILIZING THE ADAPT TECHNIQUE. WHILE WITHDRAWING THE ACE 64 FROM THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE, APPLIED ADDITIONAL PULLING FORCE IN ORDER TO WITHDRAW THE ACE 64. AN ANGIOGRAM WAS THEN PERFORMED, WHICH CONFIRMED THAT THE CLOT HAD BEEN SUCCESSFULLY REMOVED FROM THE M1; HOWEVER, IT ALSO REVEALED THAT AN APPROXIMATE 25 CENTIMETER SEGMENT OF THE ACE 64 DISTAL TIP WAS LEFT IN THE PATIENT'S ICA. THE BROKEN SEGMENT OF THE ACE 64 EXTENDED FROM THE OPHTHALMIC PORTION OF THE ICA DOWN INTO THE EXTERNAL CAROTID ARTERY. THE ACE 64 SEGMENT WAS NOT OCCLUSIVE TO THE ICA AND ADEQUATE BLOOD FLOW AROUND THE ACE 64 WAS OBSERVED

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 5544982 ↗
• MalfunctionMar 28, 2016Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE INJECTING CONTRAST, THE HUB OF THE ACE 64 FELL OFF. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5530527 ↗
• MalfunctionMar 25, 2016Fracture; Unraveled Material; Fracture; Unraveled Material

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE PHYSICIAN MADE A TOTAL OF TEN PASSES USING THE ACE64 AND MULTIPLE OTHER DEVICES. DURING ONE OF THE PASSES, A PART OF THE ORGANIZED OCCLUSIVE FIRM CLOT ON THE ATHEROSCLEROTIC PLAQUE AT THE CAVERNOUS INTERNAL CAROTID ARTERY (ICA) WAS ASPIRATED INTO THE ACE64. THEREAFTER, THE PHYSICIAN NOTICED THAT THERE WERE MULTIPLE SEGMENTS WITHIN THE ACE64 THAT BECAME BLOCKED WITH CLOT OR PLAQUE. THE PHYSICIAN BELIEVES THAT THE ACE64 MAY HAVE BEEN KINKED AT ONE OF THE SEGMENTS AND CAUSED THE ACE64 TO UNRAVEL AND BECOME FRACTURED AS IT WAS BEING REMOVED FROM THE NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). THE FRACTURED ACE64 WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5527703 ↗
• MalfunctionMar 4, 2016Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNICIAN NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS KINKED UPON REMOVAL FROM THE DISPENSER HOOP. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5480296 ↗
• MalfunctionFeb 4, 2016Air Leak; Physical Property Issue; Air Leak; Physical Property Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE MIDDLE OF PROCEDURE, THE TECHNOLOGIST HEARD AIR AND THEN NOTICED THAT THERE WAS A LEAK AT THE HUB OF THE ACE 64. THE ACE 64 WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW ACE 64. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5411661 ↗
• MalfunctionFeb 2, 2016Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS BROKEN AROUND THE PROXIMAL SHAFT NEAR THE HUB UPON REMOVAL FROM ITS PACKAGING. THE BROKEN ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 5405588 ↗
• InjuryJan 20, 2016Failure to Advance; Physical Resistance; Difficult to Advance; Failure to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A CERVICAL LOOP IN THE DISTAL RIGHT M1 SECTION OF THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, THE FIRST PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S MICROCATHETER THROUGH THE LOOP WITHOUT ANY ISSUES AND ATTEMPTED TO TRACK THE ACE 64 THROUGH THE LOOP BUT WAS UNABLE TO. A SECOND PHYSICIAN THEN ATTEMPTED TO TRACK THE ACE 64 BUT WAS ALSO UNSUCCESSFUL AND INDICATED THAT THERE WAS A LOT OF WALL TENSION. SINCE THE MICROCATHETER WAS UNABLE TO REACH THE OCCLUSION, THE PHYSICIANS DECIDED TO REMOVE THE ACE 64 AND GO BACK IN WITH A NEW ACE 64. HOWEVER, AFTER REMOVING THE ACE 64 FROM THE PATIENT, THE PHYSICIANS NOTICED THAT THE ICA WAS DISSECTED IN THE LOOP AND THEY WERE UNABLE TO GET BACK UP TO THE ICA. AN ANGIOGRAM WAS PERFORMED TO CONFIRM CROSS FILLING AND THE PROCEDURE WAS STOPPED. IT IS UNKNOWN EXACTLY WHEN THE DISSECTION OCCURRED BECAUSE THERE WERE NO INTERIM ANGIOGRAMS PERFORMED WHILE THE PHYSICIANS WERE ATTEMPTING TO TRACK THE ACE 64. HOWEVER, THE SECOND PHYSICIAN INDICATED THAT THE ICA MAY HAVE BEEN DISSECTED ABOUT 15-20 MINUTES BEFORE THEY RECOGNIZED IT. THE P

  Patient problems: Vascular Dissection

  MAUDE report 5381627 ↗
• MalfunctionJan 14, 2016Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE DOING A PASS, THE ACE 64 WAS BEING RETRACTED AND BECAME STRETCHED. THE PHYSICIAN REMOVED THE ACE 64 FROM THE PATIENT AND COMPLETED THE PROCEDURE USING A NEW PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAX). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5367677 ↗
• MalfunctionDec 23, 2015Component Missing; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE LEAD TECHNOLOGIST NOTICED THAT A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS MISSING FROM ITS PACKAGING. THE PROCEDURE CONTINUED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5324793 ↗
• InjuryDec 11, 2015Retraction Problem; Material Separation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE IN USE WITH A NEURON MAX 088 (NEURON MAX), THE PHYSICIAN ATTEMPTED TO RETRACT THE ACE 64 FROM THE PATIENT'S ICA; HOWEVER, THE TIP OF THE ACE 64 GOT CAUGHT BETWEEN THE VESSEL AND THE NEURON MAX. UPON PULLING BACK THE ACE 64, THE TIP OF THE ACE 64 BECAME DISPLACED AND WAS FOUND IN THE DISTAL END OF THE NEURON MAX. THE PHYSICIAN REQUIRED ANOTHER MANUFACTURER'S DEVICE TO SUCCESSFULLY REMOVE THE TIP OF THE ACE 64 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW ACE 64 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 5288707 ↗
• MalfunctionDec 7, 2015Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) WAS FOUND KINKED UPON REMOVAL FROM ITS PACKAGING. THE KINKED ACE 64 WAS FOUND PRIOR TO USE AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE CONTINUED USING A NEW ACE 64.

  Patient problems: No Patient Involvement

  MAUDE report 5272539 ↗
• InjuryDec 1, 2015Bent; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64). DURING THE PROCEDURE, WHILE REMOVING THE ACE 64 FROM THE PATIENT VIA PUMP ASPIRATION, THE PHYSICIAN ASPIRATED THE OTHER MANUFACTURER'S SHEATH AS THE ACE 64 WAS BEING RETRACTED; HOWEVER, THE SHEATH COLLAPSED AND CRIMPED THE TIP OF THE ACE 64. THE ACE 64 BECAME BENT AT THE Y-ARM AND THE DISTAL END OF THE TIP BROKE OFF INTO THE INTERNAL CAROTID ARTERY (ICA) AS THEY PULLED ON THE ACE 64. THE PHYSICIAN REQUIRED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE BROKEN ACE 64 FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SINCE THE TARGET ARTERY WAS CLEARED UP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5259643 ↗