Penumbra System PAPS3-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00814548010007), received between Mar 21, 2019 and Oct 8, 2021 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (15 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA ENGINE (ENGINE), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER A SHORT TIME OF BEING IN USE, THE ENGINE DID NOT WORK PROPERLY. NONE OF THE ENGINE INDICATOR LIGHTS WERE ILLUMINATED AND THE ISSUE PERSISTED AFTER THE CANISTER WAS RESET AND THE TUBING WAS RE-CONNECTED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, THE SAME ENGINE, THE SAME GUIDE CATHETER, THE SAME CATHETERS, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599353 ↗
• MalfunctionMar 29, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, AFTER ONE PASS WAS MADE, THE ASPIRATION SPEED SLOWED, AND THE INDICATOR LIGHTS ON THE ENGINE WERE OFF. THE PHYSICIAN RESET THE DEVICES TWICE AND CHECKED THE LID OF THE CANISTER. THE INDICATOR LIGHTS REMAINED OFF, AND THE FLOW SWITCH WAS OFF. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME ENGINE AND ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586462 ↗
• MalfunctionJan 20, 2021Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PHYSICIAN TURNED ON THE ENGINE AND NOTICED ONLY THREE INDICATOR LIGHTS WOULD ILLUMINATE ON THE ENGINE. THEREFORE, THE PHYSICIAN REMOVED THE TUBING FROM THE CANISTER AND BLOCKED THE PORT ON THE CANISTER BY HAND TO HAVE ALL FOUR LIGHTS ILLUMINATED ON THE ENGINE. IT WAS ALSO REPORTED THAT THE PHYSICIAN REATTACHED THE TUBING BACK ON THE CANISTER; HOWEVER, ALL FOUR INDICATOR LIGHTS ON THE ENGINE WOULD NOT ILLUMINATE. THEREFORE, THE CANISTER AND ENGINE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. 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 11201393 ↗
• MalfunctionNov 13, 2020Connection Problem; Infusion or Flow Problem; Connection Problem; Infusion or Flow Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 AND M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JETD INTO THE M1 AND TURNED ON THE ENGINE. IT WAS OBSERVED THAT THE CANISTER WAS NOT SET PROPERLY IN THE ENGINE, AND MULTIPLE ATTEMPTS WERE MADE TO RESOLVE THE ISSUE. AFTER THE CANISTER WAS SET PROPERLY IN THE ENGINE, THE FOUR INDICATOR LIGHTS ON THE ENGINE WERE NOT ILLUMINATED AS THERE WAS NOT ENOUGH VACUUM PRESSURE. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, AND THE SAME ENGINE. 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 10838708 ↗
• MalfunctionOct 8, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA ENGINE (ENGINE), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A BALLOON GUIDE CATHETER AND A REVASCULARIZATION DEVICE. DURING THE PROCEDURE, THE DEVICES WERE SET UP AND CONNECTED TO THE PATIENT AND THE ENGINE WAS POWERED ON. THE ENGINE INDICATOR LIGHTS DID NOT ILLUMINATE UNTIL PRESSURE WAS APPLIED BY HAND TO THE CANISTER. WHEN THE PRESSURE WAS REMOVED, THE LIGHTS CEASED TO ILLUMINATE. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, THE SAME ENGINE, AND THE SAME 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 10653246 ↗
• MalfunctionSep 14, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TOP OF THE BASILAR ARTERY (BA-TOP) USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND A STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE STENT RETRIEVER AFTER COMPLETING ONE PASS AND SUBSEQUENTLY INITIATED ASPIRATION. HOWEVER, THE ENGINE STOPPED ASPIRATING AND IT WAS REPORTED THAT NO INDICATOR LIGHTS WERE ILLUMINATED AND THE ENGINE WAS NOT INCREASING IN PRESSURE. TROUBLESHOOTING WAS PERFORMED BUT THE ISSUE REMAINED UNRESOLVED. THEREFORE, THE ENGINE AND CANISTER WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION 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 10532202 ↗
• MalfunctionAug 25, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), ASPIRATION TUBING (TUBING), A PENUMBRA ENGINE (ENGINE), A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE TUBING WAS CONNECTED TO THE PATIENT AND ASPIRATION WAS INITIATED. HOWEVER, NONE OF THE ENGINE INDICATOR LIGHTS WERE ILLUMINATED. THE PHYSICIAN RESET THE ENGINE BUT THE ISSUE WAS NOT RESOLVED. NEXT, THE PHYSICIAN DECIDED TO REMOVE THE CANISTER AND EXCHANGE IT FOR A NEW ONE. IT WAS ALSO REPORTED THAT THE LID OF THE CANISTER FELT LOOSE. THE PROCEDURE WAS THEN COMPLETED USING THE NEW CANISTER, THE SAME ENGINE, THE SAME TUBING, THE SAME ACE60, AND THE SAME STENT RETRIEVER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451953 ↗
• MalfunctionAug 13, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, WHEN THE ASPIRATION TUBING (TUBING) WAS CONNECTED TO THE PATIENT, THE PENUMBRA ENGINE (ENGINE) INDICATOR LIGHTS WERE NOT TURNING ON AND NO ASPIRATION WAS BEING PRODUCED. THEREFORE, THE TUBING WAS REMOVED FROM THE PATIENT AND THE CANISTER AND ENGINE WERE NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA ASPIRATION DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT ON THE FOLLOWING DAY A NEW CANISTER WAS TESTED WITH THE SAME ENGINE AND THE ISSUE RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404638 ↗
• MalfunctionJun 30, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), ASPIRATION TUBING (TUBING), PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A CANISTER IN THE ENGINE, AND AFTER IT WAS POWERED ON, THE FOUR INDICATOR LIGHTS ON THE ENGINE WERE NOT ILLUMINATED. THE PHYSICIAN WAS CONCERNED THAT THERE WAS A BAD CONNECTION WITH THE ENGINE AND JET7, WHICH WERE CONNECTED BY THE TUBING; SUBSEQUENTLY, THE PHYSICIAN HELD THE TUBING WITH FORCEPS BUT WAS NOT ABLE TO RESOLVE THE ISSUE. THE PHYSICIAN THEN REMOVED THE TUBING FROM THE ENGINE, PLACED THEIR FINGER ONTO THE SUCTION PORT OF THE ENGINE, AND NOTED THAT THEY DID NOT FEEL THE VACUUM PRESSURE; THEREFORE, THE CANISTER WAS REMOVED. NEXT, THE PHYSICIAN PLACED ANOTHER CANISTER IN THE ENGINE. THE FOUR INDICATOR LIGHTS ON THE ENGINE WERE INITIALLY ILLUMINATED BUT LATER DECREASED TO TWO INDICATOR LIGHTS. THE PROCEDURE WAS COMPLETED USING THE SECOND CANISTER AND SAME ENGINE. IT WAS REPORTED THAT WHILE THE VACUUM PRESSURE WAS NOT STABLE, A THROMBOLYSIS IN CEREBRAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10215803 ↗
• MalfunctionMay 8, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE CANISTER IN THE ENGINE AND NOTICED THAT THE ENGINE WAS NOT ACHIEVING VACUUM PRESSURE. IT WAS REPORTED THAT ONLY TWO OF THE FOUR INDICATOR LIGHTS ON THE ENGINE WERE ILLUMINATED; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037369 ↗
• MalfunctionApr 23, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTERS (CANISTERS). DURING THE PROCEDURE, THE ENGINE WAS NOT MAINTAINING FULL VACUUM PRESSURE. ALL FOUR INDICATOR LIGHTS ON THE ENGINE WERE ILLUMINATED AT THE START BUT WOULD DROP DOWN TO TWO INDICATOR LIGHTS. THE HOSPITAL TECHNOLOGIST ATTEMPTED TO TROUBLESHOOT THE ENGINE BY REMOVING THE LID OF THE FIRST CANISTER AND THEN PLACING IT BACK ON; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE TECHNOLOGIST THEN SWITCHED TO A SECOND CANISTER; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE AND A THIRD CANISTER. IT WAS REPORTED THAT IN ORDER TO MAINTAIN FULL VACUUM PRESSURE, THE TECHNOLOGIST HAD TO PRESS DOWN ON THE THIRD CANISTER THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991563 ↗
• MalfunctionApr 23, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTERS (CANISTERS). DURING THE PROCEDURE, THE ENGINE WAS NOT MAINTAINING FULL VACUUM PRESSURE. ALL FOUR INDICATOR LIGHTS ON THE ENGINE WERE ILLUMINATED AT THE START BUT WOULD DROP DOWN TO TWO INDICATOR LIGHTS. THE HOSPITAL TECHNOLOGIST ATTEMPTED TO TROUBLESHOOT THE ENGINE BY REMOVING THE LID OF THE FIRST CANISTER AND THEN PLACING IT BACK ON; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE TECHNOLOGIST THEN SWITCHED TO A SECOND CANISTER; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE AND A THIRD CANISTER. IT WAS REPORTED THAT IN ORDER TO MAINTAIN FULL VACUUM PRESSURE, THE TECHNOLOGIST HAD TO PRESS DOWN ON THE THIRD CANISTER THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991561 ↗
• MalfunctionApr 22, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA ENGINE CANISTER (CANISTER), A PENUMBRA ENGINE (ENGINE), A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE JET7 TOWARDS THE TARGET VESSEL AND SIMULTANEOUSLY POWERED ON THE ENGINE. IT WAS REPORTED THAT NONE OF THE INDICATOR LIGHTS ILLUMINATED. THE PHYSICIAN CHECKED THE SEAL OF THE CANISTER LID AS WELL AS THE CONNECTION TO THE ASPIRATION TUBING (TUBING), THEN TURNED THE ENGINE ON AND OFF; HOWEVER, THE PROBLEM PERSISTED. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER, THE SAME ENGINE, THE SAME JET7, AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988781 ↗
• MalfunctionApr 10, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A PENUMBRA ENGINE CANISTER (CANISTER), AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE WOULD NOT ASPIRATE; THEREFORE, THE PHYSICIAN REMOVED AND RE-INSTALLED THE CANISTER BUT THE ISSUE DID NOT CHANGE. THEREFORE, THE CANISTER WAS REMOVED. IT WAS ALSO REPORTED THAT THE JET7 KINKED AND WOULD NOT ASPIRATE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JET7, A NEW CANISTER, AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9950280 ↗
• MalfunctionApr 3, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING A PENUMBRA SYSTEM ACE68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA GUIDE CATHETER (OPTIMO), A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER) AND AN ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE68 THROUGH THE OPTIMO TO THE FACE OF THE CLOT. THEN, THE ENGINE AND CANISTER WERE SETUP, THE TUBING WAS CONNECTED TO THE ACE68 AND THE ENGINE WAS TURNED ON; HOWEVER, NO NEGATIVE PRESSURE WAS GENERATED. THE ENGINE WAS TURNED OFF, THE TUBING WAS RECONNECTED, AND THE ENGINE WAS TURNED BACK ON; HOWEVER, NO NEGATIVE PRESSURE WAS GENERATED. THE PHYSICIAN, THEN REMOVED THE TUBING AND USED A NEW TUBING; HOWEVER, NO NEGATIVE PRESSURE WAS GENERATED; THEREFORE, THE ENGINE WAS TURNED OFF. IT WAS REPORTED THAT POST-PROCEDURE, A DEMO TUBING AND DEMO CANISTER WERE CONNECTED TO THE ENGINE AND THE ENGINE WORKED FINE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9925338 ↗
• MalfunctionMar 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A THROMBECTOMY IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE CATRX IN THE TARGET VESSEL AND THE CANISTER IN THE RECEPTACLE OF THE ENGINE. WHILE THE ENGINE WAS POWERED ON, ONLY THREE OUT OF THE FOUR INDICATOR LIGHTS WERE ILLUMINATED ON THE ENGINE; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE AND CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863081 ↗
• MalfunctionFeb 27, 2020Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) AND RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA SYSTEM JET7 REPERFUSION CATHETER (JET7), AND A NON-PENUMBRA BALLOON GUIDING CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE JET7 IN THE MCA, THE BALLOON GUIDING CATHETER IN THE RIGHT ICA, AND THE CANISTER IN THE ENGINE. THE ENGINE WAS THEN CONNECTED TO THE JET7 AND POWERED ON, BUT THE PHYSICIAN NOTICED THAT ONE OUT OF FOUR INDICATOR LIGHTS ON THE ENGINE WAS ILLUMINATED, AND THE VACUUM PRESSURE WAS NOT INCREASING. THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT THE ENGINE BY POWERING IT OFF AND POWERING IT ON, BUT THE ISSUE WAS NOT RESOLVED; THEREFORE, THE ENGINE AND CANISTER WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) AND THE SAME JET7 AND BALLOON GUIDING CATHETER. IT WAS REPORTED THAT THE AFTER THE PROCEDURE, THE HOSPITAL STAFF TROUBLESHOOTED THE ENGINE AND CANISTER AGAIN. THE ENGINE WAS FOUND TO BE WORKING AND THE CANISTER NOT WORKING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9760305 ↗
• MalfunctionJan 2, 2020Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER), PENUMBRA ENGINE (ENGINE), AND VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE CANISTER WAS PLACED ON THE ENGINE. THE HOSPITAL STAFF THEN POWERED ON THE ENGINE AND NOTICED THERE WAS NO ASPIRATION. SUBSEQUENTLY, THEY ATTEMPTED TO TROUBLESHOOT THIS ISSUE BUT WAS NOT ABLE TO SOLVE THE PROBLEM; THEREFORE, THE CANISTER WAS REPLACED. NEXT, THE HOSPITAL STAFF OPENED A VELOCITY AND NOTICED THE HUB WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE VELOCITY WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SECOND CANISTER, THE SAME ENGINE, AND ANOTHER VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9541165 ↗
• MalfunctionNov 18, 2019Break; Device Fell; Break; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE ENGINE WAS PLACED ON A STROKE CART. IT WAS REPORTED THAT A CANISTER WAS PLACED ONTO THE ENGINE. WHILE THE ENGINE WAS POWERED ON, THE VIBRATION CAUSED THE ENGINE, ALONG WITH THE CANISTER, TO MIGRATE OVER THE EDGE OF THE CART AND FALL TO THE FLOOR. IT WAS ALSO REPORTED THAT THE CANISTER BROKE DURING THE FALL, BUT THERE WAS NO NOTICEABLE DAMAGE ON THE ENGINE; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER ENGINE AND CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9337610 ↗
• MalfunctionNov 18, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE CANISTER WAS NOT HOLDING PRESSURE; THEREFORE, THE CANISTER REMOVED. A SECOND CANISTER AND THE PENUMBRA ENGINE (ENGINE) WERE NOT USED TO CONTINUE THE PROCEDURE; IT WAS REPORTED THAT BY THE TIME THE SECOND CANISTER WAS BROUGHT IN TO THE ROOM, THE PHYSICIAN HAD ALREADY USED A 60CC SYRINGE. THE PROCEDURE WAS COMPLETED USING AN ASPIRATION METHOD WITH THE 60CC SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336802 ↗
• MalfunctionNov 1, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN CONNECTED THE CANISTER TO AN ASPIRATION TUBING (TUBING) AND POWERED ON A PENUMBRA ENGINE (ENGINE); HOWEVER, NO VACUUM WAS PRODUCED. THE PHYSICIAN NOTICED THE CANISTER WAS NOT SEATED SECURELY TO THE ENGINE AND RE-SEATED THE ENGINE SEVERAL TIMES; HOWEVER, NO VACUUM WAS PRODUCED; THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269681 ↗
• MalfunctionNov 1, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE CANISTER ON THE PENUMBRA ENGINE PUMP (ENGINE) AND NOTICED ONLY THREE LIGHTS WOULD ILLUMINATE INDICATING THAT THE ENGINE WAS NOT AT A FULL ASPIRATION POWER. THEREFORE, THE CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269679 ↗
• MalfunctionOct 25, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE CANISTER WOULD NOT SEAT PROPERLY ONTO THE PENUMBRA ENGINE (ENGINE) AND ONLY 3 OF THE 4 LED LIGHTS WOULD LIGHT UP. AFTER A FEW FAILED ATTEMPTS TO REPOSITION THE CANISTER, THE PHYSICIAN REMOVED THE CANISTER. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9239729 ↗
• MalfunctionOct 17, 2019Pressure Problem; Pressure Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF ATTEMPTED TO RESEAT THE CANISTER MULTIPLE TIMES ON THE PENUMBRA ENGINE (ENGINE). HOWEVER, THE CANISTER WOULD NOT BUILD VACUUM; THEREFORE, THE CANISTER WAS REMOVED. IT WAS REPORTED THAT NONE OF THE FOUR INDICATOR LIGHTS ON THE ENGINE WERE ILLUMINATED. THE PROCEDURE WAS COMPLETED USING ANOTHER CANISTER AND THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203065 ↗
• MalfunctionSep 25, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE HOSPITAL STAFF REMOVED THE CANISTER MULTIPLE TIMES FROM THE PENUMBRA ENGINE (ENGINE) AND RE-SEATED IT; HOWEVER, THE CANISTER FAILED TO PRODUCE VACUUM. IT WAS REPORTED THAT ONLY TWO OF THE FOUR INDICATOR LIGHTS WOULD ILLUMINATE. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9120761 ↗