Penumbra System PMXENGN-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00815948020023), received between Oct 24, 2018 and Nov 19, 2021 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (24 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Electrical /Electronic Property Problem; Device Fell; Electrical /Electronic Property Problem; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ILIAC VEIN USING A PENUMBRA ENGINE (ENGINE) AND A PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE ENGINE FELL OFF THE TABLE AND BECAME BROKEN. IT WAS ALSO REPORTED THAT THERE WAS NO NOTICEABLE DAMAGE TO THE ENGINE; HOWEVER, THE ENGINE WOULD NOT POWER ON AT ALL. THEREFORE, THE ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ENGINE AND A NEW CANISTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849326 ↗
• MalfunctionNov 12, 2021Decrease in Suction; Decrease in Suction

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN AND INFERIOR VENA CAVA (IVC) USING A PENUMBRA ENGINE (ENGINE) AND A LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, WHILE ASPIRATING CLOT USING THE ENGINE AND THE LIGHTNING, THE ENGINE LOST POWER TOWARDS THE END OF THE PROCEDURE. TO TROUBLESHOOT, THE ENGINE WAS POWER CYCLED, AND THE LIGHTNING WAS UNPLUGGED AND REPLUGGED INTO THE ENGINE; HOWEVER, THE ISSUE WAS NOT RESOLVED. IT WAS REPORTED THAT A NEW LIGHTNING WAS PLUGGED INTO THE ENGINE; HOWEVER, THE LIGHTNING UNIT DID NOT POWER ON. THEREFORE, THE FIRST LIGHTNING AND ENGINE WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. NEXT, THE PHYSICIAN PLUGGED THE NEW LIGHTNING INTO ANOTHER ENGINE AND THE LIGHTNING UNIT POWERED ON; HOWEVER, UPON POWERING ON THE ENGINE, IT WAS REPORTED ONLY TWO OF THE FOUR INDICATOR LIGHTS ILLUMINATED, AND THE INDICATOR LIGHTS WERE VERY DIM. THE PROCEDURE WAS COMPLETED USING THE NEW LIGHTNING AND THE SECOND ENGINE WITH ONLY TWO OF THE FOUR INDICATOR LIGHTS ILLUMINATED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807277 ↗
• MalfunctionNov 12, 2021Complete Loss of Power; Complete Loss of Power

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN AND INFERIOR VENA CAVA (IVC) USING A PENUMBRA ENGINE (ENGINE) AND A LIGHTNING ASPIRATION TUBING (LIGHTNING). DURING THE PROCEDURE, WHILE ASPIRATING CLOT USING THE ENGINE AND THE LIGHTNING, THE ENGINE LOST POWER TOWARDS THE END OF THE PROCEDURE. TO TROUBLESHOOT, THE ENGINE WAS POWER CYCLED, AND THE LIGHTNING WAS UNPLUGGED AND RE-PLUGGED INTO THE ENGINE; HOWEVER, THE ISSUE WAS NOT RESOLVED. IT WAS REPORTED THAT A NEW LIGHTNING WAS PLUGGED INTO THE ENGINE; HOWEVER, THE LIGHTNING UNIT DID NOT POWER ON. THEREFORE, THE FIRST LIGHTNING AND ENGINE WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. NEXT, THE PHYSICIAN PLUGGED THE NEW LIGHTNING INTO ANOTHER ENGINE AND THE LIGHTNING UNIT POWERED ON; HOWEVER, UPON POWERING ON THE ENGINE, IT WAS REPORTED ONLY TWO OF THE FOUR INDICATOR LIGHTS ILLUMINATED, AND THE INDICATOR LIGHTS WERE VERY DIM. THE PROCEDURE WAS COMPLETED USING THE NEW LIGHTNING AND THE SECOND ENGINE WITH ONLY TWO OF THE FOUR INDICATOR LIGHTS ILLUMINATED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807240 ↗
• MalfunctionSep 13, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), ASPIRATION TUBING (TUBING), AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, SOME OF THE ENGINE INDICATOR LIGHTS DID NOT ILLUMINATE WHEN THE DEVICE WAS POWERED ON. THE TECHNOLOGIST EXCHANGED THE CANISTER FOR A NEW ONE AND ATTEMPTED TO RE-SEAT IT IN THE ENGINE; HOWEVER, THE ISSUE PERSISTED. THEREFORE, THE CANISTER WAS REMOVED AND THE TUBING WAS EXCHANGED FOR A NEW ONE. WHILE USING THE NEW TUBING AND A NEW CANISTER, ONLY TWO OF THE ENGINE INDICATOR LIGHTS ILLUMINATED. THEREFORE, THE ENGINE AND THE CANISTER WERE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ENGINE, A NEW CANISTER, THE SAME TUBING, AND THE SAME ACE68. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465484 ↗
• MalfunctionSep 3, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) AND THE BASILAR ARTERY USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), A NON-PENUMBRA REVASCULARIZATION DEVICE, A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A NON-PENUMBRA STENT RETRIEVER. DURING THE PROCEDURE, THE ENGINE SOUNDED LIKE IT WAS FUNCTIONAL; HOWEVER, NONE OF THE INDICATOR LIGHTS ILLUMINATED AND NO ASPIRATION WAS BEING PRODUCED. IT WAS REPORTED THAT THE LID OF THE CANISTER AND THE ENGINE WERE CHECKED SEVERAL TIMES BUT THE ISSUE PERSISTED. THEREFORE, THE ENGINE AND THE CANISTER WERE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SYRINGE TO PERFORM MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423787 ↗
• MalfunctionJun 9, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE CORONARY ARTERY USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN NOTICED NONE OF THE INDICATOR LIGHTS ON THE ENGINE WOULD ILLUMINATE AND THE ENGINE WAS NOT GENERATING ASPIRATION. THE GROMMETS NEAR THE CANISTERS WERE REMOVED IN AN ATTEMPT TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE VACUUM RELEASE LEVER WAS DEPRESSED. THEREFORE, ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A MANUAL ASPIRATION CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971308 ↗
• MalfunctionJun 4, 2021Break; Vibration; Device Fell; Break; Vibration; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE FELL OFF THE TABLE DUE TO VIBRATIONS THEREBY CAUSING THE VACUUM RELEASE LEVER TO BREAK. THE PUMP FELL PRIOR TO THE CATHETER BEING ADVANCED INTO THE PATIENT. THE FOUR LED LIGHTS WERE ON AND THE PHYSICIAN FOUND THE ENGINE TO BE FUNCTIONAL. THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939356 ↗
• MalfunctionMay 19, 2021Failure to Power Up; Failure to Power Up

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) GRAFT IN THE UPPER ARM USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE WOULD NOT POWER ON. THE PENUMBRA SALES REPRESENTATIVE MADE SEVERAL ATTEMPTS TO TURN THE ENGINE ON AND PLUGGED THE ENGINE INTO MULTIPLE WORKING ELECTRICAL PLUGS; HOWEVER, THE ENGINE WOULD NOT TURN ON. THEREFORE, THE ENGINE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN EMBOLECTOMY BALLOON AND ASPIRATION THROUGH A CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848861 ↗
• MalfunctionMay 5, 2021Connection Problem; Connection Problem

  THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), PENUMBRA ENGINE CANISTER (CANISTER), AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN PLUGGED IN THE LIGHTNING UNIT INTO THE BACK OF THE ENGINE; HOWEVER, THE LIGHTNING UNIT WOULD NOT POWER ON AND THE INDICATOR LIGHT WAS NOT ILLUMINATED. THE PHYSICIAN TURNED THE POWER TO THE ENGINE OFF AND TURNED IT BACK ON IN AN ATTEMPT TO TROUBLESHOOT BUT, IT WAS UNSUCCESSFUL AND THE LIGHTNING UNIT WOULD NOT POWER ON. THEREFORE, THE LIGHTNING UNIT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION TUBING (TUBING) WITH THE SAME CAT7 AND ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780701 ↗
• MalfunctionApr 15, 2021Device Fell; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING A PENUMBRA ENGINE (ENGINE) AND INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX). DURING THE PROCEDURE, THE ENGINE VIBRATED OFF THE TABLE AND FELL. THIS OCCURRED WHILE THE ENGINE WAS CONNECTED TO THE CATRX, WHICH WAS OUTSIDE THE PATIENT BODY. SUBSEQUENTLY, THE TOP OF THE ENGINE BROKE OFF. THE PHYSICIAN WAS ABLE TO USE THE SAME ENGINE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671323 ↗
• MalfunctionApr 14, 2021Vibration; Device Fell; Vibration; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE PRIOR TO ACCESSING THE VESSEL, THE ENGINE VIBRATED OFF THE TABLE AND FELL ONTO THE FLOOR; CONSEQUENTLY, THE ENGINE STOPPED WORKING AND WAS NOT ABLE TURN BACK ON AT ALL. THE PROCEDURE WAS COMPLETED USING ANOTHER ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668242 ↗
• MalfunctionApr 8, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ON/OFF POWER BUTTON BROKE AND FELL INTO THE PUMP. THEREFORE, THE ENGINE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638414 ↗
• MalfunctionApr 5, 2021Crack; Suction Problem; Crack; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE WAS NOTICED TO BE CRACKED AND NOT FUNCTIONING PROPERLY. THE CRACK WAS NOTICED DURING THE START OF THE PROCEDURE WHEN THE FOUR INDICATOR LIGHTS WOULD NOT INITIATE, AND THE VACUUM PRESSURE WAS SUB-PAR. THEREFORE, THE ENGINE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616774 ↗
• MalfunctionApr 2, 2021Connection Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MAIN PULMONARY ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTING) AND A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE LIGHTNING WAS CONNECTED TO THE ENGINE AND POWERED ON. HOWEVER, NONE OF THE INDICATOR LIGHTS ON THE LIGHTNING UNIT ILLUMINATED, EVEN THOUGH THE ENGINE HAD ALL FOUR INDICATOR LIGHTS ILLUMINATED AND FULL ASPIRATION WAS ACHIEVED. THEREFORE, THE LIGHTNING WAS REMOVED. AFTERWARDS, A NEW LIGHTNING WAS CONNECTED TO THE ENGINE AND POWERED ON; HOWEVER, THE SAME ISSUE OCCURRED. TO TROUBLESHOOT, THE ENGINE WAS REMOVED, AND THE SECOND LIGHTNING WAS CONNECTED TO A SECOND ENGINE AND IT WAS NOTED THAT THE SECOND LIGHTNING UNIT WORKED. IT WAS REPORTED THAT THERE WERE NO ATTEMPTS TO CHECK IF THE FIRST LIGHTNING WORKED USING THE SECOND ENGINE; HOWEVER, THERE WAS NO ALLEGATION AGAINST THE FIRST LIGHTNING. IT WAS BELIEVED TO BE AN ISSUE WITH POSSIBLY THE USB PORT ON THE FIRST ENGINE. THE PROCEDURE WAS COMPLETED USING THE SAME SECOND LIGHTNING AND THE SAME SECOND ENGINE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608351 ↗
• MalfunctionMar 7, 2021Device Fell; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE). DURING THE MIDDLE OF THE PROCEDURE, IN BETWEEN PASSES, THE ENGINE RATTLED OFF THE CART AND SUBSEQUENTLY, THE TOP OF THE ENGINE CRACKED. HOWEVER, THE ENGINE STILL FUNCTIONED. THE PROCEDURE WAS COMPLETED USING THE SAME ENGINE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429717 ↗
• MalfunctionMar 4, 2021Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68). DURING THE PROCEDURE, AFTER THE TUBING WAS REMOVED FROM THE PATIENT, THE ENGINE WAS ON THE BACK TABLE AND IT WAS REPORTED THAT NONE OF THE INDICATOR LIGHTS ILLUMINATED WHEN THE ENGINE WAS GENERATING ASPIRATION. THEREFORE, THE ENGINE WAS NO LONGER USED. ON (B)(6) 2021, THE SECOND CHECK WAS PERFORMED AND THE ISSUE RESOLVED. IT WAS UNKNOWN WHETHER THE SAME CANISTER WAS IN USE AT THIS TIME. THE PROCEDURE WAS COMPLETED USING A STENT RETRIEVER. 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 11417416 ↗
• MalfunctionFeb 2, 2021Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY USING A PENUMBRA ENGINE (ENGINE), PENUMBRA ENGINE CANISTER (CANISTER), ASPIRATION TUBING (TUBING), NON-PENUMBRA REPERFUSION CATHETER, NON-PENUMBRA STENT RETRIEVER, AND NON-PENUMBRA ASPIRATION TUBING. DURING THE PROCEDURE, AFTER THE ENGINE WAS POWERED ON, THE INDICATOR LIGHTS TURNED ON ONE BY ONE BUT WERE FLASHING ON AND OFF. SUBSEQUENTLY, THE PHYSICIAN POWERED OFF THE ENGINE AND REPLACED THE NON-PENUMBRA ASPIRATION TUBING WITH THE PENUMBRA ASPIRATION TUBING. HOWEVER, THE SAME ISSUE WITH THE ENGINE OCCURRED. THEREFORE, THE ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). POST-PROCEDURE, THE PHYSICIAN CONFIRMED THE ENGINE WAS WORKING FINE EXCEPT FOR THE ISSUE WITH THE INDICATOR LIGHTS. 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 11266661 ↗
• MalfunctionJan 20, 2021Noise, Audible; Device Fell; Noise, Audible; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE ENGINE MADE A LOUD NOISE AND SLID OFF OF THE BACK TABLE ONTO THE FLOOR WHEN IT WAS POWERED ON. THEREFORE, THE ENGINE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) AND A STENT RETRIEVER ONLY SINCE THERE WAS NOT ANOTHER ENGINE AVAILABLE. 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 11205697 ↗
• MalfunctionDec 5, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A PULMONARY EMBOLISM USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE ENGINE WAS UNABLE TO PRODUCE ASPIRATION APPROXIMATELY HALFWAY THROUGH THE PROCEDURE. THEREFORE, THE ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10955128 ↗
• MalfunctionDec 5, 2020Decrease in Suction; Decrease in Suction

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A PULMONARY EMBOLISM USING A PENUMBRA ENGINE (ENGINE) AND PENUMBRA ENGINE CANISTER (CANISTER). DURING THE PROCEDURE, THE PHYSICIAN TURNED ON THE ENGINE AND NOTICED THE ASPIRATION POWER TO BE LOW. THE PHYSICIAN REMOVED THE CANISTER AND REPLACED IT WITH A NEW CANISTER TO TROUBLESHOOT; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE ENGINE AND CANISTER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10950637 ↗
• MalfunctionNov 19, 2020Intermittent Loss of Power; Intermittent Loss of Power

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL VEIN USING A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND LIGHTNING ASPIRATION TUBING (LIGHTING). DURING THE PROCEDURE, AFTER THE CAT8 WAS CONNECTED TO THE PATIENT AND ALL FOUR INDICATOR LIGHTS ON THE ENGINE WERE ILLUMINATED, THE ENGINE POWERED OFF AND STAYED OFF UNTIL THE PENUMBRA SALES REPRESENTATIVE TURNED IT BACK ON. THIS ISSUE OCCURRED MULTIPLE TIMES. THEREFORE, THE ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW ENGINE, THE SAME CANISTER, THE SAME CAT8, AND THE SAME LIGHTNING. 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 10870136 ↗
• MalfunctionNov 16, 2020Break; Device Fell; Break; Device Fell

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN TRIPPED OVER THE POWER CORD OF THE ENGINE AND THE ENGINE INADVERTENTLY FELL OFF THE TABLE AND BECAME BROKEN. THEREFORE, THE ENGINE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 10843828 ↗
• MalfunctionOct 29, 2020Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE TUBING WAS CONNECTED TO THE PATIENT WHEN IT WAS REPORTED THAT MORE THAN THIRTY SECONDS ELAPSED BEFORE ALL FOUR INDICATOR LIGHTS ILLUMINATED. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING 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 10759920 ↗
• MalfunctionOct 29, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ILIAC VEIN USING LIGHTNING ASPIRATION TUBING (LIGHTNING), A PENUMBRA ENGINE (ENGINE), A PENUMBRA ENGINE CANISTER (CANISTER), AND AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12). DURING THE PROCEDURE, THE ENGINE WAS POWERED ON AND ALTHOUGH THE INDICATOR LIGHTS ILLUMINATED AND THE ENGINE SOUNDED OPERATIONAL, IT WAS NOT ASPIRATING. THEREFORE, THE ENGINE WAS EXCHANGED FOR A NEW ONE AND THE PROCEDURE WAS COMPLETED USING THE NEW ENGINE AND THE SAME CANISTER. AFTER THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PHYSICIAN DECIDED TO MAKE A FINAL RUN-THROUGH AND NOTICED THAT THE LIGHTNING MICROPROCESSOR INDICATOR LIGHT ALTERNATED BETWEEN GREEN AND SOLID RED. THE TUBING WAS REMOVED FROM THE PATIENT AND WAS FLUSHED TWICE IN A BOWL OF SALINE. NEXT, THE PHYSICIAN CONFIRMED THAT THE PROCEDURE WAS COMPLETED AND NO FURTHER ACTION WAS NECESSARY. 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 10757310 ↗
• MalfunctionOct 15, 2020Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR VENA CAVA (SVC) USING AN INDIGO SYSTEM CAT12 ASPIRATION CATHETER (CAT12) AND PENUMBRA ENGINE (ENGINE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO OBTAIN ASPIRATION USING A CAT12 WITH THE ENGINE; THEREFORE, THE CAT12 WAS REMOVED. IT WAS REPORTED THAT ALL FOUR LIGHTS ON THE ENGINE WERE ILLUMINATED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW CAT12 WITH THE SAME ENGINE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN THEREFORE REMOVED THE ENGINE. THE PROCEDURE WAS COMPLETED USING A NEW ENGINE AND THE SAME CAT12. 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 10687656 ↗