Smart Coil 400SMTSFT0615Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00814548014975), received between Jan 4, 2016 and Jan 17, 2023 — classified as 2 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (14 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETERS, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS INTO ONE TARGET LOCATION AND TWO RUBY COILS INTO ANOTHER TARGET LOCATION. WHILE ADVANCING A SMART COIL THROUGH THE DISTAL END OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SMART COIL WAS STUCK. UPON RETRACTION, RESISTANCE WAS ENCOUNTERED AND, SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, THREE NON-PENUMBRA COILS, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16189203 ↗
• MalfunctionJan 6, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL WOULD STILL NOT DETACH. SUBSEQUENTLY, AFTER MANY UNSUCCESSFUL ATTEMPTS TO DETACH THE SMART COIL, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE GENTLY RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE PHYSICIAN ALSO USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113814 ↗
• MalfunctionFeb 7, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS INTO THE TARGET VESSEL. SUBSEQUENTLY, THE PHYSICIAN ADVANCED THE FIFTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY BENDING THE PROXIMAL END OF THE PUSHER ASSEMBLY AND PULLING THE WIRE; HOWEVER, THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITH APPROXIMATELY THREE FOURTHS OF THE SMART COIL IN THE MICROCATHETER AND APPROXIMATELY ONE FOURTH OF THE SMART COIL IN THE TARGET VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE DETACHED SMART COIL INSIDE. NEXT, THE PHYSICIAN INSERTED A NEW NON-PENUMBRA MICROCATHETER INTO THE PATIENT AND SUCCESSFULLY IMPLANTED THREE NEW SMART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476979 ↗
• MalfunctionNov 8, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS REPORTED TO BE STIFF AND COULD NOT BE FULLY INSERTED INTO THE ANEURYSM. IT WAS ALSO REPORTED THAT THE SMART COIL KICKED THE MICROCATHETER OUT OF THE TARGET LOCATION. AFTER SEVERAL ATTEMPTS TO IMPLANT THE SAME SMART COIL, THE SAME ISSUE CONTINUED TO OCCUR. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THESE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771454 ↗
• MalfunctionNov 6, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A SMART COIL IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA FLOW DIVERTER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12755685 ↗
• MalfunctionAug 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, AFTER ADVANCING TWO THIRDS OF THE SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12313675 ↗
• MalfunctionAug 3, 2021Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. NEXT, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, IT FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL AND USED A MICROWIRE TO PUSH THE SMART COIL INTO POSITION. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, THE SAME HANDLE, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270551 ↗
• MalfunctionJun 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN REMOVED THE HANDLE AND TRIED USING TWO NEW HANDLES TO DETACH THE SAME SMART COIL, BUT THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW SMART COIL INTO THE ANEURYSM USING THE FIRST HANDLE. AFTERWARDS, A NEW SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054013 ↗
• MalfunctionJun 7, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED SMART COILS USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE COIL WOULD NOT DETACH AFTER APPROXIMATELY FIVE ATTEMPTS WERE MADE TO DETACH IT. THE PHYSICIAN MADE AN ATTEMPT TO DETACH THE SMART COIL MANUALLY WITHOUT SUCCESS. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11949765 ↗
• MalfunctionMar 31, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND DID NOT PERMIT THE GUIDE CATHETER TO COMPLETELY SUPPORT THE MICROCATHETER DURING ADVANCEMENT TO THE TARGET LOCATION. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-PENUMBRA COIL TO FRAME THE TARGET LOCATION. AFTER ADVANCING THE FIRST SMART COIL (6MM X 15CM) TO THE TARGET LOCATION AND REPOSITIONING IT, THE PHYSICIAN EXPERIENCED MODERATE MICROCATHETER TIP KICKBACK WHILE MAKING FIVE ATTEMPTS TO DETACH THE COIL USING THE HANDLE. THE SMART COIL (6MM X 15CM) WAS THEREFORE MANUALLY DETACHED AND SUCCESSFULLY IMPLANTED. WHILE ATTEMPTING TO IMPLANT THE SECOND SMART COIL (5MM X 10CM), THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AFTER EIGHT ATTEMPTS WERE MADE; THEREFORE, THE SMART COIL (5MM X 10CM) WAS MANUALLY DETACHED AND SUCCESSFULLY IMPLANTED. AFTER ADVANCING THE SIXTH SMART COIL (2MM X 4CM) TO THE TARGET LOCATION, SEVEN UNSUCCESSFUL ATTEMPTS WERE MADE TO DETACH THE COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600596 ↗
• MalfunctionMar 25, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, TWENTY-TWO NON-PENUMBRA COILS WERE IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING A SMART COIL THROUGH ITS INTRODUCER SHEATH INTO THE MICROCATHETER, THE COIL BECAME STUCK IN THE HUB. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT ADDITIONAL SMART COILS, TEN OTHER COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572688 ↗
• MalfunctionFeb 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A NEURO FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE THREE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. 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 11359925 ↗
• MalfunctionFeb 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA MICROCATHETERS, AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING A MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN NOTICED THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE AT ALL WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER COILS, AND THE SAME MICROCATHETER. 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 11325978 ↗
• MalfunctionFeb 7, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE IMPLANTED INTO THE TARGET LOCATION. NEXT, IT WAS REPORTED THAT THERE WERE SEVERAL FAILED ATTEMPTS TO DETACH THE FOURTH SMART COIL USING THE HANDLE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL SMART COILS, THE SAME HANDLE, THE SAME MICROCATHETER, 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 11290495 ↗
• MalfunctionNov 25, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL, AND THE HANDLE WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL SMART COILS AND A NEW HANDLE. 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 10902422 ↗
• MalfunctionApr 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETER AND, NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MICROCATHETER FROM THE ACA TO THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH THE GUIDE CATHETER AND PLACED FOUR COILS IN THE TARGET VESSEL. WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN PLACED A NEW SMART COIL AND ANOTHER COIL IN THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9917943 ↗
• MalfunctionMar 12, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE; HOWEVER, THE COIL DID NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9826455 ↗
• MalfunctionOct 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A 6X15 SMART COIL INTO THE NON-PENUMBRA MICROCATHETER. THE PHYSICIAN ALSO REPORTED THAT THE 6X15 SMART COIL STOPPED ADVANCING AT THE MIDDLE OF THE MICROCATHETER. THE 6X15 SMART COIL WAS THEREFORE REMOVED FROM THE PROCEDURE. A NEW 6X15 SMART COIL WAS THEN IMPLANTED SUCCESSFULLY USING THE SAME MICROCATHETER. WHILE ADVANCING THE NEXT 4X6 SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT IT BECAME STUCK AND WOULD NO LONGER ADVANCE. THE 4X6 SMART COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. ANOTHER SMART COIL AND THE SAME MICROCATHETER WERE THEN USED 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 9195032 ↗
• MalfunctionSep 17, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076263 ↗
• MalfunctionFeb 8, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AND BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319839 ↗
• MalfunctionFeb 4, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL, BUT FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL FROM ITS STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL AND THE SAME ISSUE OCCURRED. THE SECOND SMART COIL WAS ALSO REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301565 ↗
• MalfunctionJan 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS AND OTHER COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE PHYSICIAN CUT THE TIP OF THE INTRODUCER SHEATH OFF TO TRY TO ADVANCE THE COIL. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE SMART COIL. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248906 ↗
• MalfunctionOct 9, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND USED A HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) WAS SEPARATED IN HALF BUT THE SMART COIL WAS NOT DETACHED. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT, BUT THE SMART COIL DID NOT DETACH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949749 ↗
• MalfunctionJun 28, 2018Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BENIGN LIPOMA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A SMART COIL INTO THE HUB OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE INITIAL PUSH AND THE SMART COIL PUSHER ASSEMBLY WOULD NOT ADVANCE AT ALL. SUBSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY BECAME KINKED; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648949 ↗
• MalfunctionMar 15, 2018Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER AND INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND ATTEMPTED TO PULL THE COIL BACK INTO THE INTRODUCER SHEATH. THE PHYSICIAN THEN NOTICED THAT THE SMART COIL INTRODUCER SHEATH WAS DAMAGED WHICH ALSO CAUSED DAMAGE TO THE EMBOLIZATION COIL. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7343679 ↗