Smart Coil 400SMTHXSFT0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00814548015699), received between Aug 1, 2017 and Oct 12, 2022 — classified as 36 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SMART COILS AND NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, THE SMART COIL DID NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED SMART COIL AND THEN REMOVED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING 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 15592119 ↗
• MalfunctionDec 31, 2021Separation Failure; Unintended Movement; Migration; Difficult or Delayed Separation; Separation Failure; Unintended Movement; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THEN, THE PHYSICIAN ADVANCED THREE SMART COILS (F106492, F106751, AND F106751) TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THEM USING A HANDLE; HOWEVER, THE SMART COILS FAILED TO DETACH. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS USING A SECOND HANDLE; HOWEVER, THEY WERE UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COILS USING A HEMOSTAT; HOWEVER, IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COILS WERE REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT SMART COIL (F86218) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. HOWEVER, UPON RETRACTING THE MICROCATHETER FROM THE ANEURYSM, THE SMART COIL CAME OUT OF THE ANEURYSM. THEREFORE, THE PHYSICIAN ADVANCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13130519 ↗
• MalfunctionAug 11, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A SMART COIL. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A SMART COIL; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307845 ↗
• MalfunctionJul 23, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND DETACH IT USING A HANDLE. WHILE THE PHYSICIAN ATTEMPTED TO REMOVE THE PUSHER ASSEMBLY OF THE SMART COIL FROM THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE SMART COIL WAS STILL CONNECTED TO ITS PUSHER ASSEMBLY. SUBSEQUENTLY, IT WAS NOTICED THAT APPROXIMATELY TWO CENTIMETERS OF THE PROXIMAL END OF THE SMART COIL WAS IN THE MICROCATHETER AND THE DISTAL END WAS IN THE ANEURYSM. THE PHYSICIAN THEN PULLED GENTLY ON THE PUSHER ASSEMBLY AFTER THINKING THAT THE SMART COIL MIGHT HAVE BEEN DETACHED ALREADY; HOWEVER, THE SMART COIL ALSO MOVED BACK. CONSEQUENTLY, IT WAS NOTICED THAT MOST OF THE SMART COIL WAS ALREADY IN THE MICROCATHETER. ON RETRIEVAL, IT WAS NOTICED THAT THE SMART COIL HAD BECOME DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222338 ↗
• MalfunctionApr 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11739710 ↗
• MalfunctionApr 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE COILS INTO THE ANEURYSM USING THE MICROCATHETER. NEXT, THE HOSPITAL TECHNOLOGIST ATTEMPTED TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PHYSICIAN FLUSHED THE INTRODUCER SHEATH AND ATTEMPTED TO RE-ADVANCE THE SMART COIL WITHIN ITS INTRODUCER SHEATH BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE INTRODUCER SHEATH OF THE SMART COIL WAS STUCK ON ITS PUSHER ASSEMBLY. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638591 ↗
• MalfunctionMar 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED EIGHT NON-PENUMBRA COILS. WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COIL WAS STUCK MID-SHAFT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER TWO SMART COIL, FIVE 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 11556200 ↗
• MalfunctionFeb 17, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FROM THE BASILAR ARTERY TO THE SUPERIOR CEREBELLAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS AND SUBSEQUENTLY DETACHED THE THIRD SMART COIL. ON WITHDRAWAL, THE PUSHER ASSEMBLY OF THE SMART COIL WAS STUCK IN THE HUB OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE PUSHER ASSEMBLY BUT WAS NOT ABLE TO INSERT THE FOURTH SMART COIL INTO THE MICROCATHETER. THE PHYSICIAN NOTED THAT THERE MAY HAVE BEEN SOME BLACK PARTICULATE IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED, AND THE PHYSICIAN INSERTED A NEW MICROCATHETER. WHEN ADVANCING THE SAME SMART COIL IN THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT. 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 11341026 ↗
• MalfunctionDec 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ADVANCING A SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE HUB OF THE MICROCATHETER AND, THE SMART COIL WOULD NOT ADVANCE ANY FURTHER. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 11089526 ↗
• MalfunctionNov 19, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA MICROCATHETER, 6FR GUIDING CATHETER, AND 9FR BALLOON GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN SMART COILS AND EIGHT NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN PLACED ANOTHER SMART COIL AT THE HUB OF THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE COIL; HOWEVER, THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 10872323 ↗
• MalfunctionMay 29, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE SMART COIL USING THE HANDLE, THE SMART COIL FAILED TO DETACH; THEREFORE, THE SMART COIL WAS REMOVED, AND THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE VESSEL AND ATTEMPTED TO DETACH IT USING ANOTHER HANDLE, BUT THE SAME ISSUE OCCURRED; THEREFORE, THE SECOND SMART COIL WAS REMOVED, AND THE PHYSICIAN DECIDED NOT TO USE THE SECOND HANDLE. THE PROCEDURE WAS COMPLETED USING OTHER NON-PENUMBRA COILS (OPTIMA). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10099884 ↗
• MalfunctionApr 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS 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 Consequences Or Impact To Patient

  MAUDE report 9914380 ↗
• MalfunctionMar 13, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL AND ANOTHER COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT A PART OF THE SMART COIL WAS STUCK IN THE MICROCATHETER AND HAD DETACHED INSIDE OF THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE AND ATTEMPTED TO PLACE TWO ADDITIONAL SMART COILS; HOWEVER, THE ANEURYSM WAS ALREADY PACKED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831536 ↗
• MalfunctionFeb 7, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER (SL-10). IT WAS NOTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS, NARROWED, AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS AND SEVEN NON-PENUMBRA COILS IN THE TARGET LOCATION USING THE SL-10. THEN, THE PHYSICIAN WAS UNABLE TO ADVANCE ANOTHER SMART COIL BEYOND THE DISTAL END OF THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME SL-10. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682382 ↗
• MalfunctionJan 14, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND IT WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9588557 ↗
• MalfunctionDec 27, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETER AND, NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL. WHILE ADVANCING A SMART COIL, IT BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH. THE SMART COIL WAS THEN PUSHED AGAINST RESISTANCE AND ITS END BECAME BENT; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS 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 9527274 ↗
• MalfunctionMay 9, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A SMART COIL USING THE HANDLE. THEREFORE, THE PHYSICIAN USED A NEW HANDLE AND WAS ABLE TO DETACH THE SAME SMART COIL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8596574 ↗
• MalfunctionMar 28, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL COILS USING A NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN IMPLANTED TWO SMART COILS USING THE HANDLE AND THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE SIXTH COIL, A SMART COIL, INTO THE TARGET VESSEL AND FAILED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) WAS PUSHED TOO FAR INTO THE HANDLE AND UNABLE TO BE REPOSITIONED. THE SMART COIL AND THE HANDLE WERE THEREFORE REMOVED AND WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460384 ↗
• MalfunctionMar 19, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED TEN COILS INTO THE TARGET VESSEL. WHILE ADVANCING THE ELEVENTH COIL, A SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND COULD NOT ADVANCE THE SMART COIL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE SMART COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434827 ↗
• MalfunctionMar 14, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS OVERLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH A SMART COIL USING THE HANDLE BEFORE THE SMART COIL DETACHED IN THE TARGET LOCATION. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS. HOWEVER, ALL THREE COILS WERE SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420733 ↗
• MalfunctionDec 4, 2018Difficult 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). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH IT USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE); HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE COATING ON THE PULL WIRE HAD FALLEN OFF. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL WAS PULLED BACK INTO THE MICROCATHETER. THE PHYSICIAN THOUGHT THAT THE SMART COIL WAS STUCK AT THE TIP OF THE MICROCATHETER AND ADVANCED AND RETRACTED THE SMART COIL A FEW TIMES; HOWEVER, THE SMART COIL WOULD NOT DETACH USING THE HANDLE. WHILE ATTEMPTING TO WITHDRAW THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE TO REMOVE THE DETACHED SMART COIL FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING 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 8131468 ↗
• MalfunctionNov 29, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL WITHIN ITS INTRODUCER SHEATH AND THEREFORE, THE SMART COIL 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 8117318 ↗
• MalfunctionNov 7, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING A PENUMBRA SMART COIL 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 ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. ALTHOUGH THE PHYSICIAN OBSERVED THAT THE BLACK ALIGNMENT ZONE WAS SEPARATED IN HALF AFTER THE SECOND DETACHMENT ATTEMPT, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY PULLED THE PULL WIRE OF THE SMART COIL PUSHER ASSEMBLY; HOWEVER, THE SMART COIL DID NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL; HOWEVER, DURING RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8046928 ↗
• MalfunctionNov 2, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. NEXT, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL IN THE TARGET VESSEL; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, 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 8032840 ↗
• MalfunctionOct 24, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS AND ONE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO INSERT A NEW SMART COIL INTO THE MICROCATHETER, THE SMART COIL BECAME STUCK INSIDE ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE ANOTHER SMART COIL BUT THE ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000926 ↗