Smart Coil 400SMTHXSFT1H02Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00814548015651), received between Mar 29, 2017 and Apr 23, 2025 — classified as 2 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (27 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PENILE ARTERY USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS INTO THE TARGET VESSEL USING THE HANDLE. AFTER ADVANCING THE THIRD SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE COIL WOULD NOT DETACH. THEREFORE, THE HANDLE WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO USE A SECOND HANDLE TO DETACH THE SAME SMART COIL; HOWEVER, THE COIL STILL DID NOT DETACH. WHILE ATTEMPTING TO MANUALLY DETACH THE SMART COIL, THE COIL WAS INADVERTENTLY PULLED BACK INTO THE MICROCATHETER AND DETACHED WITHIN THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN THEN USED THE SMART COIL PUSHER ASSEMBLY TO SUCCESSFULLY IMPLANT THE COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS, THE SECOND 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 21896096 ↗
• MalfunctionAug 2, 2023Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE TWO TIMES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED THE DETACHED SMART COIL''S PUSHER WIRE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 17446153 ↗
• MalfunctionAug 12, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS AND ONE SMART COIL USING THE HANDLE. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN USED THE HANDLE TO DETACH THE SMART COIL; HOWEVER, THE COIL DID NOT DETACH. WHILE REMOVING THE SMART COIL, THE DISTAL END OF THE COIL WAS IN THE MIDDLE OF THE MICROCATHETER WHEN IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED FROM THE PATIENT AND THE SMART COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE HANDLE WAS NO LONGER REQUIRED AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL, THE SAME MICROCATHETER, THE SAME SHEATH, 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 15217695 ↗
• MalfunctionDec 6, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL THORACIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ELEVEN SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE ATTEMPTING TO RETRACT THE SMART COIL, IT WAS NOTICED THAT THE SMART COIL WAS STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER AND SMART COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS, TEN OTHER COILS, AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932217 ↗
• MalfunctionNov 4, 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 (ACA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, TWO SMART COILS AND FOUR NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, RESISTANCE WAS ENCOUNTERED, AND THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, THE SAME MICROCATHETER, THE SAME CATHETER, 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 12751599 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING (PCOM) ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED EIGHT SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE SMART COIL; HOWEVER, THEY WERE UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN IMPLANTED FIVE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO REPOSITION THE MICROCATHETER TO FIND A GOOD POSITION FOR THE SMART COIL. WHILE REPOSITIONING THE MICROCATHETER, THE SMART COIL AND MICROCATHETER EXTENDED BEYOND THE ANEURYSM WALL WHICH CAUSED A PERFORATION. THE PHYSICIAN THEN REPOSITIONED THE MICROCATHETER AND SMART COIL AND DETACHED THE SMART COIL IN THE TARGET LOCATION. A

  Patient problems: Perforation of Vessels

  MAUDE report 12297651 ↗
• MalfunctionJul 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, TWO SMART COILS AND SIX NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND REPORTED THAT THE COIL WAS STUCK INSIDE ITS INTRODUCER SHEATH SHORTLY AFTER ADVANCING PAST THE INITIAL POSITION. THEREFORE, THE SMART COIL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12205988 ↗
• MalfunctionJul 17, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED MULTIPLE SMART COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE ADVANCING THE NEXT SMART COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE COIL BECAME KINKED DUE TO THE RHV BEING TOO TIGHT. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE ANEURYSM AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN MADE MULTIPLE TROUBLESHOOTING TECHNIQUES TO DETACH THE SMART COIL; HOWEVER, THE COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL AND HANDLE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12186220 ↗
• MalfunctionJun 26, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AFTER THE PHYSICIAN MADE SEVERAL ATTEMPTS. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072418 ↗
• MalfunctionJun 17, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PERICALLOSAL ANEURYSM USING PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL INTO THE TARGET LOCATION USING A MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL AND HANDLE WERE 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 12018249 ↗
• MalfunctionMay 21, 2021Failure 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 COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, ONE SMART COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL IN THE MICROCATHETER HUB, RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT THE DISTAL TIP OF THE SMART COIL WAS STUCK IN THE GAP BETWEEN THE MICROCATHETER HUB AND THE COIL SHEATH. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL OF THE SAME SIZE 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 11867070 ↗
• MalfunctionMay 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERIES (IC-PC) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND THROMBOSED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX NON-PENUMBRA COILS. WHILE ADVANCING A SMART COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTED THAT THE COIL WAS ONLY ABLE TO ADVANCE A SHORT DISTANCE THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. AFTER IMPLANTING TWO OTHER SMART COILS, THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEXT SMART COIL AND REPORTED THAT IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11852522 ↗
• MalfunctionApr 29, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR CEREBELLUM VESSEL USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA NON-PENUMBRA SHEATH, NON-PENUMBRA CATHETER, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, ONE SMART COIL WAS SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE A SECOND SMART COIL INTO THE TARGET VESSEL, THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) WAS UNABLE TO DETACH IT. THE PHYSICIAN THEN DECIDED TO REMOVE SMART COIL. HOWEVER, WHILE RETRACTING, THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN INJECTED SALINE THROUGH THE MICROCATHETER TO PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM. WHILE ATTEMPTING TO PLACE A THIRD SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THE SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749764 ↗
• MalfunctionApr 26, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE FRICTION LOCK CAUSED A SMART COIL TO BE UNABLE TO BE PUSHED OUT OF INTRODUCER SHEATH. THE SMART COIL WAS THEN TESTED IN A SALINE BATH AND WOULD NOT ADVANCE. THEREFORE, THE SMART COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727143 ↗
• MalfunctionApr 25, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY TO POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AND WAS STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, ANOTHER COIL AND A NEW SMART COIL WAS SUCCESSFULLY PLACED THE TARGET LOCATION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11722061 ↗
• MalfunctionApr 8, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, SMART COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. WHILE ATTEMPTING TO PLACE THE NEXT SMART COIL, A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) WAS UNABLE TO DETACH IT AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS. THEREFORE, THE SMART COIL WAS RETRACTED FOR REMOVAL. WHEN THE SMART COIL WAS WITHDRAWN INTO THE MICROCATHETER, IT DETACHED. SUBSEQUENTLY, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED FROM THE PATIENT AND THE SMART COIL WAS REMOVED FROM THE MICROCATHETER. 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 11635996 ↗
• MalfunctionMar 11, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN INJECTED AN EMBOLIZATION AGENT INTO THE TARGET LOCATION. WHILE ATTEMPTING TO IMPLANT A SMART COIL USING THE HANDLE, THE COIL WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL MANUALLY WITHOUT SUCCESS. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, THE SAME HANDLE, AND THREE NON-PENUMBRA COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467450 ↗
• MalfunctionMar 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE TWO ADDITIONAL SMART COILS IN THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS ONLY ABLE TO ADVANCE THE SMART COILS PARTIALLY THROUGH THE MICROCATHETER. THEREFORE, BOTH SMART COILS WERE REMOVED. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED THE SAME RESISTANCE ADVANCING A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE PHYSICIAN WAS ABLE TO ADVANCE THE SMART COIL THROUGH THE RESISTANCE AND SUCCESSFULLY PLACE THE SMART COIL IN THE TARGET LOCATION. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456923 ↗
• MalfunctionDec 13, 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) A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND TWO NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND SIXTEEN NON-PENUMBRA COILS INTO THE TARGET VESSEL USING A MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL BY BREAKING THE PUSHER ASSEMBLY OF THE SMART COIL AND PULLING THE PULL WIRE. AFTERWARDS, WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, 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; No Consequences Or Impact To Patient

  MAUDE report 10999067 ↗
• MalfunctionNov 25, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT WOULD NOT ADVANCE FROM ITS INITIAL POSITION IN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL; THEREFORE, THIS SMART COIL WAS ALSO 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 10901114 ↗
• MalfunctionNov 19, 2020Failure 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), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS AND TWO NON-PENUMBRA COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL ADVANCED A LITTLE AND BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL KINKED. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL ADVANCED A LITTLE BEFORE BECOMING STUCK; THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 10869859 ↗
• MalfunctionNov 19, 2020Failure 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 INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS AND TWO NON-PENUMBRA COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL ADVANCED A LITTLE AND BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL KINKED. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL ADVANCED A LITTLE BEFORE BECOMING STUCK; THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 10869845 ↗
• MalfunctionNov 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT WOULD NOT ADVANCE FROM ITS INITIAL POSITION IN 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10834712 ↗
• MalfunctionNov 11, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT P1 AND P2 SEGMENTS OF THE POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA COILS. 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 10826279 ↗
• MalfunctionNov 6, 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 USING A PENUMBRA SMART COIL (SMART COIL), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR NON-PENUMBRA COILS IN THE TARGET LOCATION USING THE MICROCATHETER. THEN, WHILE ADVANCING A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10805463 ↗