Smart Coil 400SMTXSFT0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00814548015408), received between Jul 28, 2016 and Feb 1, 2022 — classified as 4 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (26 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TEN NON-PENUMBRA COILS. SUBSEQUENTLY, 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 ALSO ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITH PART OF THE COIL IN THE TARGET VESSEL AND THE OTHER PART IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE SMART COIL INTO THE TARGET VESSEL. IT WAS REPORTED THAT A FEW CENTIMETERS OF THE PUSHER ASSEMBLY DISTAL END HAD BROKEN OFF INSIDE OF THE MICROCATHETER. THE PHYSICIAN ALSO IMPLANTED THE BROKEN SEGMENT OF THE PUSHER ASSEMBLY IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND FIVE NEW NON-PENUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416435 ↗
• MalfunctionDec 30, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT A SECOND HANDLE WAS USED TO DETACH THE SAME SMART COIL; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PHYSICIAN THEN PLACED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING BOTH HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE ATTEMPTING TO RETRACT THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. 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

  MAUDE report 13119746 ↗
• MalfunctionNov 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUPRACLINOID ANEURYSM OFF THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL APPROXIMATELY THREE QUARTERS OF THE WAY INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED. 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 12840656 ↗
• MalfunctionNov 18, 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 USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA CATHETER, A NON-PENUMBRA GUIDEWIRE, A NON-PENUMBRA BALLOON CATHETER, AND A NON-PENUMBRA STENT. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, 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 12840567 ↗
• MalfunctionNov 15, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817311 ↗
• MalfunctionOct 27, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING (ACOM) ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12704955 ↗
• MalfunctionSep 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WERE STUCK AND WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410180 ↗
• MalfunctionSep 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WERE STUCK AND WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410145 ↗
• MalfunctionAug 26, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE SINUS 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 EIGHT SMART COILS AND NINE OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER SMART COIL THROUGH ITS 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

  MAUDE report 12369851 ↗
• MalfunctionMay 27, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE SMART COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATHS OF THE SMART COILS SEPARATED AROUND THE FRICTION LOCK WHEN FORCE WAS USED. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE SMART COILS, THREE 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 11898378 ↗
• MalfunctionMay 14, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, AND AN ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SMART COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING APPROXIMATELY FOUR TO FIVE CENTIMETERS INTO THE TARGET VESSEL. THEREFORE, THE SMART COIL WAS REMOVED AND SAVED FOR LATER USE. NEXT, THE PHYSICIAN SUCCESSFULLY PLACED A NON-PENUMBRA COIL AND ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SMART COIL IN THE TARGET VESSEL. WHILE ATTEMPTING TO RE-ADVANCE THE PREVIOUSLY REMOVED SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN WHEN ADVANCING APPROXIMATELY FOUR TO FIVE CENTIMETERS INTO THE TARGET VESSEL. THEREFORE, THE SMART COIL WAS RETRACTED AND REMOVED. IT WAS REPORTED THAT THE SMART COIL KNOTTED ITSELF UPON REMOVAL. THE PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829453 ↗
• MalfunctionMay 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. 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

  MAUDE report 11820189 ↗
• MalfunctionMay 3, 2021Failure 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) AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE ANY FURTHER; THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766171 ↗
• MalfunctionMar 22, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE SMART COIL BECAME STUCK AT THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 11547828 ↗
• MalfunctionDec 21, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS MODERATELY TORTUOUS, CALCIFIED AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE FORMING THE SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN WAS NOT SATISFIED WITH HOW THE SMART COIL WAS FORMING AND DECIDED TO RETRACT THE SMART COIL TO RE-FORM IT. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE SMART COIL WOULD NOT RETRACT. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL AND MICROCATHETER TOGETHER AND THEN REMOVED THE SMART COIL FROM THE DISTAL END OF THE MICROCATHETER. NEXT, THE MICROCATHETER WAS FLUSHED TO CONFIRM THE PATENCY USING A GUIDEWIRE. AFTERWARDS, THE PHYSICIAN PLACED FOUR NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11045427 ↗
• MalfunctionNov 23, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA)-POSTERIOR COMMUNICATION ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER (SL-10). DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE FRICTION LOCK OF THE SMART COIL AND SUBSEQUENTLY, THE PUSHER ASSEMBLY SMART COIL KINKED. 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 10885895 ↗
• MalfunctionNov 19, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA ANGIO-CATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS AND TWO OTHER COILS IN THE TARGET VESSEL. WHILE ADVANCING THE SMART COIL WITHIN THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT NEW SMART COILS, THREE 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; No Consequences Or Impact To Patient

  MAUDE report 10870254 ↗
• MalfunctionAug 28, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY 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 INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN PLACED ANOTHER SMART COIL INTO THE TIP OF THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, AFTER TWO ATTEMPTS, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN DEPRESSED THE HANDLE AND PULLED IT BACK BEFORE HEARING AN AUDIBLE CLICK; BUT THE SMART COIL DID NOT DETACH. THEN, THE PHYSICIAN MANUALLY PULLED APART THE MICROCATHETER TO PULL THE PUSHER ASSEMBLY OF THE SMART COIL TO DETACH IT; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. NEXT, THE PHYSICIAN PLACED AND DETACHED MULTIPLE SMART COILS INTO THE TARGET VESSEL USING A NEW HANDLE. WHILE ADVANCING TWO ADDITIONAL SMART COILS, THE PHYSICIAN EXPERIENCED RESISTANCE WITHIN ITS INTRODUCER SHEATH. HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PLACE AND DETACHED BOTH SMART COILS INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467125 ↗
• MalfunctionAug 25, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  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, NON-PENUMBRA COILS, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED EIGHT NON-PENUMBRA COILS AND USED THE HANDLE TO IMPLANT ONE SMART COIL. WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL WITH THE HANDLE, IT WAS REPORTED THAT THE COIL WOULD NOT DETACH. UPON WITHDRAWAL, THE SMART COIL DETACHED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM THE PATIENT AND THE DETACHED COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, THE SAME HANDLE, THREE 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 10450663 ↗
• MalfunctionJul 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) 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. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SMART COIL BECAME STUCK IN THE MIDDLE OF ITS INTRODUCER SHEATH AND WAS UNABLE TO ADVANCE AFTER SEVERAL ATTEMPTS WERE MADE TO DO SO. THEREFORE, THE SMART COIL 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 10257803 ↗
• MalfunctionMar 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT TAKING THE SPACE IN THE ANEURYSM. THEREFORE, THE PHYSICIAN RE-SHEATHED THE SMART COIL AND REPOSITIONED THE MICROCATHETER IN THE ANEURYSM SAC. THE HOSPITAL TECHNOLOGIST THEN RE-LOADED THE SAME SMART COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV) OF THE MICROCATHETER AND ATTEMPTED TO ADVANCE IT; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. A SECOND ATTEMPT WAS THEN MADE BUT THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED 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 9794052 ↗
• MalfunctionDec 16, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA GUIDEWIRE, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIVE SMART COILS INTO THE TARGET VESSEL WITHOUT ISSUE USING THE HANDLE. HOWEVER, THE SIXTH SMART COIL DID NOT DETACH FROM ITS PUSHER ASSEMBLY UNTIL THE SECOND ATTEMPT USING THE HANDLE. THE PHYSICIAN CONTINUED THE PROCEDURE USING ANOTHER SMART COIL AND ENCOUNTERED RESISTANCE DURING ADVANCEMENT THROUGH THE MICROCATHETER. IT WAS THEN REPORTED THAT THE SMART COIL BECAME STUCK AND NEITHER THE SMART COIL NOR THE GUIDEWIRE COULD ADVANCE PAST THE SAME POSITION WITHIN THE MICROCATHETER. THE DEVICES WERE THEN REMOVED FROM THE PATIENT. UPON REMOVAL, A WHITE POWDERY SUBSTANCE CAME OUT OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NON-PENUMBRA MICROCATHETER, THE SAME SMART COIL, TWO ADDITIONAL SMART COILS, THE SAME HANDLE AND A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475187 ↗
• MalfunctionSep 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND THREE OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN DID EXPERIENCE RESISTANCE WHILE ADVANCING THE THREE SMART COIL THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112878 ↗
• MalfunctionSep 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND THREE OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN DID EXPERIENCE RESISTANCE WHILE ADVANCING THE THREE SMART COIL THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112876 ↗
• MalfunctionSep 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND THREE OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN DID EXPERIENCE RESISTANCE WHILE ADVANCING THE THREE SMART COIL THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112874 ↗