Smart Coil 400SMTXSFT0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00814548015361), received between Mar 8, 2017 and Aug 1, 2022 — classified as 3 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (49 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 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A STENT DEVICE, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE STENT IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED THE SMART COIL INSIDE THE ANEURYSM USING THE MICROCATHETER AND DETACHED IT USING THE HANDLE. HOWEVER, UPON RETRACTION OF THE SMART COIL PUSHER ASSEMBLY, IT WAS NOTICED THAT THE SMART COIL WAS ALSO BEING PULLED OUT OF THE ANEURYSM. SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED AND REMAINED ON THE STENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15143116 ↗
• MalfunctionDec 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR 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. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, 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, 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 12926052 ↗
• MalfunctionOct 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX NON-PENUMBRA COILS AND TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS AND THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686693 ↗
• MalfunctionOct 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE NEXT SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. SUBSEQUENTLY, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602287 ↗
• MalfunctionOct 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE NEXT SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. SUBSEQUENTLY, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602274 ↗
• MalfunctionJun 10, 2021Failure 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 ARTERIES (IC-PC) TRANSVERSE SINUS 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, THE PHYSICIAN IMPLANTED ELEVEN SMART COILS AND SEVENTEEN NON-PENUMBRA COIL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND WAS STUCK. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS AND EIGHT OTHER 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 11977342 ↗
• MalfunctionJun 10, 2021Failure 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 ARTERIES (IC-PC) TRANSVERSE SINUS 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, THE PHYSICIAN IMPLANTED ELEVEN SMART COILS AND SEVENTEEN NON-PENUMBRA COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND WAS STUCK. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS AND EIGHT OTHER 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 11977307 ↗
• MalfunctionMar 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (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 THREE SMART COILS. WHILE ATTEMPTING TO ADVANCE A SMART COIL, THE COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL SMART COILS, TWO 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 11441247 ↗
• MalfunctionJan 20, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, NON-PENUMBRA MICROCATHETERS, AND BALLOON CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND FOUR OTHER COILS USING THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WAS STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE AT ALL. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED A NEW SMART COIL, 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 11206017 ↗
• MalfunctionJan 9, 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, THE PHYSICIAN PLACED FOUR SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND 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 11144082 ↗
• MalfunctionDec 21, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; 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 11045430 ↗
• MalfunctionDec 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS INTO THE TARGET LOCATION. IT WAS REPORTED THAT THE NEXT SMART COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR 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 10950953 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FETAL POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA STENT, A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, 10 MG OF VERAPAMIL AND AGGRASTAT WERE ADMINISTERED PRIOR TO STENT PLACEMENT IN THE VESSEL. THE PHYSICIAN THEN ADVANCED THE MICROCATHETER OVER THE GUIDEWIRE AND INTO THE PCA. NEXT, THE STENT WAS PLACED FROM THE PCA TO THE INTERNAL CAROTID ARTERY (ICA), COVERING THE ANEURYSM. THE PHYSICIAN THEN IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL. HOWEVER, UPON PLACEMENT OF THE FORTH SMART COIL, THE ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION INDICATIVE FOR ANEURYSM RUPTURE. SUBSEQUENTLY, THREE ADDITIONAL SMART COILS WERE IMPLANTED IN THE TARGET VESSEL AND PROTAMINE WAS ADMINISTERED TO CONTROL EXTRAVASATION. FOLLOWING THE COIL EMBOLIZATION, THERE WAS COMPLETE OCCLUSION OF THE ANEURYSM AND THE CONTROL ANGIOGRAPHY DEMONSTRATED NO EVIDENCE OF BRANCH VESSEL OCCLUSION AND NO FURTHER EXTRAVASATION. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE ANEURYSM PERFORATION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A DEFI

  Patient problems: Ruptured Aneurysm

  MAUDE report 10837985 ↗
• MalfunctionNov 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED NON-PENUMBRA COILS INTO THE TARGET LOCATION. NEXT, A SMART COIL BECAME STUCK WHILE ADVANCING THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 10804976 ↗
• MalfunctionOct 31, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE NON-PENUMBRA COILS AND SIX SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE SMART COIL BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN IMPLANTED TWO NEW SMART COILS INTO THE TARGET VESSEL USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE SMART COIL BECAME STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT AN ANGIOGRAPHY SHOWED THE BLOOD FLOW STOPPED WITH THE ALREADY IMPLANTED SMART COILS AND NO ADDITIONAL COILS WERE NEEDED. 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 10767136 ↗
• MalfunctionOct 31, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A SMART COIL IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, THE SAME SMART COIL AND ADDITIONAL SMART 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 10767112 ↗
• MalfunctionOct 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED NINE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE 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 10766800 ↗
• MalfunctionOct 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE SMART COILS AND FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL 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 10764788 ↗
• MalfunctionOct 29, 2020Failure 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 (DAVF) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS AND A NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SMART COIL WAS STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN PLACED THREE ADDITIONAL SMART COILS IN THE VESSEL. THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL THROUGH THE INTRODUCER SHEATH; HOWEVER, THE SAME ISSUE OCCURRED; THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS, 20 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 10759739 ↗
• MalfunctionOct 8, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVENOUS SINUS USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL AND EIGHT NON-PENUMBRA COILS INTO THE TARGET LOCATION USING A MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL APPROXIMATELY THIRTY CENTIMETERS THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN PLACED ONE SMART COIL AND FIFTEEN NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE SMART COIL BECAME STUCK AND WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ONE SMART COIL, THREE NON-PENUMBRA COILS AND THE SAME MICROCATHETERS. 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 10652322 ↗
• MalfunctionSep 18, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER AND, THEREFORE, IT 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 10557455 ↗
• MalfunctionSep 15, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE FIRST SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED. 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; No Consequences Or Impact To Patient

  MAUDE report 10538467 ↗
• MalfunctionSep 11, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE INITIAL POSITION. THE SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER SMART COIL. HOWEVER, THE SAME ISSUE OCCURRED, AND THE SECOND SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED FOUR SMART COILS INDIVIDUALLY TO THE TARGET VESSEL. THE HANDLE TOOK TWO TO THREE ATTEMPTS TO DETACH THE FIRST, SECOND, AND THIRD SMART COILS, AND THE HANDLE WAS UNABLE TO DETACH THE FOURTH SMART COIL. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE FOURTH SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND ANOTHER HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522675 ↗
• MalfunctionAug 12, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HANDLE FAILED TO DETACH THE SEVENTH SMART COIL AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS STILL UNABLE TO DETACH THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10399617 ↗
• MalfunctionJul 31, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIFTEEN NON-PENUMBRA COILS IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL, RESISTANCE WAS ENCOUNTERED, AND THE PHYSICIAN WAS ONLY ABLE TO ADVANCE THE SMART COIL A SHORT DISTANCE PAST THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, A TOTAL OF FOURTEEN SMART COILS AND NON-PENUMBRA COILS WERE IMPLANTED IN THE TARGET LOCATION AND THE HANDLE WAS USED TO DETACH THE SMART COILS. THE PHYSICIAN ATTEMPTED TO IMPLANT A SMART COIL AS THE THIRTIETH COIL; HOWEVER, THE HANDLE WOULD UNABLE TO DETACH THE SMART COIL. IT WAS ALSO NOTED THAT THE PHYSICIAN DID NOT HEAR THE "CLICK" SOUND WHEN DEPRESSING THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED BY USING A NEW HANDLE TO DETACH THE SAME SMART COIL AND A TOTAL OF THIRTY-FOUR ADDITIONAL SMART COILS AND NON-PENUMBRA COILS. IT WAS ALSO REPORTED THAT AFTER THE PROCEDURE THE HANDL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10348536 ↗