Smart Coil 400SMTHXSFT0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 165 adverse event reports that list this exact device (DI 00814548015996), received between May 2, 2017 and Apr 19, 2024 — classified as 165 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (135 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 165 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE 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 ADVANCED A SMART COIL INTO THE TARGET LOCATION AND REPORTED THAT IT WAS NOT TAKING ITS INTENDED SHAPE. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ADVANCING ANOTHER SMART COIL OF THE SAME SIZE THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE SMART COIL WAS UNRAVELED WITHIN THE MICROCATHETER AND HAD BECOME STUCK. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL AND NOTICED THAT IT HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED FROM THE PATIENT. AT THIS POINT, THE PHYSICIAN LACKED SMALLER COIL OPTIONS TO BE ABLE TO PROCEED WITH THE PROCEDURE AND THEREFORE, THE PROCEDURE WAS SUSPENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148901 ↗
• MalfunctionJul 18, 2022Difficult 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), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR NON-PENUMBRA COILS INTO THE TARGET LOCATION. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING A HANDLE; HOWEVER, THE COIL DID NOT DETACH. UPON REMOVAL, THE SMART COIL DETACHED AND WAS CONTAINED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE SMART COIL PUSHER WIRE TO SUCCESSFULLY IMPLANT THE COIL INTO THE TARGET LOCATION. THE HANDLE WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, NON-PENUMBRA COILS, THE SAME GUIDE CATHETER, 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 15041321 ↗
• MalfunctionNov 2, 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 TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, 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 TEN SMART COILS AND TWENTY NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741019 ↗
• MalfunctionOct 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING A PENUMBRA SMART COIL. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWENTY-FIVE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686582 ↗
• MalfunctionOct 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS 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 TWO SMART COILS INTO THE TARGET LOCATION. 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 SIX 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 12674137 ↗
• MalfunctionOct 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW SMART COIL IN THE TARGET VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE SMART COIL BECAME STUCK. THEREFORE, THE SMART COIL AND MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 12619255 ↗
• MalfunctionOct 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL BRANCH OF THE POSTERIOR INTERCOSTAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, FOUR SMART COILS AND TEN NON-PENUMBRA COILS WERE IMPLANTED INTO THE TARGET LOCATION. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED EACH TIME A COIL WAS INSERTED. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, IT BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL SMART COILS, ELEVEN 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 12602505 ↗
• MalfunctionSep 2, 2021Failure 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) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO REMOVED. AFTERWARDS, THE NEXT THREE SMART COILS ADVANCED SLIGHTLY PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS BEFORE BECOMING STUCK WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL TO THE TARGET LOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419030 ↗
• MalfunctionAug 18, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLONIAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE MICROCATHETER, THE SMART COIL WAS STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339910 ↗
• MalfunctionAug 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR PETROSAL SINUS USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND NARROWED. DURING THE PROCEDURE, TWO SMART COILS AND SIXTEEN NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT WAS REPORTED THAT THE COIL WAS STUCK AND 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, SIXTEEN 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 12297828 ↗
• MalfunctionJul 16, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED THREE SMART COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE FOURTH SMART COIL, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED NINE SMART COILS IN THE TARGET VESSEL USING THE SAME HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN ALSO MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186058 ↗
• MalfunctionJul 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OCCIPITAL ARTERY 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, SIX SMART COILS AND ELEVEN NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT BECAME STUCK AFTER ADVANCING A SHORT DISTANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS AND TWELVE 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 12108889 ↗
• MalfunctionJun 1, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COIL), POD PACKING COILS (POD PC), AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE POD PC AND NINE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE SMART COIL AND NOTICED THE PUSHER ASSEMBLY TO BE DEFORMED. 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 11918094 ↗
• MalfunctionMay 13, 2021Failure 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 BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE, AND CONSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON REMOVAL, IT WAS NOTICED THAT THE SMART COIL WAS KINKED. 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 11820163 ↗
• MalfunctionMay 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL IN THE TARGET LOCATION. WHEN ADVANCING THE NEXT SMART COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER A FEW CENTIMETERS INTO THE HUB OF THE MICROCATHETER. IT WAS REPORTED THE INTRODUCER SHEATH HAD BEEN PROPERLY ALIGNED INSIDE THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810017 ↗
• MalfunctionMay 10, 2021Failure 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), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE MICROCATHETER, THE SMART COIL ADVANCED APPROXIMATELY ONE MM OUT OF ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE ANY FURTHER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE SMART COIL; HOWEVER, THE SMART COIL BECAME STUCK 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

  MAUDE report 11802516 ↗
• MalfunctionApr 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAXILLARY ARTERY USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL TO THE MICROCATHETER, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739467 ↗
• MalfunctionApr 20, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY PLACED THE THIRD SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN 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. THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691630 ↗
• MalfunctionApr 20, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY PLACED THE THIRD SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN 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. THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691628 ↗
• MalfunctionApr 14, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING PLACE ANOTHER SMART COIL IN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING THE SMART COIL IN THE MIDDLE OF THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE INTRODUCER SHEATH WAS PROPERLY ALIGNED INSIDE THE HUB OF THE MICROCATHETER. THEREFORE, SMART COIL WAS REMOVED. 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 11662640 ↗
• MalfunctionApr 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL ONLY ADVANCE APPROXIMATELY TWO TO THREE MILLIMETERS PAST ITS INITIAL POSITION BEFORE BECOMING STUCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. THE SMART COIL ONLY ADVANCE APPROXIMATELY TWO TO THREE MILLIMETERS PAST ITS INITIAL POSITION BEFORE BECOMING STUCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR SMART COILS, TWO NON-PENUMBRA COILS, THE SAME MICROCATHETER, AND A N-BUTYL CYANOACRYLATE (NBCA) INJECTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11652610 ↗
• MalfunctionApr 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL ONLY ADVANCE APPROXIMATELY TWO TO THREE MILLIMETERS PAST ITS INITIAL POSITION BEFORE BECOMING STUCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. THE SMART COIL ONLY ADVANCE APPROXIMATELY TWO TO THREE MILLIMETERS PAST ITS INITIAL POSITION BEFORE BECOMING STUCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR SMART COILS, TWO NON-PENUMBRA COILS, THE SAME MICROCATHETER, AND A N-BUTYL CYANOACRYLATE (NBCA) INJECTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11652602 ↗
• MalfunctionApr 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER THE INTRODUCER SHEATH WAS PROPERLY ALIGNED TO THE MICROCATHETER HUB, THE FIRST SMART COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. AFTER IMPLANTING ANOTHER SMART COIL AND THREE OTHER COILS USING THE SAME MICROCATHETER, THE INTRODUCER SHEATH OF ANOTHER SMART COIL WAS PROPERLY ALIGNED TO THE HUB OF THE MICROCATHETER BEFORE THE PHYSICIAN EXPERIENCED THE SAME ISSUE. THIS SMART COIL WAS ALSO STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, TWO 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 11606710 ↗
• MalfunctionApr 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL PUDENDAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, A SMART COIL WAS STUCK WITHIN THE INTRODUCER SHEATH AND WOULD NOT ADVANCE FROM THE STARTING POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606698 ↗
• MalfunctionMar 15, 2021Failure to Advance; Failure to Advance

  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 SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR COILS. NEXT, 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 SIX SMART COILS, SIX 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 11485189 ↗