Smart Coil 400SMTXSFT0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00814548015286), received between Dec 29, 2015 and Apr 13, 2023 — classified as 5 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (31 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 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2023Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. IT WAS REPORTED THAT UPON MANIPULATION OF THE PUSHER ASSEMBLY AFTER DETACHING THE SMART COIL CAUSED SEVERAL LOOPS OF THE SMART COIL TO MOVE AND PROTRUDE SLIGHTLY FROM THE ANEURYSM SAC. THE PHYSICIAN THEN USED A BALLOON CATHETER TO RESHAPE THE DETACHED SMART COIL IN THE ANEURYSM AND CAUSED A DISSECTION IN THE INTERNAL CAROTID ARTERY (ICA). THE DISSECTION WAS NOT RELATED TO THE SMART COIL. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT RELATED TO THE SMART COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733939 ↗
• MalfunctionJan 20, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature 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), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST SMART COIL THROUGH THE DISTAL END OF THE MICROCATHETER. UPON RETRACTION, RESISTANCE WAS ENCOUNTERED AND, SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16217795 ↗
• MalfunctionJul 26, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER TWO ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. WHILE ATTEMPTING TO REMOVE THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. 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 15100845 ↗
• MalfunctionJul 26, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A GUIDEWIRE, AND A STENT DEVICE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SMART COIL IN THE ANEURYSM USING THE MICROCATHETER. THE SECOND SMART COIL WAS ADVANCED IN THE TARGET LOCATION USING THE MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE AND BY MANUALLY DETACHING IT USING MEDICAL CLAMPS BUT WERE UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN IMPLANTED THE NEXT SMART COIL IN THE ANEURYSM USING THE MICROCATHETER. THE NEXT SMART COIL WAS THEN ADVANCED IN THE ANEURYSM USING THE MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL USING MEDICAL CLAMPS. ANOTHER SMART COIL WAS THEN ADVANCED IN THE ANEURYSM USING THE MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO DETACH IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100746 ↗
• MalfunctionJul 14, 2022Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED FOUR SMART COILS IN THE TARGET LOCATION USING THE HANDLE. SUBSEQUENTLY, A NON-PENUMBRA COIL WAS THEN PLACED AFTER THE FOUR SMART COILS USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL AS WELL AS USING A NEW HANDLE TO DETACH THE COIL; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING THE COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE SMART COIL HAD UNINTENTIONALLY DETACHED. IT WAS ALSO REPORTED THAT HALF OF THE DETACHED SMART COIL WAS INSIDE ANEURYSM AND THE OTHER HALF OF THE COIL WAS OUTSIDE ANEURYSM. THE PHYSICIAN, THEREFORE, USED A GOOSENECK SNARE TO REMOVE THE DETACHED SMART COIL. THE PROCEDURE WAS COMPLETED US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023651 ↗
• MalfunctionApr 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE 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 IMPLANTED ONE SMART COIL IN THE ANEURYSM USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL BY BREAKING THE PUSHER ASSEMBLY OF THE COIL. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY MANUALLY DETACHING THE SMART COIL, AND UPON DETACHMENT, THE MICROCATHETER WAS NO LONGER IN THE ANEURYSM. CONSEQUENTLY, A PORTION OF THE SMART COIL PROLAPSED INTO THE PARENT VESSEL. THE PROCEDURE ENDED AT THIS POINT. THE PHYSICIAN THEN ADMINISTERED BLOOD THINNERS TO THE PATIENT TO PREVENT THROMBOSIS. ON THE FOLLOWING DAY, THE PHYSICIAN IMPLANTED A STENT TO STABILIZE THE PREVIOUSLY PROLAPSED SMART COIL UP AGAINST THE VESSEL WALL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031811 ↗
• MalfunctionNov 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS, NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVERAL PENUMBRA AND NON-PENUMBRA COILS INTO THE ANEURYSM. NEXT, WHILE ATTEMPTING TO ADVANCE THE SMART COIL, IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE SMART COILS WERE 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 12755925 ↗
• MalfunctionOct 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED AND RE-SHEATHED. THE PROCEDURE WAS COMPLETED USING OTHER 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 12682824 ↗
• MalfunctionOct 6, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. WHILE THE PHYSICIAN ADVANCED ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO 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 12583549 ↗
• MalfunctionSep 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12510237 ↗
• MalfunctionAug 13, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318820 ↗
• MalfunctionJul 17, 2021Material Deformation; Material Deformation

  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 12186221 ↗
• MalfunctionApr 30, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY 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 SIX SMART COILS IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED AND ANOTHER SMART COIL WAS SUCCESSFULLY IMPLANTED INSTEAD. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. 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 11758242 ↗
• MalfunctionApr 28, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A TRANS-ARTERIAL COIL EMBOLIZATION PROCEDURE FROM THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS, RUBY COIL LPS, PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT HAD POSSIBLE STENOSIS AND NARROWED VESSELS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT THE PACKING COIL LP AS THE FIRST COIL, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER. AFTER POSITIONING THE PACKING COIL LP IN THE TARGET LOCATION, THE COIL COULD NOT BE DETACHED USING THE HANDLE. IT WAS ALSO REPORTED THAT SEVERAL ATTEMPTS TO MANUALLY DETACH THE COIL FAILED; THEREFORE, THE PACKING COIL LP WAS REMOVED. WHILE ADVANCING A 2X4 RUBY COIL LP (F102505) THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL LP WOULD NOT ADVANCE BEYOND THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO USE A SMART COIL WHICH HAD A SMALLER DIAMETER THAN THE PREVIOUS COILS. HOWEVER, RESISTANCE WAS ALSO ENCOUNTERED WHILE ADVANCING THE SMART C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739953 ↗
• MalfunctionMar 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETERS, AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. AFTER REMOVING THE SMART COIL, THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE COIL BY PLACING THE INTRODUCER SHEATH IN SALINE SOLUTION; HOWEVER, THE SMART COIL STILL DID NOT ADVANCE AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477918 ↗
• MalfunctionOct 30, 2020Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AT THE BIFURCATION USING PENUMBRA SMART COILS (SMART COIL), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE ANEURYSM USING THE MICROCATHETER AND BENCHMARK. THE PHYSICIAN THEN INSERTED ANOTHER SMART COIL INTO THE MICROCATHETER AND WHILE ADVANCING THE COIL, THE TIP OF THE MICROCATHETER BEGAN TO KICKBACK OUT OF THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN SLIGHTLY RETRACTED SMART COIL AND THEN DECIDED TO REMOVE THE SMART COIL. THEREFORE, THE HOSPITAL TECHNICIAN GRABBED THE DETACHMENT ZONE OF THE SMART COIL AND BEGAN TO RETRACT THE PROXIMAL END OF THE SMART COIL OUT FROM THE MICROCATHETER AND BACK INTO ITS INTRODUCER SHEATH. WHILE THE HOSPITAL TECHNICIAN WAS ATTEMPTING TO REMOVE THE SMART COIL, THE PHYSICIAN PERFORMED A FLUOROSCOPY AND NOTICED THE SMART COIL HAD UNINTENTIONALLY DETACHED. CONSEQUENTLY, THE SMART COIL HAD MIGRATED OUT OF THE MICROCATHETER AND INTO THE M3 AND M4 SEGMENT OF THE MCA. THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY OF THE SMART COIL AND ATTACHED A SYRINGE TO TH

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

  MAUDE report 10766576 ↗
• MalfunctionOct 1, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERICALLOSAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA STENT, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT AND MULTIPLE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, IT GOT STUCK AND WOULD NOT ADVANCE OR RETRACT WITHIN ITS INTRODUCER SHEATH AFTER MAKING SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND NON-PENUMBRA COILS WITH THE SAME BENCHMARK AND 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 10617347 ↗
• MalfunctionSep 4, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA COILS 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT WAS IN POOR CONDITION PRIOR TO THE PROCEDURE; THE PATIENT HAD A BLEED AND AN ARTERIOVENOUS (AV) FISTULA. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE FRICTION LOCK. SUBSEQUENTLY, THE SMART COIL WAS REMOVED, AND THE PHYSICIAN IMPLANTED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED IN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497408 ↗
• MalfunctionJul 31, 2020Separation 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 NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE. THE PHYSICIAN VERIFIED THAT THE BLACK ALIGNMENT MARKER ON THE PUSHER ASSEMBLY WAS SEPARATED AND PROCEEDED TO PULL THE PUSHER ASSEMBLY OUT UNDER FLUOROSCOPY. HOWEVER, THE HANDLE FAILED TO DETACH SMART COIL, AND THE SMART COIL CAME BACK WITH THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ATTEMPTED TO POSITION THE SMART COIL BACK INTO THE ANEURYSM BUT WAS NOT SUCCESSFUL. 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 10348550 ↗
• MalfunctionApr 1, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ELEVEN OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913997 ↗
• MalfunctionMar 20, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND AN UNKNOWN MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE SMART COIL KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND AN UNKNOWN MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863177 ↗
• MalfunctionDec 16, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS AND TWENTY NON-PENUMBRA COILS IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, TWENTY 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 9475023 ↗
• MalfunctionNov 14, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LARGE TEMPORAL OCCIPITAL ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9323065 ↗
• MalfunctionNov 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9287525 ↗
• MalfunctionSep 4, 2019Failure 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 (F88573 AND F84429) WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS, AND ONE SMART COIL (F87328) WOULD NOT ADVANCE THROUGH THE NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962974 ↗