Smart Coil 400SMTXSFT0206Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00814548016030), received between Apr 12, 2017 and Mar 17, 2022 — classified as 2 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (34 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID TERMINUS USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA EMBOLIZATION DEVICE. DURING THE PROCEDURE, AFTER SUCCESSFULLY IMPLANTING A NON-PENUMBRA COIL IN THE ANEURYSM, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL AND MICROCATHETER ALTOGETHER. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED IN THE PARENT VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE DETACHED SMART COIL USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE IS NO REPORTED ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793462 ↗
• MalfunctionNov 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL COLLATERAL CIRCULATION USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A 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 SEVEN SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871735 ↗
• MalfunctionNov 23, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) 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 LOCATION AS THE FIRST COIL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS WITH THE SAME HANDLE AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12864410 ↗
• MalfunctionNov 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE INTO THE MICROCATHETER. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER AND ATTEMPTED TO RE-ADVANCE THE SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN ALSO USED A GUIDEWIRE TO CHECK IF THE MICROCATHETER WAS KINKED AND FOUND NO ISSUES WITH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS NOT USED. 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 12838145 ↗
• MalfunctionSep 14, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A SMART COIL WITH THE HANDLE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471562 ↗
• MalfunctionAug 9, 2021Failure to Advance; Failure to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297627 ↗
• MalfunctionMay 4, 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). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITION IN THEIR INTRODUCER SHEATHS. THEREFORE, THEY WERE 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 11773307 ↗
• MalfunctionMay 4, 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). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITION IN THEIR INTRODUCER SHEATHS. THEREFORE, THEY WERE 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 11773291 ↗
• MalfunctionMay 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766506 ↗
• MalfunctionDec 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIVE COILS IN THE TARGET LOCATION. SUBSEQUENTLY, A SMART COIL WAS STUCK AT THE INITIAL POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, 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 11042069 ↗
• MalfunctionDec 13, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR SMART COILS AND FOUR NON-PENUMBRA COILS IN THE TARGET LOCATION. SUBSEQUENTLY, WHILE ADVANCING THE NEXT SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL BECAME STUCK AT THE HUB, TOWARDS THE ROTATING HEMOSTASIS VALVE. TO REDUCE RESISTANCE, THE PHYSICIAN MANIPULATED THE SMART COIL BACK AND FORTH, AND THE PUSHER ASSEMBLY OF THE SMART COIL BECAME KINKED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, 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; No Consequences Or Impact To Patient

  MAUDE report 10997636 ↗
• MalfunctionDec 5, 2020Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA STENT, NON-PENUMBRA MICROCATHETER, NON-PENUMBRA ACCESS CATHETER, AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A STENT AND TWO SMART COILS IN THE TARGET LOCATION. WHILE DETACHING THE FINAL SMART COIL WITH THE HANDLE, THE BLACK ALIGNMENT ZONE SEPARATED, BUT THE PHYSICIAN WAS UNABLE TO CONFIRM IF THE SMART COIL HAD DETACHED. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME STUCK IN THE MICROCATHETER. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO REMOVE THE SMART COIL AND MICROCATHETER. EACH TIME THE PHYSICIAN ATTEMPTED TO REMOVE THE SMART COIL AND MICROCATHETER, THE SMART COIL WOULD PULL ON THE STENT AND COIL MASS, AS WELL AS THE MICROCATHETER BECOMING STUCK ON ONE OF THE STENT TINES AT A CERTAIN POINT. THEREFORE, THE PHYSICIAN DECIDED TO CUT THE PROXIMAL END OF THE MICROCATHETER AND PUSHER ASSEMBLY AT THE GROIN REGION. THE REMAINING PART OF THE PUSHER ASSEMBLY AND MICROCATHETER WERE LEFT IN THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO R

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

  MAUDE report 10954068 ↗
• MalfunctionOct 10, 2020Failure 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), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA CATHETER. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE SECOND SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL DID NOT ADVANCE SMOOTHLY AND BECAME STUCK AT THE DISTAL END OF THE INTRODUCER SHEATH. SUBSEQUENTLY, THE SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE, AND IMPLANTED ANOTHER SMART COIL. WHILE ADVANCING THE FOURTH SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL ADVANCED A LITTLE BEFORE BECOMING STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER THREE 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 10659917 ↗
• MalfunctionSep 4, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE SMART COILS SEPARATELY INTO THE AVM AND CLICKED ON THE HANDLE. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED TO A SECOND HANDLE AFTER EXPERIENCING THIS ISSUE WITH TWO TO THREE SMART COILS; HOWEVER, THE SECOND HANDLE FAILED TO DETACH THE REMAINING SMART COILS. THE PUSHER ASSEMBLY OF EACH SMART COIL INDICATED THE SMART COIL WAS DETACHED CORRECTLY, BUT BOTH HANDLE FAILED TO DETACH FIVE SMART COILS. THEREFORE, THE SMART COILS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10497023 ↗
• MalfunctionAug 7, 2020Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Advance; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, IT WAS REPORTED THAT THE PX SLIM AND TWO SMART COILS WERE "DEFECTIVE". NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382946 ↗
• MalfunctionAug 7, 2020Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Advance; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, IT WAS REPORTED THAT TWO SMART COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS AND A PX SLIM WAS ¿DEFECTIVE¿. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382945 ↗
• MalfunctionMay 7, 2020Failure 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). DURING THE PROCEDURE, IT WAS REPORTED THAT A SMART COIL WOULD NOT ADVANCE NORMALLY THROUGH THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036793 ↗
• MalfunctionMay 6, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A PENUMBRA SMART COIL (SMART COIL), A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE COIL IN THE TARGET VESSEL USING THE NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO INSERT THE SMART COIL IN THE Y CONNECTOR, THE SMART COIL WAS UNABLE TO ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE 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 10029283 ↗
• MalfunctionApr 23, 2020Physical Resistance/Sticking; 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. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCING THE SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE SMART COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, THE SAME MICROCATHETER, AND N-BUTYL CYANOACRYLATE (NBCA) INJECTIONS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9993596 ↗
• MalfunctionApr 10, 2020Failure 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 WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE SAME ISSUE OCCURRED TO ANOTHER SMART COIL; THEREFORE, IT WAS ALSO 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 9949382 ↗
• MalfunctionApr 8, 2020Failure to Advance; Failure to Advance

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938352 ↗
• InjuryJan 6, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX COILS IN THE ANEURYSM USING THE MICROCATHETER. WHILE PLACING THE NEXT SMART COIL, THE PHYSICIAN FELT THE SMART COIL WAS STIFF BUT WAS ABLE TO PLACE THE REST OF IT. SUBSEQUENTLY, THE ANEURYSM RUPTURED. THE PHYSICIAN CONTINUED THE PROCEDURE. DUE TO A LOOP OF THE SMART COIL BEING DISPLACED IN THE ANTERIOR CEREBRAL ARTERY (ACA), A STENT WAS PLACED. IT WAS REPORTED THAT THE PATIENT HAD MINIMAL INTRACRANIAL BLEEDING THAT STOPPED WITHIN SECONDS. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THE OUTCOME WAS A COMPLETE ANEURYSM COILING WITH MINIMAL RESIDUAL FILLING.

  Patient problems: Rupture

  MAUDE report 9555515 ↗
• MalfunctionNov 8, 2019Failure 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 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS AND FOUR OTHER COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. UPON ADVANCEMENT OF THE NEXT SMART COIL INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE SMART COIL WAS THEN REMOVED AND FLUSHED IN SALINE SOLUTION; HOWEVER, THE SAME ISSUE OCCURRED UPON RE-ADVANCEMENT. 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 Consequences Or Impact To Patient

  MAUDE report 9298240 ↗
• MalfunctionOct 8, 2019Failure 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). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AND WAS STUCK ON FRICTION LOCK; 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 Consequences Or Impact To Patient

  MAUDE report 9168817 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WAS STUCK AT THE STARTING POSITION AND WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND PENUMBRA COIL 400S (PC400S). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866289 ↗