Smart Coil 400SMTXSFT0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00814548015354), received between Apr 7, 2016 and Feb 8, 2023 — classified as 5 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (40 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN DELIVERED AN EMBOLIZATION AGENT IN THE TARGET VESSEL USING THE MICROCATHETER. AFTERWARDS, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER INTO THE TARGET VESSEL, THE SMART COIL BECAME STUCK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED WITH PART OF THE SMART COIL IN THE TARGET VESSEL AND THE OTHER PART IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN FLUSHED THE REMAINING PART OF THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, 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 PHYSICIAN MANUALLY DETACHED THE SMART COIL. 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 16329771 ↗
• MalfunctionNov 23, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PUSHER ASSEMBLY BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED AND REPLACED. NEXT, AFTER PLACING FOUR SMART COILS IN THE TARGET LOCATION SUCCESSFULLY, THE PHYSICIAN ATTEMPTED TO DETACH THE NEXT SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SAME SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863127 ↗
• MalfunctionNov 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, A NON-PENUMBRA BALLOON CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, ONE SMART COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE COIL WAS UNABLE TO ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL, THREE SMART COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741029 ↗
• MalfunctionOct 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TRANSVENOUS FISTULA 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 SIX SMART COILS AND TEN NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. NEXT, A NEW 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 A NEW SMART COIL, THREE NON-PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712134 ↗
• MalfunctionJul 14, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK AT THE HUB OF THE MICROCATHETER AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS ALSO 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 12164713 ↗
• MalfunctionMay 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) USING A PENUMBRA SMART COIL (SMART COIL), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL, THE SAME BENCHMARK, 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 11852450 ↗
• MalfunctionMar 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING SMART COILS. DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS; THEREFORE THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582659 ↗
• MalfunctionMar 29, 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 USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, ALL THREE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581621 ↗
• MalfunctionJan 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULDN'T ADVANCE PAST THE INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. 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; No Consequences Or Impact To Patient

  MAUDE report 11152389 ↗
• MalfunctionDec 24, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND 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. THE HANDLE WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN MADE ANOTHER ATTEMPT TO DETACH THE SMART COIL USING A NEW HANDLE, BUT THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A HEMOSTAT ON THE BACK OF THE PUSHER ASSEMBLY TO MANUALLY DETACH THE SMART COIL. NEXT, ANOTHER SMART COIL WAS ADVANCED INTO THE VESSEL AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING BOTH HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, BOTH HANDLES AND THE SMART COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND 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 11070899 ↗
• MalfunctionDec 11, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PHYSICIAN WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FISTULA IN THE OCCIPITAL BRANCH USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO ADVANCE THE SMART COIL; HOWEVER, IT WAS UNSUCCESSFUL. CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME BENT AND, 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; No Consequences Or Impact To Patient

  MAUDE report 10993110 ↗
• MalfunctionNov 18, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 10858156 ↗
• MalfunctionNov 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 10856446 ↗
• MalfunctionNov 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 10856396 ↗
• MalfunctionNov 11, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE SMART COIL KINKED. 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; No Consequences Or Impact To Patient

  MAUDE report 10821017 ↗
• MalfunctionOct 21, 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 AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE SAME ISSUED OCCURRED. THE SMART COIL ALSO WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 10709463 ↗
• MalfunctionOct 8, 2020Physical Resistance/Sticking; 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 10652319 ↗
• MalfunctionAug 27, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULAS (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. HOWEVER, THE NEXT SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AND WAS STUCK AT THE INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER NINETEEN 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 10462947 ↗
• MalfunctionAug 25, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DETACHING A SMART COIL WITH THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED AND IMPLANTED THE SMART COIL IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS 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 10451243 ↗
• MalfunctionAug 12, 2020Failure to Advance; Failure to Advance

  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 WAS UNABLE TO ADVANCE THE SMART COIL PAST ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH AFTER SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL WAS NOT USED. 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 Consequences Or Impact To Patient

  MAUDE report 10395778 ↗
• MalfunctionMay 28, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ICA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WERE IMPLANTED IN THE ANEURYSM. WHILE ATTEMPTING TO ADVANCE THE THIRD SMART COIL THROUGH ITS INTRODUCER SHEATH, THE SCRUB TECHNICIAN REPORTED THAT THE SMART COIL WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 10098331 ↗
• MalfunctionJan 29, 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 AT ALL 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 Consequences Or Impact To Patient

  MAUDE report 9644632 ↗
• MalfunctionDec 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, NON-PENUMBRA GUIDE CATHETER AND NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, AND THE VESSEL HAD CALCIFIED PLAQUES. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND FOURTEEN NON-PENUMBRA COILS USING THE MICROCATHETER IN THE ANEURYSM. THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE FOURTH SMART COIL TWICE BEYOND THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SMART COIL, TWO NON-PENUMBRA 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 9477434 ↗
• MalfunctionDec 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBELLAR ARTERY (VA-PICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND ANOTHER COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. AFTER INSERTING ANOTHER SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO REMOVE THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9477022 ↗
• MalfunctionDec 16, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN INSERTED A SMART COILS INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN INSERTED A NEW SMART COIL INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 9475125 ↗