Smart Coil 400SMTXSFT0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00814548015187), received between Mar 4, 2016 and Aug 21, 2025 — classified as 1 injury, 57 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOMM) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET LOCATION AND MANUALLY DETACHED THE SMART COIL INTO THE TARGET LOCATION. WHILE RETRACTING THE SMART COIL PUSHER ASSEMBLY, THE PHYSICIAN FELT SOMETHING HUNG ON TO THE SMART COIL PUSHER ASSEMBLY AND THE SMART COIL WAS SLIGHTLY PULLED OUT OF THE ANEURYSM BEFORE FULLY DETACHING. IT WAS NOTED THAT THE LAST IMAGING REVEALED THAT THE TAIL END OF THE EMBOLIZATION COIL WAS IN THE PARENT VESSEL AND WAS NOT INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED THE SMART COIL PUSHER ASSEMBLY AND THE MICROCATHETER TO PUSH THE SMART COIL BACK INTO THE TARGET LOCATION, BUT A SMALL PART OF THE SMART COIL WAS STILL LEFT FREE FLOWING IN THE PARENT VESSEL. THE PHYSICIAN DECIDED TO LEAVE THE SMART COIL IN THE PCOMM AS THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22865221 ↗
• MalfunctionFeb 17, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUPERIOR SAGITTAL CAVERNOUS FISTULA USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS INTO THE TARGET VESSEL USING THE HANDLE. NEXT, THE PHYSICIAN ADVANCED A NEW 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 DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN PUSHED THE DETACHED SMART COIL INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, THE SAME HANDLE, 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 16396733 ↗
• InjuryDec 23, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A SMART COIL IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SMART COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE TARGET VESSEL. THE PHYSICIAN THEN TRIED TO PUSH THE SMART COIL INTO THE TARGET LOCATION USING THE PUSHER ASSEMBLY. IT WAS REPORTED THAT PART OF THE COIL WAS LEFT IN THE PARENT VESSEL. SUBSEQUENTLY, THE PHYSICIAN USED A STENT DEVICE TO PUSH THE REMAINING SMART COIL AGAINST THE VESSEL WALL. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT HAD AN ISCHEMIC STROKE WITH A POSSIBLE RELATION TO THE SMART COIL.

  Patient problems: Ischemia Stroke

  MAUDE report 13082732 ↗
• MalfunctionNov 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, 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 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 12845421 ↗
• MalfunctionOct 13, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (ICPC) 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 PLACED A SMART COIL AND THREE NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING SEVERAL TIMES TO ADVANCE THE NEXT SMART COIL IN THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 12627668 ↗
• MalfunctionSep 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK APPROXIMATELY THREE-FOURTHS OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE SMART COIL BECAME STUCK IN THE MICROCATHETER; THEREFORE, THE SMART COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW SMART COILS AND A NEW VELOCITY DELIVERY MICROCATHETER (VELOCITY). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457570 ↗
• MalfunctionSep 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH AFTER THE PHYSICIAN MADE SEVERAL ATTEMPTS; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, 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 12450358 ↗
• MalfunctionJul 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL IN THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, WHILE ADVANCING ANOTHER SMART COIL IN THE HUB OF THE MICROCATHETER, THE SAME ISSUE OCCURRED, THE PHYSICIAN EXPERIENCED RESISTANCE. 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 12188423 ↗
• MalfunctionJul 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL IN THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, WHILE ADVANCING ANOTHER SMART COIL IN THE HUB OF THE MICROCATHETER, THE SAME ISSUE OCCURRED, THE PHYSICIAN EXPERIENCED RESISTANCE. 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 12188074 ↗
• MalfunctionJul 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERICALLOSAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, ANOTHER SMART COIL WAS ADVANCED IN THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER ATTEMPTING VARIOUS METHODS TO DETACH THE SMART COIL, THE PHYSICIAN WAS FINALLY ABLE TO DETACH THE SMART COIL. THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL AS WELL; HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH 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 12154837 ↗
• MalfunctionApr 25, 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, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH A SECOND SMART COIL; THEREFORE, IT WAS ALSO 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 11722081 ↗
• MalfunctionMar 8, 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 COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING A MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE IT BEYOND THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN PLACED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE A NON-PENUMBRA COIL THROUGH THE MICROCATHETER BUT WAS UNABLE TO AND THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 11437230 ↗
• MalfunctionFeb 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS PUT ASIDE AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN USED A NEW HANDLE TO DETACH THE SMART COIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 11304619 ↗
• MalfunctionFeb 4, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR 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, SIX SMART COILS WERE IMPLANTED INTO THE TARGET LOCATION WITHOUT ISSUE. AFTER ALIGNING THE NEXT SMART COIL INTRODUCER SHEATH WITH THE MICROCATHETER HUB, THE SMART COIL BECAME STUCK AT THE DISTAL TIP DURING ADVANCEMENT. THEREFORE, THE SMART COIL WAS NO LONGER USED IN THE PROCEDURE. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THAT SMART COIL WAS NO LONGER USED IN THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11283396 ↗
• MalfunctionJan 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR SUPERIOR PANCREATICODUODENAL ARTERY USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED AND THE MICROCATHETER WAS FLUSHED. AFTERWARDS, THE PHYSICIAN EXAMINED THE SMART COIL ON THE BACK TABLE AND NOTICED NO ABNORMALITIES. NEXT, THE PHYSICIAN RE-ADVANCED THE SMART COIL THROUGH THE MICROCATHETER AND THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING EIGHT 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 11198017 ↗
• MalfunctionJan 13, 2021Failure 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). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION IN THE INTRODUCER SHEATH. 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 11167406 ↗
• MalfunctionDec 13, 2020Physical Resistance/Sticking; Separation Problem; Physical Resistance/Sticking; Separation Problem

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION, HOWEVER, DECIDED TO REPOSITION THE SMART COIL. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE SMART COIL BACK INTO THE ANEURYSM. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE MICROCATHETER. THEN, TO TEST THE SMART COIL THE PHYSICIAN ADVANCED AND RETRACTED THE SMART COIL SEVERAL TIMES IN THE PROXIMAL END OF THE MICROCATHETER AND THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE SMART COIL. SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE SMART COIL BACK INTO THE ANEURYSM. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10999075 ↗
• 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 10856443 ↗
• MalfunctionJul 30, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE SMART COIL STOPPED ADVANCING FURTHER. THE PHYSICIAN THEN RETRACTED THE SMART COIL BACK INTO ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH; HOWEVER, THE SMART COIL WOULD NOT ADVANCE FORWARD. THEREFORE, THE SMART COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN PLACED TWO SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL OUT OF ITS INTRODUCER SHEATH; 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 10348041 ↗
• MalfunctionJun 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WAS STUCK IN ITS INITIAL POSITION; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN OTHER SMART COILS, TWENTY-SIX 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 10141559 ↗
• MalfunctionApr 15, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), OTHER COILS AND, NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS AND FIVE OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE PROXIMAL END OF THE SPRING OF THE SMART COIL HAD UNRAVELED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 9962994 ↗
• MalfunctionMar 19, 2020Failure to Advance; Failure to Advance

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856968 ↗
• MalfunctionDec 17, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN OPENED A THIRD SMART COIL, AND IT WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE FOURTH SMART COIL; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE THE SMART COILS OUT OF THE INTRODUCER SHEATHS, THE PUSHER ASSEMBLIES OF THE SMART COILS WERE INADVERTENTLY BENT. THE PHYSICIAN THEN ADVANCED ANOTHER TWO SMART COILS TO THE TARGET VESSEL SEPARATELY AND EXPERIENCED DIFFICULTY DETACHING THEM; THE PHYSICIAN HAD TO CLICK THE BUTTON ON THE HANDLE SEVERAL TIMES. THE PROCEDURE WAS COMPLETED USING THE SAME TWO SMART COILS AND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483926 ↗
• MalfunctionDec 17, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN OPENED A THIRD SMART COIL, AND IT WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE FOURTH SMART COIL; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE THE SMART COILS OUT OF THE INTRODUCER SHEATHS, THE PUSHER ASSEMBLIES OF THE SMART COILS WERE INADVERTENTLY BENT. THE PHYSICIAN THEN ADVANCED ANOTHER TWO SMART COILS TO THE TARGET VESSEL SEPARATELY AND EXPERIENCED DIFFICULTY DETACHING THEM; THE PHYSICIAN HAD TO CLICK THE BUTTON ON THE HANDLE SEVERAL TIMES. THE PROCEDURE WAS COMPLETED USING THE SAME TWO SMART COILS AND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483889 ↗
• MalfunctionNov 20, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT EXTERNAL CAROTID ARTERY (ECA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SMART COIL THROUGH ITS INTRODUCER SHEATH AND REPORTED THAT THE SMART COIL WAS UNABLE TO ADVANCE INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9347951 ↗