Smart Coil 400SMTHXSFT0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00814548015781), received between Mar 1, 2017 and Aug 27, 2025 — classified as 2 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (28 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SMART COIL INTO THE TARGET LOCATION USING THE HANDLE. AFTER ADVANCING ANOTHER SMART COIL INTO THE TARGET VESSEL, THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN REMOVED AND REINSERTED THE PUSHER ASSEMBLY OF THE SMART COIL INTO THE HANDLE AND MADE ANOTHER ATTEMPT TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL STILL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL STILL DID NOT DETACH. WHILE ATTEMPTING TO RETRACT THE SMART COIL AND REMOVE IT FROM THE PATIENT, THE COIL UNINTENTIONALLY DETACHED. HOWEVER, THE SMART COIL WAS ABLE TO BE REMOVED FROM THE PATIENT MANUALLY. THE PROCEDURE WAS COMPLETED BY 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 22908935 ↗
• MalfunctionJun 29, 2022Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS IN THE V3 TOWARDS THE V4. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWELVE COILS (UNKNOWN). AFTER ADVANCING A SMART COIL INTO THE TARGET VESSEL, THE HANDLE WAS USED TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH AFTER FIVE ATTEMPTS WERE MADE. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, ANOTHER SMART COIL WAS SUCCESSFULLY DETACHED IN THE TARGET LOCATION USING THE SAME HANDLE. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE HANDLE WAS USED TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH AFTER MULTIPLE ATTEMPTS WERE MADE. IT WAS REPORTED THAT WHEN THE HANDLE SLIDER WAS PULLED, THE PHYSICIAN FELT THE SMART COIL WAS BEING PULLED BACKWARDS. THEREFORE, THE HANDLE WAS REMOVED. A NEW HANDLE WAS USED TO DETACH THE SAME SMART COIL; HOWEVER, THE COIL DID NOT DETACH. IT WAS REPORTED THAT WHEN THE HANDLE SLIDER WAS PULLED, THE SAME ISSUE OCCURRED. THEREFORE, THE HANDLE WAS REMOVED. UPON REM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860572 ↗
• MalfunctionMar 26, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE SEVERAL ADDITIONAL ATTEMPTS TO DETACH THE SMART COIL MANUALLY AND USING THE HANDLE, BUT THE SMART COIL STILL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE GENTLY RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, IT WAS NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INSIDE THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS. THE SMART COILS FAILED TO DETACH AFTER THE PHYSICIAN MADE SEVERAL ATTEMPTS TO DETACH THE SMART COILS MANUALLY AND USING THE SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925110 ↗
• MalfunctionDec 2, 2021Separation Failure; Separation Failure

  .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921230 ↗
• MalfunctionNov 19, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  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), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN NON-PENUMBRA COILS AND THREE SMART COILS USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER 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. THEREFORE, THE PHYSICIAN 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 12844458 ↗
• MalfunctionNov 15, 2021Physical 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) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, FOUR NON-PENUMBRA COILS WERE IMPLANTED INTO THE TARGET VESSEL. WHILE ADVANCING A SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, IT BECAME STUCK. THEREFORE, THE SMART COIL AND MICROCATHETER WERE REMOVED TOGETHER. THE PHYSICIAN VISUALIZED VIA ANGIOGRAM THAT THE ANEURYSM WAS SUCCESSFULLY EMBOLIZED. NO FURTHER COILS WERE NEEDED; THEREFORE, THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813636 ↗
• MalfunctionNov 8, 2021Difficult to Advance; Difficult 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, A SMART COIL WAS REPORTED TO BE STIFF AND COULD NOT BE FULLY INSERTED INTO THE ANEURYSM. IT WAS ALSO REPORTED THAT THE SMART COIL KICKED THE MICROCATHETER OUT OF THE TARGET LOCATION. AFTER SEVERAL ATTEMPTS TO IMPLANT THE SAME SMART COIL, THE SAME ISSUE CONTINUED TO OCCUR. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THESE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING 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 12771465 ↗
• MalfunctionOct 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW 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 12701115 ↗
• MalfunctionOct 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID TERMINUS ANEURYSM USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WAS UNABLE TO BE ADVANCED AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS. THEREFORE, THE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12618378 ↗
• MalfunctionOct 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID TERMINUS ANEURYSM USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WAS UNABLE TO BE ADVANCED AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS. THEREFORE, THE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12618276 ↗
• MalfunctionSep 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT ONE SMART COIL FAILED TO DETACH IN THE TARGET LOCATION USING THE HANDLE AND ANOTHER SMART COIL WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, BOTH SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME HANDLE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493464 ↗
• MalfunctionJul 30, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING A PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), 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 TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER TWO ATTEMPTS. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING A NEW HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER TWO ATTEMPTS. CONSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE 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 12256964 ↗
• MalfunctionMay 10, 2021Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING 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 DETACHED A SMART COIL IN THE TARGET VESSEL USING THE HANDLE. HOWEVER, AFTER THE DETACHMENT, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME STUCK IN THE HANDLE. SUBSEQUENTLY, THE PUSHER ASSEMBLY WAS REMOVED FROM THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11802902 ↗
• MalfunctionApr 21, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR CIRCULATION-BASILAR TRUNK USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A SMART COIL THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS 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 11704136 ↗
• MalfunctionApr 20, 2021Failure 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) 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. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS; THEREFORE, THE SMART COILS WERE ALSO 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

  MAUDE report 11698461 ↗
• MalfunctionJan 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED NINE NON-PENUMBRA COILS AND FOUR SMART COILS. IT WAS REPORTED THAT ONE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF THE DISTAL PORTION OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE ADDITIONAL SMART COILS AND FORTY-FIVE OTHER COILS WITH 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 11198503 ↗
• MalfunctionNov 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL AND TEN OTHER COILS IN THE TARGET VESSEL USING A MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER, THE SMART COIL BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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; No Consequences Or Impact To Patient

  MAUDE report 10844117 ↗
• MalfunctionOct 29, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS AND SIX NON-PENUMBRA COILS IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL, HOWEVER, THE SMART COIL WAS STUCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATH OF THE SMART COIL WAS FLUSHED BEFORE IT WAS INSERTED INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, 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 10759428 ↗
• MalfunctionSep 24, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS, 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 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 BY PULLING THE PROXIMAL PORTION OF THE DELIVERY SYSTEM AND AFTER TWO ATTEMPTS THE SMART COIL DETACHED. NEXT, WHILE ADVANCING THE SECOND SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THEN, WHILE ADVANCING THE THIRD SMART COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL AND THE MICROCATHETER WERE REMOVED. 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 10584068 ↗
• MalfunctionSep 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THIRTEEN SMART COILS AND THIRTY-ONE OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, THE NEXT SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, SEVEN ADDITIONAL 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 10516570 ↗
• 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 10497003 ↗
• MalfunctionAug 27, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN SMART COILS AND TWO OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF SMART COIL'S INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 10463361 ↗
• MalfunctionAug 27, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN SMART COILS AND TWO OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF SMART COIL'S INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 10463338 ↗
• MalfunctionAug 11, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATHS AND WERE STUCK IN THEIR INITIAL POSITION. THEREFORE, THE PHYSICIAN PULLED THE SMART COILS OUT FROM THE BACKEND OF THE INTRODUCER SHEATHS AND BACKLOADED THE SMART COILS INTO THE INTRODUCER SHEATHS. THE PROCEDURE WAS COMPLETED USING THE SAME TWO SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394483 ↗
• MalfunctionAug 8, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SERIES OF SMART COILS IN THE ANEURYSM. WHILE ATTEMPTING TO PUSH THE LAST TWO SMART COILS SEPARATELY OUT OF THE INTRODUCER SHEATH, THE SMART COILS WOULD NOT ADVANCE FROM THE INITIAL POSITION. THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382991 ↗