Smart Coil 400SMTHXSFT0206Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00814548015972), received between Jun 20, 2017 and Sep 1, 2022 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (32 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Premature Separation; Premature Separation

  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), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TEN SMART COILS USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE LAST SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN TRIED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL STILL WOULD NOT DETACH. WHILE ATTEMPTING TO REMOVE THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED AND THE SMART COIL WAS FLUSHED OUT ON THE TABLE. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND NO ADDITIONAL COILS WERE IMPLANTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15338059 ↗
• MalfunctionMay 7, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  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), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED SMART COILS IN THE TARGET VESSEL USING THE HANDLE. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, THE COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PHYSICIAN THEN ADVANCED AND DETACHED NEW SMART COILS IN THE VESSEL USING A NEW HANDLE. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO VESSEL AND ATTEMPTED TO DETACH IT USING THE SECOND HANDLE BUT, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING, THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NEW MICROCATHETER. THERE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322118 ↗
• MalfunctionApr 22, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER TO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE SMART COIL FROM THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN DETERMINED VIA ANGIOGRAM THAT NO ADDITIONAL 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 14187311 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 03-NOV-2021 INDICATED THAT THE ISCHEMIC STROKE WAS ADJUDICATED BY THE CLINICAL INVESTIGATOR TO BE UNRELATED TO THE SMART COILS AND RELATED TO THE INDEX PROCEDURE.

  Patient problems: Ischemia Stroke

  MAUDE report 12651567 ↗
• MalfunctionSep 19, 2021Separation Failure; Separation Failure

  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 12493463 ↗
• MalfunctionJul 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE HOSPITAL TECHNOLOGIST MADE A SECOND ATTEMPT TO ADVANCE THE SMART COIL, BUT IT WAS UNSUCCESSFUL; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER SMART COIL OF THE SAME SIZE AND SEVERAL OTHER COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE SAME ISSUE OCCURRED; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER SMART COIL OF THE SAME SIZE IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186814 ↗
• MalfunctionJun 3, 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 COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FOUR OTHER SMART COILS; THEREFORE, THE FOUR 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 11927502 ↗
• MalfunctionApr 16, 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 OUT OF THE INTRODUCER SHEATH DUE TO THE FRICTION LOCK. 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 11682728 ↗
• 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 11586907 ↗
• MalfunctionMar 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH 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

  MAUDE report 11586276 ↗
• 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 11582653 ↗
• MalfunctionMar 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NEW SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. 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

  MAUDE report 11574540 ↗
• MalfunctionFeb 4, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL. 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 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 11283416 ↗
• MalfunctionFeb 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA 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 11259833 ↗
• MalfunctionJan 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS STARTING POSITION WITHIN ITS INTRODUCER SHEATH. 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 11220262 ↗
• MalfunctionJan 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11216585 ↗
• MalfunctionJan 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED 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; No Consequences Or Impact To Patient

  MAUDE report 11136257 ↗
• MalfunctionDec 24, 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 (ECHELON). DURING THE PROCEDURE TWO SMART COILS WERE UNABLE TO ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. 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; No Consequences Or Impact To Patient

  MAUDE report 11070921 ↗
• MalfunctionNov 17, 2020Failure 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, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE 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; No Consequences Or Impact To Patient

  MAUDE report 10853300 ↗
• 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 10709466 ↗
• MalfunctionSep 25, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A NEURON SELECT CATHETER 5F (5F SELECT), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR SMART COILS INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT SMART COIL, IT WAS UNABLE TO ADVANCE INTO THE HUB OF MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NO ADDITIONAL COILS WERE NEEDED AND THEREFORE, THE PROCEDURE WAS ENDED. 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 10587836 ↗
• 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 10496995 ↗
• MalfunctionAug 25, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ARTERIOVENOUS FISTULA (AVF) USING PENUMBRA SMART COIL (SMART COIL). 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 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 10448900 ↗
• MalfunctionAug 5, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL OUT OF THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE ALL; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 10368885 ↗
• MalfunctionJul 24, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE AT THE TIP OF THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. 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 10322131 ↗