Smart Coil 400SMTXSFT2H06Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00814548015330), received between Mar 29, 2017 and Jun 5, 2023 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL), A 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 INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL WOULD NOT DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE COIL BUT THE SMART COIL STILL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN PUSHED THE DETACHED SMART COIL INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056628 ↗
• MalfunctionFeb 6, 2022Physical Resistance/Sticking; Difficult or Delayed Separation; Premature Separation; Physical Resistance/Sticking; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF 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, 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 DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED ANOTHER SMART COIL TO PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM AND IMPLANTED BOTH SMART COILS SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS 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 13467370 ↗
• MalfunctionJan 4, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM) USING A PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL (LOT#F106024) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE SAME ISSUE OCCURRED WITH THE SECOND SMART COIL (LOT#F105543); HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH THE SMART COIL MANUALLY. NEXT, THE PHYSICIAN OPENED A SECOND HANDLE AND ATTEMPTED TO DETACH THE THIRD SMART COIL (LOT#F106201); HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS USING THE HANDLE AS WELL AS MANUALLY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PHYSICIAN AGAIN EXPERIENCED DIFFICULTY DETACHING THE FOURTH SMART COIL (LOT#F83607) USING THE HANDLE; HOWEVER, THE SMART COIL WAS ABLE TO BE DETACHED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155346 ↗
• MalfunctionNov 30, 2021Failure 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 LINGUAL ARTERY USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. CONSEQUENTLY, THE SMART COIL BECAME KINKED AND DAMAGED. 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 12897628 ↗
• 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 12741033 ↗
• MalfunctionSep 11, 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 COIL), A NON-PENUMBRA MICROCATHETER, A 5F NON-PENUMBRA SHEATH , A 4F NON-PENUMBRA ANGIOGRAPHIC CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE PHYSICIAN FLUSHED THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK AT THE DISTAL TIP AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE SMART COIL WAS ALSO RETRACTED AND REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457576 ↗
• MalfunctionAug 24, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE INTRODUCER SHEATH OF A SMART COIL THOUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND INTO THE HUB OF MICROCATHETER. THE HOSPITAL TECH ATTEMPTED ADVANCING THE COIL INTO THE MICROCATHETER, BUT THE FRICTION LOCK WOULD NOT RELEASE THE PUSHER ASSEMBLY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL AS WELL BUT COULD NOT, AND THE PUSHER ASSEMBLY KINKED. 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 12362364 ↗
• MalfunctionMar 30, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL DID NOT DETACH WITH THE HANDLE. THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL BY HAND, BUT THE SMART COIL DID NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED, AND THE HANDLE WAS NO LONGER USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SMART COIL AND DETACHED BY HAND. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590654 ↗
• MalfunctionJan 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). 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 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 11136371 ↗
• MalfunctionDec 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL; THEREFORE, IT WAS ALSO REMOVED. THE PHYSICIAN THEN IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL SMART COILS, TWO 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 10925223 ↗
• MalfunctionOct 31, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAJOR AORTOPULMONARY COLLATERAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE SMART COIL BECAME STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN PLACED SIX ADDITIONAL SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. AFTERWARDS, WHILE THE NEXT SMART COIL WAS ADVANCED THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN CONFIRMED A DEVIATION IN THE MICROCATHETER TIP POSITION. THEREFORE, THE SMART COIL WAS RETRACTED INTO ITS INTRODUCER SHEATH. THEN, WHILE ATTEMPTING TO RE-ADVANCE THE SAME SMART COIL INTO THE MICROCATHETER, THE DISTAL TIP OF THE SMART COIL BECAME STUCK WHEN IT REACHED THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 10767139 ↗
• MalfunctionApr 22, 2020Failure 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). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AFTER SEVERAL ATTEMPTS AND, 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 OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988515 ↗
• MalfunctionMar 31, 2020Material Deformation; Physical Resistance/Sticking; Difficult or Delayed Separation; Material Deformation; Physical Resistance/Sticking; Difficult or Delayed 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), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA STENT DEVICE. DURING THE PROCEDURE, THE PHYSICIAN USED THE STENT DEVICE TO HOLD OPEN THE VESSEL, THEN, THE SMART COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL USING THE HANDLE AND MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE BUT WAS ABLE TO REACH THE TARGET LOCATION. AFTER MAKING AN ATTEMPT TO DETACH THE SMART COIL USING THE HANDLE, THE PHYSICIAN WAS UNSURE WHETHER IT DETACHED OR NOT, AND MADE AN ATTEMPT TO MANUALLY DETACH IT. THE PHYSICIAN WAS STILL UNSURE WHETHER THE SMART COIL TRULY DETACHED; THEREFORE, IT WAS WITHDRAWN. UPON REMOVAL OF THE PUSHER ASSEMBLY, THE PHYSICIAN REALIZED THAT THE SMART COIL HAD DETACHED IN THE MICROCATHETER; THEREFORE, IT WAS COMPLETELY REMOVED. THE NEXT SMART COIL WAS ADVANCED APPROXIMATELY 10 CENTIMETERS INTO THE SAME MICROCATHETER AND BECAME STUCK. THE PHYSICIAN SUSPECTED THAT THE MICROCATHETER WAS OCCLUDED AND DECIDED TO REMOVE THE SMA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908084 ↗
• MalfunctionFeb 12, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER AND N-BUTYL CYANOACRYLATE (NBCA). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, 13% NBCA WAS INJECTED AND A COIL WAS PLACED INTO THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED A SMART COIL THROUGH THE MICROCATHETER INTO THE TARGET VESSEL BUT DECIDED TO RETRACT THE SMART COIL FOR RECOILING. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED, AND THE SMART COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, SIX 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 9702690 ↗
• MalfunctionNov 11, 2019Failure 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, THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL AND REPORTED THAT IT WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304690 ↗
• MalfunctionNov 5, 2019Failure 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, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A SMART COIL WITHIN THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE, BUT IT WOULD NOT ADVANCE. 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 9279630 ↗
• MalfunctionDec 12, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND ANOTHER COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156105 ↗
• MalfunctionNov 21, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN ADVANCED SMART COIL IN THE TARGET VESSEL USING NON-PENUMBRA MICROCATHETER THEN USED A HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER ANOTHER FAILED ATTEMPT WITH THE HANDLE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, THE SMART COIL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER COILS AND A NEW NON-PENUMBRA MICROCATHETER WITH THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8093526 ↗
• MalfunctionJul 5, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS AND SIX NON-PENUMBRA SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA SMART COILS. WHILE ATTEMPTING TO INSERT A NEW SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE SMART COIL INTRODUCER SHEATH AND SUBSEQUENTLY, THE SMART COIL STOPPED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 7663995 ↗
• MalfunctionApr 12, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART COILS USING THE HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH ANOTHER SMART COIL USING THE HANDLE, DESPITE ATTEMPTING TO DETACH THE SMART COIL TWICE. THE PHYSICIAN THEN TESTED THE HANDLE AND HEARD A DIFFERENT SOUND THAN USUAL. THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE AGAIN, HOWEVER WAS STILL UNSUCCESSFUL. THEREFORE THE PHYSICIAN USED A NEW HANDLE TO DETACH THE SMART COIL, AND COMPLETED THE PROCEDURE USING THE SECOND HANDLE AND ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7426510 ↗
• MalfunctionDec 11, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT GO INTO THE ANEURYSM DUE TO POSITIONING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105126 ↗
• MalfunctionJul 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE SMART COIL HAD NO SHAPE AS IT WAS ADVANCED OUT OF THE NON-PENUMBRA MICROCATHETER TO BE PLACED IN THE PATIENT; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS ENDED AFTER ATTEMPTING TO PLACE ADDITIONAL COILS, THOUGH NO COILS WERE SUCCESSFULLY PLACED DUE TO THE SHAPE OF THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726645 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR BIFURCATION ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) WITH NO COMPLICATIONS. THE NEXT DAY, THE PATIENT COMPLAINED OF LEFT BODY WEAKNESS. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND REVEALED A SMALL RIGHT PONTINE INFARCT. THE PATIENT REMAINED HOSPITALIZED WITH NO OTHER ACTIONS TAKEN AND WAS DISCHARGED TO REHAB IN STABLE CONDITION ON (B)(6) 2017. THE REPORTED RIGHT PONTINE INFARCT WAS ADJUDICATED BY THE PHYSICIAN TO BE POSSIBLY RELATED TO THE DISEASE STATE AND THE SMART COIL SYSTEM AND PROBABLY RELATED TO THE PROCEDURE.

  Patient problems: Infarction, Cerebral

  MAUDE report 6675344 ↗
• MalfunctionMar 29, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE A SMART COIL IN THE TARGET VESSEL. HOWEVER, WHILE ADVANCING THE SMART COIL, THE MICROCATHETER KICKED BACK; THEREFORE THE SMART COIL WAS RETRACTED. AFTER REPOSITIONING THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SMART COIL; HOWEVER, THE SMART COIL BECAME STUCK AND UNABLE TO ADVANCE PAST THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW SMART COIL, HOWEVER, RESISTANCE WAS EXPERIENCED WHILE ADVANCING THE SMART COIL THROUGH THE HUB OF THE MICROCATHETER AND THE SMART COIL BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW COILS AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6443165 ↗