Smart Coil 400SMTSFT0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00814548015040), received between Feb 19, 2016 and Jun 6, 2022 — classified as 6 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2022Premature Separation; Premature Separation

  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, THE PHYSICIAN ADVANCED A SMART COIL IN 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 BUT WAS UNSUCCESSFUL. WHILE THE PHYSICIAN GENTLY RETRACTED THE PUSHER ASSEMBLY OF THE SMART COIL, IT WAS NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE DETACHED SMART COIL SUCCESSFULLY INTO THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE PHYSICIAN ALSO USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14607947 ↗
• MalfunctionMay 19, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE NEXT SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND USED THE HANDLE TO DETACH IT. WHILE RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE SMART COIL STARTED TO COME BACK INTO THE MICROCATHETER, AND THE PHYSICIAN THEN REALIZED THAT THE SMART COIL WAS NOT DETACHED. SUBSEQUENTLY, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE BUT WAS UNSUCCESSFUL. THEN AFTER SOME MANIPULATION, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DETACH THE SMART COIL; HOWEVER, A FEW MILLIMETERS OF THE PROXIMAL END OF THE DETACHED SMART COIL WERE HANGING OUT OF THE ANEURYSM. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO ADVANCE THE GUIDEWIRE THROUGH THE MICROCATHETER TO PUSH THE PROXIMAL END OF THE DETACHED SMART COIL INTO THE ANEURYSM DUE TO AN UNKNOWN MATERIAL BEING INSIDE THE MICROCATHETER. THE MICROCATHETER WAS THEN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434915 ↗
• MalfunctionNov 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS 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 12739880 ↗
• MalfunctionOct 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12716719 ↗
• MalfunctionOct 1, 2021Separation Failure; Difficult or Delayed Separation; Separation Failure; 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 ADVANCED A SMART COIL INTO THE TARGET LOCATION. AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, WHILE ADVANCING ANOTHER SMART COIL INTO THE TARGET LOCATION. THE PHYSICIAN NOTICED, THAT THE LAST TWO-THREE MILLIMETERS OF THE SMART COIL WAS VERY STIFF AND WOULD NOT ADVANCE INTO THE ANEURYSM SAC. SUBSEQUENTLY, THE SMART COIL KICKED BACK AND PUNCTURED THE WALL OF THE ANEURYSM. IT WAS REPORTED, THAT THERE WAS A BALLOON CATHETER ALREADY IN PLACE THAT PREVENTED FURTHER INJURY. AFTER THAT, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL INTO THE ANEURYSM SAC. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565740 ↗
• MalfunctionSep 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC 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 SUCCESSFULLY PLACED THREE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO REMOVED. AFTERWARDS, THE NEXT THREE SMART COILS ADVANCED SLIGHTLY PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS BEFORE BECOMING STUCK WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL TO THE TARGET LOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419037 ↗
• MalfunctionApr 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER. THEREFORE, IT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11604732 ↗
• InjuryFeb 10, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA STENT. DURING THE PROCEDURE, THE OPERATOR PLACED A STENT. THEN, THE ANEURYSM RUPTURED WHILE AN OPERATOR WAS PLACING A SMART COIL. WHILE THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING A HANDLE (F100891), AN AUDIBLE CLICK WAS HEARD AND THE BLACK ALIGNMENT ZONE HAD SEPARATED, BUT THE SMART COIL FAILED TO DETACH. ANOTHER ATTEMPT WAS MADE TO DETACH THE SMART COIL USING THE HANDLE BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, THE SMART COIL DID NOT DETACH. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO USE A SECOND HANDLE (F94335) TO DETACH THE SMART COIL; HOWEVER, THE SMART COIL FAILED TO DETACH. ANOTHER OPERATOR CAME IN TO HELP AND WAS ABLE TO MANUALLY DETACH THE SMART COIL. THE PHYSICIAN WAS ABLE TO STOP THE BLEEDING FROM THE RUPTURE BY INFLATING A BALLOON. THE PHYSICIAN WAS SATISFIED WITH THE ANGIOGRAPHIC OUTCOME AND ANTICIPATES THE PATIENT WILL DO WELL.

  Patient problems: Aneurysm

  MAUDE report 11311049 ↗
• MalfunctionJan 21, 2021Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SMART COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE SMART COIL WAS THEREFORE, REMOVED. WHILE ADVANCING ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND 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 11209489 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE ANGIOGRAM REVEALED THAT THE SMART COIL WENT THROUGH THE BLISTER OF THE ANEURYSM AND RUPTURED IT. HOWEVER, THE SMART COIL WAS STILL IMPLANTED AND THE PHYSICIAN CONTINUED TO IMPLANT COILS TO STOP THE BLEED. IT WAS ALSO REPORTED THAT ANOTHER SMART COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER AND WAS THEREFORE REMOVED. WHILE ATTEMPTING TO ADVANCE TWO MORE SMART COILS, THEY WOULD NOT ADVANCE FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THESE TWO SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PATIENT IS STABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10671238 ↗
• MalfunctionOct 13, 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE ANGIOGRAM REVEALED THAT THE SMART COIL WENT THROUGH THE BLISTER OF THE ANEURYSM AND RUPTURED IT. HOWEVER, THE SMART COIL WAS STILL IMPLANTED AND THE PHYSICIAN CONTINUED TO IMPLANT COILS TO STOP THE BLEED. IT WAS ALSO REPORTED THAT ANOTHER SMART COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER AND WAS THEREFORE REMOVED. WHILE ATTEMPTING TO ADVANCE TWO MORE SMART COILS, THEY WOULD NOT ADVANCE FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THESE TWO SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PATIENT IS STABLE.

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

  MAUDE report 10671229 ↗
• MalfunctionJul 14, 2020Material Deformation; Material Deformation

  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 PLACED TWO SMART COILS INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL ON THE BACK TABLE, THE SMART COIL WOULD NOT EXIT ITS INTRODUCER SHEATH AND SUBSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE SMART COIL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS ON REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273866 ↗
• MalfunctionDec 3, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET VESSEL AFTER MAKING MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. WHILE ATTEMPTING TO PLACE TWO MORE SMART COILS USING A SECOND HANDLE, THE PHYSICIAN AGAIN MADE MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. ALL FOUR COILS WERE PLACED SUCCESSFUL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9406020 ↗
• MalfunctionNov 28, 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 COIL). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS EXPERIENCED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL FROM ITS STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW SMART 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 8111079 ↗
• MalfunctionOct 24, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AND THEREFORE, 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 8001726 ↗
• MalfunctionJul 19, 2018Difficult 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). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER SMART COIL IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A NEW SMART COIL IN THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE SMART COIL WOULD NOT COMPLETELY DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS ENDED AFTER THE MANUAL DETACHMENT OF THE SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704596 ↗
• MalfunctionJun 28, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  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 SUCCESSFULLY PLACED A COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL THROUGH THE HUB OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL, 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 7646161 ↗
• MalfunctionMay 24, 2018Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE HOSPITAL STAFF EXPERIENCED DIFFICULTY LOADING TWO SMART COILS INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND, THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543282 ↗
• MalfunctionMay 24, 2018Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE HOSPITAL STAFF EXPERIENCED DIFFICULTY LOADING TWO SMART COILS INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND, THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543277 ↗
• MalfunctionApr 3, 2018Failure 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, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE TWO SMART COILS WITHIN THEIR INTRODUCER SHEATHS, AND THEREFORE THE 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 Consequences Or Impact To Patient

  MAUDE report 7392427 ↗
• MalfunctionFeb 27, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY - POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS). THE PHYSICIAN FIRST ADVANCED A COIL THROUGH A NON-PENUMBRA MICROCATHETER, HOWEVER THE COIL DID NOT WIND WELL AND WAS THEREFORE REMOVED. THE PHYSICIAN THEN ADVANCED AND ATTEMPTED TO DETACH A SMART COIL, HOWEVER UPON RETRACTING TO REMOVE THE PUSHER WIRE, THE PHYSICIAN FOUND THAT THE SMART COIL HAD NOT FULLY DETACHED. THE SMART COIL THEN BECAME FULLY DETACHED WHILE PARTIALLY WITHIN THE MICROCATHETER, AND THE PHYSICIAN THEREFORE USED A GUIDEWIRE TO PUSH THE DETACHED SMART COIL INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER COIL PAST ABOUT FIVE CENTIMETERS FROM THE DISTAL TIP OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A GUIDEWIRE THROUGH THE MICROCATHETER TO TEST IT, AND THE GUIDEWIRE WAS UNABLE TO FULLY ADVANCE THROUGH THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER, AND COMPLETED THE PROCEDURE USING A NEW MICROCATHETER AND ADDITIONAL COILS. IT WAS REPORTED THAT THERE WAS A FOREIGN OBJECT 10 CM PROXIMAL OF THE DISTAL TIP OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7301620 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUPERIOR CEREBELLAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THERE WAS THROMBUS FORMATION IN THE PARENT VESSEL. THEREFORE, THE PATIENT WAS GIVEN INTEGRILIN AND THE EVENT RESOLVED ON THE SAME DAY. THE REPORTED THROMBUS FORMATION WAS ADJUDICATED TO HAVE A DEFINITE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE PENUMBRA SMART COIL SYSTEM.

  Patient problems: Thrombosis; Thrombus

  MAUDE report 7146478 ↗
• MalfunctionSep 14, 2017Separation Failure; Difficult or Delayed Activation; Physical Resistance; Separation Failure; Difficult or Delayed Activation; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH A NON-PENUMBRA GUIDE CATHETER, TOWARDS THE RIGHT IC-PC AND THEN DEPLOYED AND DETACHED THREE SMART COILS INTO THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN HAD DIFFICULTY DETACHING THE FOURTH SMART COIL (LOT # F73015) USING THE HANDLE. AFTER SEVERAL ATTEMPTS, THE COIL SUCCESSFULLY DETACHED. WHILE ATTEMPTING TO ADVANCE THE FIFTH SMART COIL (LOT #F70649), THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE FOURTH COIL''S DISTAL DETACHMENT TIP (DDT) WAS FRACTURED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DDT INTO THE ANEURYSM. THE PHYSICIAN RE-ADVANCED THE FIFTH COIL THROUGH THE MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE AND THE COIL WAS DETACHED WITHOUT ISSUE. WHILE ATTEMPTING TO ADVANCE THE NINTH SMART COIL (LOT # F70768) THROUGH THE MICROCATH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867053 ↗
• MalfunctionJun 16, 2017Mechanical Problem; Difficult to Remove; Mechanical Problem; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (SCH1). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL USING THE SCH1, HOWEVER THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE PROXIMAL END OF THE PUSHER WIRE FROM THE SCH1. AFTER MULTIPLE ATTEMPTS MANIPULATING THE WIRE AND SCH1, THE PUSHER WIRE WAS REMOVED FROM THE SCH1. THIS OCCURRED WITH TWO ADDITIONAL SMART COILS, HOWEVER THE PROCEDURE WAS COMPLETED USING THE THREE SMART COILS AND THE SCH1. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6648945 ↗
• MalfunctionMay 9, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED CEREBRAL ARTERY ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING THE DISTAL DETACHMENT TIP OF TWO SMART COILS THROUGH THE TIP OF THE MICROCATHETER; HOWEVER, THE SMART COILS WERE SUCCESSFULLY DEPLOYED AND DETACHED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555937 ↗