Smart Coil 400SMTXSFT2H04Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00814548015323), received between Apr 7, 2016 and Oct 26, 2022 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATION ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED THE NEXT SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED IN THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN USED A NON-PENUMBRA COIL TO COMPLETELY PUSH THE DETACHED SMART COIL IN THE ANEURYSM. THE PROCEDURE ENDED AFTER PLACING THE NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671829 ↗
• MalfunctionAug 3, 2022Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY (ACOM). USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING THE SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER; HOWEVER, AFTER THE SMART COIL HAD PARTIALLY ENTERED THE ANEURYSM, THE MICROCATHETER KICKED BACK OUT. THE PHYSICIAN REPOSITIONED THE MICROCATHETER AND, THEN DECIDED TO REMOVE AND REPLACE THE SMART COIL WITH A SMALLER SIZE SMART COIL. NEXT, THE PHYSICIAN ADVANCED THE NEW SMART COIL INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE HANDLE AND DETACHED THE SMART COIL USING A NEW HANDLE. UPON REMOVING THE PUSHER ASSEMBLY OF THE SMART COIL, APPROXIMATELY ONE MILLIMETERS OF THE TAIL OF THE DETACHED SMART COIL CAME OUT OF THE ANEURYSM AND WAS LEFT IN THE PARENT VESSEL. SUBSEQUENTLY, THE PHYSICIAN INSERTED THE NEXT SMART CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157619 ↗
• MalfunctionNov 22, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  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 PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE NEXT SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO PRESS THE TRIGGER OF THE HANDLE HALFWAY WHILE PULLING ON THE PUSHER ASSEMBLY, BUT THE SMART COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN USED FORCEPS TO MANUALLY DETACH THE SMART COIL. SUBSEQUENTLY, THE NEXT TWO SMART COILS WOULD NOT DETACH USING A NEW HANDLE. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO PRESS THE TRIGGER OF THE HANDLE HALFWAY WHILE PULLING ON THEIR RESPECTIVE PUSHER ASSEMBLY, BUT THE SMART COILS DID NOT DETACH. THE PHYSICIAN ALSO ATTEMPTED TO USE FORCEPS TO MANUALLY DETACH THE SMART COILS BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856858 ↗
• MalfunctionNov 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL 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 12849382 ↗
• MalfunctionOct 6, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. WHILE THE PHYSICIAN ADVANCED ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO 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 12583551 ↗
• MalfunctionJul 29, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING A SECOND HANDLE, BUT IT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY HAND, BUT IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED A SECOND SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 12249202 ↗
• MalfunctionJul 14, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) 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 INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS. THEREFORE, THE SMART COIL AND THE HANDLE WERE REMOVED. 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 12170291 ↗
• MalfunctionJan 15, 2021Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, NON-PENUMBRA MICROCATHETERS, A NON-PENUMBRA PARENT CATHETER, NON-PENUMBRA GUIDING CATHETER, AND STENT. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A STENT IN THE TARGET VESSEL WITH THE NON-PENUMBRA MICROCATHETER, FOLLOWED BY SEVEN COILS AND FOUR SMART COILS WITH ANOTHER NON-PENUMBRA MICROCATHETER USING A TRANSCELL TECHNIQUE. SUBSEQUENTLY, AFTER ADVANCING THE NEXT SMART COIL FROM THE DISTAL TIP OF THE SECOND MICROCATHETER AND APPROXIMATELY 3CM INTO THE VESSEL, THE SMART COIL WAS STUCK. THEREFORE, THE SMART COIL AND MICROCATHETER WERE REMOVED TOGETHER, AND THE SMART COIL WAS REMOVED FROM THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING SIX NON-PENUMBRA COILS AND A DIFFERENT NON-PENUMBRA 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 11178585 ↗
• MalfunctionDec 5, 2020Premature Separation; Premature Separation

  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, IT WAS REPORTED THAT THE SMART COIL "DEPLOYED" IN THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10953346 ↗
• MalfunctionOct 1, 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. DURING THE PROCEDURE, THE SMART COIL WOULD NEITHER ADVANCE NOR RETRACT FROM ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO USE ANOTHER SMART COIL, IT WAS REPORTED THAT THE WIDE NECK OF THE ANEURYSM COULD NOT HOLD THE SMART COIL WITHOUT USE OF A STENT. THEREFORE, THIS SMART COIL WAS REMOVED AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS ADMINISTERED MEDICATIONS (PLAVIX AND ASPIRIN) AND SENT HOME AND IS SCHEDULED TO RETURN IN ONE MONTH FOR PLACEMENT OF A STENT AND ADDITIONAL 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 10613786 ↗
• MalfunctionAug 28, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY FRAMED THE VESSEL USING THREE COILS. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO TO THE TARGET LOCATION AND USED A HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER, THREE FAILED ATTEMPTS, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE TO DETACH THE SAME SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10469227 ↗
• MalfunctionAug 7, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ANEURYSM AT THE ANTERIOR INFERIOR CEREBELLAR ARTERY (AICA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK AND WOULD NOT ADVANCE FROM THE STARTING 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 10380461 ↗
• MalfunctionJul 17, 2020Failure 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 ATTEMPTING TO ADVANCE A SMART COIL OUT OF THE INTRODUCER SHEATH, THE SMART COIL WAS STUCK IN THE INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290570 ↗
• MalfunctionJul 7, 2020Failure 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 COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 10242695 ↗
• MalfunctionJun 12, 2020Separation Problem; Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, IT WAS REPORTED THAT A SMART COIL ¿DETACHED, BUT NOT PROPERLY¿. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10150933 ↗
• MalfunctionMay 19, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS, NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER AND GUIDEWIRE. THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEXT SMART COIL WITHIN ITS INTRODUCER SHEATH; HOWEVER, THE SMART COIL BECAME STUCK AFTER ADVANCING A FEW MILLIMETERS WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 10071183 ↗
• MalfunctionMar 31, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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 9908099 ↗
• MalfunctionMar 31, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE HUB OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, THE SMART COIL AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9907671 ↗
• MalfunctionMar 19, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SMART COIL INTO THE HUB OF THE MICROCATHETER. THE PHYSICIAN CONTINUED ADVANCING THE SMART COIL AND SUCCESSFULLY IMPLANTED THE SMART COIL INTO THE TARGET LOCATION. WHILE ADVANCING ANOTHER SMART COIL, THE SAME ISSUE OCCURRED. HOWEVER, WHEN THE PHYSICIAN CONTINUED TO ADVANCE THE SMART COIL, THE PUSHER ASSEMBLY BECAME KINKED; 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 9856594 ↗
• InjuryFeb 14, 2020Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PERICALLOSAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS WITH A LOOP IN THE CAROTID ARCH. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE SMART COIL KICKED THE MICROCATHETER OUT OF THE ANEURYSM; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN MENTIONED THAT THE SMART COIL WAS "STIFF". NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND WAS THEREFORE REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE ANEURYSM AND USED THE HANDLE TO DETACH IT. HOWEVER, THE SMART COIL FAILED TO DETACH AFTER THREE TO FOUR ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY PULLING THE PULL WIRE, BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE SMART COIL NOT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. WHILE ADVANCING THE NON-PENUMB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712217 ↗
• MalfunctionApr 25, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE SHEATH AND REPORTED THAT THE SMART COIL WAS UNABLE TO ADVANCE BEYOND THE POINT OF RESISTANCE. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS AND FOUR ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549280 ↗
• MalfunctionApr 24, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CLINOID SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE RUPTURED ANEURYSM USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER SMART COIL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AND ITS PUSHER ASSEMBLY BECAME KINKED. THE PROCEDURE WAS THEN 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 8544891 ↗
• MalfunctionFeb 15, 2019Peeled/Delaminated; Separation Failure; Peeled/Delaminated; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTER (VA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). IT WAS REPORTED THAT THE PATIENT HAD A MILDLY TORTUOUS VERTEBRAL ARTERY. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS AND A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS UNABLE TO DETACH ANOTHER SMART COIL USING THE HANDLE AND THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, A NEW HANDLE, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345268 ↗
• MalfunctionOct 23, 2018Failure to Fold; Stretched; Failure to Fold; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA)/OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT¿S ANEURYSM HAD AN IRREGULAR SHAPE. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT CONFORM TO THE ANEURYSM AND KEPT FALLING OUT INTO THE PARENT VESSEL. UPON REMOVING THE SMART COILS, THE PHYSICIAN NOTICED THE SMART COILS PUSHER ASSEMBLIES WERE CURLED AND STRETCHED. THE PHYSICIAN ALSO COMMENTED THAT THE PUSHER ASSEMBLIES WERE VERY FLIMSY. THE PROCEDURE WAS COMPLETED WITHOUT PLACING ANY COILS IN THE ANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7996012 ↗
• MalfunctionAug 6, 2018Failure 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 SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE AND THEN 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 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 7754303 ↗