Smart Coil 400SMTHXSFT0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00814548015712), received between Jul 22, 2016 and Sep 29, 2023 — classified as 8 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (58 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 95 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 BRANCH OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), 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 USING A MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A MICROWAVE TO ADVANCE THE SMART COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET LOCATION SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED A FOURTH SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. WHILE RETRACTING

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17844125 ↗
• MalfunctionAug 24, 2022Break; Material Deformation; Break; Material Deformation

  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, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SMART COIL INTO THE TARGET LOCATION. AFTER REMOVING THE SMART COIL PUSHER WIRE FROM THE MICROCATHETER, THE PHYSICIAN NOTED IT WAS STRETCHED AND BROKEN INTO TWO PIECES AT THE DISTAL END. THEREFORE, THE MICROCATHETER WAS REMOVED AND FLUSHED TO REMOVE THE BROKEN PIECE OF THE SMART COIL PUSHER WIRE. THE PROCEDURE WAS CONTINUED USING THREE SMART COILS, THE SAME HANDLE, THE SAME MICROCATHETER, THE SAME CATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283245 ↗
• MalfunctionDec 3, 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 COIL), A NON-PENUMBRA MICROCATHETER AND GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN USED FORCE TO PUSH FORWARD AND PULL BACK THE PUSHER ASSEMBLY OF THE SMART COIL AND SUBSEQUENTLY THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO ADVANCE THE LAST SMART COIL WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN USED FORCE TO ADVANCE THE SMART COIL OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE SMART COIL INTO THE TARGET VESSEL AND NOTICED THAT THE VESSEL WAS SUFFICIENTLY PACKED; THEREFORE, THE SMART COIL WAS REMOVED. 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 12926182 ↗
• MalfunctionDec 2, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE). 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. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT, THE COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH TWO DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921167 ↗
• MalfunctionNov 22, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED FOUR SMART COILS USING THE HANDLE AND TWO NON-PENUMBRA COILS IN THE TARGET VESSEL. AFTER ADVANCING ANOTHER SMART COIL INTO THE TARGET LOCATION, THE HANDLE FAILED TO DETACH THE COIL AFTER SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER COILS, THE SAME MICROCATHETER AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857608 ↗
• MalfunctionNov 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PARACLINOID INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS AND ONE SMART COIL. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH IT BY USING THE HANDLE AND BY MANUAL DETACHMENT BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE SMART COIL ALIGNMENT ZONE WAS SEPARATED BUT THE COIL WAS NOT DETACHED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, THE SAME HANDLE, TWO 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 12849354 ↗
• MalfunctionNov 15, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE SMART COIL. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH. WHILE RETRIEVING THE SMART COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY THE SMART COIL DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING THE SAME MICROCATHETER TO IMPLANT ONE ADDITIONAL SMART COIL AND TEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813634 ↗
• 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 12701087 ↗
• 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 12651408 ↗
• MalfunctionOct 13, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MILDLY NARROWED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A SMART COIL TO THE TARGET VESSEL, THE SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN ALSO ATTEMPTED TO ADVANCE THE SMART COIL WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING 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

  MAUDE report 12628551 ↗
• MalfunctionOct 9, 2021Failure to Advance; Failure to Advance

  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 12601971 ↗
• MalfunctionSep 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) 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, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE FIRST SMART COIL INTO THE MICROCATHETER AND THE COIL BECAME STUCK INSIDE THE HUB. THE SMART COIL WAS RE-ADVANCED SEVERAL TIMES BUT THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT 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 12497477 ↗
• MalfunctionAug 24, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (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. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING A SECOND HANDLE, BUT IT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN BROKE THE PUSHER ASSEMBLY OF THE SMART COIL AND ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363262 ↗
• MalfunctionAug 4, 2021Break; Break

  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, THE PHYSICIAN IMPLANTED COILS IN THE TARGET LOCATION. SUBSEQUENTLY, WHILE THE HOSPITAL TECH WAS ATTEMPTING TO ADVANCE A SMART COIL (F102548), THE PUSHER ASSEMBLY KINKED WHEN THE SMART COIL WAS AT THE STARTING POSITION OF THE INTRODUCER SHEATH. THE SMART COIL WAS THEN REMOVED. NEXT, WHILE THE PHYSICIAN WAS RETRACTING A SMART COIL (F81966) TO REPOSITION THE TIP OF THE MICROCATHETER, THE SMART COIL BROKE OFF BETWEEN THE LEFT ICA AND THE STENT. THE PHYSICIAN DECIDED TO HAVE THE SMART COIL REMAIN IN THE PATIENT AS THE SMART COIL WAS SECURED BETWEEN THE STENT AND VESSEL WALL. 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

  MAUDE report 12278317 ↗
• MalfunctionAug 4, 2021Material Deformation; Material Deformation

  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, THE PHYSICIAN IMPLANTED COILS IN THE TARGET LOCATION. SUBSEQUENTLY, WHILE THE HOSPITAL TECH WAS ATTEMPTING TO ADVANCE A SMART COIL (F102548), THE PUSHER ASSEMBLY KINKED WHEN THE SMART COIL WAS AT THE STARTING POSITION OF THE INTRODUCER SHEATH. THE SMART COIL WAS THEN REMOVED. NEXT, WHILE THE PHYSICIAN WAS RETRACTING A SMART COIL (F81966) TO REPOSITION THE TIP OF THE MICROCATHETER, THE SMART COIL BROKE OFF BETWEEN THE LEFT ICA AND THE STENT. THE PHYSICIAN DECIDED TO HAVE THE SMART COIL REMAIN IN THE PATIENT AS THE SMART COIL WAS SECURED BETWEEN THE STENT AND VESSEL WALL. 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

  MAUDE report 12278302 ↗
• MalfunctionJul 13, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AS THE PHYSICIAN WAS TRYING TO ADVANCE THE SMART COIL THROUGH THE MICROCATHETER, RESISTANCE WAS EXPERIENCED. THE PHYSICIAN SLOWLY PULLED THE SMART COIL OUT OF THE MICROCATHETER AND THE SMART COIL STRETCHED. 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 12163694 ↗
• MalfunctionJul 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO OTHER COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH ITS INTRODUCER SHEATH, IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. AFTER ADVANCING APPROXIMATELY HALF OF THE NEXT SMART COIL INTO THE LOCATION, THE VESSEL WENT INTO SPASM AND THE COIL COULD NOT BE IMPLANTED. THEREFORE, THE SMART COIL WAS REMOVED. ANGIOGRAPHY SHOWED THAT BLEEDING HAD STOPPED; THEREFORE, NO ADDITIONAL COILS WERE NEEDED AND THE PROCEDURE ENDED. THE RELATIONSHIP BETWEEN THE SMART COIL AND THE VASOSPASM WAS NOT SPECIFIED. AS OF (B)(6) 2021, THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131983 ↗
• MalfunctionJun 22, 2021Physical 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. DURING THE PROCEDURE, A SMART COIL BECAME STUCK IN THE INTRODUCER SHEATH AFTER THE PHYSICIAN HAD EXPERIENCED RESISTANCE WHILE ADVANCING THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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

  MAUDE report 12046867 ↗
• MalfunctionJun 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), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE SMART COIL AND ONE NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT TWO SMART COILS THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COILS WERE RETRACTED AND REMOVED. THE PROCEDURE WAS COMPLETING USING ONE ADDITIONAL SMART COIL, TEN 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 11921351 ↗
• MalfunctionJun 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), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE SMART COIL AND ONE NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT TWO SMART COILS THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COILS WERE RETRACTED AND REMOVED. THE PROCEDURE WAS COMPLETING USING ONE ADDITIONAL SMART COIL, TEN 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 11921336 ↗
• MalfunctionJun 1, 2021Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) AND ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN PLACED ANOTHER SMART COIL IN THE TARGET VESSEL; HOWEVER, THE SMART COIL WOULD NOT REMAIN IN THE ANEURYSM AFTER BEING DEPLOYED. THEREFORE, IT 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 11916476 ↗
• MalfunctionApr 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE COILS INTO THE ANEURYSM USING THE MICROCATHETER. NEXT, THE HOSPITAL TECHNOLOGIST ATTEMPTED TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PHYSICIAN FLUSHED THE INTRODUCER SHEATH AND ATTEMPTED TO RE-ADVANCE THE SMART COIL WITHIN ITS INTRODUCER SHEATH BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE INTRODUCER SHEATH OF THE SMART COIL WAS STUCK ON ITS PUSHER ASSEMBLY. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638615 ↗
• 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 11582664 ↗
• 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 11574542 ↗
• MalfunctionMar 15, 2021Failure 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) AND A MICROCATHETER. DURING THE PROCEDURE, FOUR SMART COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. WHILE ATTEMPTING TO INTRODUCE THE FIFTH SMART COIL TO THE MICROCATHETER, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED AND SET ASIDE. NEXT, ANOTHER SMART COIL WAS SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. WHEN THE PHYSICIAN MADE A SECOND ATTEMPT TO ADVANCE THE SAME SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH, THE COIL ADVANCED INTO THE MICROCATHETER AND SUBSEQUENTLY BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. 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

  MAUDE report 11489682 ↗