Smart Coil 400SMTXSFT0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00814548015279), received between May 10, 2016 and Feb 2, 2023 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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.

• MalfunctionFeb 2, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATION ARTERY (PCOM) USING A PENUMBRA SMART COIL (SMART COIL) A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 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 MADE MULTIPLE ATTEMPTS TO MANUALLY DETACH THE SMART COIL IN THREE DIFFERENT LOCATIONS OF THE PUSHER ASSEMBLY; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITH PART OF THE SMART COIL IN THE ANEURYSM AND THE OTHER PART IN THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED THE MICROCATHETER TO PUSH THE REMAINING PART OF THE SMART COIL INTO THE ANEURYSM; HOWEVER, THE MICROCATHETER WAS DISPLACED INTO THE PARENT VESSEL. THE PHYSICIAN DECIDED TO LEAVE THE COIL PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE PARENT VESSEL. THE PROCEDURE HAD 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 16287641 ↗
• MalfunctionSep 12, 2022Difficult 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 COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. SUBSEQUENTLY, WHILE RETRACTING THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN ADVANCED THE DETACHED SMART COIL INTO THE TARGET LOCATION USING THE PUSHER ASSEMBLY OF THE COIL. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407040 ↗
• MalfunctionNov 22, 2021Separation Failure; Separation Failure

  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 12856834 ↗
• MalfunctionNov 9, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN 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 WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED SMART COIL INTO THE ANEURYSM USING A WIRE. 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 12780290 ↗
• MalfunctionJul 1, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE ANEURYSM AND REALIZED THAT THE SMART COIL WAS UNDERSIZED; THEREFORE, IT WAS REMOVED FOR LATER USE. HOWEVER, WHEN THE SMART COIL WAS REMOVED FROM THE PATIENT'S BODY IT WAS NOTICED THAT THE PUSHER ASSEMBLY OF THE SMART COIL WAS KINKED. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE PUSHER ASSEMBLY OF THE SMART COIL WOULD NOT ADVANCE BEYOND THE HUB OF THE MICROCATHETER AND WAS FOUND TO BE BENT; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12104557 ↗
• MalfunctionFeb 15, 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 A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO MOVE THE INTRODUCER SHEATH PROXIMAL TO THE FRICTION LOCK BEFORE ADVANCING THE SMART COIL AND KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11326331 ↗
• MalfunctionNov 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE PREPARING THE SMART COIL FOR FLUSHING, THE COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10789820 ↗
• MalfunctionOct 16, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME KINKED. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL 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 10690726 ↗
• MalfunctionSep 26, 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). DURING THE PROCEDURE, A SMART COIL WAS STUCK, AND WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10591104 ↗
• MalfunctionMay 29, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE SMART COIL USING THE HANDLE, THE SMART COIL FAILED TO DETACH; THEREFORE, THE SMART COIL WAS REMOVED, AND THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE VESSEL AND ATTEMPTED TO DETACH IT USING ANOTHER HANDLE, BUT THE SAME ISSUE OCCURRED; THEREFORE, THE SECOND SMART COIL WAS REMOVED, AND THE PHYSICIAN DECIDED NOT TO USE THE SECOND HANDLE. THE PROCEDURE WAS COMPLETED USING OTHER NON-PENUMBRA COILS (OPTIMA). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10099889 ↗
• MalfunctionMar 5, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED NINE SMART COILS INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE TENTH SMART COIL IN THE TARGET USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE TWO ADDITIONAL ATTEMPTS; HOWEVER, THE SMART COIL DID NOT DETACH. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795431 ↗
• MalfunctionMay 30, 2019Failure 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, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH AND THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND OTHER COILS 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 8655265 ↗
• MalfunctionMay 23, 2019Separation Failure; Separation Failure

  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 VESSEL USING NON PENUMBRA MICROCATHETER AND USED THE HANDLE TO DETACH; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE AN ATTEMPT TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS AND THE SAME HANDLE. THEREFORE, THE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636778 ↗
• MalfunctionOct 23, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL THROUGH THE NON-PENUMBRA 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 7997260 ↗
• MalfunctionSep 25, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN FOUND THAT THE INTRODUCER SHEATH OF A PENUMBRA SMART COIL SMART COIL WAS BROKEN INTO TWO PIECES UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE SMART COIL INTRODUCER SHEATH WAS FOUND PRIOR TO USE AND, THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7908235 ↗
• MalfunctionJul 11, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET LOCATION USING THE HANDLE AND A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH THE SMART COIL USING THE HANDLE, DESPITE ATTEMPTING MULTIPLE TIMES. THE PHYSICIAN, THEREFORE, REMOVED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME MICROCATHETER. IT WAS ALSO REPORTED THAT THERE WAS SEVERE TORTUOSITY IN THE PATIENT'S INTERNAL CAROTID ARTERY (ICA). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678438 ↗
• MalfunctionApr 30, 2018Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBELLAR ARTERY (VA-PICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL AND TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE COIL BECAME STUCK AT THE HUB OF 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 Consequences Or Impact To Patient

  MAUDE report 7474144 ↗
• InjuryDec 6, 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 IN THE ANTERIOR CEREBRAL ARTERY (ACA) PERICALLOSAL USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THERE WAS THROMBUS FORMATION IN THE PARENT VESSEL WHERE A STENT DEVICE WAS PLACED. THE PATIENT WAS GIVEN INTRA-ARTERIAL EPTIFIBATIDE INFUSION. THE EVENT WAS RESOLVED THE SAME DAY, ON (B)(6) 2017. THE THROMBUS FORMATION WAS ADJUDICATED TO BE AN ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM AND ANGIOGRAPHIC PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7088155 ↗
• MalfunctionOct 25, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, THE SMART COIL FAILED TO DETACH USING A HANDLE. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 6978318 ↗
• InjuryMay 23, 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 IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA BALLOON CATHETER. THERE WAS NO REPORTED ISSUES DURING THE PROCEDURE OR THROMBUS FORMATION AFTER THE PROCEDURE. HOWEVER, ON (B)(6) 2017 THE PATIENT EXPERIENCED MICRO EMBOLI IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE MICRO EMBOLI IN THE MCA WAS ADJUDICATED TO BE A NON-SERIOUS ADVERSE EVENT WITH PROBABLE RELATIONSHIP TO THE SMART COILS. THE PATIENT RECEIVED ASPIRIN AND THE EVENT WAS RESOLVED ON (B)(6) 2017.

  Patient problems: Embolus

  MAUDE report 6584574 ↗
• MalfunctionMay 18, 2017Physical Resistance; Deformation Due to Compressive Stress; Physical Resistance; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPINAL TUMOR USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO SMART COILS THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE SMART COILS SEEMED TO BE BUCKLING ON THEMSELVES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6576618 ↗
• MalfunctionMay 2, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE SMART COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND THE HANDLE. THE PHYSICIAN THEN HAD DIFFICULTY DETACHING A FOURTH SMART COIL BUT WAS ABLE TO DETACH THE COIL AFTER MULTIPLE MANIPULATION ATTEMPTS USING THE SAME HANDLE. A FIFTH SMART COIL WAS DEPLOYED INTO THE TARGET VESSEL AND AN ATTEMPT WAS MADE TO DETACH THE COIL USING THE SAME HANDLE. HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL EVEN AFTER MANIPULATION. SUBSEQUENTLY, THE PROXIMAL END OF THE PUSHER ASSEMBLY BECAME FRACTURED. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL USING FORCEPS AND SUCCESSFULLY COMPLETED THE PROCEDURE USING ADDITIONAL COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538536 ↗
• MalfunctionApr 18, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE AT THE INTERNAL CEREBRAL ARTERY (ICA) AND THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED AND DEPLOYED MULTIPLE SMART COILS AND NON-PENUMBRA COILS IN THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL IN THE ANEURYSM; HOWEVER, UPON RETRACTION TO REPOSITION THE SMART COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE TO ASPIRATE AND REMOVE THE DETACHED SMART COIL AND DECIDED THAT THE EXISTING COIL MASS WAS SUFFICIENT AND ENDED THE PROCEDURE AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6501437 ↗
• MalfunctionMay 10, 2016Bent; Device Handling Problem; Bent; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A PENUMBRA SMART COIL (SMART COIL) PUSHER ASSEMBLY BECAME BENT WHILE THE HOSPITAL STAFF WAS REMOVING THE COIL FROM THE PACKAGING HOOP. THE SMART COIL PUSHER ASSEMBLY BECAME BENT PRIOR TO USE AND THEREFORE, THE SMART COIL WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5645573 ↗