Smart Coil 400SMTXSFT0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00814548015385), received between Jun 2, 2016 and Aug 31, 2022 — classified as 2 injuries, 25 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE ANEURYSM WAS PARTIALLY COILED PREVIOUSLY WITH THE SMART COILS AND A STENT WAS PLACED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE MULTIPLE TIMES. HOWEVER, THE SMART COIL FAILED TO DETACH. NEXT, THE PHYSICIAN TRIED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL WOULD NOT DETACH. WHILE ATTEMPTING TO REMOVE THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE TARGET LOCATION. THE PHYSICIAN THEN USED A GUIDEWIRE TO PUSH THE REMAINING SMART COIL IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, IT WAS UNSUCCESSFUL. THE SECOND HANDLE WAS OPENED, AND THREE ATTEMPTS WERE MADE TO DETACH THE SMART COIL BUT THE SMART COIL WOULD NOT DETACH. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331863 ↗
• 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 14607961 ↗
• MalfunctionDec 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) 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, THE PHYSICIAN WAS UNABLE TO ADVANCE THE FIRST SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, THREE 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 12926415 ↗
• MalfunctionNov 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), PENUMBRA SMART COILS (SMART COIL), PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A SMART COIL IN THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED A PACKING COIL LP IN THE TARGET VESSEL USING A SECOND HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP ALSO FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP WAS REMOVED. THEN, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. IT WAS REPORTED THAT A SECOND ATTEMPT MADE TO DETACH THE PACKING COIL LP WITH THE FIRST HANDLE WAS ALSO UNSUCCESSFUL. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841351 ↗
• 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 12701082 ↗
• MalfunctionOct 22, 2021Failure 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) TO THE PARACLINOID ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, ONE SMART COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, A NON-PENUMBRA 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 12682902 ↗
• 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 12104484 ↗
• MalfunctionMay 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE SMART COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATHS OF THE SMART COILS SEPARATED AROUND THE FRICTION LOCK WHEN FORCE WAS USED. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE SMART COILS, THREE 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 11898357 ↗
• MalfunctionMar 25, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND DETACH IT USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PHYSICIAN NOTICED VIA AN ANGIOGRAM THAT THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE TWO ADDITIONAL ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS MANUALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED TWO ADDITIONAL SMART COILS INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THEM USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN MADE ADDITIONAL ATTEMPTS TO CLICK THE HANDLE AND BOTH SMART COILS EVENTUALLY DETACHED SUCCESSFULLY. 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 11566903 ↗
• MalfunctionJan 21, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS PLACED IN THE ANEURYSM USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL IN THE TARGET LOCATION, THE SMART COIL WOULD NOT ADVANCE ALL THE WAY THROUGH THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL AND UPON INSPECTION ON THE BACK TABLE, THE PUSHER ASSEMBLY OF THE SMART COIL WAS NOTICED TO BE KINKED. 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; No Consequences Or Impact To Patient

  MAUDE report 11211360 ↗
• MalfunctionJan 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WERE STUCK WITHIN THEIR INTRODUCER SHEATHS AND WOULD NOT ADVANCE NOR RETRACT. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPETED 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 11144074 ↗
• MalfunctionDec 17, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN BEGAN TO ADVANCE A SMART COIL AND REPORTED THAT IT PREMATURELY DETACHED WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9484085 ↗
• MalfunctionNov 11, 2019Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE SMART COIL PUSHER ASSEMBLY BECAME BENT AND, THEREFORE, IT 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 9304966 ↗
• MalfunctionOct 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT COMMUNICATING SEGMENT OF THE INTRADURAL ANEURYSM USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE SMART COIL WAS UNABLE TO ADVANCE OUT OF THE INTRODUCER SHEATH; THEREFORE, IT WAS 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 9219636 ↗
• MalfunctionOct 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A 6X15 SMART COIL INTO THE NON-PENUMBRA MICROCATHETER. THE PHYSICIAN ALSO REPORTED THAT THE 6X15 SMART COIL STOPPED ADVANCING AT THE MIDDLE OF THE MICROCATHETER. THE 6X15 SMART COIL WAS THEREFORE REMOVED FROM THE PROCEDURE. A NEW 6X15 SMART COIL WAS THEN IMPLANTED SUCCESSFULLY USING THE SAME MICROCATHETER. WHILE ADVANCING THE NEXT 4X6 SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT IT BECAME STUCK AND WOULD NO LONGER ADVANCE. THE 4X6 SMART COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. ANOTHER SMART COIL AND THE SAME MICROCATHETER WERE THEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195033 ↗
• MalfunctionOct 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SMART COIL WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9191891 ↗
• MalfunctionOct 1, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL 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 Consequences Or Impact To Patient

  MAUDE report 9142317 ↗
• MalfunctionSep 20, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SMART COIL PUSHER WIRE BECAME KINKED DURING AN ATTEMPT TO ADVANCE IT THROUGH ITS INTRODUCER SHEATH. AS A RESULT, THE SMART COIL WAS UNABLE TO ADVANCE THROUGH ITS INTRODUCER SHEATH. THE SMART COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9099200 ↗
• MalfunctionJun 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL THROUGH THE MIDDLE OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW SMART COIL AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675595 ↗
• MalfunctionMay 2, 2019Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A SMART COIL USING NEITHER THE HANDLE NOR MANUALLY PULLING THE PROXIMAL END OF THE PUSHER ASSEMBLY. THE PHYSICIAN THEN CUT INTO THE NON-PENUMBRA MICROCATHETER AND WAS THEN ABLE TO DETACH AND PLACE THE SMART COIL IN THE TARGET LOCATION. IT WAS REPORTED THAT THE PHYSICIAN FELT RESISTANCE ADVANCING THE SMART COIL BEFORE BEING UNABLE TO DETACH IT. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER, NEW SMART COILS, ADDITIONAL COILS, AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 09 MAY 2019 PER USER FACILITY REPORT # (B)(4): A STICKY DEBRIS WAS NOTED ON THE COIL AND MICROCATHETER UPON REMOVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573032 ↗
• MalfunctionApr 19, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A SMART COIL IN THE TARGET LOCATION; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE SMART COIL USING THE HANDLE, DESPITE ATTEMPTING THREE TIMES. THEREFORE, THE SMART COIL WAS REMOVED AND A NEW SMART COIL WAS SUCCESSFULLY PLACED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL IN THE TARGET LOCATION; HOWEVER, THE SMART COIL DID NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN ATTEMPTED TO REPOSITION THE SMART COIL; HOWEVER, THE COIL WOULD NOT FORM CORRECTLY. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, THE SAME MICROCATHETER, AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531638 ↗
• MalfunctionApr 6, 2018Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED THE SMART COIL INTO THE NON-PENUMBRA MICROCATHETER, AND THEN ATTEMPTED TO REMOVE THE INTRODUCER SHEATH FROM THE PROXIMAL END OF THE PUSHER ASSEMBLY. HOWEVER, THE INTRODUCER SHEATH BECAME STUCK ON THE PROXIMAL END OF THE PUSHER ASSEMBLY, AND WAS THEREFORE UNABLE TO BE REMOVED. THE PHYSICIAN THEREFORE REMOVED THE SMART COIL AND CONTINUED THE PROCEDURE USING A NEW 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 7403735 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING FIVE PENUMBRA SMART COILS. WITHIN TWO HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ACUTE NEUROLOGIC DECLINE AND BECAME HEMIPARETIC. THE PATIENT UNDERWENT AN ENDOVASCULAR REVASCULARIZATION THERAPY (ERT) WITH A SUCCESSFUL THROMBOLYSIS FOR ACUTE STROKE THERAPY AND RECANALIZATION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), ACHIEVING TICI GRADE 3 FLOW. THIS EVENT WAS RESOLVED ON (B)(6) 2017. THE CEREBROVASCULAR ACCIDENT (CVA) WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE DISEASE STATE, A DEFINITE RELATIONSHIP TO THE PROCEDURE, AND A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Neurological Deficit/Dysfunction; Paresis; Stroke/CVA

  MAUDE report 7068208 ↗
• MalfunctionSep 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE THREE SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE HUB OF THE MICROCATHETER; 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 6856316 ↗
• MalfunctionMar 28, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE NURSE ADVANCED THE SMART COIL TOO FAST THROUGH A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC) AND INADVERTENTLY KINKED THE SMART COIL PUSHER ASSEMBLY. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL SMART COIL AND THE SAME BENCHMARK DC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6441488 ↗