Smart Coil 400SMTXSFT1H03Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00814548015231), received between Dec 30, 2015 and Oct 14, 2022 — classified as 5 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (21 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN SWITCHED TO A NEW HANDLE AND DETACHED THE SMART COIL. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL INTO THE VESSEL AND WAS UNABLE TO DETACH IT USING BOTH HANDLES. THEREFORE, THE PHYSICIAN USED HIS FINGERS TO PULL THE PUSHER ASSEMBLY AND MANUALLY DETACHED THE SMART COIL. NEXT, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER AND INTO ANOTHER BRANCH OF THE MMA, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE SMART COIL. HOWEVER, UPON REMOVING THE PUSHER ASSEMBLY OF THE SMART COIL OUT FROM THE MICROCATHETER, THE PHYSICIAN NOTICED THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE MICROCATHETER AND PL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611773 ↗
• InjuryDec 7, 2021Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  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 PLACED AND DETACHED SIX SMART COILS IN THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE. AFTER AN AUDIBLE CLICK WAS HEARD AND THE BLACK ALIGNMENT ZONE HAD SEPARATED, THE PHYSICIAN ATTEMPTED TO REMOVE THE PUSHER ASSEMBLY; HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE SMART COIL HAD NOT DETACHED. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE SMART COIL, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE AND THE SMART COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE MICROCATHETER. THE PHYSICIAN THEN TRIED TO PUSH THE SMART COIL INTO THE TARGET LOCATION BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN USED A STENT TO PUSH THE SMART COIL AGAINST THE VESSEL WALL. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT AN ANEURYSM RUPTURE OCCURRED AFTER TWO SMART COILS HAD BEEN PLACED. SUBSEQUENTLY, ADDITIONAL SMART COILS WERE PLACED TO ADDRESS THE RUPTURE. IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957938 ↗
• MalfunctionSep 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  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, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK APPROXIMATELY THREE-FOURTHS OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE SMART COIL BECAME STUCK IN THE MICROCATHETER; THEREFORE, THE SMART COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW SMART COILS AND A NEW VELOCITY DELIVERY MICROCATHETER (VELOCITY). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457569 ↗
• MalfunctionAug 26, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE THROUGH 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12369046 ↗
• MalfunctionJun 28, 2021Failure to Advance; Failure to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081096 ↗
• MalfunctionMar 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SMART COIL (SMART COIL). 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11401973 ↗
• MalfunctionFeb 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE FOUR SMART COILS WERE 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 11264413 ↗
• MalfunctionJan 25, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THIS SMART COIL WAS ALSO REMOVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE. 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 11227026 ↗
• MalfunctionJan 13, 2021Failure 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 NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11166986 ↗
• MalfunctionJan 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, SEVERAL SMART COILS WERE IMPLANTED INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL PAST ITS INITIAL POSITION IN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11143338 ↗
• MalfunctionAug 28, 2020Separation Failure; Separation Failure

  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 PLACED THE INITIAL SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED ADDITIONAL SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTED TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS ALSO REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AND, WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 10463839 ↗
• MalfunctionAug 21, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS UNABLE TO ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED MULTIPLE SMART COILS IN THE TARGET VESSEL USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN NOTICED THE PUSHER ASSEMBLY OF THE SMART COIL TO KINKED 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 10438682 ↗
• MalfunctionMar 13, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED SMART COILS IN THE ANEURYSM USING THE HANDLE AND THEN ADVANCED THE NEXT SMART COIL. SEVERAL ATTEMPTS WERE MADE TO DETACH IT USING THE HANDLE BUT WAS UNSUCCESSFUL. THE PHYSICIAN ALSO ATTEMPTED TO USE THEIR FINGERS TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PHYSICIAN USED A NEEDLE DRIVER TO SUCCESSFULLY DETACH THE COIL. 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 9831281 ↗
• MalfunctionFeb 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE 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 TOT THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707576 ↗
• MalfunctionDec 31, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE SMART COIL INTO THE TARGET VESSEL, THE HOSPITAL TECHNICIAN NOTICED THE SMART COIL PUSHER ASSEMBLY WAS STUCK TO THE INTRODUCER SHEATH. CONSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY BECAME BENT; 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 Consequences Or Impact To Patient

  MAUDE report 9537093 ↗
• MalfunctionNov 5, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SMART COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE SAME ISSUE THEN OCCURRED WITH ANOTHER SMART COIL. THIS SMART COIL WAS ALSO NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SMART COILS AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279627 ↗
• MalfunctionNov 5, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SMART COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE SAME ISSUE THEN OCCURRED WITH ANOTHER SMART COIL. THIS SMART COIL WAS ALSO NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SMART COILS AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279624 ↗
• MalfunctionJul 31, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE SMART COIL WAS STUCK IN ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH AND WAS UNABLE TO ADVANCE INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN 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 8846827 ↗
• MalfunctionMay 30, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL PAST THE HUB OF THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 8654923 ↗
• MalfunctionApr 9, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY 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 TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND USED A HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, A NEW HANDLE WAS OPENED AND USED TO SUCCESSFULLY DETACH THE SAME SMART COIL. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8495200 ↗
• MalfunctionMar 14, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS OVERLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH A SMART COIL USING THE HANDLE BEFORE THE SMART COIL DETACHED IN THE TARGET LOCATION. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS. HOWEVER, ALL THREE COILS WERE SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420731 ↗
• MalfunctionDec 26, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE TWO SMART COILS WITHIN THE INTRODUCER SHEATHS AND THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 8197574 ↗
• MalfunctionDec 21, 2018Separation 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 WAS UNABLE TO DETACH TWO SMART COILS USING THE HANDLE. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191511 ↗
• MalfunctionDec 21, 2018Separation 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 WAS UNABLE TO DETACH TWO SMART COILS USING THE HANDLE. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191508 ↗
• MalfunctionJul 20, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE INITIAL SMART COILS INTO THE TARGET VESSEL AND USED A HANDLE TO SUCCESSFULLY DETACH THE COILS. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL IN THE TARGET VESSEL AND USED THE HANDLE IN AN ATTEMPT TO DETACH IT; HOWEVER, THE SMART COIL DID NOT DETACH AND INSTEAD WAS PULLED OUT OF THE ANEURYSM WHEN THE HANDLE WAS USED. SUBSEQUENTLY, THE PHYSICIAN WITHDREW THE ENTIRE SMART COIL. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL AND THE SAME HANDLE. THE PROCEDURE WAS ENDED AFTER REMOVAL OF THE SECOND SMART COIL AS THE PHYSICIAN WAS SATISFIED WITH THE RESULT OBTAINED WITH THE INITIAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706705 ↗