Smart Coil 400SMTHXSFT1H04Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00814548015675), received between Dec 26, 2017 and Mar 15, 2022 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBER ARTERY USING A PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THEN USED THE HANDLE TO DETACH IT. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE BUT THE ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. HOWEVER, UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED FROM THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13765024 ↗
• MalfunctionJan 10, 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), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND A SMART COIL IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, UPON RETRACTING, 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 ON THE BACK TABLE. THE SAME MICROCATHETER WAS THEN REINSERTED BACK INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING 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 13214366 ↗
• MalfunctionNov 19, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX COILS IN THE TARGET LOCATION. AFTER ADVANCING A SMART COIL INTO THE TARGET LOCATION, THE HANDLE FAILED TO DETACH THE SMART COIL AFTER THREE ATTEMPTS. THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL MANUALLY BY HAND AND BY CUTTING THE PUSHER ASSEMBLY USING PEAN FORCEPS, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. AFTER REMOVAL OF THE PUSHER ASSEMBLY OF THE SMART COIL FROM THE HUB OF THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE SMART COIL HAD DETACHED AROUND THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED AT THIS POINT SINCE THE ANEURYSM WAS SUFFICIENTLY PACKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847544 ↗
• MalfunctionJun 10, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL BECAME STUCK AND WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ELEVEN SMART COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11976150 ↗
• MalfunctionJun 10, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL BECAME STUCK AND WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ELEVEN SMART COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11976149 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY PLACED THE THIRD SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. 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. THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691629 ↗
• MalfunctionApr 1, 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. DURING THE PROCEDURE, AFTER THE INTRODUCER SHEATH WAS PROPERLY ALIGNED TO THE MICROCATHETER HUB, THE FIRST SMART COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. AFTER IMPLANTING ANOTHER SMART COIL AND THREE OTHER COILS USING THE SAME MICROCATHETER, THE INTRODUCER SHEATH OF ANOTHER SMART COIL WAS PROPERLY ALIGNED TO THE HUB OF THE MICROCATHETER BEFORE THE PHYSICIAN EXPERIENCED THE SAME ISSUE. THIS SMART COIL WAS ALSO STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, 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 11606709 ↗
• MalfunctionMar 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING A MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE IT BEYOND THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN PLACED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE A NON-PENUMBRA COIL THROUGH THE MICROCATHETER BUT WAS UNABLE TO AND THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 11437189 ↗
• MalfunctionOct 9, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL. WHILE ADVANCING AN ADDITIONAL SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE AT ALL 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10659666 ↗
• MalfunctionOct 8, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ASCENDING PHARYNGEAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA COILS, NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS, AND ONE SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE AN ADDITIONAL SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, TWO ADDITIONAL SMART COILS AND TWO OTHER 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 10650002 ↗
• MalfunctionJun 5, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN FEEDING 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, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCING THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE SMART COIL WAS STUCK AT THE INITIAL POSITION; THEREFORE, IT 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 10123998 ↗
• MalfunctionMar 25, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WAS STUCK AND WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, OTHER 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 9881301 ↗
• MalfunctionMar 18, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE SINUS USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THE SMART COIL WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, OTHER 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 9850767 ↗
• MalfunctionMar 18, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE SINUS USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THE SMART COIL WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, OTHER 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 9850762 ↗
• MalfunctionJan 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE MICROCATHETER INTO THE TARGET LOCATION AND IMPLANTED A SMART COIL. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, IT BECAME STUCK AND WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; 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 9644542 ↗
• MalfunctionDec 18, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHEN A SMART COIL WAS ADVANCED APPROXIMATELY 2 CM INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE AND THE SMART COIL WAS SUBSEQUENTLY REMOVED. UPON ADVANCEMENT OF THE NEXT SMART COIL APPROXIMATELY 3 CM OUT OF THE DISTAL TIP OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE FIRST SMART COIL WAS ABLE TO ADVANCE OUTSIDE OF THE MICROCATHETER AGAINST STRONG RESISTANCE WHEN TESTED ON THE BACK TABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490876 ↗
• MalfunctionDec 18, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHEN A SMART COIL WAS ADVANCED APPROXIMATELY 2 CM INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE AND THE SMART COIL WAS SUBSEQUENTLY REMOVED. UPON ADVANCEMENT OF THE NEXT SMART COIL APPROXIMATELY 3 CM OUT OF THE DISTAL TIP OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE FIRST SMART COIL WAS ABLE TO ADVANCE OUTSIDE OF THE MICROCATHETER AGAINST STRONG RESISTANCE WHEN TESTED ON THE BACK TABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9490863 ↗
• MalfunctionSep 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CORONARY ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE SMART COILS INTO THE TARGET LOCATION. UPON ADVANCEMENT OF THE SIXTH SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND REPORTED THAT THE SMART COIL BECAME STUCK IN THE MIDDLE OF 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 9123865 ↗
• MalfunctionAug 7, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE TO TREAT ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SECOND SMART COIL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY KINKED AND THEREFORE, IT WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER 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 8870878 ↗
• MalfunctionJun 10, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL AND TWO OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 8683298 ↗
• MalfunctionApr 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE THIRD SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND REPORTED THAT THE SMART COIL WAS UNABLE TO ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE SMART COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557749 ↗
• MalfunctionMar 27, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED EIGHT SMART COILS USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL, CONSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458273 ↗
• MalfunctionMar 19, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED TWO PENUMBRA COIL 400S (PC400S), THREE SMART COILS AND ONE NON-PENUMBRA COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE THE SEVENTH COIL, A 1.5X4 SMART COIL, THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE AND REPORTED THAT THE COIL WOULD NOT ADVANCE FROM ITS STARTING POSITION. THE PHYSICIAN THEN ATTEMPTED TO FLUSH THE SMART COIL OUTSIDE THE PATIENT AND RE-ADVANCE; HOWEVER THE SAME ISSUE OCCURRED. THE SMART COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434258 ↗
• MalfunctionMar 18, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR SMART COILS AND TWENTY-TWO OTHER COILS USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE HUB OF THE MICROCATHETER. THE PHYSICIAN DECIDED TO RETRACT THE PUSHER ASSEMBLY AND ATTEMPTED TO ADVANCE THE SMART COIL AGAIN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, IT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING 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 8430400 ↗
• MalfunctionJan 10, 2019Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL, HOWEVER RETRACTED TO REMOVE IT BECAUSE THE SMART COIL WAS OF THE INCORRECT SIZE. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE SMART COIL INSIDE AND FLUSHED THE COIL OUT OF THE MICROCATHETER. THE SAME MICROCATHETER WAS THEN RE-INSERTED, AND 10 ADDITIONAL SMART COILS WERE PLACED. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING WITHIN THE INTRODUCER SHEATH AND WAS UNABLE TO ADVANCE ANOTHER SMART COIL THROUGH THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED, AND IT WAS NOTICED THAT THE TIP OF THE SMART COIL WAS BENT, AND THE PROXIMAL END OF THE COIL WAS ELONGATED. 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 8236521 ↗