Smart Coil 400SMTHXSFT1H03Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00814548015668), received between Jul 29, 2016 and Feb 27, 2023 — classified as 2 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (44 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS USING THE MICROCATHETER. NEXT, PHYSICIAN ADVANCED THE THIRD SMART COIL INTO 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 DETACH THE SMART COIL USING A NEW HANDLE, BUT THE SMART COIL WOULD STILL NOT DETACH. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE FOURTH AND THE FIFTH SMART COILS USING THE MICROCATHETER AND THE SECOND HANDLE. THE PHYSICIAN THEN ADVANCED A SIXTH SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING BOTH HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449219 ↗
• MalfunctionDec 8, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LINGUAL ARTERY (LA) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND 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 ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961755 ↗
• MalfunctionNov 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID- PARA ARTERY (IC-PARA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL AND FIVE NON-PENUMBRA COILS INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, 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 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 12814338 ↗
• MalfunctionNov 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TEN NON-PENUMBRA COILS AND SIX SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A SMART COIL, THE SMART COIL BECAME STUCK IN THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 12783738 ↗
• MalfunctionAug 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDOANEURYSM USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIVE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12292068 ↗
• MalfunctionJun 25, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RADIAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO SMART COILS INTO THE ANEURYSM SUCCESSFULLY. ANOTHER SMART COIL WAS ADVANCED INTO THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN REMOVED THE HANDLE AND USED A NEW HANDLE TO DETACH THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH AND WAS REMOVED. NEXT, ANOTHER SMART COIL WAS ADVANCED; HOWEVER, THE PHYSICIAN HAD THE SAME ISSUE WITH THE SMART COIL AND THEREFORE, THE SMART COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD DIFFICULTY DETACHING THE OTHER SMART COILS TOO, BUT HE WAS ABLE TO DETACH THEM MANUALLY. 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 12064691 ↗
• MalfunctionJun 25, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RADIAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO SMART COILS INTO THE ANEURYSM SUCCESSFULLY. ANOTHER SMART COIL WAS ADVANCED INTO THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN REMOVED THE HANDLE AND USED A NEW HANDLE TO DETACH THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH AND WAS REMOVED. NEXT, ANOTHER SMART COIL WAS ADVANCED; HOWEVER, THE PHYSICIAN HAD THE SAME ISSUE WITH THE SMART COIL AND THEREFORE, THE SMART COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD DIFFICULTY DETACHING THE OTHER SMART COILS TOO, BUT HE WAS ABLE TO DETACH THEM MANUALLY. 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 12064690 ↗
• MalfunctionJun 10, 2021Failure 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) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIXTEEN NON-PENUMBRA COILS AND TWO SMART COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE COIL BECAME STUCK AND WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ONE SMART COIL OF THE SAME SIZE AND TWO ADDITIONAL 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 11975930 ↗
• MalfunctionMar 30, 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) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED NINE SMART COILS AND FIFTEEN OTHER COILS INTO THE TARGET LOCATION. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER, THE SMART COIL BECAME STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11590069 ↗
• MalfunctionMar 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATHS; 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

  MAUDE report 11579662 ↗
• MalfunctionFeb 22, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, TWO NON-PENUMBRA COILS AND FOUR SMART COILS WERE IMPLANTED IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A SMART COIL IN ITS INTRODUCER SHEATH BUT THE COIL WAS SUCCESSFULLY IMPLANTED. WHILE REMOVING THE SMART COIL PUSHER ASSEMBLY, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE PUSHER WIRE BROKE OFF NEAR THE HUB OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED FROM THE PATIENT SO THAT THE BROKEN WIRE COULD BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL SMART COILS, THE SAME MICROCATHETER, AND THE SAME GUIDE CATHETER. 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 11362617 ↗
• 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 11227034 ↗
• MalfunctionJan 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) AND ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER AND GLIDE CATHETER. DURING THE PROCEDURE, A SMART COIL WAS NOTICED TO BE KINKED UPON REMOVAL FROM THE HOOP. THE DAMAGE TO THE SMART COIL WAS FOUND PRIOR TO USE, AND THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY ADVANCING A NEW SMART COIL IN THE INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN PLACED FOUR SMART COILS IN THE ANEURYSM LUMEN. IT WAS NOTED THAT A COIL MIGRATED INTO THE LEFT ACA. DUE TO THE COMPLEX ANEURYSM AND ESTABLISHED LEFT FRONTAL INTRAVENTRICULAR HEMORRHAGE, THE DECISION WAS MADE TO AVOID RETRIEVING THE MIGRATED SMART COIL. THIS EVENT IS ONGOING. THE COIL MIGRATION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE.

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

  MAUDE report 11206187 ↗
• MalfunctionJan 5, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE IC-ACHA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL. NEXT, A SMART COIL INTRODUCER SHEATH WAS PROPERLY ALIGNED TO THE HUB OF THE MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL. WHILE ATTEMPTING TO ADVANCE THE SMART COIL, IT BECAME STUCK AT ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11117516 ↗
• MalfunctionOct 16, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10693559 ↗
• MalfunctionOct 9, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE MICROCATHETER BACKED OUT OF THE ANEURYSM. THEREFORE, THE SMART COIL WAS RETRACTED, RE-SHEATHED AND RINSED IN SALINE SOLUTION. WHILE ATTEMPTING TO REINSERT THE SMART COIL INTO THE MICROCATHETER, THE SMART COIL FELT ¿GRITTY¿ AND THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SMART COIL INTO THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SMART COIL PUSHER ASSEMBLY WAS DEFORMED IN A ¿WAVE¿ SHAPE. 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 10659378 ↗
• MalfunctionSep 11, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR PANCREATICODUODENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SMART COIL BEYOND THE HUB OF THE MICROCATHETER AND SUBSEQUENTLY, THE COIL BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN 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 10524972 ↗
• MalfunctionAug 21, 2020Material Deformation; Material Deformation

  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 10438599 ↗
• MalfunctionJul 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUPERIOR CEREBELLAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETE USING ADDITIONAL PENUMBRA 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 10348097 ↗
• MalfunctionJul 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE GASTRODUODENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WAS STUCK IN ITS INITIAL POSITION; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10318495 ↗
• MalfunctionJul 9, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TIP OF THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WAS THEREFORE 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 10254412 ↗
• MalfunctionJun 30, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TESTICULAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS, CALCIFIED AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THEN, WHILE ADVANCING THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK WITHIN THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, TWO NON-PENUMBRA 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 10215622 ↗
• MalfunctionJun 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERFICIAL TEMPORAL ARTERY (STA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, NARROWED AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT COIL, A SMART COIL, OUT OF THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL BECAME STUCK AT THE DISTAL END; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN CONTINUED THE PROCEDURE AND PLACED A SMART COIL AND THREE OTHER COILS. WHILE ADVANCING THE THIRD SMART COIL OUT OF THE INTRODUCER SHEATH, THE SMART COIL BECAME STUCK AT THE SAME POSITION AS THE FIRST SMART COIL; THEREFORE, IT WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL, THE SAME MICROCATHETER, AND N-BUTYL CYANOACRYLATE (NBCA) INJECTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172581 ↗
• MalfunctionMay 8, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS, OTHER COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND NARROW. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND SEVEN OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS NOTED THAT THERE WERE KINKS ON THE PUSHER ASSEMBLY OF THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, AN ADDITIONAL 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 10039685 ↗
• MalfunctionApr 29, 2020Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND SLIGHTLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT COIL, A SMART COIL, THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED DIFFICULTY, AND THE SMART COIL BECAME STUCK IN THE HUB; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, TWO ADDITIONAL NON-PENUMBRA 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 10010732 ↗