Smart Coil 400SMTHXSFT0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00814548015620), received between Aug 17, 2016 and Nov 22, 2022 — classified as 3 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (70 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL THROUGH THE MICROCATHETER, HOWEVER, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED SMART COIL FROM THE MICROCATHETER. IT WAS REPORTED THAT A SECOND SMART COIL ALSO UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER AND WAS REMOVED WITH A SNARE DEVICE. THE PROCEDURE WAS COMPLETED WITH 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

  MAUDE report 15845130 ↗
• MalfunctionOct 11, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE MENINGEAL ARTERY 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 INTO THE TARGET VESSEL AND MADE FOUR ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS, BUT THE COIL STILL WOULD NOT DETACH AFTER MAKING THREE ATTEMPTS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED SMART COIL IN THE TARGET LOCATION USING A MICROWIRE. 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 15584033 ↗
• MalfunctionJan 27, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RT CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL COULD NOT BE DETACHED USING THE HANDLE. THEN, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY BREAKING THE PUSHER ASSEMBLY; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. SALINE WAS THEN USED TO PUSH THE SMART COIL TO THE TARGET LOCATION. THE SAME ISSUE OCCURRED WITH ADDITIONAL THREE SMART COILS. ALL THREE DETACHED SMART COILS WERE IMPLANTED IN THE CAVERNOUS SINUS BY USING SALINE. THE PROCEDURE WAS COMPLETED USING THIRTY-ONE 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 13367446 ↗
• MalfunctionOct 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO 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 SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THE SMART COILS WERE ALSO REMOVED. 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 12600750 ↗
• MalfunctionAug 11, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND, CONSEQUENTLY, THE SMART COIL BECAME STUCK INSIDE THE MICROCATHETER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12309211 ↗
• MalfunctionJul 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEMORRHAGIC STROKE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12206915 ↗
• MalfunctionJul 18, 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 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. THE HOSPITAL TECHNOLOGIST MADE A SECOND ATTEMPT TO ADVANCE THE SMART COIL, BUT IT WAS UNSUCCESSFUL; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER SMART COIL OF THE SAME SIZE AND SEVERAL OTHER COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE SAME ISSUE OCCURRED; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER SMART COIL OF THE SAME SIZE IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186816 ↗
• MalfunctionJul 14, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. 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 12164594 ↗
• MalfunctionJul 9, 2021Device Dislodged or Dislocated; Physical Resistance/Sticking; Device Dislodged or Dislocated; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPRACLINOID SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE TIP OF THE MICROCATHETER KICKED OUT. SUBSEQUENTLY, THE SMART COIL WAS PULLED BACK INTO THE PARENT VESSEL; THEREFORE, THE SMART COIL WAS REMOVED INTACT. IT WAS REPORTED THAT THE PRESENCE OF A STENT MADE IT DIFFICULT TO REINTRODUCE THE MICROCATHETER BACK INTO THE ANEURYSM SAC. 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 12144407 ↗
• MalfunctionJul 6, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL BASILAR JUNCTION USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT DETACH WITH THE HANDLE. THE PHYSICIAN THEN DETACHED THE SMART COIL WITH A HEMOSTAT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125939 ↗
• MalfunctionMay 13, 2021Separation Failure; Separation Failure

  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 PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A COIL IN THE TARGET LOCATION. NEXT, THE PHYSICIAN IMPLANTED SMART COILS USING A HANDLE. SUBSEQUENTLY, THE NEXT SMART COIL ADVANCED COMPLETELY INTO THE ANEURYSM BUT WAS UNABLE TO BE DETACHED WITH THE HANDLE. IT WAS REPORTED THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO DETACH THE SMART COIL BY GRABBING THE PROXIMAL SECTION OF THE PUSHER ASSEMBLY WITH THE HANDLE AND PULLING. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. 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 11823689 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION TO TREAT A RUPTURE OF AN INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), BALLOON CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUPTURE OF THE ICA AND PCOM WAS NOTED. THE PHYSICIAN USED A BALLOON CATHETER TO CONTROL THE RUPTURE. SUBSEQUENTLY, THE BALLOON CATHETER WAS DEFLATED AND THE CLOT IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY WAS REMOVED USING THE 3MAXC. THE PHYSICIAN PERFORMED A COMPUTERIZED TOMOGRAPHY (CT) SCAN POST PROCEDURE THAT REVEALED MINIMAL BLOOD. POST PROCEDURE, PATIENT IS ALERT AND ORIENTED, SYMMETRIC AND NO DRIFT. ON (B)(6) 2021, PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. THE RUPTURE ANEURYSM WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND TO THE SMART COIL.

  Patient problems: Ruptured Aneurysm

  MAUDE report 11809548 ↗
• MalfunctionApr 14, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE SMART COIL INTO THE MICROCATHETER, IT BECAME STUCK IN THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND NOTICED THAT THE ANEURYSM WAS SUFFICIENTLY PACKED; THEREFORE, NO ADDITIONAL COILS WERE REQUIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662634 ↗
• MalfunctionMar 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) 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 11401935 ↗
• MalfunctionFeb 23, 2021Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HANDLE SUCCESSFULLY DETACHED SMART COILS IN THE TARGET LOCATION. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE HANDLE WAS UNSUCCESSFUL. AFTER MAKING AN ATTEMPT TO MANUALLY DETACH THE SMART COIL, THE PHYSICIAN PULLED THE MICROCATHETER BACK AND THE SMART COIL MIGRATED TO THE DISTAL ANTERIOR COMMUNICATING ARTERY (ACA). IT WAS REPORTED THAT THE PHYSICIAN DID NOT NOTICE THAT THE SMART COIL HAD DETACHED DURING THE MANUAL ATTEMPT. NEXT, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) WAS THEN POSITIONED DISTALLY AND THE DETACHED COIL WAS ASPIRATED OUT OF THE PATIENT; SUBSEQUENTLY, THE 3MAXC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 11369890 ↗
• MalfunctionDec 28, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE IMPLANTED INTO THE TARGET LOCATION AND DETACHED USING THE HANDLE. WHILE ATTEMPTING TO IMPLANT THE FOURTH SMART COIL, IT WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. UPON WITHDRAWAL OF THE PUSHER ASSEMBLY, THE PHYSICIAN NOTICED THAT THE SMART COIL HAD DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PUSHER WIRE WAS USED TO PUSH THE SMART COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING FOUR 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; No Consequences Or Impact To Patient

  MAUDE report 11084941 ↗
• MalfunctionNov 20, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA 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 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 10880411 ↗
• MalfunctionSep 11, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO SMART COILS INTO THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE SMART COIL; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING IT. IT WAS REPORTED THAT EVENTUALLY THE SMART COIL WAS PLACED SUCCESSFULLY USING THE SAME HANDLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS 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 10525825 ↗
• MalfunctionAug 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), RUBY COILS AND A NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN REMOVED THE SMART COIL AND CHECKED IT ON THE BACK TABLE BY ADVANCING THE SMART COIL WITHIN ITS INTRODUCER SHEATH AND SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. NEXT, THE PHYSICIAN PLACED TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. THEN, WHILE ADVANCING ANOTHER SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN SMART COILS, FOUR RUBY COILS AND THE SAME MICROCATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10462770 ↗
• MalfunctionAug 21, 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS. WHILE ADVANCING THE NEXT SMART COIL, IT BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ADVANCING ANOTHER SMART COIL, IT STARTED TAKING SHAPE IN THE HUB OF THE MICROCATHETER AND BECAME STUCK. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING THIRTEEN 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 10439729 ↗
• MalfunctionAug 21, 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS. WHILE ADVANCING THE NEXT SMART COIL, IT BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ADVANCING ANOTHER SMART COIL, IT STARTED TAKING SHAPE IN THE HUB OF THE MICROCATHETER AND BECAME STUCK. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING THIRTEEN 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 10439664 ↗
• MalfunctionJul 28, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL AND FIVE OTHER COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT SMART COIL IN THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. 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 10333603 ↗
• MalfunctionMar 27, 2020Failure to Advance; Failure to Advance

  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 PLACED THE SMART COIL INTRODUCER SHEATH IN THE ROTATING HEMOSTASIS VALVE (RHV); HOWEVER, THE COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS RE-SHEATHED AND SAVED FOR LATER USE. THE PHYSICIAN PLACED ANOTHER SMART COIL, THEN ATTEMPTED TO RE-ADVANCE THE SAME SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED; 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 9889848 ↗
• MalfunctionMar 3, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL AND EIGHT OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCE RESISTANCE, AND THE SMART COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIFTEEN OTHER SMART COILS, TWO OTHER 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 9782427 ↗
• MalfunctionJan 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCING THE SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, SEVENTEEN 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 9634897 ↗