Smart Coil 400SMTXSFT0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00814548015552), received between Apr 10, 2017 and Nov 11, 2021 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (40 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL THORACIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR 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 12800655 ↗
• MalfunctionOct 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. 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 PHYSICIAN THEN PLACED A NEW SMART COIL IN THE TARGET VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE SMART COIL BECAME STUCK. THEREFORE, THE SMART COIL AND MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619253 ↗
• MalfunctionSep 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, A 5F NON-PENUMBRA SHEATH , A 4F NON-PENUMBRA ANGIOGRAPHIC CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE PHYSICIAN FLUSHED THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK AT THE DISTAL TIP AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE SMART COIL WAS ALSO RETRACTED AND REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457575 ↗
• MalfunctionJul 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COIL, AND NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL AND FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, A SMART COIL WAS STUCK, AND THE PUSHER ASSEMBLY WOULD NOT ADVANCE AT ALL WITHIN THE INTRODUCER SHEATH. 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 12175638 ↗
• MalfunctionJun 25, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  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 12064698 ↗
• MalfunctionFeb 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERCOSTAL ARTERIES USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SIX SMART COILS IN THE TARGET VESSEL AND FLUSHED THE MICROCATHETER AFTER EACH IMPLANTATION. WHEN ADVANCING THE NEXT SMART COIL, THE SMART COIL BECAME STUCK AT THE MID-SHAFT OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN NEW 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 11290485 ↗
• MalfunctionDec 29, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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 SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE OTHER COIL INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN A SMART COIL WAS ADVANCED APPROXIMATELY SIX TO SEVEN CENTIMETERS INTO THE TARGET VESSEL. IT WAS REPORTED UNDER FLUOROSCOPY THAT THE SMART COIL WAS SNAKED INSIDE THE MICROCATHETER. THEREFORE THE SMART COIL WAS REMOVED. UPON REMOVAL, IT WAS NOTED THAT THE SMART COIL WAS KINKED APPROXIMATELY 1 CM AWAY FROM THE PROXIMAL END OF THE COIL. THE PROCEDURE WAS COMPLETED BY IMPLANTING THREE OTHER COILS WITH THE SAME MICROCATHETER, AS WELL AS IMPLANTING FOUR OTHER COILS THROUGH A PARENT 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 11088885 ↗
• MalfunctionDec 21, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SMART COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE SMART COIL WAS THEREFORE, REMOVED. WHILE ADVANCING ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED.THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND 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 11045668 ↗
• MalfunctionDec 21, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SMART COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE SMART COIL WAS THEREFORE, REMOVED. WHILE ADVANCING ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND 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 11045661 ↗
• MalfunctionDec 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY 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 IMPLANTED A SMART COIL INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THIS SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THESE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NON-PENUMBRA COILS WITH 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 10997537 ↗
• MalfunctionDec 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY 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 IMPLANTED A SMART COIL INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THIS SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THESE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NON-PENUMBRA COILS WITH 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 10997530 ↗
• MalfunctionDec 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY 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 IMPLANTED A SMART COIL INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THIS SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THESE SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NON-PENUMBRA COILS WITH 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 10997497 ↗
• MalfunctionDec 5, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ONE SMART COIL, TWO 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; No Consequences Or Impact To Patient

  MAUDE report 10955316 ↗
• MalfunctionDec 5, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ONE SMART COIL, TWO 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; No Consequences Or Impact To Patient

  MAUDE report 10955315 ↗
• MalfunctionDec 4, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 10946355 ↗
• MalfunctionDec 4, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 10946265 ↗
• MalfunctionOct 30, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERIPHERAL AXILLARY ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED EIGHT SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ADVANCING ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE DISTAL END OF THE MICROCATHETER BACKED OUT OF THE TARGET VESSEL. THEREFORE, THE SMART COIL WAS REMOVED, RINSED IN SALINE ON THE BACK TABLE AND REPOSITIONED IN THE INTRODUCER SHEATH. WHILE RE-ADVANCING THE SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE BEYOND THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER 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 10766879 ↗
• MalfunctionOct 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA CATHETER. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE SECOND SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL DID NOT ADVANCE SMOOTHLY AND BECAME STUCK AT THE DISTAL END OF THE INTRODUCER SHEATH. SUBSEQUENTLY, THE SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND IMPLANTED ANOTHER SMART COIL. WHILE ADVANCING THE FOURTH SMART COIL IN THE INTRODUCER SHEATH, THE SMART COIL ADVANCED A LITTLE BEFORE BECOMING STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER THREE 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 10659921 ↗
• MalfunctionOct 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UPPER OCULAR VENOUS 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 IMPLANTED TWENTY-FOUR COILS IN THE TARGET VESSEL, INCLUDING FIVE SMART COILS. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL OUT IN ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL PAST THE ROTATING HEMOSTASIS VALVE (RHV) OF THE MICROCATHETER. IT WAS REPORTED THAT THE DISTAL TIP OF THE SMART COIL WAS LOCATED IN THE RHV. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE SMART COILS, 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 10659908 ↗
• MalfunctionAug 20, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DEEP FEMORAL ARTERY (DFA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER, THE SMART COIL BECAME STUCK IN THE HUB OF 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 Consequences Or Impact To Patient

  MAUDE report 10434827 ↗
• MalfunctionJun 25, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL BECAME STUCK; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE 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 10195121 ↗
• MalfunctionMay 14, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING A MICROCATHETER. WHILE ADVANCING ANOTHER SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, ANOTHER 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 10054815 ↗
• MalfunctionApr 10, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE SAME ISSUE OCCURRED TO ANOTHER SMART COIL; THEREFORE, IT WAS ALSO REMOVED. 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 9949385 ↗
• MalfunctionJan 15, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SINUS TRANSVERSUS USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIFTEEN COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL REMAINED STUCK IN ITS INITIAL POSITION; THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL COILS. WHILE ADVANCING THE NINETEENTH SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SMART COIL BECAME STUCK IN THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL COILS. WHILE ADVANCING THE TWENTY-SIXTH SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SMART COIL BECAME STUCK IN THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ADDITIONAL 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 9593239 ↗
• MalfunctionJan 15, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SINUS TRANSVERSUS USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIFTEEN COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL REMAINED STUCK IN ITS INITIAL POSITION; THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL COILS. WHILE ADVANCING THE NINETEENTH SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SMART COIL BECAME STUCK IN THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL COILS. WHILE ADVANCING THE TWENTY-SIXTH SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SMART COIL BECAME STUCK IN THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ADDITIONAL 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 9593215 ↗