Smart Coil 400SMTSFT0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00814548015101), received between May 10, 2016 and Jun 22, 2022 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (17 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN Y STENTED AND PLACED THE MICROCATHETER IN THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED THE SMART COIL INTO THE TARGET LOCATION 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 THE COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED SMART COIL INTO THE ANEURYSM USING A GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING TWO 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 14780305 ↗
• MalfunctionMar 26, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE SEVERAL ADDITIONAL ATTEMPTS TO DETACH THE SMART COIL MANUALLY AND USING THE HANDLE, BUT THE SMART COIL STILL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE GENTLY RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, IT WAS NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INSIDE THE ANEURYSM. 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 13923494 ↗
• MalfunctionFeb 2, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), 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 SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL. AFTER ADVANCING A SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE SMART COIL DID NOT DETACH AFTER TWO ATTEMPTS. WHEN APPROXIMATELY TWO CENTIMETERS OF THE SMART COIL WAS RETRACTED BACK INTO THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED. NEXT, THE PHYSICIAN USED THE SMART COIL PUSHER WIRE TO SUCCESSFULLY IMPLANT THE COIL. THE HANDLE WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING 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 13429280 ↗
• MalfunctionJan 4, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM) USING A PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL (LOT#F106024) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE SAME ISSUE OCCURRED WITH THE SECOND SMART COIL (LOT#F105543); HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH THE SMART COIL MANUALLY. NEXT, THE PHYSICIAN OPENED A SECOND HANDLE AND ATTEMPTED TO DETACH THE THIRD SMART COIL (LOT#F106201); HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS USING THE HANDLE AS WELL AS MANUALLY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PHYSICIAN AGAIN EXPERIENCED DIFFICULTY DETACHING THE FOURTH SMART COIL (LOT#F83607) USING THE HANDLE; HOWEVER, THE SMART COIL WAS ABLE TO BE DETACHED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155375 ↗
• MalfunctionOct 7, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL (400SMTSFT3H06) INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE (F103332); HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL DID NOT DETACH. SUBSEQUENTLY, 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 (400SMTSFT3H06) INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE (F103332); HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PHYSICIAN THEN PLACED THREE NON-PENUMBRA COILS AND FOUR SMART COILS INTO THE TARGET LOCATION USING A NEW HANDLE (F96975). NEXT, THE PHYSICIAN ADVANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595119 ↗
• MalfunctionSep 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VENOUS SINUS USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SIX SMART COILS IN TOTAL. SUBSEQUENTLY, A SMART COIL WOULD NOT ADVANCE BEYOND FRICTION LOCK. THEREFORE, THE SMART COIL WAS REMOVED. 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 12540622 ↗
• MalfunctionAug 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, ANOTHER NON-PENUMBRA MICROCATHETER, AND A 5F ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL IN THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. 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 SIX SMART COILS, ONE POD PACKING 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 12283000 ↗
• MalfunctionJul 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS (SMART COIL), A RUBY COIL LP, A PACKING COIL LP, A BENCHMARK BMX96 ACCESS SYSTEM (BENCHMARK MAX) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BENCHMARK MAX IN THE RIGHT JUGULAR VEIN. THE PHYSICIAN THEN PLACED TWO SMART COILS INTO THE CAROTID CAVERNOUS SINUS USING THE MICROCATHETER. AFTERWARDS, A RUBY COIL LP AND A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS; THEREFORE, THE RUBY COIL LP AND THE SMART COIL WERE REMOVED. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING APPROXIMATELY TEN CENTIMETERS OF A PACKING COIL LP THROUGH THE DISTAL END OF THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO RETRACT THE PACKING COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND HEARD A POPPING SOUND. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE PACKING COIL LP AND NOTICED THE COIL BROKE AND UNRAVELED. AFTERWARDS, THE MICROCATHETER WAS REMOVED AND IT WAS NOTICED THAT THE REMAINING COIL WAS HANGING FROM THE HUB OF THE BENCHMARK MAX. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO PULL ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171166 ↗
• MalfunctionJun 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041719 ↗
• MalfunctionMay 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) 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. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE SMART COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATHS OF THE SMART COILS SEPARATED AROUND THE FRICTION LOCK WHEN FORCE WAS USED. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE SMART COILS, THREE 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 11898393 ↗
• MalfunctionMay 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) 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. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. THEREFORE, THE SMART COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE INTRODUCER SHEATHS OF THE SMART COILS SEPARATED AROUND THE FRICTION LOCK WHEN FORCE WAS USED. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, RESISTANCE WAS ENCOUNTERED, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME BENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE SMART COILS, THREE 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 11898380 ↗
• MalfunctionMay 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE HOSPITAL STAFF KINKED THE SMART COIL; THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL WITHIN ITS INTRODUCER SHEATH; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898135 ↗
• MalfunctionMay 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE HOSPITAL STAFF KINKED THE SMART COIL; THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL WITHIN ITS INTRODUCER SHEATH; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898134 ↗
• MalfunctionMay 23, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED SMART COILS IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE FINAL SMART COIL INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST REMOVED THE SMART COIL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE ON THE BACK TABLE BUT, THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS NOT LONGER USED FOR THE PROCEDURE. THE PROCEDURE HAD 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 11868454 ↗
• MalfunctionMay 10, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE MICROCATHETER, THE TECHNICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER; THE SAME ISSUE OCCURRED. THE TECHNICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL; 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 11801202 ↗
• MalfunctionMar 29, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, ALL THREE SMART COILS WERE 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 11581412 ↗
• MalfunctionMar 5, 2021Separation Failure; Separation Failure

  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 PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL AND SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER WIRE. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL USING THE HANDLE, IT WAS REPORTED THAT THE SMART COIL WOULD NOT DETACH. ALTHOUGH THE CLICK OF THE HANDLE WAS AUDIBLE AND THE SMART COIL APPEARED TO DETACH, THE COIL DID NOT DETACH. THE PHYSICIAN MADE FIVE ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE BEFORE MANUALLY DETACHING THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, THE SAME HANDLE, 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 11425196 ↗
• MalfunctionMar 5, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  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 PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL AND SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER WIRE. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL USING THE HANDLE, IT WAS REPORTED THAT THE SMART COIL WOULD NOT DETACH. ALTHOUGH THE CLICK OF THE HANDLE WAS AUDIBLE AND THE SMART COIL APPEARED TO DETACH, THE COIL DID NOT DETACH. THE PHYSICIAN MADE FIVE ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE BEFORE MANUALLY DETACHING THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, THE SAME HANDLE, 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 11425156 ↗
• MalfunctionMar 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL AND SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER WIRE. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL USING THE HANDLE, IT WAS REPORTED THAT THE SMART COIL WOULD NOT DETACH. ALTHOUGH THE CLICK OF THE HANDLE WAS AUDIBLE AND THE SMART COIL APPEARED TO DETACH, THE COIL DID NOT DETACH. THE PHYSICIAN MADE FIVE ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE BEFORE MANUALLY DETACHING THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, THE SAME HANDLE, 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 11425141 ↗
• MalfunctionMar 1, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND TWO NON-PENUMBRA GUIDE CATHETERS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED ONE SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT. HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE AN ADDITIONAL ATTEMPT; HOWEVER, THE SMART COIL DID NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON REMOVAL, THE SMART COIL DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS, A NEW HANDLE, THREE OTHER COILS, AND THE SAME MICROCATHETER. IT WAS ALSO REPORTED THAT SCRATCH MARKS WERE FOUND ON THE PROXIMAL END OF THE HANDLE POST-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 11391144 ↗
• MalfunctionFeb 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A NEURO FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE THREE SMART COILS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 11359890 ↗
• MalfunctionFeb 22, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND DID NOT PERMIT THE GUIDE CATHETER TO COMPLETELY SUPPORT THE MICROCATHETER DURING ADVANCEMENT TO THE TARGET LOCATION. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-PENUMBRA COIL TO FRAME THE TARGET LOCATION. AFTER ADVANCING THE FIRST SMART COIL (6MM X 15CM) TO THE TARGET LOCATION AND REPOSITIONING IT, THE PHYSICIAN EXPERIENCED MODERATE MICROCATHETER TIP KICKBACK WHILE MAKING FIVE ATTEMPTS TO DETACH THE COIL USING THE HANDLE. THE SMART COIL (6MM X 15CM) WAS THEREFORE MANUALLY DETACHED AND SUCCESSFULLY IMPLANTED. WHILE ATTEMPTING TO IMPLANT THE SECOND SMART COIL (5MM X 10CM), THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AFTER EIGHT ATTEMPTS WERE MADE; THEREFORE, THE SMART COIL (5MM X 10CM) WAS MANUALLY DETACHED AND SUCCESSFULLY IMPLANTED. AFTER ADVANCING THE SIXTH SMART COIL (2MM X 4CM) TO THE TARGET LOCATION, SEVEN UNSUCCESSFUL ATTEMPTS WERE MADE TO DETACH THE COI

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

  MAUDE report 11357985 ↗
• MalfunctionDec 2, 2020Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), NON-PENUMBRA CATHETER, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER FLUSHING THE INTRODUCER SHEATHS OF TWO SMART COILS, THE PHYSICIAN WAS ABLE TO ADVANCE THE SMART COILS FROM THEIR STARTING POSITIONS WITHIN THE INTRODUCER SHEATHS BUT NEEDED A LOT OF PRESSURE. THEREFORE, THE PHYSICIAN REMOVED THE SMART COILS. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND NON-PENUMBRA 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 10931846 ↗
• MalfunctionNov 20, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL AND FIVE OTHER COILS IN THE TARGET VESSEL. HOWEVER, THE NEXT SMART COIL WOULD NOT ADVANCE FROM THE INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 10876623 ↗
• MalfunctionSep 28, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TERMINAL INTERNAL CAROTID ARTERY (ICA) ANEURYSM USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE SMART COIL. WHILE RETRACTING THE SMART COIL TO REPOSITION IT, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED 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; No Consequences Or Impact To Patient

  MAUDE report 10597395 ↗