Smart Coil 400SMTXSFT0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00814548015347), received between Dec 30, 2015 and Nov 22, 2021 — classified as 3 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (24 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING 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 SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE NEXT SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO PRESS THE TRIGGER OF THE HANDLE HALFWAY WHILE PULLING ON THE PUSHER ASSEMBLY, BUT THE SMART COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN USED FORCEPS TO MANUALLY DETACH THE SMART COIL. SUBSEQUENTLY, THE NEXT TWO SMART COILS WOULD NOT DETACH USING A NEW HANDLE. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO PRESS THE TRIGGER OF THE HANDLE HALFWAY WHILE PULLING ON THEIR RESPECTIVE PUSHER ASSEMBLY, BUT THE SMART COILS DID NOT DETACH. THE PHYSICIAN ALSO ATTEMPTED TO USE FORCEPS TO MANUALLY DETACH THE SMART COILS BUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856116 ↗
• MalfunctionNov 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A STENT-ASSISTED COILING EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), AND A NON-PENUMBRA MICROCATHETER. DURING DEPLOYMENT OF THE SECOND SMART COIL, AN ANEURYSM RUPTURE AND A SUBARACHNOID HEMORRHAGE (SAH) OCCURRED. SUBSEQUENTLY, A BALLOON CATHETER WAS INTRODUCED TO STOP THE BLEEDING. THE COILING MICROCATHETER WAS REMOVED AND A STENTING MICROCATHETER WAS INTRODUCED FROM THE LEFT INTERNAL CAROTID ARTERY (ICA) IN THE ACA A2 SEGMENT. AN ANEURYSM BRIDGING STENT WAS DEPLOYED INTO THE LEFT A1 SEGMENT WITHOUT COMPLICATIONS. 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. A TOTAL OF FIVE SMART COILS AND THE SAME MICROCATHETER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED TECHNICAL COMPLICATIONS DURING USE OF THE SMART COILS. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO THE ANEURYSM RUPTURE AND SUBSEQUENT SAH. HOWEVER, THE RELATIONSHIP BETWEEN THE SAH AND USE OF THE SMART COIL IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833308 ↗
• MalfunctionOct 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701144 ↗
• MalfunctionAug 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A MICROCATHETER. DURING THE PROCEDURE THE 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 12285021 ↗
• MalfunctionJul 29, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING A SECOND HANDLE, BUT IT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY HAND, BUT IT WAS ALSO UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED A SECOND SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 12249167 ↗
• 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 11801145 ↗
• MalfunctionApr 23, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), AND TWO NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE FIRST SMART COIL WOULD NOT DETACH AFTER MULTIPLE ATTEMPTS WERE MADE WITH THREE HANDLES. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WAS STUCK IN THE FIRST MICROCATHETER. THE SMART COIL WAS THEN REMOVED. SUBSEQUENTLY, THE PHYSICIAN USED A SECOND SMART COIL, THE THIRD HANDLE, AND THE SAME MICROCATHETER. HOWEVER, THE PHYSICIAN WAS ALSO UNABLE TO DETACH THE SMART COIL WITH THE HANDLE AFTER MULTIPLE ATTEMPTS WERE MADE. WHILE RETRACTING THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WAS STUCK IN THE MICROCATHETER. THE SMART COIL AND MICROCATHETER WERE THEN REMOVED. THE PHYSICIAN RESUMED THE PROCEDURE AND SUCCESSFULLY PLACED THE THIRD SMART COIL WITH THE HANDLE AND SECOND MICROCATHETER. NEXT, THE PHYSICIAN USED A FOURTH SMART COIL, THE SAME HANDLE, AND THE SAME SECOND MICROCATHETER. HOWEVER, THE PHYSICIAN WAS ALSO UNABLE TO DETACH THE SMART COIL WITH THE HANDLE AFTER MULTIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716633 ↗
• MalfunctionFeb 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITIONS OF THEIR INTRODUCER SHEATHS. THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11276691 ↗
• MalfunctionJan 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING A SMART COIL APPROXIMATELY ONE THIRD OF THE WAY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE ANY FURTHER. 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; No Consequences Or Impact To Patient

  MAUDE report 11167854 ↗
• MalfunctionJan 9, 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 COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 11144080 ↗
• MalfunctionJan 5, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE FROM THEIR STARTING POSITION WITHIN THEIR INTRODUCER SHEATHS, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COILS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 11117694 ↗
• MalfunctionJan 5, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE FROM THEIR STARTING POSITION WITHIN THEIR INTRODUCER SHEATHS, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COILS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 11117691 ↗
• MalfunctionDec 18, 2020Failure 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE FIRST SMART COIL WAS UNABLE TO ADVANCE PAST THE HUB OF THE MICROCATHETER. 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 11042154 ↗
• MalfunctionDec 5, 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 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 10953550 ↗
• MalfunctionNov 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK OF THE 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; No Consequences Or Impact To Patient

  MAUDE report 10919992 ↗
• MalfunctionOct 21, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, IT WAS REPORTED THAT THE SMART COIL FAILED TO DEPLOY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10714960 ↗
• MalfunctionOct 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE ANGIOGRAM REVEALED THAT THE SMART COIL WENT THROUGH THE BLISTER OF THE ANEURYSM AND RUPTURED IT. HOWEVER, THE SMART COIL WAS STILL IMPLANTED AND THE PHYSICIAN CONTINUED TO IMPLANT COILS TO STOP THE BLEED. IT WAS ALSO REPORTED THAT ANOTHER SMART COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER AND WAS THEREFORE REMOVED. WHILE ATTEMPTING TO ADVANCE TWO MORE SMART COILS, THEY WOULD NOT ADVANCE FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THESE TWO SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PATIENT IS STABLE.

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

  MAUDE report 10671235 ↗
• MalfunctionOct 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE ANGIOGRAM REVEALED THAT THE SMART COIL WENT THROUGH THE BLISTER OF THE ANEURYSM AND RUPTURED IT. HOWEVER, THE SMART COIL WAS STILL IMPLANTED AND THE PHYSICIAN CONTINUED TO IMPLANT COILS TO STOP THE BLEED. IT WAS ALSO REPORTED THAT ANOTHER SMART COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER AND WAS THEREFORE REMOVED. WHILE ATTEMPTING TO ADVANCE TWO MORE SMART COILS, THEY WOULD NOT ADVANCE FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THESE TWO SMART COILS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PATIENT IS STABLE.

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

  MAUDE report 10671233 ↗
• MalfunctionSep 11, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE INITIAL POSITION. THE SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER SMART COIL. HOWEVER, THE SAME ISSUE OCCURRED, AND THE SECOND SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED FOUR SMART COILS INDIVIDUALLY TO THE TARGET VESSEL. THE HANDLE TOOK TWO TO THREE ATTEMPTS TO DETACH THE FIRST, SECOND, AND THIRD SMART COILS, AND THE HANDLE WAS UNABLE TO DETACH THE FOURTH SMART COIL. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE FOURTH SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND ANOTHER HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10523294 ↗
• MalfunctionAug 21, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, FOUR OTHER COILS WERE SUCCESSFULLY IMPLANTED. NEXT, THE PHYSICIAN POSITIONED A SMART COIL IN THE TARGET VESSEL AND PREPARED TO DETACH IT HOWEVER, THE HANDLE WAS UNABLE TO DETACH THE SMART COIL. THE PHYSICIAN ALSO MADE AN ATTEMPT TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS. WHILE RETRACTING THE SMART COIL, IT DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE SMART COIL AND MICROCATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING TEN SMART COILS, THE SAME HANDLE, ONE OTHER 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 10439410 ↗
• MalfunctionApr 4, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9926191 ↗
• MalfunctionApr 3, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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. IT WAS REPORTED THAT PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL BECAME STUCK AND WOULD NOT ADVANCE FORWARD OR BACKWARD. THE PHYSICIAN THEN ATTEMPTED TO PUSH OUT THE SMART COIL USING SALINE SOLUTION BUT THE SMART COIL WOULD NOT ADVANCE. THE PHYSICIAN THEN USED A GUIDEWIRE TO PUSH THE SMART COIL INTO THE ANEURYSM, AND AFTER SEVERAL PUSHES THE SMART COIL WAS ADVANCED INTO THE ANEURYSM. HOWEVER, A SMALL TAIL OF THE SMART COIL REMAINED OUTSIDE OF THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN DID NOT WANT TO TAKE FURTHER RISKS; THEREFORE, THE PROCEDURE ENDED AT THIS POINT. IT WAS ALSO REPORTED THAT THE PATIENT¿S CONDITION WAS DELICATE PRIOR TO THE PROCEDURE AND THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9922967 ↗
• MalfunctionFeb 14, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PERICALLOSAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS WITH A LOOP IN THE CAROTID ARCH. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE SMART COIL KICKED THE MICROCATHETER OUT OF THE ANEURYSM; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN MENTIONED THAT THE SMART COIL WAS "STIFF". NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND WAS THEREFORE REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE ANEURYSM AND USED THE HANDLE TO DETACH IT. HOWEVER, THE SMART COIL FAILED TO DETACH AFTER THREE TO FOUR ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY PULLING THE PULL WIRE, BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE SMART COIL NOT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. WHILE ADVANCING THE NON-PENUMB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712192 ↗
• MalfunctionFeb 14, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PERICALLOSAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS WITH A LOOP IN THE CAROTID ARCH. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE SMART COIL KICKED THE MICROCATHETER OUT OF THE ANEURYSM; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN MENTIONED THAT THE SMART COIL WAS "STIFF". NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND WAS THEREFORE REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE ANEURYSM AND USED THE HANDLE TO DETACH IT. HOWEVER, THE SMART COIL FAILED TO DETACH AFTER THREE TO FOUR ATTEMPTS. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY PULLING THE PULL WIRE, BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE SMART COIL NOT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. WHILE ADVANCING THE NON-PENUMB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712179 ↗
• MalfunctionJan 7, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560101 ↗