Smart Coil 400SMTXSFT3H06Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00814548017112), received between May 30, 2017 and Oct 1, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THE INITIAL COIL IN THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE ANEURYSM, THEN ATTEMPTED TO MANUALLY DETACH IT; HOWEVER, THE SMART COIL FAILED DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL WITH THE HANDLE; HOWEVER, THE SMART COIL STILL WOULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING FOUR OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565572 ↗
• MalfunctionJun 21, 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), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE ANEURYSM AND DETACHED IT USING A HANDLE. SUBSEQUENTLY, ANOTHER SMART COIL WAS ADVANCED INTO 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 SAME SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL WITH THE SAME HANDLE AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038145 ↗
• MalfunctionApr 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATION ARTERY (PCOM) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 11717042 ↗
• MalfunctionMar 25, 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND DETACH IT USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A SECOND SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PHYSICIAN NOTICED VIA AN ANGIOGRAM THAT THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE TWO ADDITIONAL ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS MANUALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED TWO ADDITIONAL SMART COILS INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THEM USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN MADE ADDITIONAL ATTEMPTS TO CLICK THE HANDLE AND BOTH SMART COILS EVENTUALLY DETACHED SUCCESSFULLY. 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 11566906 ↗
• MalfunctionDec 1, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL; THEREFORE, IT WAS ALSO REMOVED. THE PHYSICIAN THEN IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL SMART COILS, TWO 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 10925363 ↗
• MalfunctionDec 1, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL; THEREFORE, IT WAS ALSO REMOVED. THE PHYSICIAN THEN IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN IN THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL SMART COILS, TWO 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 10925300 ↗
• MalfunctionSep 11, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  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 10522644 ↗
• MalfunctionMar 19, 2020Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SMART COIL INTO THE HUB OF THE MICROCATHETER. THE PHYSICIAN CONTINUED ADVANCING THE SMART COIL AND SUCCESSFULLY IMPLANTED THE SMART COIL INTO THE TARGET LOCATION. WHILE ADVANCING ANOTHER SMART COIL, THE SAME ISSUE OCCURRED. HOWEVER, WHEN THE PHYSICIAN CONTINUED TO ADVANCE THE SMART COIL, THE PUSHER ASSEMBLY BECAME KINKED; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856330 ↗
• MalfunctionSep 12, 2019Separation Failure; Appropriate Device Problem Term/Code Not Available; Separation Failure; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, IT WAS REPORTED THAT THE SMART COIL WOULD NOT DEPLOY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9008839 ↗
• MalfunctionJul 10, 2019Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL AND WHILE DETACHING, THE SMART COIL RETRACTED A BIT. THE PHYSICIAN ATTEMPTED TO RE-INSERT THE SMART COIL AND EXPERIENCED DIFFICULTY IN PUSHING IT IN. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SMART COIL USING THE PUSHER ASSEMBLY AND IT WOULD NOT GO IN FURTHER. THE PHYSICIAN DECIDED TO USE A NON-PENUMBRA GUIDE WIRE THAT IS RADIOPAQUE AT THE TIP, AND SLIGHT RESISTANCE WAS EXPERIENCED. IT WAS REPORTED THAT THE PHYSICIAN FELT LIKE THERE WAS SOMETHING BETWEEN THE SMART COIL AND THE GUIDE WIRE, AND THE SEGMENT BETWEEN THE SMART COIL AND THE GUIDE WIRE WAS NOT RADIOLUCENT. AT THIS POINT, THE PHYSICIAN MANAGED TO PUSH THE SMART COIL, BUT DID NOT KNOW WHERE THE NON-RADIOLUCENT FRAGMENT WAS. THIS OCCURRED AFTER RELEASING THE SMART COIL AND THE PHYSICIAN ENDED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8777297 ↗
• MalfunctionMay 22, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (A-COM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE SMART COIL BECAME STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, 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 8631952 ↗
• MalfunctionSep 25, 2018Device Damaged Prior to Use; Failure to Advance; Device Damaged Prior to Use; Failure to Advance

  DURING PREPARATION FOR A COIL EMBOLIZATION, THE HOSPITAL TECHNOLOGIST WAS UNABLE TO ADVANCE A PENUMBRA SMART COILS (SMART COILS) THROUGH THE INTRODUCER SHEATH ON THE BACK TABLE; THEREFORE, IT WAS REMOVED. NEXT, THE TECHNOLOGIST OPENED A NEW SMART COIL AND TRIED ADVANCING IT ON THE BACK TABLE; HOWEVER, THE SMART COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. IT WAS NOTED THAT THE ISSUES WITH THE SMART COILS WERE FOUND PRIOR TO USE AND, THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7908259 ↗
• MalfunctionSep 25, 2018Failure to Fold; Device Damaged Prior to Use; Failure to Fold; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION, THE HOSPITAL TECHNOLOGIST WAS UNABLE TO ADVANCE A PENUMBRA SMART COILS (SMART COILS) THROUGH THE INTRODUCER SHEATH ON THE BACK TABLE; THEREFORE, IT WAS REMOVED. NEXT, THE TECHNOLOGIST OPENED A NEW SMART COIL AND TRIED ADVANCING IT ON THE BACK TABLE; HOWEVER, THE SMART COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. IT WAS NOTED THAT THE ISSUES WITH THE SMART COILS WERE FOUND PRIOR TO USE AND, THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7908257 ↗
• MalfunctionAug 28, 2018Failure 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). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE HUB OF THE MICROCATHETER AND THE SMART COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 7822925 ↗
• MalfunctionJun 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE PLACING A SMART COIL IN THE TARGET VESSEL, APPROXIMATELY FIVE MILLIMETERS OF THE PROXIMAL END OF THE SMART COIL STOPPED TAKING ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO OTHER COILS AND A SMART COIL IN THE ICA. WHILE ATTEMPTING TO ADVANCE A NON-PENUMBRA COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE NEAR THE HUB OF THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE GUIDEWIRE INTO THE MICROCATHETER WITH SOME RESISTANCE AND THE GUIDEWIRE STOPPED APPROXIMATELY FIVE CENTIMETERS FROM THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND THE GUIDEWIRE ALTOGETHER FROM THE PATIENT¿S BODY. UPON FLUSHING THE MICROCATHETER, A RED-COLORED FOREIGN OBJECT THAT LOOKED LIKE THROMBUS CAME OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631727 ↗
• MalfunctionNov 10, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL OUT ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH FOUR ADDITIONAL SMART COILS. THE PROCEDURE WAS COMPLETED USING FIVE OTHER SMART COILS, A NON-PENUMBRA COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023152 ↗
• MalfunctionSep 28, 2017Kinked; Failure to Advance; Kinked; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER SMART COIL MORE THAN 15CM THROUGH THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE COIL AND DISTAL TIP OF THE PUSHER WIRE OF THE SMART COIL HAD BECOME KINKED; THEREFORE, THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902839 ↗
• MalfunctionMay 30, 2017Failure to Advance; Physical Resistance; Device Operates Differently Than Expected; Failure to Advance; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A NON-PENUMBRA COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A SMART COIL, HOWEVER THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL THROUGH THE HUB OF THE NON-PENUMBRA MICROCATHETER; THE PHYSICIAN RE-ATTEMPTED SEVERAL TIMES TO ADVANCE THE SMART COIL INTO THE MICROCATHETER, BUT THE SMART COIL WOULD NOT ADVANCE. THEREFORE THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6598677 ↗