Smart Coil 400SMTHXSFT0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00814548015705), received between Oct 2, 2017 and May 2, 2023 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (28 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, TWO NON-PENUMBRA CATHETERS, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS USING THE HANDLE AND TWO ADDITIONAL COILS INTO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. NEXT, THE PHYSICIAN TRIED TO MANUALLY DETACH THE SMART COIL INTO THE TARGET VESSEL, BUT THE SMART COIL WOULD STILL NOT DETACH. AFTER MORE THAN EIGHT FAILED ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE AGAINST RESISTANCE, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL AND THE MICROCATHETER TOGETHER. WHILE SLIGHTLY RETRACTING THE MICROCATHETER, THE SMART COIL DETACHED INTO THE TARGET VESSEL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16853246 ↗
• MalfunctionJul 1, 2022Difficult 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), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS. AFTER ADVANCING THE FIRST SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE COIL DID NOT DETACH. THEREFORE, THE HANDLE WAS REMOVED AND ANOTHER HANDLE WAS USED; HOWEVER, THE COIL STILL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL BY MANUALLY BREAKING THE PUSHER WIRE WITHOUT SUCCESS. WHILE REMOVING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER AND, SUBSEQUENTLY, THE SMART COIL WAS PUSHED INTO THE TARGET LOCATION WITH THE COIL PUSHER WIRE.THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, THE SECOND HANDLE, A NON-PENUMBRA COIL, THE SAME MICROCATHETER, AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887132 ↗
• MalfunctionFeb 9, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PARACLINOID INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, ONE NON-PENUMBRA COIL WAS SUCCESSFULLY IMPLANTED. NEXT, A SMART COIL WAS SUCCESSFULLY IMPLANTED USING THE HANDLE. AFTER ADVANCING THE NEXT SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE HANDLE; HOWEVER, THE COIL DID NOT DETACH. IT WAS REPORTED THAT THE SMART COIL REMAINED IN A STRAIGHT SHAPE WHEN THE PUSHER ASSEMBLY WAS RETRACTED INTO THE MICROCATHETER. THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER; THEREFORE, THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE SMART COIL INTO THE TARGET LOCATION. DURING FLUOROSCOPY, THE PHYSICIAN IDENTIFIED A RADIODENSITY OBJECT BEHIND THE PROXIMAL END OF THE SMART COIL BUT DECIDED TO IMPLANT IT TOGETHER WITH THE SMART COIL USING THE GUIDEWIRE. THE IDENTITY OF THE OBJECT WAS NOT CONFIRMED, AND NO ATTEMPTS WERE MADE TO REMOVE THE OBJECT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498509 ↗
• MalfunctionOct 18, 2021Failure to Advance; Failure to Advance

  ON (B)(6) 2021, THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH, THE 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 ADDITIONAL SMART COILS. ON (B)(6) 2021, THE PATIENT SUFFERED SEVERAL MINI EMBOLIC SUBACUTE BIHEMISPHERIC INFARCTIONS. THE PATIENT WAS STARTED ON 100 MG OF ACETYLSALICYLIC ACID DAILY. ON (B)(6) 2021, INFORMATION WAS RECEIVED INDICATING THAT THE EVENT WAS RESOLVED ON (B)(6) 2021. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ON (B)(6) 2021 THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WITH SLIGHT PSYCHOMOTOR SLOWDOWN WITHOUT FOCAL NEUROLOGIC SIGNS AND PAIN COMPENSATION. THE SEVERAL MINI EMBOLIC SUBACUTE BIHEMISPHERIC INFARCTIONS WERE REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12652674 ↗
• MalfunctionJul 19, 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 COILS), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, A GUIDEWIRE, AND TWO ADDITIONAL NON-PENUMBRA DEVICES. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, TWO SMART COILS AND TWO NON-PENUMBRA COILS WERE IMPLANTED INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186952 ↗
• MalfunctionJun 23, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (A-COM) USING PENUMBRA SMART COILS (SMART COIL) AND A MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK AND WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN THEN APPLIED FORCE TO TRY TO ADVANCE THE SMART COIL AND KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE FLUSHING OF THE SMART COIL DURING PREPARATION WAS VERY SLOW. THE PROCEDURE WAS COMPLETED USING 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

  MAUDE report 12054453 ↗
• MalfunctionMay 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS HAD FRICTION LOCKS THAT WOULD NOT RELEASE. THE PHYSICIAN THEN PULLED THE SMART COILS OUT FROM THE BACKSIDE OF THE INTRODUCER SHEATHS, CUT THE FRICTION LOCKS WITH A PAIR OF SCISSORS, AND BACKLOADED THE INTRODUCER SHEATHS. THE PROCEDURE WAS COMPLETED USING THE SAME SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872438 ↗
• MalfunctionApr 25, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY TO POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AND WAS STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, ANOTHER COIL AND A NEW SMART COIL WAS SUCCESSFULLY PLACED THE TARGET LOCATION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722062 ↗
• MalfunctionApr 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL AND TWELVE OTHER COILS IN THE TARGET LOCATION. SUBSEQUENTLY, THE NEXT SMART COIL BECAME STUCK AT THE HUB OF THE MICROCATHETER WHEN IT WAS BEING ADVANCED. 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 11603693 ↗
• MalfunctionMar 29, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING A NEW HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. SUBSEQUENTLY, UPON REMOVAL OF THE SMART COIL, THE SMART COIL DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. AFTERWARDS, A CONTRAST RUN WAS PERFORMED THAT INDICATED THAT THE TARGET LOCATION WAS SUCCESSFULLY EMBOLIZED WITH THE PREVIOUSLY PLACED COILS. 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 11586637 ↗
• MalfunctionMar 25, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) 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 FOUR NON-PENUMBRA COILS AND FOUR SMART COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, RESISTANCE WAS ENCOUNTERED, AND IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED, AND ANOTHER SMART COIL WAS ADVANCED AND SUCCESSFULLY IMPLANTED. NEXT, THE PHYSICIAN FAILED SEVERAL TIMES TO DETACH A SMART COIL USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL WITHOUT MAKING ANY MANUAL ATTEMPTS TO DETACH THE COIL; HOWEVER, THE SMART COIL COULD NOT BE RETRACTED OUT OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER SMART COILS, THE SAME HANDLE, 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 11570122 ↗
• 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 CO

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

  MAUDE report 11357996 ↗
• MalfunctionFeb 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FROM THE BASILAR ARTERY TO THE SUPERIOR CEREBELLAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS AND SUBSEQUENTLY DETACHED THE THIRD SMART COIL. ON WITHDRAWAL, THE PUSHER ASSEMBLY OF THE SMART COIL WAS STUCK IN THE HUB OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE PUSHER ASSEMBLY BUT WAS NOT ABLE TO INSERT THE FOURTH SMART COIL INTO THE MICROCATHETER. THE PHYSICIAN NOTED THAT THERE MAY HAVE BEEN SOME BLACK PARTICULATE IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED, AND THE PHYSICIAN INSERTED A NEW MICROCATHETER. WHEN ADVANCING THE SAME SMART COIL IN THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11341016 ↗
• MalfunctionDec 8, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, TWO SMART COILS WOULD NOT ADVANCE WITHIN THE INTRODUCER SHEATHS AND WERE STUCK IN THEIR INITIAL POSITION. THEREFORE, THE PHYSICIAN PULLED THE SMART COILS OUT FROM THE BACK END OF THE INTRODUCER SHEATHS AND BACKLOADED BOTH SMART COILS INTO THE INTRODUCER SHEATHS OF THE COILS THAT WERE PREVIOUSLY IMPLANTED. THE PROCEDURE WAS COMPLETED USING THE SAME TWO 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 10970248 ↗
• MalfunctionNov 20, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BIFURCATION OF THE ANTERIOR CEREBRAL ARTERY (ACA) AND ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, BOTH SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, BOTH SMART COILS WERE REMOVED. NEXT, A NEW SMART COIL WAS ADVANCED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN DECIDED TO RETRACT THE SMART COIL TO REPOSITION THE MICROCATHETER. WHILE RETRACTING THE SMART COIL BACK INTO THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE SMART COIL PARTIALLY BACK INTO THE INTRODUCER SHEATH AND REMOVED THE SMART COIL. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTICED A GAP IN THE PUSHER ASSEMBLY OF THE SMART COIL WITHIN THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING 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 10877469 ↗
• MalfunctionSep 10, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE FOURTH SMART COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY TWO CENTIMETERS THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED AND THE MICROCATHETER WAS FLUSHED. 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 Consequences Or Impact To Patient

  MAUDE report 10518661 ↗
• MalfunctionJul 29, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERIES (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL HALFWAY THROUGH ITS INTRODUCER SHEATH, THE SMART COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10340850 ↗
• MalfunctionJun 25, 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), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE MICROCATHETER WAS USED TO IMPLANT TWO OTHER COILS AND TWO SMART COILS INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT SMART COIL, IT BECAME STUCK JUST PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195173 ↗
• MalfunctionMar 26, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; SUBSEQUENTLY, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO RE-ADVANCE THE SMART COIL INTO SALINE, BUT THE SAME ISSUE OCCURRED; THEREFORE, IT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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 9884094 ↗
• MalfunctionMar 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE NEXT SMART COIL HAD THE SAME ISSUE; 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 9850907 ↗
• MalfunctionMar 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE NEXT SMART COIL HAD THE SAME ISSUE; 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 9850903 ↗
• MalfunctionMar 11, 2020Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PARACLINOID OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL HALFWAY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND HAD DIFFICULTY ADVANCING THE SMART COIL FURTHER; THEREFORE, THE SMART COIL WAS 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 Consequences Or Impact To Patient

  MAUDE report 9819375 ↗
• MalfunctionFeb 20, 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), NON-PENUMBRA COILS, A NON-PENUMBRA STENT AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE STENT IN THE TARGET VESSEL VIA THE PATIENT¿S NECK TO PREVENT COIL MIGRATION, FOLLOWED BY THIRTY-ONE COILS AND ONE SMART COIL. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE MICROCATHETER, IT WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS, OTHER NON-PENUMBRA COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9734165 ↗
• MalfunctionDec 23, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT SUBARACHNOID HEMORRHAGE (SAH) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE SMART COIL KINKED UPON FURTHER ADVANCEMENT; THEREFORE, IT WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THE SMART COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513099 ↗
• MalfunctionNov 19, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE SECOND SMART COIL TO THE TARGET VESSEL AND DETACHED IT FROM THE PUSHER ASSEMBLY; SUBSEQUENTLY, THE PUSHER ASSEMBLY WAS REMOVED. NEXT, WHILE ADVANCING A THIRD SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE BEGINNING BUT CONTINUED TO ADVANCE THE SMART COIL UNTIL IT REACHED THE DISTAL TIP OF THE MICROCATHETER, WHERE IT BECAME STUCK; THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN CHECKED THE MICROCATHETER AND NOTICED THAT A FRAGMENT OF THE SECOND SMART COIL PUSHER ASSEMBLY WAS INSIDE THE MICROCATHETER; SUBSEQUENTLY, THE FRAGMENT WAS FLUSHED OUT. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE SECOND SMART COIL WAS STUCK IN THE ROTATING HEMOSTASIS VALVE (RHV) AND FRACTURED INSIDE THE RHV WHILE BEING REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342152 ↗