Smart Coil 400SMTHXSFT2H04Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00814548015750), received between May 23, 2016 and Nov 15, 2021 — classified as 2 injuries, 27 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE NEXT SMART COIL INTO THE ANEURYSM THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN PUT THE DISTAL END OF THE MICROCATHETER AGAINST THE ANEURYSM AND PUSHED THE SMART COIL IN IT. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL AGAIN AFTER WITHDRAWING THE MICROCATHETER A LITTLE, BUT THE SMART COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 12817042 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED ON 03-NOV-2021 INDICATED THAT THE ISCHEMIC STROKE WAS ADJUDICATED BY THE CLINICAL INVESTIGATOR TO BE UNRELATED TO THE SMART COILS AND RELATED TO THE INDEX PROCEDURE.

  Patient problems: Ischemia Stroke

  MAUDE report 12651444 ↗
• MalfunctionSep 14, 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 (ICA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, A BALLOON CATHETER, AND GUIDEWIRES. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS AND ONE SMART COIL INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL, RESISTANCE WAS ENCOUNTERED, AND THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12470703 ↗
• MalfunctionJun 30, 2021Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL DID NOT FULLY DETACH WITH THE ALIGNMENT ZONE NOT COMPLETELY SEPARATED. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE PUSHER ASSEMBLY AND NOTICED THE SMART COIL WAS STILL ATTACHED UNDER ANGIOGRAPHY FROM THE ORIGIN OF THE INNER CAROTID ARTERY. THE PHYSICIAN CONTINUED RETRACTING THE PUSHER ASSEMBLY UNDER ANGIOGRAPHY AND NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED, AND THE SMART COIL WAS AT THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM USING THE PUSHER ASSEMBLY AND THE SMART COIL MOVED INTO THE PARENT VESSEL. THEREFORE, THE PHYSICIAN USED A STENT TO PRESS THE SMART COIL AGAINST THE VESSEL WALL. IT WAS ALSO REPORTED THAT THE PARENT VESS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097186 ↗
• MalfunctionMar 25, 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 (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 11570123 ↗
• MalfunctionNov 20, 2020Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  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 10877379 ↗
• MalfunctionSep 10, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10513344 ↗
• MalfunctionAug 7, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL AND THIRTEEN NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, TWELVE 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 10380114 ↗
• MalfunctionJul 9, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TIP OF THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. THE SMART COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254401 ↗
• MalfunctionJun 19, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA COILS 400 (PC400S), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SMART COILS AND PC400S IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE REMOVING THE PUSHER ASSEMBLY OF THE LAST SMART COIL THROUGH THE ROTATING HEMOSTASIS VALVE (RHV); THE TIP OF THE PUSHER ASSEMBLY BROKE; THEREFORE, THE BROKEN TIP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10175365 ↗
• MalfunctionMar 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE COILS IN THE ANEURYSM. NEXT, WHILE ATTEMPTING TO ADVANCING A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND TWO OTHER NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857987 ↗
• MalfunctionSep 20, 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 (ACOM) USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SMART COIL APPROXIMATELY 3-4 CM INTO ITS INTRODUCER SHEATH. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN 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 9098340 ↗
• MalfunctionApr 17, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE HANDLE WAS DEPRESSED SEVERAL TIMES BEFORE THE SMART COIL DETACHED INTO THE VESSEL. THE SAME ISSUE OCCURRED AGAIN WITH FOUR ADDITIONAL SMART COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524988 ↗
• MalfunctionApr 17, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE HANDLE WAS DEPRESSED SEVERAL TIMES BEFORE THE SMART COIL DETACHED INTO THE VESSEL. THE SAME ISSUE OCCURRED AGAIN WITH FOUR ADDITIONAL SMART COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524981 ↗
• MalfunctionApr 17, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE HANDLE WAS DEPRESSED SEVERAL TIMES BEFORE THE SMART COIL DETACHED INTO THE VESSEL. THE SAME ISSUE OCCURRED AGAIN WITH FOUR ADDITIONAL SMART COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524883 ↗
• MalfunctionApr 17, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE HANDLE WAS DEPRESSED SEVERAL TIMES BEFORE THE SMART COIL DETACHED INTO THE VESSEL. THE SAME ISSUE OCCURRED AGAIN WITH FOUR ADDITIONAL SMART COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524861 ↗
• MalfunctionApr 17, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY (VA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE HANDLE WAS DEPRESSED SEVERAL TIMES BEFORE THE SMART COIL DETACHED INTO THE VESSEL. THE SAME ISSUE OCCURRED AGAIN WITH FOUR ADDITIONAL SMART COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524813 ↗
• MalfunctionMar 14, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS OVERLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH A SMART COIL USING THE HANDLE BEFORE THE SMART COIL DETACHED IN THE TARGET LOCATION. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS. HOWEVER, ALL THREE COILS WERE SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420844 ↗
• MalfunctionNov 9, 2018Failure 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). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS, CALCIFIED AND NARROWING VESSELS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL AND FOUR SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE TWO OTHER SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING SIX 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 8057338 ↗
• MalfunctionOct 23, 2018Failure to Advance; Failure to Advance

  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 SUCCESSFULLY PLACED THREE NON-PENUMBRA COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL NON-PENUMBRA COIL AND A SMART COIL WITH THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997479 ↗
• MalfunctionOct 18, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A RUPTURED CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE COILS AND TWO SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH TWO SMART COILS USING THE HANDLE AND, THEREFORE, THE PHYSICIAN MANUALLY DETACH THE SMART COILS. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7978823 ↗
• MalfunctionOct 10, 2018Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Handling Problem; Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING PREPARATION FOR THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY BENT THE PUSHER ASSEMBLY OF A SMART COIL. THE DAMAGE TO THE SMART COIL WAS FOUND PRIOR TO USE. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER SMART COIL INTO A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL AND THE SAME MICROCATHETER. THERE NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7953472 ↗
• MalfunctionJul 19, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE SMART COIL BECAME STUCK AFTER GETTING INSIDE THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED TWO OTHER COILS IN THE TARGET VESSEL USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL ALSO BECAME STUCK AT THE SAME POSITION AS THE FIRST SMART COIL; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 7704712 ↗
• MalfunctionJul 11, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS AND TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE INTO THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS, ANOTHER SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678691 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN SMART COILS. DURING THE PROCEDURE, THE PATIENT SUFFERED AN ACUTE ISCHEMIC LEFT ANTERIOR CEREBRAL ARTERY (ACA) STROKE AND THE HOSPITAL STAFF ADMINISTERED THROMBOLYTICS INTRA-ARTERIALLY, FOLLOWED BY BALLOON ANGIOPLASTY AND A NON-PENUMBRA STENT DEVICE. AS OF (B)(6) 2018, THE PATIENT REMAINED HOSPITALIZED. THE ACUTE ISCHEMIC LEFT ANTERIOR CEREBRAL ARTERY (ACA) STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH PROBABLE RELATIONSHIP TO THE SMART COILS AND DEFINITE RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 7441741 ↗