Smart Coil 400SMTHXSFT0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00814548015613), received between Feb 7, 2017 and Jul 6, 2023 — classified as 1 death, 4 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (72 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) 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 MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THEN ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER MULTIPLE FAILED ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO NEW SMART COILS, A NEW HANDLE, AND FOUR NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17275036 ↗
• MalfunctionSep 14, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL AS THE FIRST COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL USING HEMOSTATS AFTER MULTIPLE ATTEMPTS. THEN, THE PHYSICIAN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. SUBSEQUENTLY, THE PHYSICIAN ALSO MANUALLY DETACHED THE SMART COIL USING HEMOSTATS AFTER MULTIPLE ATTEMPTS. IT WAS ALSO REPORTED THAT THE SMART COIL ALMOST CAME OUT OF THE ANEURYSM AFTER DETACHMENT AFTER PULLING ON THE PUSHER ASSEMBLY OF THE COIL TO MANUALLY DETACH IT; HOWEVER, THE PHYSICIAN WAS ABLE TO CAREFULLY PLACE THE SMART COIL BACK INTO THE ANEURYSM BY PUSHING IT INTO THE ANEURYSM USING THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415640 ↗
• MalfunctionJun 6, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS, A SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, 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. AFTER MANY ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE, THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO ADDITIONAL SMART COILS AND THE TWO SMART COILS WERE ALSO SUCCESSFULLY MANUALLY DETACHED IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A FOURTH SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE. HOWEVER; THE SMART COIL FAILED TO DETACH. AFTER MANY ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE AND MANUAL DETACHMENT, PART OF THE SMART COIL WAS PULLED OUTSIDE OF THE ANEURYSM AND INTO THE PARENT VESSEL. WHILE ATTEMPTING TO RETRACT THE SMART COIL INTO THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED WITH PART OF THE SMART COIL IN THE PARENT VESSEL. THEREFORE; THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606249 ↗
• MalfunctionDec 6, 2021Separation Failure; Separation Failure

  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, A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA STENT, AND A NON-PENUMBRA BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN PLACED A STENT THROUGH A BALLOON CATHETER IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE EXPANDED STENT VIA THE BALLOON CATHETER TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING TWO DIFFERENT HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER COILS, THE SAME MICROCATHETER, THE SAME GUIDE CATHETER, AND THE SAME BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934631 ↗
• MalfunctionDec 4, 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). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATH. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931041 ↗
• MalfunctionDec 4, 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). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR RESPECTIVE INTRODUCER SHEATH. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931040 ↗
• MalfunctionNov 10, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12790668 ↗
• MalfunctionNov 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS 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

  MAUDE report 12782777 ↗
• MalfunctionNov 9, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET LOCATION USING THE FIRST HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE FIRST HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE BUT HAD DIFFICULTY DETACHING. THE PHYSICIAN THEN USED HIS FINGERS TO MANUALLY DETACH THE COIL AND SUCCESSFULLY IMPLANTED THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778923 ↗
• MalfunctionNov 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET LOCATION USING THE FIRST HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE FIRST HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE BUT HAD DIFFICULTY DETACHING. THE PHYSICIAN THEN USED HIS FINGERS TO MANUALLY DETACH THE COIL AND SUCCESSFULLY IMPLANTED THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778855 ↗
• MalfunctionNov 4, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL AND SIX NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, 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 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 12751544 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WITHOUT ANY PROCEDURAL COMPLICATIONS OR DEVICE MALFUNCTIONS. ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND AN ISCHEMIC STROKE IN THE IPSILATERAL M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS NOTED. SUBSEQUENTLY, THE PATIENT¿S BLOOD PRESSURE WAS MONITORED. THE PATIENT WAS ALSO ADMINISTERED MILD HEPARIN AND NO PROGRESSION OF THE STROKE WAS OBSERVED. THE PATIENT WAS IN STABLE CONDITION, INTUBATED AND ON ANALGESICS. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY WITH CLINICAL SEQUELAE. ON 09-MAR-2021, INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS UNRELATED TO THE SMART COILS AND PROBABLY RELATED TO THE INDEX PROCEDURE. ON 23-SEP-2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS POSSIBLY RELATED TO THE SMART COILS.

  Patient problems: Ischemia Stroke

  MAUDE report 12651368 ↗
• MalfunctionOct 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL AND FOUR NON-PENUMBRA COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, RESISTANCE WAS ENCOUNTERED AND THE COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, ONE 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 12566303 ↗
• MalfunctionSep 24, 2021Separation Failure; Separation Failure

  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 A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, EIGHT COILS AND TWO SMART COILS WERE IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE HANDLE FAILED TO DETACH THE COIL. IT WAS ALSO REPORTED THAT MANUAL DETACHMENT FAILED. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, 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

  MAUDE report 12530595 ↗
• MalfunctionSep 24, 2021Separation Failure; Separation Failure

  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 A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, EIGHT COILS AND TWO SMART COILS WERE IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE HANDLE FAILED TO DETACH THE COIL. IT WAS ALSO REPORTED THAT MANUAL DETACHMENT FAILED. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, 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

  MAUDE report 12530593 ↗
• MalfunctionSep 8, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE ANEURYSM WAS BI-LOBED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE LARGER LOBE OF THE ANEURYSM USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND, WHILE POSITIONING THE SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO STOP COILING THE LARGER LOBE OF THE ANEURYSM. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SMART COIL IN THE SMALLER LOBE OF THE ANEURYSM USING THE HANDLE. WHILE ATTEMPTING TO DETACH ANOTHER SMART COIL IN THE TARGET LOCATION USING THE HANDLE, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REPOSITION THE SMART COIL. HOWEVER, WHILE REPOSITIONING, THE PHYSICIAN LOST ACCESS WITH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO RETRAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443634 ↗
• MalfunctionAug 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12379915 ↗
• MalfunctionAug 20, 2021Physical Resistance/Sticking; 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 DISTAL TIP OF THE FIRST SMART COIL BECAME STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH DURING ADVANCEMENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, FIVE ADDITIONAL 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 12351480 ↗
• MalfunctionAug 18, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CHOROIDAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE AT ALL 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 12339584 ↗
• MalfunctionAug 13, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT DETACH MANUALLY. 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 12319434 ↗
• MalfunctionAug 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A 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 OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267447 ↗
• MalfunctionJul 28, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) 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, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, SIX SMART COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION USING THE HANDLE. WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL, THE HANDLE FAILED TO DETACH THE COIL AFTER SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, 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

  MAUDE report 12241641 ↗
• MalfunctionJul 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERICALLOSAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE SMART COIL IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, ANOTHER SMART COIL WAS ADVANCED IN THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER ATTEMPTING VARIOUS METHODS TO DETACH THE SMART COIL, THE PHYSICIAN WAS FINALLY ABLE TO DETACH THE SMART COIL. THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL AS WELL; HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12154874 ↗
• MalfunctionJun 21, 2021Separation Failure; Separation Failure

  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 12038143 ↗
• MalfunctionJun 7, 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, NON-PENUMBRA MICROCATHETER, AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS AND TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN PLACED THE SMART COIL INSIDE THE HUB OF THE MICROCATHETER AND THEN ATTEMPTED TO ADVANCE IT; HOWEVER, THE SMART COIL WOULD NOT ADVANCE AND WAS STUCK IN THE DISTAL TIP OF ITS INTRODUCER SHEATH. SUBSEQUENTLY, AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO ADVANCE THE SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN REMOVED SMART COIL. 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 11948399 ↗