Smart Coil 400SMTXSFT0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00814548015392), received between Apr 6, 2017 and Dec 3, 2021 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (14 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER AND GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN USED FORCE TO PUSH FORWARD AND PULL BACK THE PUSHER ASSEMBLY OF THE SMART COIL AND SUBSEQUENTLY THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO ADVANCE THE LAST SMART COIL WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN USED FORCE TO ADVANCE THE SMART COIL OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE SMART COIL INTO THE TARGET VESSEL AND NOTICED THAT THE VESSEL WAS SUFFICIENTLY PACKED; THEREFORE, THE SMART COIL WAS REMOVED. 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 12926109 ↗
• MalfunctionSep 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), PAC400 COIL, POD400 COIL AND PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED A FEW POD400 AND PAC400 INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE PX SLIM TO CROSS A LESION SECOND TIME, THE PROXIMAL END OF THE PX SLIM KINKED. CONSEQUENTLY, THE PAC400 AND POD400 WOULD NOT DEPLOY. THEREFORE, THE PX SLIM, PAC400 AND POD400 WERE REMOVED. IT WAS REPORTED THAT THE POD400 AND PAC400 DID NOT HAVE ANY ISSUE. NEXT, THE PHYSICIAN USED A NON-PENUMBRA MICROCATHETER AND PLACED SEVERAL SMART COILS IN THE TARGET LOCATION; HOWEVER, THE SUBSEQUENT SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NON-PENUMBRA COILS, TWO MORE 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 12543842 ↗
• MalfunctionSep 20, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE AND SIGMOID SINUS USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE SMART COIL BECAME DAMAGED. 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 12502687 ↗
• MalfunctionJul 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SEVEN SMART COILS. SUBSEQUENTLY, THE NEXT SMART COIL WAS STUCK IN THE INITIAL POSITION OF ITS 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

  MAUDE report 12175908 ↗
• MalfunctionJun 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAXILLARY ARTERY (MA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL COULD NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. 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 11984761 ↗
• MalfunctionMar 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIO-LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE SMART COIL NEAR THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS RETRACTED BACK INTO ITS INTRODUCER SHEATH AND REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, TWO NON-PENUMBRA COILS, 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 11555515 ↗
• MalfunctionApr 3, 2020Failure to Advance; Failure to Advance

  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. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL AND THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. IT WAS REPORTED THAT THE NEXT SMART COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE ADDITIONAL SMART COILS, TWENTY-ONE 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 9922257 ↗
• MalfunctionMar 19, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND, A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE RUPTURED ANEURYSM AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT ONLY ONE TO THREE MILLIMETERS OF THE BLACK ALIGNMENT ZONE (PET LOCK) WAS SEPARATED, AND THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS OF USING THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY HAND AND WITH A NEEDLE DRIVER, INCLUDING REMOVING PART OF THE PUSHER ASSEMBLY FOR GREATER ACCESS TO THE PULL WIRE BUT THE SMART COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED 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 9856665 ↗
• MalfunctionNov 11, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPTHALMIC ARTERY (OA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN MADE THE FIRST ATTEMPT TO DETACH THE SMART COIL INTO THE TARGET VESSEL USING THE HANDLE AND REPORTED THAT THE SMART COIL ONLY PARTIALLY DETACHED AT THE DETACHMENT ZONE. THE SMART COIL WAS THEN RETRACTED BACK INTO THE NON-PENUMBRA MICROCATHETER AND RE-POSITIONED IN THE ANEURYSM. DURING THE SECOND ATTEMPT TO DETACH, THE SMART COIL WAS SUCCESSFULLY IMPLANTED INTO THE ANEURYSM USING THE HANDLE. HOWEVER, THE PATIENT'S BLOOD PRESSURE INCREASED WHICH CAUSED THE PHYSICIAN TO REALIZE THAT THE ANEURYSM HAD A MINOR RE-BLEED WHILE RE-POSITIONING THE COIL. AFTER THE RE-BLEED WAS UNDER CONTROL, A THIRD SMART COIL WAS IMPLANTED USING THE SAME HANDLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306735 ↗
• MalfunctionSep 20, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ADVANCING, IT WAS REPORTED THAT THE SMART COIL WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9099464 ↗
• MalfunctionJun 13, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT VERTEBRAL ARTERY 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 USING A NON-PENUMBRA MICROCATHETER AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER SEVERAL FAILED DETACHMENT ATTEMPTS USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY SEPARATING THE END OF THE PUSHER ASSEMBLY; HOWEVER, IT WOULD NOT TO DETACH. THE PHYSICIAN THEN MADE A SECOND ATTEMPT TO MANUALLY DETACH THE SMART COIL AND WAS ABLE TO SUCCESSFULLY DETACH IT IN THE TARGET VESSEL. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL SMART COILS, THE SAME HANDLE AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8696133 ↗
• MalfunctionFeb 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL THROUGH THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NEW SMART COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370433 ↗
• MalfunctionFeb 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING THE THIRD COIL, A SMART COIL, THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE AND THE SMART COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH INTO THE MICROCATHETER. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND A SMART COIL, AS WELL AS THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344366 ↗
• MalfunctionDec 19, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL 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 Consequences Or Impact To Patient

  MAUDE report 8179453 ↗
• MalfunctionOct 4, 2018Failure to Fold; Failure to Advance; Failure to Fold; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY PLACING A SMART COIL IN THE TARGET LOCATION AND, THEREFORE THE SMART COIL WAS REMOVED. THE HOSPITAL STAFF THEN EXPERIENCED DIFFICULTY RE-SHEATHING THE SMART COIL AND, THEREFORE, THE SMART COIL WAS NOT RE-SHEATHED, DESPITE MULTIPLE ATTEMPTS. THE PROCEDURE WAS THEN 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 7936853 ↗
• MalfunctionMar 21, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL THROUGH THE HUB OF THE MICROCATHETER, AND THEREFORE THE SMART COIL WAS REMOVED. THE PHYSICIAN RE-ATTEMPTED TO ADVANCE THE SAME SMART COIL INTO THE MICROCATHETER, HOWEVER THE SAME RESISTANCE WAS FELT AGAIN. THE PHYSICIAN THEREFORE REMOVED THE SMART COIL AND COMPLETED THE PROCEDURE USING ADDITIONAL 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 7358417 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING FIVE PENUMBRA SMART COILS. WITHIN TWO HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ACUTE NEUROLOGIC DECLINE AND BECAME HEMIPARETIC. THE PATIENT UNDERWENT AN ENDOVASCULAR REVASCULARIZATION THERAPY (ERT) WITH A SUCCESSFUL THROMBOLYSIS FOR ACUTE STROKE THERAPY AND RECANALIZATION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), ACHIEVING TICI GRADE 3 FLOW. THIS EVENT WAS RESOLVED ON (B)(6) 2017. THE CEREBROVASCULAR ACCIDENT (CVA) WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE DISEASE STATE, A DEFINITE RELATIONSHIP TO THE PROCEDURE, AND A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Neurological Deficit/Dysfunction; Paresis; Stroke/CVA

  MAUDE report 7068216 ↗
• MalfunctionSep 28, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER; HOWEVER, THE END OF THE COIL DID NOT FIT IN THE ANEURYSM. THEREFORE, THE PHYSICIAN RE-SHEATHED THE SMART COIL AND SAVED IT ON THE BACK TABLE LATER USE. THE PHYSICIAN THEN PLACED A NON-PENUMBRA COIL IN THE ANEURYSM USING THE SAME MICROCATHETER. AFTER THAT, THE PHYSICIAN RE-DEPLOY THE PREVIOUSLY REMOVED SMART COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE SMART COIL WAS REMOVED AND THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE SAME MICROCATHETER. THEREAFTER, THE PHYSICIAN ADVANCED A NEW SMART COIL INTO THE ANEURYSM USING THE SAME MICROCATHETER; HOWEVER, THE END OF THE COIL DID NOT ALSO FIT IN THE ANEURYSM. THEREFORE, THE PHYSICIAN RE-SHEATHED THE SMART COIL AND SAVED IT ON THE BACK TABLE LATER USE. THE PHYSICIAN THEN PLACED A NON-PENUM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902207 ↗
• MalfunctionSep 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE THREE SMART COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE HUB OF THE MICROCATHETER; THEREFORE, THE SMART COILS WERE 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 Consequences Or Impact To Patient

  MAUDE report 6856342 ↗
• MalfunctionAug 28, 2017Detachment Of Device Component; Entrapment of Device; Failure to Advance; Detachment Of Device Component; Entrapment of Device; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL AND PIPELINE EMBOLIZATION PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL MORE THAN SLIGHTLY INTO THE HUB OF A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN ATTEMPTED TO MANIPULATE THE SMART COIL TO ADVANCE; CONSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED WHILE PARTIALLY ADVANCED INTO THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE ANY OTHER COILS THROUGH THE MICROCATHETER BECAUSE THE SMART COIL WAS STUCK WITHIN THE MICROCATHETER; THEREFORE THE MICROCATHETER WAS REMOVED. THE PROCEDURE WAS CONTINUED USING ADDITIONAL PIPELINE DEVICES. IT WAS NOTED THAT THE PHYSICIAN WILL FURTHER EVALUATE AT A FOLLOW UP ANGIOGRAM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6824643 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING EIGHT PENUMBRA SMART COILS (SMART COILS) WITH NO COMPLICATIONS. LATER THAT DAY, THE PATIENT WAS FOUND TO HAVE TRANSIENT EYE FLOATERS IN THE LEFT EYE OF MODERATE SEVERITY. A COMPUTED TOMOGRAPHY (CT) WAS TAKEN AND WAS NEGATIVE FOR STROKE. THE PHYSICIAN SUSPECTED THAT THE EYE FLOATERS MAY HAVE BEEN TRANSIENT DUE TO THE LARGER AMOUNT OF CONTRAST ADMINISTERED DURING THE PROCEDURE THAN NORMAL. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. ON (B)(6) 2017, THE PATIENT EXPERIENCED NEUROLOGICAL DECLINE OF RIGHT-SIDED WEAKNESS, RESULTING IN PROLONGED HOSPITALIZATION. A CT ANGIOGRAPHY WAS TAKEN, WHICH SHOWED SCATTERED PUNCTUATED INFARCTS THROUGHOUT THE BILATERAL FRONTAL AND PARIETAL LOBES SUGGESTIVE OF EMBOLIC DISEASE. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2017. THE REPORTED TRANSIENT EYE FLOATERS WAS ADJUDICATED BY THE PHYSICIAN TO BE POSSIBLY RELATED TO THE DISEASE STATE, PROCEDURE, AND THE SMART COIL SYSTEM. THE REPORTED NEUROLOGICAL DECLINE WAS ADJUDICATED BY THE PHYSICIAN TO BE UNRELATED TO THE DISEASE STATE, POSSIBLY RELATED

  Patient problems: Infarction, Cerebral; Vitreous Floaters; Weakness

  MAUDE report 6664907 ↗
• MalfunctionApr 10, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN UNRUPTURED ANEURYSM AT THE LEFT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO DETACH A SMART COIL USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). AFTER MULTIPLE ATTEMPTS THE PHYSICIAN SUCCESSFULLY DETACHED THE SMART COIL. THE PROCEDURE WAS CONTINUED 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 6478494 ↗
• MalfunctionApr 6, 2017Out-Of-Box Failure; Defective Device; Device Operates Differently Than Expected; Out-Of-Box Failure; Defective Device; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR-COMMUNICATING (A-COMM) ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO FRAME THE ANEURYSM WITH A SMART COIL, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT TAKING ITS COMPLEX SHAPE INSIDE THE PATIENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE ADVANCING OR RETRACTING THE SMART COIL. THE PHYSICIAN THEN TESTED THREE ADDITIONAL SMART COILS IN A BOWL OF SALINE ON THE BACK TABLE TO SEE IF THEY WOULD FORM THEIR COMPLEX SHAPES; HOWEVER, ALL THREE COILS DID NOT FORM THEIR INTENDED COMPLEX SHAPE. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6466256 ↗
• MalfunctionApr 6, 2017Out-Of-Box Failure; Defective Device; Device Operates Differently Than Expected; Out-Of-Box Failure; Defective Device; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR-COMMUNICATING (A-COMM) ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO FRAME THE ANEURYSM WITH A SMART COIL, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT TAKING ITS COMPLEX SHAPE INSIDE THE PATIENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE ADVANCING OR RETRACTING THE SMART COIL. THE PHYSICIAN THEN TESTED THREE ADDITIONAL SMART COILS IN A BOWL OF SALINE ON THE BACK TABLE TO SEE IF THEY WOULD FORM THEIR COMPLEX SHAPES; HOWEVER, ALL THREE COILS DID NOT FORM THEIR INTENDED COMPLEX SHAPE. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6465627 ↗
• MalfunctionApr 6, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Defective Device; Device Operates Differently Than Expected; Device Damaged Prior to Use; Out-Of-Box Failure; Defective Device; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR-COMMUNICATING (A-COMM) ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO FRAME THE ANEURYSM WITH A SMART COIL, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT TAKING ITS COMPLEX SHAPE INSIDE THE PATIENT. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE ADVANCING OR RETRACTING THE SMART COIL. THE PHYSICIAN THEN TESTED THREE ADDITIONAL SMART COILS IN A BOWL OF SALINE ON THE BACK TABLE TO SEE IF THEY WOULD FORM THEIR COMPLEX SHAPES; HOWEVER, ALL THREE COILS DID NOT FORM THEIR INTENDED COMPLEX SHAPE. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6465604 ↗