Smart Coil 400SMTXSFT0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00814548015262), received between Apr 22, 2016 and Jan 4, 2022 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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.

• MalfunctionJan 4, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOMM) USING A PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL (LOT#F106024) TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE SAME ISSUE OCCURRED WITH THE SECOND SMART COIL (LOT#F105543); HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH THE SMART COIL MANUALLY. NEXT, THE PHYSICIAN OPENED A SECOND HANDLE AND ATTEMPTED TO DETACH THE THIRD SMART COIL (LOT#F106201); HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS USING THE HANDLE AS WELL AS MANUALLY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PHYSICIAN AGAIN EXPERIENCED DIFFICULTY DETACHING THE FOURTH SMART COIL (LOT#F83607) USING THE HANDLE; HOWEVER, THE SMART COIL WAS ABLE TO BE DETACHED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155345 ↗
• MalfunctionNov 18, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834179 ↗
• MalfunctionOct 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION USING THE HANDLE. WHILE ATTEMPTING TO DETACH 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 A DIFFERENT SIZE OF 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 12602506 ↗
• MalfunctionSep 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO REMOVED. AFTERWARDS, THE NEXT THREE SMART COILS ADVANCED SLIGHTLY PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS BEFORE BECOMING STUCK WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL TO THE TARGET LOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419069 ↗
• MalfunctionJul 21, 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 (ACOM) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK AND WOULD NOT ADVANCE AT ALL WITHIN 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 12207563 ↗
• MalfunctionMay 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN THE 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 11872181 ↗
• MalfunctionApr 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) 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 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 11651592 ↗
• MalfunctionFeb 2, 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). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 11264399 ↗
• MalfunctionFeb 2, 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). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 11264398 ↗
• MalfunctionFeb 2, 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). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS; THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 11264397 ↗
• MalfunctionJan 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING A MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT. SUBSEQUENTLY, WHILE RETRACTING THE PUSHER WIRE, THE PHYSICIAN NOTICED THAT THE SMART COIL HAD NOT DETACHED. THEREFORE, THE PHYSICIAN RE-ADVANCED THE SMART COIL AND ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED BY RELIEVING TENSION ON THE TIP OF THE MICROCATHETER AND PLACING THREE OTHER 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 11228321 ↗
• MalfunctionJan 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS), A SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET VESSEL USING A MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT. SUBSEQUENTLY, WHILE RETRACTING THE PUSHER WIRE, THE PHYSICIAN NOTICED THAT THE SMART COIL HAD NOT DETACHED. THEREFORE, THE PHYSICIAN RE-ADVANCED THE SMART COIL AND ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED BY RELIEVING TENSION ON THE TIP OF THE MICROCATHETER AND PLACING THREE OTHER 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 11228320 ↗
• MalfunctionDec 4, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE THE PHYSICIAN STARTED PREPARING AND FLUSHING A SMART COIL, IT WAS NOTICED THAT THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH ON THE BACK TABLE. THE ISSUE WITH THE SMART COIL WAS FOUND PRIOR TO USE, THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND A NEW HANDLE. 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 10943371 ↗
• MalfunctionAug 28, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED ADDITIONAL SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTED TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS ALSO REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AND, WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 10463840 ↗
• MalfunctionAug 28, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED ADDITIONAL SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTED TO ADVANCE ANOTHER SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS ALSO REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AND, WAS THEREFORE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL 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 10463838 ↗
• InjuryJul 25, 2020Premature Separation; Premature Separation

  ON (B)(6) 2020, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA STENT AND, NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, AFTER PLACING THE STENT IN THE ANEURYSM USING THE MICROCATHETER, THE PHYSICIAN REMOVED THE MICROCATHETER AND ADVANCED A NEW MICROCATHETER INTO THE TARGET VESSEL. NEXT, WHILE ADVANCING A SMART COIL (2MM X 2CM) INTO THE ANEURYSM, THE MICROCATHETER BEGAN TO KICK BACK DURING POSITION OF THE LAST PORTION OF THE SMART COIL. CONSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED WITH MOST OF THE COIL PLACED IN THE ANEURYSM AND THE TAIL END OF THE SMART COIL WAS PROTRUDING OUT OF THE ANEURYSM LUMEN AND INTO THE PARENT VESSEL WITHIN THE STENT. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER AND RE-ADVANCED THE SAME MICROCATHETER THAT WAS PREVIOUSLY USED THROUGH THE STENT AND PLACED INSIDE OF THE ANEURYSM.THE PHYSICIAN ADVANCED ANOTHER SMART COIL (1.5MM X 2CM) INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE FINAL PORTION OF THE SMART COIL AND THE MICROCATHETER BEGAN TO KICK BACK. THEREFORE, THE MICROCATHETER WAS RE-ADVANCED OVER THE SMAR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 10324186 ↗
• MalfunctionMar 31, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA STENT DEVICE. DURING THE PROCEDURE, THE PHYSICIAN USED THE STENT DEVICE TO HOLD OPEN THE VESSEL, THEN, THE SMART COIL WAS SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL USING THE HANDLE AND MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE BUT WAS ABLE TO REACH THE TARGET LOCATION. AFTER MAKING AN ATTEMPT TO DETACH THE SMART COIL USING THE HANDLE, THE PHYSICIAN WAS UNSURE WHETHER IT DETACHED OR NOT, AND MADE AN ATTEMPT TO MANUALLY DETACH IT. THE PHYSICIAN WAS STILL UNSURE WHETHER THE SMART COIL TRULY DETACHED; THEREFORE, IT WAS WITHDRAWN. UPON REMOVAL OF THE PUSHER ASSEMBLY, THE PHYSICIAN REALIZED THAT THE SMART COIL HAD DETACHED IN THE MICROCATHETER; THEREFORE, IT WAS COMPLETELY REMOVED. THE NEXT SMART COIL WAS ADVANCED APPROXIMATELY 10 CENTIMETERS INTO THE SAME MICROCATHETER AND BECAME STUCK. THE PHYSICIAN SUSPECTED THAT THE MICROCATHETER WAS OCCLUDED AND DECIDED TO REMOVE THE SMA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908096 ↗
• MalfunctionOct 17, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL INTO THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204550 ↗
• MalfunctionMar 21, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 8439361 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. COMPLETION OF THE RIGHT CAROTID CEREBRAL ANGIOGRAM INITIALLY DEMONSTRATED A SMALL AMOUNT OF THROMBUS LOCATED AT THE DISTAL NECK OF THE AZYGOS PERICALLOSAL ANEURYSM WITHIN THE AZYGOS PERICALLOSAL ARTERY; HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, THE THROMBUS WAS RESOLVED. THERE WAS NO REMEDIAL THERAPY, MEDICAL PROCEDURE OR HOSPITALIZATION REQUIRED TO ADDRESS THE THROMBUS FORMATION. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY, (B)(6) 2018. THE THROMBUS FORMATION WAS REPORTED TO HAVE A DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM AND UNRELATED TO THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7622727 ↗
• MalfunctionAug 7, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN MADE ONE ATTEMPT TO DETACH THE FIRST AND THIRD SMART COILS USING THE HANDLE BUT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE USING THE SAME HANDLE AND BOTH SMART COILS WERE SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED AFTER DETACHING THE THIRD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6772563 ↗
• MalfunctionMay 18, 2017Physical Resistance; Deformation Due to Compressive Stress; Physical Resistance; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPINAL TUMOR USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO SMART COILS THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE SMART COILS SEEMED TO BE BUCKLING ON THEMSELVES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6576671 ↗
• InjuryMar 28, 2017Adverse 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 INITIALLY PLACED A FEW SMART COILS INTO THE ANEURYSM. WHILE THE PHYSICIAN WAS ATTEMPTING TO DETACH A NEW SMART COIL (LOT #: UNKNOWN) IN THE ANEURYSM, THE TIP OF THE SMART COIL PUSHER ASSEMBLY CAME OUT OF THE TIP OF THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE ANEURYSM RUPTURED. THE PHYSICIAN THEN READJUSTED THE MARKERS ON THE PUSHER ASSEMBLY AND MICROCATHETER AND SUCCESSFULLY DETACHED THE SMART COIL. NEXT, A NEW SMART COIL WAS OPENED AND PLACED IN THE ANEURYSM. THE ANGIOGRAPHY REVEALED NO FURTHER BLEEDING. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL (LOT #: F68751) BUT ENCOUNTERED DIFFICULTY WHEN THE TIP OF THE PUSHER ASSEMBLY ADVANCED APPROXIMATELY ONE CENTIMETER FROM THE TIP OF THE MICROCATHETER. SUBSEQUENTLY, THE SMART COIL BECAME ENTANGLED WITH THE PREVIOUSLY PLACED SMART COIL AND UNRAVELED. THE PUSHER ASSEMBLY THEN KINKED. WHILE THE SMART COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA GUIDE WIRE THROUGH THE CATHETER AND SUBSEQUENTLY, THE DETACHED COIL INSIDE THE CATHETER CAME

  Patient problems: Rupture

  MAUDE report 6441258 ↗
• MalfunctionJun 2, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN EXPERIENCED FRICTION AND THE SMART COIL WAS UNABLE TO ADVANCE. THEREFORE, THE SMART COIL WAS REMOVED AND THE MICROCATHETER WAS REPLACED WITH ANOTHER MANUFACTURER'S MICROCATHETER. THE PHYSICIAN THEN DEPLOYED A NEW SMART COIL INTO THE ANEURYSM BUT MISTAKENLY USED THE WRONG RUBY COIL DETACHMENT HANDLE (HANDLE) TO DETACH THE COIL. CONSEQUENTLY, THE COIL WAS UNABLE TO DETACH AND THE SMART COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE AND COULD NOT BE REMOVED. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5695111 ↗
• InjuryApr 22, 2016Malposition of Device; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S COIL, BUT EXPERIENCED DIFFICULTY POSITIONING THE COIL FOR PROPER PLACEMENT IN THE ANEURYSM. AFTER SIX ATTEMPTS TO RE-POSITION THE COIL IN THE ANEURYSM, IT WAS FINALLY SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PHYSICIAN THEN ADVANCED A SMART COIL IN THE ANEURYSM USING ANOTHER MANUFACTURER'S MICROCATHETER; HOWEVER, THE MICROCATHETER KICKED BACK AFTER A FEW LOOPS OF THE SMART COIL WERE DEPLOYED. THE MICROCATHETER WAS SUCCESSFULLY REINSERTED BACK IN THE ANEURYSM, AND WITH CONTINUED MANIPULATION OF THE MICROCATHETER, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE SMART COIL IN THE ANEURYSM. A NEW SMART COIL WAS ADVANCED INTO THE ANEURYSM, HOWEVER, THE MICROCATHETER KICKED BACK AGAIN AND THE SMART COIL LOOP PROTRUDED BACK AGAINST THE MICROCATHETER. FURTHER ATTEMPTS TO RE-POSITION THE SMART COIL LOOKED GOOD ON AP VIEW, BUT THE SMART COIL LOOP WAS NOTED ON LATERAL VIEW. UPON RE-POSITIONING AND SUBSEQUENT RUN, IT WAS DETERMINED THAT THE FINAL LOOP OF THE SMART COIL HAD BEEN IN THE SUBARACHNOID SPACE AND EXTRAVASATION WAS OBSERVED. PROTAMINE WAS GIVEN TO

  Patient problems: Extravasation; Hemorrhage, Subarachnoid

  MAUDE report 5600894 ↗