Smart Coil 400SMTSFT0515Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00814548014944), received between Dec 29, 2015 and Jun 21, 2023 — classified as 6 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (17 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), A SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) AND TWO NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING A MICROCATHETER, THEN ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE SMART COIL HAD SUGGESTED THAT THE SMART COIL WAS DETACHED INTO THE TARGET VESSEL. HOWEVER, WHILE REMOVING THE PUSHER ASSEMBLY AND CATHETER, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED OUTSIDE OF THE TARGET VESSEL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER; HOWEVER, THE MICROCATHETER KICKED OUT OF THE TARGET VESSEL. SUBSEQUENTLY, THE SMART COIL MOVED A FEW CENTIMETERS OUTSIDE OF THE TARGET VESSEL. THE MICROCATHETER WAS THEN REMOVED, AND THE PHYSICIAN SUCCESSFULLY REMOVED THE SMART COIL USING THE NON-PENUMBRA CATHETER AND A SNARE DEVICE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17178112 ↗
• MalfunctionDec 10, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL AND ONE SMART COIL IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT NON-PENUMBRA COIL THROUGH THE MICROCATHETER, THE COIL BECAME STUCK AND THE PHYSICIAN NOTICED THAT A PIECE OF THE SMART COIL PUSHER ASSEMBLY HAD BROKEN OFF INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE BROKEN PART OF THE PUSHER ASSEMBLY WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS, TWO OTHER COILS, AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981005 ↗
• MalfunctionDec 2, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) 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 INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MADE SEVERAL ATTEMPTS AND BROKE THE PUSHER ASSEMBLY TO MANUALLY DETACH THE SMART COIL. 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 12919690 ↗
• MalfunctionNov 24, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A SMART COIL IN THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, ONLY A PARTIAL OF THE SMART COIL WAS INSERTED INTO THE ANEURYSM. IT WAS THEN NOTICED THAT THERE WAS THROMBUS IN THE ANEURYSM THAT WAS NOT SEEN DURING THE PLANNING STAGES. THEREFORE, AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE SMART COIL MORE, IT STARTED TO CAUSE PUSH BACK AND PROLAPSE THE MICROCATHETER INSTEAD OF FILLING IN AROUND THE THROMBUS. THEREFORE, THE SMART COIL WAS REMOVED. WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE THROUGH THE DISTAL END MICROCATHETER AFTER A FEW ATTEMPTS WERE MADE. THEREFORE, THE SMART COIL WAS REMOVED AND WHILE ATTEMPTING TO RE-SHEATH THE SMART COIL, THE HOSPITAL STAFF KINKED THE SMART COIL. THE MICROCATHETER WAS ALSO REMOVED TO FLUSH AS IT WAS CLOGGED, AND THE PHYSICIAN THEN DECIDED TO CONTINUE THE PROCEDURE USING A NEW MICROCATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870935 ↗
• 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 (B)(6) 2021, INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS UNRELATED TO THE SMART COILS AND PROBABLY RELATED TO THE INDEX PROCEDURE. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS POSSIBLY RELATED TO THE SMART COILS.

  Patient problems: Ischemia Stroke

  MAUDE report 12651486 ↗
• MalfunctionOct 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL 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. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THE SMART COILS WERE ALSO 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 12600795 ↗
• MalfunctionAug 6, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL; HOWEVER, THE DETACHED SMART COIL REMAINED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE SMART COIL BACK INTO THE ANEURYSM. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THREE OTHER SMART COILS. THE THREE SMART COILS FAILED TO DETACH USING THE HANDLE. HOWEVER, THE PHYSICIAN MANUALLY DETACHED THE THREE SMART COILS INSIDE THE MICROCATHETER AND THEN USED THEIR RESPECTIVE PUSHER ASSEMBLIES TO PUSH THE SMART COILS BACK INTO THE ANEURYSM SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING FOUR 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 12291284 ↗
• MalfunctionJul 30, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITION OF THEIR INTRODUCER SHEATHS DUE TO THE FRICTION LOCKS BEING TOO TIGHT. 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 12252794 ↗
• MalfunctionJul 22, 2021Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE FOURTH SMART COIL WAS UNABLE TO ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN PULLED THE SMART COIL OUT OF THE SHEATH AND INADVERTENTLY BROKE THE SMART COIL OFF THE DETACHMENT WIRE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 12214368 ↗
• MalfunctionJul 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), PUSHABLE COIL, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND A PUSHABLE COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE ANEURYSM AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE ALIGNMENT ZONE OF THE SMART COIL WAS SEPARATED ONLY A CENTIMETER. THE PHYSICIAN PULLED THE PUSHER ASSEMBLY OF THE SMART COIL IN AN ATTEMPT TO MANUALLY DETACH IT BUT, THE SMART COIL STILL FAILED TO DETACH. THEREFORE, IT WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12140258 ↗
• MalfunctionJun 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION 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 12041735 ↗
• MalfunctionJun 9, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL KINKED. 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 11966759 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED SEVERAL SMART COILS USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL USING THE HANDLE, THE COIL DID NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL. THEREFORE, THIS SMART COIL AND THE HANDLE WERE ALSO REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. IT WAS ALSO REPORTED THAT OUT OF TWENTY-THREE SMART COILS TOTAL, TWO DID NOT DETACH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770602 ↗
• MalfunctionFeb 16, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SMART COIL WOULD NOT ADVANCE AT ALL. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11335652 ↗
• MalfunctionJan 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL), OTHER COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO PLACE A SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THE SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL INTO THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE ALL THE WAY INTO THE ANEURYSM. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11135724 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A COIL EMBOLIZATION TO TREAT A SENTINEL RUPTURE OF AN INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE ANEURYSM; HOWEVER, IT WAS NOTED THAT THE FIRST LOOP OF THE SMART COIL FORMED OUTSIDE OF THE COIL MASK INFERIOR BOUNDARY OF THE ANEURYSM AND, CONSEQUENTLY, THE PATIENT EXPERIENCED SEVERE HEADACHE. THE FIRST LOOP OF THE SMART COIL WAS LEFT IN PLACE AND THE REMAINDER OF THE SMART COIL WAS RAPIDLY ADVANCED INTO THE ANEURYSM TO TAMPONADE THE RUPTURE POINT. FOLLOWING THE COIL PLACEMENT, AN ANGIOGRAPHY SHOWED NO COIL LOOPS HERNIATING INTO THE PARENT VESSEL AND THE PREVIOUSLY NOTED EXTRAVASATION WAS NO LONGER PRESENT. THE EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2020 WITH NO MEDICATION. THE RUPTURE ANEURYSM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND TO THE SMART COIL.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10962930 ↗
• MalfunctionDec 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, SEVEN ADDITIONAL 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 10954195 ↗
• MalfunctionNov 19, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE SMART COIL WOULD NOT EXIT ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX SMART COILS, 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; No Consequences Or Impact To Patient

  MAUDE report 10870517 ↗
• MalfunctionOct 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY (SA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL WAS STUCK AND WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED TWO ADDITIONAL SMART COILS INTO THE VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SMART COIL WAS STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL 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 10659925 ↗
• MalfunctionSep 3, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR BIFURCATION IN THE POSTERIOR CIRCULATION USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, SMART COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ONE 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 10491007 ↗
• MalfunctionAug 12, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SMART COIL INTO THE TARGET LOCATION; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH HOW THE SMART COIL FORMED. THEREFORE, THE SMART COIL WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396284 ↗
• MalfunctionApr 14, 2020Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED NINE NON-PENUMBRA COILS. SUBSEQUENTLY, A SMART COIL WOULD NOT ADVANCE BEYOND ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN CONTINUED ATTEMPTING TO ADVANCE THE SMART COIL; HOWEVER, THE PUSHER ASSEMBLY BECAME BENT AND BROKE AT THE PROXIMAL END. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS, THREE NON-PENUMBRA COILS, THE SAME MICROCATHETER, THE SAME CATHETER, AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960491 ↗
• MalfunctionMar 12, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED SIX NON-PENUMBRA COILS AND THREE SMART COILS INTO THE TARGET VESSEL USING THE HANDLE. AFTER SEVERAL ATTEMPTS WERE MADE TO IMPLANT THE NEXT SMART COIL USING THE HANDLE, THE COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME HANDLE TO DETACH ANOTHER SMART COIL, FOUR 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 9825858 ↗
• MalfunctionJan 9, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS, A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 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; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE PHYSICIAN CUT THE PUSHER ASSEMBLY NEAR THE ROTATING HEMOSTASIS VALVE (RHV) AND THE SMART COIL SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572259 ↗
• MalfunctionNov 11, 2019Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, CONTRAST ACCIDENTLY GOT ON THE PUSHER ASSEMBLY OF THE SMART COIL. CONSEQUENTLY, THE PUSHER ASSEMBLY BECAME HUNG-UP AND BENT WHILE ADVANCING THROUGH THE NON-PENUMBRA 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 Consequences Or Impact To Patient

  MAUDE report 9304923 ↗