Smart Coil 400SMTSFT0820Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00814548014753), received between Mar 16, 2016 and Sep 6, 2024 — classified as 3 injuries, 24 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 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 MULTIPLE ATTEMPTS. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO DETACH THE SMART COIL USING A SECOND HANDLE; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITH HALF OF THE SMART COIL STILL IN THE ANEURYSM AND THE OTHER HALF IN THE MCA. THE PHYSICIAN THEN USED THE MICROCATHETER TO SUCCESSFULLY PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM. 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 20163650 ↗
• MalfunctionOct 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR INFERIOR CEREBELLAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITIONS OF THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE 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 12661627 ↗
• MalfunctionOct 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWENTY-SIX SMART COILS IN THE TARGET LOCATION. SUBSEQUENTLY, THE NEXT SMART COIL WAS STUCK IN THE INTRODUCER SHEATH WITH RESISTANCE AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619291 ↗
• MalfunctionOct 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, ONE SMART COIL WAS USED TO FRAME THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE COIL WAS STUCK IN ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, FIVE SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE COIL WAS ALSO STUCK IN ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT ADDITIONAL SMART COILS, THE SAME MICROCATHETER, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602043 ↗
• 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 12252814 ↗
• MalfunctionJul 16, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED THREE SMART COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE FOURTH SMART COIL, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED NINE SMART COILS IN THE TARGET VESSEL USING THE SAME HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN ALSO MANUALLY DETACHED 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 12186057 ↗
• InjuryJul 2, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT WAS IN A COMA BEFORE THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN USED A DUAL MICROCATHETER TECHNIQUE. A 7X15 SMART COIL WAS ADVANCED INTO THE TARGET LOCATION THROUGH THE FIRST MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN TRIED MULTIPLE TIMES TO DETACH THE SMART COIL, BUT THE SMART COIL WOULDN'T DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITH APPROXIMATELY 1CM INSIDE THE MICROCATHETER. AT THIS POINT, THE PHYSICIAN DECIDED TO PLACE THE 8X20 SMART COIL IN THE ANEURYSM THROUGH THE SECOND MICROCATHETER WITHOUT DETACHING IT. NEXT, HE DECIDED TO PUSH THE REST OF THE 7X15 SMART COIL USING THE PUSHER ASSEMBLY THROUGH THE FIRST MICROCATHETER. THE PHYSICIAN WAS ABLE TO PUSH 7X15 SMART COIL IN THE ANEURYSM; HOWEVER, A LOOP WAS SEEN. THE PHYSICIAN ASSUMED THAT LOOP CAME FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111546 ↗
• MalfunctionJan 29, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL INTO THE ANEURYSM, THE SMART COIL UNINTENTIONALLY DETACHED WITH THE TAIL END OF THE SMART COIL PROTRUDING OUT FROM THE ANEURYSM. IT WAS REPORTED THAT THE SMART COIL WAS LEFT IN PLACE AS THE PROTRUDING STRAND OF THE SMART COIL WAS NOT FLOW LIMITING. 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; No Consequences Or Impact To Patient

  MAUDE report 11255424 ↗
• MalfunctionJan 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT EXTERNAL CAROTID ARTERY (ECA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. 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 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; No Consequences Or Impact To Patient

  MAUDE report 11156696 ↗
• InjuryDec 5, 2020Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR BIFURCATION ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS INTO THE TARGET LOCATION USING A MICROCATHETER. WHILE PLACING ANOTHER SMART COIL, THE PHYSICIAN NOTICED A PRECIOUSLY PLACED SMART COIL HERNIATED INTO THE RIGHT POSTERIOR CEREBRAL ARTERY WITH ASSOCIATED PLATELET AGGREGATION. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) AND INTRA-ARTERIAL(IA) MEDICATIONS WHICH RESOLVED THE PLATELET AGGREGATION OVER THE REMAINDER OF THE PROCEDURE. ALSO, THE SMART COIL THAT HERNIATED INTO THE RIGHT POSTERIOR CEREBRAL ARTERY WAS STABILIZED WITH A STENT. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10954037 ↗
• 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 10659926 ↗
• MalfunctionSep 4, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CONDYLAR CONFLUENCE (ACC) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COIL, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL AND A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, A SMART COIL WAS STUCK WITHIN THE INTRODUCER SHEATH AND WOULD NOT ADVANCE OUT OF THE DISTAL TIP. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, 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 10495090 ↗
• MalfunctionApr 2, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA MICROCATHETER AND, NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MICROCATHETER FROM THE ACA TO THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH THE GUIDE CATHETER AND PLACED FOUR COILS IN THE TARGET VESSEL. WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN PLACED A NEW SMART COIL AND ANOTHER COIL IN THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED, AND THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 9917969 ↗
• MalfunctionDec 11, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL (HANDLE). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED THE FIRST THREE SMART COILS IN THE TARGET VESSEL AFTER MAKING MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. WHILE ATTEMPTING TO PLACE FOURTH SMART COIL, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING A NEW HANDLE TO DETACH THE SAME FOURTH SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9453864 ↗
• MalfunctionNov 25, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) 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 ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTICED APPROXIMATELY SIX CENTIMETERS OF THE INNER WIRE WAS PULLED OUT BY THE HANDLE AND WAS STICKING OUT FROM THE PROXIMAL END OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS, A NEW HANDLE 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 9369349 ↗
• MalfunctionFeb 4, 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 COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL, BUT FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL FROM ITS STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THE SMART COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL AND THE SAME ISSUE OCCURRED. THE SECOND SMART COIL WAS ALSO REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301577 ↗
• MalfunctionAug 17, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE HUB OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE INTRODUCER SHEATH AND COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ACCIDENTALLY KINKED THE SMART COIL PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, RUBY 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 7793696 ↗
• MalfunctionJun 22, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS AND OTHER COILS. THE PHYSICIAN THEN WAS UNABLE TO DETACH TWO PENUMBRA SMART COILS (SMART COILS) USING THE HANDLE AND, THEREFORE, THE SMART COILS WERE MANUALLY DETACHED BY BENDING THE PUSHER ASSEMBLIES. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631793 ↗
• MalfunctionApr 5, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE DISTAL TWO-THIRDS OF THE SMART COIL SEEMED STIFF AND UNABLE TO BEND WHILE BEING ADVANCED OUT OF THE NON-PENUMBRA MICROCATHETER AND INTO THE TARGET LOCATION, HOWEVER THE SMART COIL WAS SUCCESSFULLY PLACED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER THE PROXIMAL END OF THIS SMART COIL ALSO SEEMED STIFF AND UNABLE TO BEND. WHILE PLACING THIS SMART COIL, THE TAIL OF THE FIRST SMART COIL SHIFTED, CAUSING IT PROTRUDE INTO THE ICA. THE PHYSICIAN WAS ABLE TO TRAP THE PROXIMAL END OF THE SMART COIL BETWEEN THE VESSEL WALL AND A NON-PENUMBRA STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399528 ↗
• InjuryMar 14, 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 MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE SMART COIL AND A NON-PENUMBRA STENT. DURING THE PROCEDURE THERE WAS THROMBUS FORMATION, AND THEREFORE THE HOSPITAL STAFF IMMEDIATELY ADMINISTERED THROMBOLYTICS INTRA-ARTERIALLY. THERE WAS COMPLETE RESTORATION OF FLOW, AND THE PATIENT DEMONSTRATED NO NEW RESIDUAL NEUROLOGIC DEFICITS FROM THIS EVENT. THIS ADVERSE EVENT WAS RESOLVED. THE THROMBUS FORMATION WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Thrombus

  MAUDE report 7339860 ↗
• MalfunctionMar 8, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND THE SMART COIL BECAME STUCK APPROXIMATELY 20 CM FROM THE TIP OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL USING THE SAME MICROCATHETER, HOWEVER THE SAME INCIDENT OCCURRED. THE PHYSICIAN THEREFORE REMOVED THE SMART COIL, AND USED THE MICROCATHETER TO PLACE ANOTHER EMBOLIZATION SYSTEM. THE MICROCATHETER WAS THEN REMOVED, AND A NEW NON-PENUMBRA MICROCATHETER WAS PLACED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED TWO SMART COILS USING THE MICROCATHETER. NEXT, WHILE ADVANCING A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL MORE THAN ABOUT HALFWAY OUT OF THE TIP OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SMART COIL BY APPLYING MORE FORCE, AND CONSEQUENTLY THE SMART COIL PUSHER ASSEMBLY BROKE OUTSIDE OF THE PATIENT NEAR THE RHV. THE PHYSICIAN THEREFORE REMOVED THE PUSHER A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324657 ↗
• MalfunctionMar 8, 2018Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND THE SMART COIL BECAME STUCK APPROXIMATELY 20 CM FROM THE TIP OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL USING THE SAME MICROCATHETER, HOWEVER THE SAME INCIDENT OCCURRED. THE PHYSICIAN THEREFORE REMOVED THE SMART COIL, AND USED THE MICROCATHETER TO PLACE ANOTHER EMBOLIZATION SYSTEM. THE MICROCATHETER WAS THEN REMOVED, AND A NEW NON-PENUMBRA MICROCATHETER WAS PLACED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED TWO SMART COILS USING THE MICROCATHETER. NEXT, WHILE ADVANCING A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL MORE THAN ABOUT HALFWAY OUT OF THE TIP OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SMART COIL BY APPLYING MORE FORCE, AND CONSEQUENTLY THE SMART COIL PUSHER ASSEMBLY BROKE OUTSIDE OF THE PATIENT NEAR THE RHV. THE PHYSICIAN THEREFORE REMOVED THE PUSHER A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324656 ↗
• MalfunctionJan 12, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROEPIPLOIC ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE OUT OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186562 ↗
• MalfunctionJan 3, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COILS EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIALS COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE. THEREFORE, THE PHYSICIAN LET THE FLUSH RUN THROUGH THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE SMART COIL AGAIN; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PHYSICIAN REMOVED THE 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 Consequences Or Impact To Patient

  MAUDE report 7162428 ↗
• MalfunctionOct 20, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CEREBRAL ANEURYSM (BA-TOP) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED TWO SMART COILS INTO THE TARGET VESSEL BUT WAS UNABLE TO DETACH THE COILS USING THE HANDLE. AFTER A COUPLE OF ATTEMPTS USING THE SAME HANDLE, BOTH COILS FINALLY DETACHED SUCCESSFULLY. THE PHYSICIAN THEN DEPLOYED A NEW SMART COIL IN THE TARGET AND ATTEMPTED TO DETACH IT USING A NEW HANDLE. AFTER THE FIRST ATTEMPT, IT WAS CONFIRMED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE COIL PUSHER ASSEMBLY BECAME SEPARATED ABOUT THREE MILLIMETERS. AFTER MAKING ADDITIONAL ATTEMPTS, THE BLACK ALIGNMENT ZONE PEELED OFF AND PULLED INTO THE HANDLE. IT WAS FLUOROSCOPICALLY OBSERVED THAT THE SMART COIL WAS DETACHED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6967006 ↗