Smart Coil 400SMTXSFT1H02Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00814548015224), received between Mar 24, 2017 and May 19, 2023 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS), A SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL DID NOT DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL USING A HEMOSTAT WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED AND THE SMART COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968328 ↗
• MalfunctionAug 26, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER APPROXIMATELY TEN CENTIMETERS FROM THE DISTAL TIP AND THE SMART COIL WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12373846 ↗
• MalfunctionAug 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A 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 ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315849 ↗
• MalfunctionMar 2, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED AND THEN REMOVED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11401853 ↗
• MalfunctionJan 25, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL) AND NON-PENUMBRA MICROCATHETER. 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 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 11223106 ↗
• MalfunctionDec 28, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL, THE SMART COIL ADVANCED A LITTLE AND BECAME STUCK AT THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SEVEN 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 11083692 ↗
• MalfunctionNov 19, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO PUSH THE SMART COIL, BUT THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND A NEW 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 10872199 ↗
• MalfunctionNov 2, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). 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; No Consequences Or Impact To Patient

  MAUDE report 10774639 ↗
• MalfunctionNov 2, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE BEGINNING TO ADVANCE THE FIRST SMART COIL THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE SMART COIL PUSHER ASSEMBLY WAS KINKED. 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 10772065 ↗
• MalfunctionOct 20, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), PENUMBRA SMART COILS (SMART COILS), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE NON-PENUMBRA COILS AND TWO SMART COILS USING A HANDLE. HOWEVER, THE HANDLE WAS UNABLE TO DETACH THE NEXT SMART COIL. THEREFORE, THE HANDLE WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, THE SAME SMART COIL, SIX ADDITIONAL SMART COILS, AND SEVEN 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 10708631 ↗
• MalfunctionSep 23, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WERE IMPLANTED IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED. 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 10577829 ↗
• MalfunctionJul 3, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL INTO THE HUB OF THE MICROCATHETER AND, THEREFORE, THE PHYSICIAN REHEATED THE SMART COIL. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SAME SMART COIL INTO THE MICROCATHETER BUT WAS AGAIN UNSUCCESSFUL. THE PROCEDURE WAS THEN 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 8758521 ↗
• MalfunctionMay 31, 2019Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH. CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL 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 8660459 ↗
• MalfunctionFeb 8, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH THREE SMART COILS USING THE HANDLE AND; THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED 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 8323756 ↗
• MalfunctionFeb 8, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH THREE SMART COILS USING THE HANDLE AND; THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED 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 8323748 ↗
• MalfunctionJan 10, 2019Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  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 SUCCESSFULLY DEPLOYED FOUR COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. UPON ADVANCEMENT OF THE FIFTH SMART COIL, THE PHYSICIAN FELT RESISTANCE AND DECIDED TO REMOVE THE SMART COIL AND INTRODUCER SHEATH TOGETHER FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT SHOULD ALSO BE NOTED THAT, UPON INSPECTION OF THE SMART COIL AND PUSHER ASSEMBLY AFTER THE PROCEDURE, A PENUMBRA EMPLOYEE FOUND AN UNKNOWN WHITE SCALY SUBSTANCE ON THE PUSHER WIRE. THE PENUMBRA EMPLOYEE THEN CLEANED THE PUSHER WIRE AND WAS ABLE TO ADVANCE THE SMART COIL WITH LITTLE RESISTANCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8238355 ↗
• MalfunctionJan 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE SMART COILS AND OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL FROM ITS INITIAL POSITION WITHIN THE 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 8209392 ↗
• MalfunctionDec 19, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED A SMART COIL TO THE TARGET LOCATION, HOWEVER, WAS UNABLE TO DETACH THE COIL ON THE FIRST ATTEMPT USING THE HANDLE. ALTHOUGH THE PHYSICIAN OBSERVED THAT THE BLACK ALIGNMENT ZONE WAS SEPARATED IN HALF, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN PULLED THE PULL WIRE OF THE SMART COIL PUSHER ASSEMBLY IN AN ATTEMPT TO MANUALLY DETACH THE SMART COIL; HOWEVER, THE SMART COIL DID NOT DETACH. 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 Consequences Or Impact To Patient

  MAUDE report 8179305 ↗
• MalfunctionOct 4, 2018Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY PLACING TWO SMART COILS, AND REPORTED THAT THE MICROCATHETER WAS KICKING OUT OF THE TARGET LOCATION. WITH THESE SAME TWO SMART COILS, THE PHYSICIAN ALSO WAS UNABLE TO DETACH THE EMBOLIZATION COILS, DESPITE MAKING MULTIPLE ATTEMPTS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934504 ↗
• MalfunctionMay 31, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A SMART COIL. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE ANOTHER SMART COIL WITHIN ITS INTRODUCER SHEATH AND IT WAS STUCK; 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 Consequences Or Impact To Patient

  MAUDE report 7558955 ↗
• MalfunctionApr 9, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART 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 PROCEDURE WAS THEN 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 7408928 ↗
• MalfunctionOct 27, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WAS UNABLE TO ADVANCE THROUGH THE HUB OF A NON-PENUMBRA MICROCATHETER, DESPITE THE PHYSICIAN MAKING MULTIPLE ATTEMPTS. 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 6983383 ↗
• MalfunctionSep 15, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). IT WAS NOTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED INITIAL SMART COIL INTO THE TARGET VESSEL BUT WAS UNABLE TO DETACH THE COIL USING A HANDLE. THEREFORE, A NEW HANDLE WAS OPENED BUT THE PHYSICIAN WAS STILL UNABLE TO DETACH THE SMART COIL. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL. AFTER THAT, THE PHYSICIAN DEPLOYED A SECOND SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SECOND HANDLE; HOWEVER, THE SMART COIL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL AND 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 6870103 ↗
• InjuryMar 24, 2017Adverse 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, ONE OF THE SMART COILS PUNCTURED THE ANEURYSM, LEADING TO A RUPTURE. A FOLLOW-UP ANGIOGRAM WAS PERFORMED AND SHOWED THAT THIS STOPPED BLEEDING OUT OF THE ANEURYSM. FURTHERMORE, A DYNA COMPUTERIZED TOMOGRAPHY (CT) SHOWED THAT THE BLEED WAS RELATIVELY SMALL. THE PATIENT WAS GIVEN PROTAMINE, DDAVP AND PLATELETS TO TREAT THE BLEED. ON (B)(6) 2017, A 24-HOUR FOLLOW-UP CT REVEALED THAT THE BLEED INCREASED IN SIZE. A RIGHT FRONTAL EXTERNAL VENTRICULAR DRAIN (EVD) WAS THEN PLACED. SUBSEQUENT FOLLOW-UP CT SCANS HAVE SHOWN THE HEMORRHAGE SIZE TO REMAIN STABLE SINCE THE EVD PLACEMENT. AS OF (B)(6) 2017, THIS EVENT IS ONGOING AND THE PATIENT IS STILL IN THE NEUROSCIENCE INTENSIVE CARE UNIT (NSICU). THE RUPTURED ANEURYSM WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT (SAE) WITH A DEFINITE RELATIONSHIP TO THE ANEURYSM/DISEASE AND THE PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE SMART COIL.

  Patient problems: Blood Loss; Hemorrhage, Cerebral; Rupture

  MAUDE report 6430695 ↗