Smart Coil 400SMTSFT0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00814548015095), received between Aug 31, 2015 and Sep 30, 2022 — classified as 2 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (14 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA BALLOON CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A BALLOON CATHETER PAST THE ANEURYSM AND THEN PLACED THE MICROCATHETER IN THE ACOMM ANEURYSM. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AFTER MAKING THREE ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL, BUT THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING THE SMART COIL, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. SUBSEQUENTLY, WHEN THE PHYSICIAN WAS REMOVING THE MICROCATHETER CONTAINING THE DETACHED SMART COIL, THE COIL MIGRATED OUT OF THE MICROCATHETER AND INTO THE CONTRALATERAL ANTERIOR CEREBRAL ARTERY (ACA). THEREFORE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER PAST THE SMART COIL AND THEN A STENT RETRIEVER WAS USED TO REMOVE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513728 ↗
• InjuryJun 28, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATION ARTERY (ACOMM) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING A SECOND HANDLE AND THEN MANUALLY; HOWEVER, THEY WERE STILL UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE SMART COIL; HOWEVER, THE MICROCATHETER LOST POSITION AND THE SMART COIL UNINTENTIONALLY DETACHED WITH PART OF THE SMART COIL IN THE TARGET VESSEL AND THE OTHER PART IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN PUSHED PART OF THE SMART COIL INTO THE TARGET VESSEL AND PLACED A STENT TO PROTECT THE PARENT VESSEL. THE PROCEDURE WAS ENDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT¿S HEALTH CONDITION DECLINED DUE TO A SMALL ANTERIOR CEREBRAL ARTERY (ACA) TERRITORY INFARCT THAT WAS NOTED DURING A FOLLOW-UP CT SCAN. THE RELATIONSHIP BETWEEN THE SMART COIL AND THE INFARCT IS UNKNOWN.

  Patient problems: Hemorrhagic Stroke; Ischemia Stroke

  MAUDE report 14847290 ↗
• MalfunctionMar 4, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL (F109435) AS THE FIRST COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN THEN PULLED BACK ON THE MICROCATHETER AND ATTEMPTED AGAIN TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE COIL STILL WOULD NOT DETACH. SUBSEQUENTLY, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE, AND THE SMART COIL ALSO FAILED TO DETACH USING A SECOND HANDLE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL FROM THE MICROCATHETER. WHILE RETRACTING THE SMART COIL FROM THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN DECIDED TO LEAVE THE SMART COIL IN PLACE SINCE MOST OF THE SMART COIL WAS IN THE ANEURYSM AND ONLY THE TAIL OF THE COIL REMAINED OUTSIDE OF THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL (F102575) TO THE ANEURYSM AND ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675818 ↗
• MalfunctionDec 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TEN SMART COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, THE SAME MICROCATHETER, AND THE SAME ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12926090 ↗
• MalfunctionOct 23, 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, THE PHYSICIAN ADVANCED THE FIRST SMART COIL INTO THE TARGET VESSEL AND MADE FOUR ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE HANDLE DID NOT CLICK. THEREFORE, THE HANDLE AND THE SMART COIL WERE REMOVED. 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 12686755 ↗
• MalfunctionOct 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING A PENUMBRA SMART COIL (SMART COIL), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THIRTY-EIGHT NON-PENUMBRA COILS AND TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING A SMART COIL WITHIN ITS INTRODUCER SHEATH, THE SMART COIL BECAME STUCK AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX SMART COILS AND FORTY-SIX NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661714 ↗
• MalfunctionSep 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, FOUR SMART COILS AND TWO NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING ANOTHER SMART COIL A SHORT DISTANCE PAST ITS INITIAL POSITION, IT BECAME STUCK. 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

  MAUDE report 12550216 ↗
• MalfunctionAug 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351623 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX SMART COILS INTO THE TARGET LOCATION. WHEN THE DISTAL TIP OF THE SMART COIL WAS ADVANCED INTO THE HUB OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. 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

  MAUDE report 12080558 ↗
• MalfunctionJun 1, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIO-LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), RUBY COILS, LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA ANGIOGRAPHIC CATHETER, AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED 15 RUBY COILS IN THE TARGET VESSEL. WHILE ADVANCING THE SMART COIL INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE MICROCATHETER AND DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER; THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED SMART COIL. THE PROCEDURE ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918072 ↗
• MalfunctionMay 25, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO ADVANCE THE SMART COIL; HOWEVER, IT WAS UNSUCCESSFUL. CONSEQUENTLY, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE SMART COIL; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11874795 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS; THEREFORE, THE SMART COILS WERE ALSO 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 11698458 ↗
• MalfunctionNov 20, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COIL), RUBY COIL, OTHER COILS, NON-PENUMBRA CATHETER AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL AND 17 OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A SMART COIL, THE PHYSICIAN NOTICED THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10879389 ↗
• MalfunctionOct 26, 2020Difficult 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 DETACHMENT HANDLE (HANDLE), PENUMBRA SMART COILS (SMART COILS), AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO COILS IN THE TARGET VESSEL. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH A SMART COIL USING THE HANDLE, AND THE HANDLE FAILED TO DETACH THE SMART COIL. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO PULL THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE, THE SAME SMART COIL WITH THREE ADDITIONAL SMART COILS, AND TWO NON-PENUMBRA 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 10737013 ↗
• MalfunctionAug 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL BECAME STUCK IN THE HUB DURING ADVANCEMENT. THEREFORE, THE SMART COIL WAS REMOVED. THE NEXT SMART COIL COULD NOT BE ADVANCED BEYOND ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH AND WAS SUBSEQUENTLY REMOVED. THE SAME ISSUE HAPPENED WITH ANOTHER SMART COIL AND THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR SMART COILS AND ELEVEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426943 ↗
• MalfunctionAug 14, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS, A PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE SMART COILS INTO THE TARGET LOCATION USING THE HANDLE. 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. THE PHYSICIAN ATTEMPTED TO PULL THE BACK END OF THE DETACHMENT ZONE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO BREAK THE STAINLESS STEEL HYPOTUBE AND SUBSEQUENTLY, THE HYPOTUBE SNAPPED AND THERE WAS NO INNER NITINOL WIRE TO PULL ON. THEREFORE, THE SMART COIL WAS REMOVED. THEN, THE PHYSICIAN 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. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW HANDLE TO DETACH THE SMART COIL; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411312 ↗
• MalfunctionMay 14, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEN, THE PHYSICIAN MADE AN ADDITIONAL ATTEMPT; HOWEVER, IT WAS UNSUCCESSFUL; THEREFORE, THE SMART COIL 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 Consequences Or Impact To Patient

  MAUDE report 10059653 ↗
• MalfunctionOct 16, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH A SMART COIL USING THE HANDLE AND REPORTED THAT IT WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED BY MANIPULATING THE PUSHER WIRE. IT WAS ALSO REPORTED THAT ANOTHER SMART COIL WOULD NOT ADVANCE THROUGH ITS INTRODUCER SHEATH. THIS SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS 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 9200083 ↗
• MalfunctionMar 18, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND ONE SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT AND SUCCESSFULLY DETACHED THE SMART COIL. AFTERWARDS, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430597 ↗
• MalfunctionMar 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL HALFWAY INTO THE MICROCATHETER; HOWEVER, THE INTRODUCER SHEATH WAS STICKING FIRMLY TO THE PUSHER ASSEMBLY. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND OTHER COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413313 ↗
• MalfunctionDec 1, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED THIRTY-FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO INSERT A SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE BEGINNING AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL SMART COILS AND TWENTY-THREE OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8121813 ↗
• MalfunctionNov 23, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE SMART COILS AND NINE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO INSERT A NEW SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS AND THREE OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8099866 ↗
• MalfunctionNov 20, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS AND FIVE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER; HOWEVER, THE SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AND THEREFORE, 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 8089661 ↗
• MalfunctionAug 8, 2018Material Too Rigid or Stiff; Separation Failure; Material Too Rigid or Stiff; Separation Failure

  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 SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE SMART COILS USING THE HANDLE. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER SMART COIL THROUGH THE NON-PENUMBRA MICROCATHETER AND REPORTED THAT THE SMART COIL WAS TOO STIFF AND DID NOT DETACH FROM ITS PUSHER ASSEMBLY. THE SMART COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS 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 7765607 ↗
• MalfunctionJun 28, 2018Failure 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, THE PHYSICIAN SUCCESSFULLY PLACED 11 COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL THROUGH THE HUB OF THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN COMPLETED THE PROCEDURE USING A NEW MICROCATHETER, A NEW SMART COIL, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7648671 ↗