Smart Coil 400SMTSFT0406Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00814548015071), received between Feb 12, 2016 and Mar 27, 2023 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING 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 USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL USING A NEW HANDLE BUT WAS UNSUCCESSFUL. NEXT, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. AFTERWARDS, IT WAS NOTICED THAT A LOOP OF THE SMART COIL HAD MOVED OUTSIDE OF THE TARGET VESSEL AND INTO THE A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA). SUBSEQUENTLY, A THROMBOTIC AGGREGATE GENERATED ON THE SURFACE OF THE LOOP OF THE SMART COIL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE LOOP OF THE SMART COIL BACK INSIDE THE ANEURYSM USING THE MICROCATHETER BUT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN A2 TRACT STENOSIS DUE TO THE THROMBOTIC AGGREGATE THAT FORMED ON THE SURFACE OF THE LOOP OF THE SMART COIL. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE FOLLOWING DAY AN ANGIOGRAPHIC CHECK WAS

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 16623086 ↗
• MalfunctionMar 16, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING A PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION AND ATTEMPTS TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE HANDLE WAS REMOVED, AND THE PHYSICIAN USED A NEW HANDLE TO DETACH THE SMART COIL, BUT THE COIL WOULD NOT DETACH. IT WAS REPORTED THAT THE PHYSICIAN PINCHED AND PULLED THE PROXIMAL END OF THE PUSHER ASSEMBLY OF THE SMART COIL AT THE BLACK ALIGNMENT ZONE AND THEN USED A FORCEPS TO DETACH THE SMART COIL, BUT THE ATTEMPTS WERE UNSUCCESSFUL, AND THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. SUBSEQUENTLY, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED OUTSIDE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED SMART COIL BACK INTO THE ANEURYSM AND SUCCESSFULLY IMPLANTED THE COIL. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560394 ↗
• MalfunctionSep 15, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL ARTERIOVENOUS FISTULA (AVF) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN ADVANCED THE NEXT SMART COIL INTO THE TARGET VESSEL AND MADE TWO ATTEMPTS TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE SMART COIL. NEXT, THE PHYSICIAN ADVANCED A FOURTH SMART COIL INTO THE VESSEL AND THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING A HEMOSTAT, BUT THE COIL WOULD NOT DETACH, AND THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN OPENED A FIFTH SMART COIL TO USE THE PUSHER ASSEMBLY AND PUSH THE PREVIOUS DETACH SMART COIL THAT WAS INSIDE THE MICROCATHETER BACK INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING AN EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432815 ↗
• MalfunctionAug 13, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, SIX SMART COILS WERE IMPLANTED INTO THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN ATTEMPTED TO DETACH THE NEXT SMART COIL USING THE HANDLE BUT WAS UNABLE TO DO SO; MANUAL DETACHMENT ALSO FAILED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12319549 ↗
• MalfunctionJul 27, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL IN ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED AND THE SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR 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 12229794 ↗
• MalfunctionJan 29, 2021Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  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), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. 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 MADE SEVERAL ADDITIONAL ATTEMPTS; HOWEVER, THE SMART COIL DID NOT DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, APPROXIMATELY AFTER ONE THIRD OF THE SMART COIL WAS RETRACTED INTO THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN PUSHED THE SMART COIL USING ITS PUSHER ASSEMBLY AND A NON-PENUMBRA GUIDEWIRE INTO THE ANEURYSM. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE SEVERAL ADDITIONAL

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

  MAUDE report 11255344 ↗
• InjuryApr 18, 2018Adverse 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 PLACED SEVEN SMART COILS. DURING THE PROCEDURE, THE PATIENT SUFFERED AN ACUTE ISCHEMIC LEFT ANTERIOR CEREBRAL ARTERY (ACA) STROKE AND THE HOSPITAL STAFF ADMINISTERED THROMBOLYTICS INTRA-ARTERIALLY, FOLLOWED BY BALLOON ANGIOPLASTY AND A NON-PENUMBRA STENT DEVICE. AS OF (B)(6) 2018, THE PATIENT REMAINED HOSPITALIZED. THE ACUTE ISCHEMIC LEFT ANTERIOR CEREBRAL ARTERY (ACA) STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH PROBABLE RELATIONSHIP TO THE SMART COILS AND DEFINITE RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 7441821 ↗
• InjuryApr 18, 2018Adverse 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 PLACED SEVEN SMART COILS. DURING THE PROCEDURE, THE PATIENT SUFFERED AN ACUTE ISCHEMIC LEFT ANTERIOR CEREBRAL ARTERY (ACA) STROKE AND THE HOSPITAL STAFF ADMINISTERED THROMBOLYTICS INTRA-ARTERIALLY, FOLLOWED BY BALLOON ANGIOPLASTY AND A NON-PENUMBRA STENT DEVICE. AS OF (B)(6) 2018, THE PATIENT REMAINED HOSPITALIZED. THE ACUTE ISCHEMIC LEFT ANTERIOR CEREBRAL ARTERY (ACA) STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH PROBABLE RELATIONSHIP TO THE SMART COILS AND DEFINITE RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 7441723 ↗
• 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 7339862 ↗
• MalfunctionFeb 26, 2018Failure 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 TWO COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND THROUGH THE HUB OF THE MICROCATHETER SINCE IT BECAME ENTRAPPED. THEREFORE THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING TWO NEW SMART COIL, ADDITIONAL 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 7297873 ↗
• MalfunctionJan 5, 2018Failure to Advance; Failure to Advance

  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 PLACED TWO COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE TWO SMART COILS INTO THE MICROCATHETER, AND THEREFORE THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169864 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING EIGHT PENUMBRA SMART COILS (SMART COILS) WITH NO COMPLICATIONS. LATER THAT DAY, THE PATIENT WAS FOUND TO HAVE TRANSIENT EYE FLOATERS IN THE LEFT EYE OF MODERATE SEVERITY. A COMPUTED TOMOGRAPHY (CT) WAS TAKEN AND WAS NEGATIVE FOR STROKE. THE PHYSICIAN SUSPECTED THAT THE EYE FLOATERS MAY HAVE BEEN TRANSIENT DUE TO THE LARGER AMOUNT OF CONTRAST ADMINISTERED DURING THE PROCEDURE THAN NORMAL. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. ON (B)(6) 2017, THE PATIENT EXPERIENCED NEUROLOGICAL DECLINE OF RIGHT-SIDED WEAKNESS, RESULTING IN PROLONGED HOSPITALIZATION. A CT ANGIOGRAPHY WAS TAKEN, WHICH SHOWED SCATTERED PUNCTUATED INFARCTS THROUGHOUT THE BILATERAL FRONTAL AND PARIETAL LOBES SUGGESTIVE OF EMBOLIC DISEASE. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2017. THE REPORTED TRANSIENT EYE FLOATERS WAS ADJUDICATED BY THE PHYSICIAN TO BE POSSIBLY RELATED TO THE DISEASE STATE, PROCEDURE, AND THE SMART COIL SYSTEM. THE REPORTED NEUROLOGICAL DECLINE WAS ADJUDICATED BY THE PHYSICIAN TO BE UNRELATED TO THE DISEASE STATE, POSSIBLY RELATED

  Patient problems: Infarction, Cerebral; Vitreous Floaters; Weakness

  MAUDE report 6664927 ↗
• MalfunctionMay 9, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED CEREBRAL ARTERY ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING THE DISTAL DETACHMENT TIP OF TWO SMART COILS THROUGH THE TIP OF THE MICROCATHETER; HOWEVER, THE SMART COILS WERE SUCCESSFULLY DEPLOYED AND 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 6555939 ↗
• MalfunctionMay 4, 2017Unsealed Device Packaging; Out-Of-Box Failure; Unsealed Device Packaging; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE STERILE POUCH CONTAINING A NEW PENUMBRA SMART COIL (SMART COIL) WAS NOT SEALED UPON OPENING THE PACKAGING BOX. THE UNSEALED STERILE PACKAGE WAS FOUND PRIOR TO USE AND THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6546191 ↗
• MalfunctionAug 2, 2016Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) FOR A SUBARACHNOID HEMORRHAGE (SAH) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE FIRST SMART COIL INTO THE TARGET VESSEL AND THEN ATTEMPTED TO DETACH IT USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN CONFIRMED THAT THE PET LOCK WAS SEPARATED AND THEREFORE ASSUMED THAT THE SMART COIL HAD SUCCESSFULLY DETACHED IN THE TARGET VESSEL. HOWEVER, UPON RETRACTING THE SMART COIL PUSHER ASSEMBLY, THE PHYSICIAN NOTICED THAT THE EMBOLIZATION COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL IN THE TARGET VESSEL AND THEN REMOVED THE PUSHER ASSEMBLY FROM THE PATIENT'S BODY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5842009 ↗
• MalfunctionJul 22, 2016Positioning Failure; Failure to Advance; Physical Resistance; Positioning Failure; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A SMART COIL INTO THE ANEURYSM, RESISTANCE WAS MET AND THE LAST FIVE TO TEN MILLIMETERS OF THE COIL WAS UNABLE TO ADVANCE OUT OF THE OTHER MANUFACTURER'S MICROCATHETER AND INTO THE ANEURYSM. THEREFORE, THE SMART COIL WAS REMOVED AND ANOTHER MANUFACTURER'S COILS ALONG WITH THREE NEW SMART COILS WERE DELIVERED INTO THE ANEURYSM. WHILE ATTEMPTING TO DEPLOY ANOTHER NEW SMART COIL INTO THE ANEURYSM, THE PHYSICIAN MET RESISTANCE AGAIN AND THE LAST FIVE TO TEN MILLIMETERS OF THE COIL WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER AND INTO THE ANEURYSM. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE OTHER MANUFACTURER'S 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 5817645 ↗
• MalfunctionFeb 12, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN INITIALLY DEPLOYED AND DETACHED ONE OR TWO SMART COILS INTO THE ANEURYSM. WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A NEW SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO ANOTHER MANUFACTURER'S MICROCATHETER, IT BECAME STUCK AT THE COIL AND PUSHER ASSEMBLY JUNCTION AND WAS UNABLE TO BE ADVANCED ANY FURTHER. IT WAS REPORTED THAT NO RESISTANCE WAS FELT WHILE ADVANCING THE SMART COIL. THE PHYSICIAN REMOVED THE SMART COIL FROM THE PATIENT AND COMPLETED THE PROCEDURE 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 5434074 ↗