Smart Coil 400SMTHXSFT2H06Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00814548015767), received between May 10, 2017 and Apr 25, 2022 — classified as 2 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (45 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER AND HANDLE. SUBSEQUENTLY A THIRD SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN IMPLANTED THE THIRD SMART COIL IN THE TARGET VESSEL. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE FOURTH SMART COIL; THEREFORE, IT WAS ALSO IMPLANTED IN THE TARGET VESSEL. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A FIFTH SMART COIL USING THE MICROCATHETER TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE SIXTH AND SEVENTH SMART COILS; THEREFORE, THEY 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 14191574 ↗
• InjuryNov 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING (ACOM) 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 IMPLANTED ONE SMART COIL IN THE TARGET LOCATION USING THE HANDLE AND MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. WHILE RETRACTING THE SMART COIL TO REMOVE IT, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN PUSHED THE DETACHED SMART COIL OUT OF THE MICROCATHETER. IT WAS REPORTED THAT HALF OF THE COIL WAS IN THE ANEURYSM AND HALF OF THE COIL WAS IN THE TARGET VESSEL. SUBSEQUENTLY, THE PHYSICIAN USED A STENT DEVICE TO PUSH THE DETACHED SMART COIL AGAINST THE VESSEL WALL. THE PROCEDURE 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 12807675 ↗
• MalfunctionSep 28, 2021Failure 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, WHILE ADVANCING THE TWO SMART COILS, THEY BECAME STUCK WITHIN THE FRICTION LOCKS. THEREFORE, THE SMART COILS WERE REMOVED. IT WAS REPORTED MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE SMART COILS, INCLUDING DIFFERENT HAND PLACEMENTS, BUT THE ATTEMPTS WERE UNSUCCESSFUL. 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 12541125 ↗
• MalfunctionSep 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL POSTERIOR INFERIOR CEREBELLAR ARTERY 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, SEVEN NON-PENUMBRA COILS WERE IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A SMART COIL PAST ITS INITIAL POSITION IN ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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

  MAUDE report 12529229 ↗
• MalfunctionSep 16, 2021Break; Separation Failure; Break; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT DETACH WITH THE HANDLE, AND THE SMART COIL BROKE ON THE PROXIMAL END. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485417 ↗
• MalfunctionAug 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SMART COILS AND FOUR NON-PENUMBRA COILS. WHEN THE NEXT SMART COIL WAS PARTIALLY ADVANCED INTO THE HUB, RESISTANCE WAS ENCOUNTERED AT THE DISTAL TIP OF THE INTRODUCER SHEATH AND THE COIL BECAME STUCK. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND EIGHT OTHER COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343204 ↗
• MalfunctionJun 28, 2021Physical 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) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR NON-PENUMBRA COILS INTO THE TARGET LOCATION. NEXT, WHILE ATTEMPTING TO ADVANCE A SMART COIL, THE COIL BECAME STUCK IN THE DISTAL TIP OF 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

  MAUDE report 12080933 ↗
• MalfunctionMay 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERIES (IC-PC) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND THROMBOSED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX NON-PENUMBRA COILS. WHILE ADVANCING A SMART COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND NOTED THAT THE COIL WAS ONLY ABLE TO ADVANCE A SHORT DISTANCE THROUGH ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. AFTER IMPLANTING TWO OTHER SMART COILS, THE PHYSICIAN ATTEMPTED TO ADVANCE THE NEXT SMART COIL AND REPORTED THAT IT 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 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 11852521 ↗
• MalfunctionMay 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ANTERIOR CEREBRAL ARTERY 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. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED; THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766454 ↗
• MalfunctionApr 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A SHUNT PROCEDURE IN THE SUPERIOR OPTHALMIC VEIN USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWENTY-TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH ITS INTRODUCER SHEATH, THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS, SEVEN 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 11616731 ↗
• MalfunctionJan 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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 11254978 ↗
• MalfunctionJan 20, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WERE STUCK AND WOULD NOT ADVANCE FROM THEIR STARTING POSITIONS IN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE 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 11206054 ↗
• MalfunctionJan 20, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WERE STUCK AND WOULD NOT ADVANCE FROM THEIR STARTING POSITIONS IN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE 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 11206051 ↗
• MalfunctionDec 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY-TOP USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE SMART COIL AND TWENTY-TWO OTHER COILS IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ALIGNED THE INTRODUCER SHEATH OF THE NEXT SMART COIL TO THE HUB OF THE MICROCATHETER, AND THE SMART COIL WAS STUCK AT THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE 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 11090187 ↗
• MalfunctionDec 15, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS INTO THE TARGET LOCATION. WHILE ATTEMPTING TO USE THE NEXT SMART COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS 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 11008700 ↗
• MalfunctionDec 4, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COIL, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A SMART COIL THROUGH THE INTRODUCER SHEATH, THE PHYSICIAN GRADUALLY EXPERIENCED RESISTANCE AND THE SMART COIL BECAME STUCK IN THE DISTAL TIP OF THE INTRODUCER SHEATH. THEREFORE, IT 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 10944624 ↗
• MalfunctionOct 7, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT DURAL ARTERIOVENOUS FISTULA (DAVF) USING A PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX NON-PENUMBRA COILS AND ONE PENUMBRA SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL, THE DISTAL TIP OF THE SMART COIL BECAME STUCK CLOSE TO ITS INTRODUCER SHEATH DISTAL TIP. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND FIVE NON-PENUMBRA 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 10645672 ↗
• MalfunctionSep 11, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS, NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, CALCIFIED AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR NON-PENUMBRA COILS USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A SMART COIL, THE SMART COIL BECAME STUCK WITHIN ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO SMART COILS, TWO 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 10525385 ↗
• MalfunctionSep 11, 2020Failure 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), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, AND AN ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, TWELVE OTHER COILS AND TWO SMART COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE THIRD SMART COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE THE SMART COIL AND IT DID NOT MOVE AT ALL. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS AND SEVENTEEN OTHER COILS USING THE SAME MICROCATHETER, THE SAME GUIDE CATHETER, AND THE SAME ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522190 ↗
• MalfunctionAug 28, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE REMOVED. IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE ONE OF THE SMART COILS, THE PUSHER ASSEMBLY OF THE SMART COIL INADVERTENTLY BENT. IT IS UNKNOWN WHICH OF THE TWO SMART COILS PUSHER ASSEMBLY WAS THE ONE THAT BENT. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467452 ↗
• MalfunctionAug 28, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY 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 A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN PLACED ANOTHER SMART COIL INTO THE TIP OF THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, AFTER TWO ATTEMPTS, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN DEPRESSED THE HANDLE AND PULLED IT BACK BEFORE HEARING AN AUDIBLE CLICK; BUT THE SMART COIL DID NOT DETACH. THEN, THE PHYSICIAN MANUALLY PULLED APART THE MICROCATHETER TO PULL THE PUSHER ASSEMBLY OF THE SMART COIL TO DETACH IT; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. NEXT, THE PHYSICIAN PLACED AND DETACHED MULTIPLE SMART COILS INTO THE TARGET VESSEL USING A NEW HANDLE. WHILE ADVANCING TWO ADDITIONAL SMART COILS, THE PHYSICIAN EXPERIENCED RESISTANCE WITHIN ITS INTRODUCER SHEATH. HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PLACE AND DETACHED BOTH SMART COILS INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467014 ↗
• MalfunctionAug 28, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY 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 A SMART COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN PLACED ANOTHER SMART COIL INTO THE TIP OF THE ANEURYSM AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, AFTER TWO ATTEMPTS, THE SMART COIL FAILED TO DETACH. IT WAS REPORTED THAT THE PHYSICIAN DEPRESSED THE HANDLE AND PULLED IT BACK BEFORE HEARING AN AUDIBLE CLICK; BUT THE SMART COIL DID NOT DETACH. THEN, THE PHYSICIAN MANUALLY PULLED APART THE MICROCATHETER TO PULL THE PUSHER ASSEMBLY OF THE SMART COIL TO DETACH IT; HOWEVER, THE SMART COIL DID NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. NEXT, THE PHYSICIAN PLACED AND DETACHED MULTIPLE SMART COILS INTO THE TARGET VESSEL USING A NEW HANDLE. WHILE ADVANCING TWO ADDITIONAL SMART COILS, THE PHYSICIAN EXPERIENCED RESISTANCE WITHIN ITS INTRODUCER SHEATH. HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PLACE AND DETACHED BOTH SMART COILS INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10467008 ↗
• MalfunctionAug 7, 2020Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL IN THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PUSHER ASSEMBLY OF THE SMART COIL BROKE AND KINKED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THIRTEEN OTHER 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 10379583 ↗
• MalfunctionJun 11, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR SUPERIOR PANCREATIC-DUODENAL ARTERY USING 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 SMART COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO INTRODUCE THE NEXT SMART COIL TO THE MICROCATHETER, THE PHYSICIAN REPORTED THAT THE COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL SMART COILS, THREE 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 10141564 ↗
• MalfunctionAug 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND PENUMBRA SMART COILS (SMART COILS). IT SHOULD BE NOTED THAT THERE WAS A TORTUOUS TONSILLAR LOOP IN THE COMMON CAROTID ARTERY (CCA). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE PATIENT¿S ANATOMY BUT FELT THAT IT WOULD NOT PROVIDE ENOUGH SUPPORT TO GUIDE THE PX SLIM OVER THE TONSILLAR LOOP. THEREFORE, THE NEURON MAX WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN DECIDED TO USE A BENCHMARK AS THE GUIDE. HOWEVER, WHILE ADVANCING THE BENCHMARK HALFWAY THROUGH THE TONSILLAR LOOP, IT WAS REPORTED THAT THE BENCHMARK FELT STIFF. THE PHYSICIAN DECIDED NOT TO ADVANCE THE BENCHMARK ANY FURTHER INTO THE PATIENT¿S ANATOMY AND IT WAS THEREFORE REMOVED FROM THE PROCEDURE. A NON-PENUMBRA SHEATH WAS THEN ADVANCED, FOLLOWED BY THE SAME PX SLIM; HOWEVER, THE PX SLIM WAS NOT COMPATIBLE WITH THE TECHNIQUE THE PHYSICIAN PREFERRED TO USE AND WAS THEREFORE REMOVED FROM THE PROCEDURE. THERE WAS NO OTHER ISSUE NOTED WIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858103 ↗