Smart Coil 400SMTSFT0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00814548015057), received between Sep 3, 2015 and Mar 26, 2022 — classified as 4 injuries, 37 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; 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¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET LOCATION 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 TO DETACH THE SMART COIL MANUALLY AND USING THE HANDLE, BUT THE SMART COIL STILL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE GENTLY RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, IT WAS NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INSIDE THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS. THE SMART COILS FAILED TO DETACH AFTER THE PHYSICIAN MADE SEVERAL ATTEMPTS TO DETACH THE SMART COILS MANUALLY AND USING THE SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925112 ↗
• MalfunctionMar 26, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; 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¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET LOCATION 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 TO DETACH THE SMART COIL MANUALLY AND USING THE HANDLE, BUT THE SMART COIL STILL WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE GENTLY RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, IT WAS NOTICED THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INSIDE THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS. THE SMART COILS FAILED TO DETACH AFTER THE PHYSICIAN MADE SEVERAL ATTEMPTS TO DETACH THE SMART COILS MANUALLY AND USING THE SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925111 ↗
• MalfunctionNov 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), NON-PENUMBRA MICROCATHETERS, AND A NON-PENUMBRA BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN NON-PENUMBRA COILS IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO REMOVE AND EXCHANGE TO ANOTHER MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A SMART COIL THROUGH THE MICROCATHETER AGAINST RESISTANCE AND PLACED THE COIL IN THE MCA ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE SMART COIL USING THE HANDLE. THEREFORE, THE SMART COIL AND HANDLE WERE 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 12848697 ↗
• MalfunctionOct 26, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR GLUTEAL ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER AND GUIDING SHEATH. IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET SITE. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH THE SMART COIL WITH THE HANDLE AFTER MULTIPLE ATTEMPTS; THE HANDLE WAS NOT CLICKING. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND NEW HANDLE. ON THE BACK TABLE, THE PHYSICIAN RETRACTED THE SLIDER ON THE HANDLE MULTIPLE TIMES, AND THE HANDLE WAS FUNCTIONAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701481 ↗
• MalfunctionOct 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO SMART COILS. THEREFORE, THE SMART COILS 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 12600746 ↗
• MalfunctionSep 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO REMOVED. AFTERWARDS, THE NEXT THREE SMART COILS ADVANCED SLIGHTLY PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS BEFORE BECOMING STUCK WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL TO THE TARGET LOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419061 ↗
• MalfunctionSep 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE SMART COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER SMART COIL APPROXIMATELY A FEW CENTIMETERS INTO THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK PAST THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO REMOVED. AFTERWARDS, THE NEXT THREE SMART COILS ADVANCED SLIGHTLY PAST THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS BEFORE BECOMING STUCK WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER SMART COIL TO THE TARGET LOC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419032 ↗
• MalfunctionJul 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, TWO NON-PENUMBRA COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A SMART COIL, IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND SEVEN 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 12186924 ↗
• MalfunctionJul 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL THORACIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER, AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THIRTY-TWO SMART COILS AND EIGHT NON-PENUMBRA COILS INTO THE TARGET LOCATION. 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 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 12109037 ↗
• MalfunctionJun 23, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR CEREBELLAR ARTERY (SCA) USING PENUMBRA SMART COILS (SMART COILS), A SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN ADVANCED THE NEXT 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 MADE SEVERAL ADDITIONAL ATTEMPTS BUT THE SMART COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054785 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED SEVERAL SMART COILS USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT SMART COIL USING THE HANDLE, THE COIL DID NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH THE NEXT SMART COIL. THEREFORE, THIS SMART COIL AND THE HANDLE WERE ALSO REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A NEW HANDLE. IT WAS ALSO REPORTED THAT OUT OF TWENTY-THREE SMART COILS TOTAL, TWO DID NOT DETACH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770595 ↗
• MalfunctionApr 6, 2021Failure 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 COILS), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN NON-PENUMBRA COILS. WHILE ATTEMPTING TO ADVANCE A SMART COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE OR RETRACT THE COIL. THEREFORE, THE SMART COIL WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, TWENTY-FOUR OTHER COILS, THE SAME MICROCATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622171 ↗
• MalfunctionJan 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; 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, TWO SMART COILS WERE STUCK WITHIN THEIR INTRODUCER SHEATHS AND WOULD NOT ADVANCE NOR RETRACT. THEREFORE, THE TWO SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPETED 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 11144072 ↗
• MalfunctionNov 25, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER, AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO SUCCESSFULLY PUSH THE SMART COIL BACK INTO THE ANEURYSM. 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; No Consequences Or Impact To Patient

  MAUDE report 10902610 ↗
• 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 10411310 ↗
• MalfunctionAug 4, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE COILS INTO THE TARGET LOCATION USING THE HANDLE. THEN, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE FURTHER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 10364734 ↗
• MalfunctionFeb 21, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE SMART COIL OUT IF ITS INTRODUCER SHEATH, THE SMART COIL BECAME STUCK AND SUBSEQUENTLY, THE PUSHER ASSEMBLY KINKED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9739156 ↗
• MalfunctionNov 11, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM BETWEEN THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS AND SEVEN OTHER COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN ADVANCED THE NEXT SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO USE ANOTHER HANDLE, BUT THE SMART COIL FAILED TO DETACH; THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO DETACH THE SMART COIL USING THE FIRST HANDLE ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305358 ↗
• MalfunctionOct 9, 2019Failure 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 PLACED SEVERAL SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, IT BECAME STUCK AND WOULD NOT ADVANCE FROM ITS STARTING POSITION INSIDE OF THE INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL INTO THE MICROCATHETER; HOWEVER, A SMALL PARTICLE WAS BLOCKING THE INNER LUMEN OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED AND FLUSHED TO REMOVE THE SMALL PARTICLE. THE PROCEDURE WAS COMPLETED USING THE SAME SMART COIL, 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 9173471 ↗
• MalfunctionSep 17, 2019Difficult or Delayed Positioning; Physical Resistance/Sticking; Difficult or Delayed Positioning; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN PLACED SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL USING THE SAME MICROCATHETER AND ATTEMPTED TO DETACH IT; HOWEVER, UPON ACTUATION OF THE HANDLE, THE COIL PULLED BACK INTO THE MICROCATHETER AND DETACHED. SUBSEQUENTLY, THE COIL BECAME STUCK AND AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO PUSH THE SMART COIL INTO THE ANEURYSM USING A NON-PENUMBRA GUIDEWIRE. THE PROCEDURE ENDED AT THIS POINT AS THIS WAS THE LAST COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9077665 ↗
• MalfunctionJul 8, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PENUMBRA SMART COIL (SMART COIL) OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE. IT WAS REPORTED THAT THE SMART COIL WAS STUCK INSIDE ITS INTRODUCER SHEATH AND WOULD NOT ADVANCE OUT. THE ISSUE WITH THE SMART COIL OCCURRED PRIOR TO USE AND, THEREFORE, THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8768128 ↗
• MalfunctionJun 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A SMART COIL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744496 ↗
• MalfunctionApr 5, 2019Separation Problem; Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A BENCHMARK DELIVERY CATHETER (BENCHMARK). DURING PREPARATION FOR THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PROXIMAL END OF THE BENCHMARK WAS BROKEN UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE BENCHMARK WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS THEN CONTINUED WITH A NEW BENCHMARK. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SMART COIL INTO A NON-PENUMBRA MICROCATHETER, HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SMART COIL FROM THE INITIAL POSITION INSIDE ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED, AND A DIFFERENT SMART COIL WAS PLACED. THE PHYSICIAN THEN ATTEMPTED TO DETACH A SMART COIL IN THE TARGET LOCATION WITHOUT USING A PENUMBRA SMART COIL DETACHMENT HANDLE. HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED, AND THE PROCEDURE WAS CONTINUED 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 8487551 ↗
• MalfunctionMar 8, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. 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 8405086 ↗
• InjuryOct 18, 2018Failure to Advance; Difficult or Delayed Separation; Premature Separation; Failure to Advance; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL HANDLE (HANDLE) AND PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. AFTER TWO FAILED ATTEMPTS, THE PHYSICIAN MANUALLY PULLED THE SMART COIL¿S BLACK ALIGNMENT ZONE (PET LOCK) APART; HOWEVER, THE SMART COIL WAS STILL COMING BACK WITH THE PUSHER ASSEMBLY WHEN THE PHYSICIAN PULLED BACK TO REMOVE. IT WAS REPORTED THAT AFTER PULLING APPROXIMATELY ONE AND HALF CENTIMETERS OF THE SMART COIL INSIDE THE MICROCATHETER, THE SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN TRIED TO PUSH THE SMART COIL WITH ITS PUSHER ASSEMBLY BUT IT DID NOT ADVANCE PAST A CERTAIN POINT. THE PHYSICIAN THEN TRIED TO PUSH THE SMART COIL WITH A WIRE BUT THE SMART COIL DID NOT ADVANCE PAST THE SAME POINT IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN PULLED THE CATHETER BACK, LEAVING ONE AND HALF CENTIMETERS OF THE SMART COIL TAIL OUTSIDE THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED BY HOLDING THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7980376 ↗