Smart Coil 400SMTXSFT0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00814548015194), received between Dec 11, 2015 and Oct 22, 2021 — classified as 3 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (73 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 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), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND SEVEN OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEXT TWO SMART COILS IN THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COILS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 12686029 ↗
• MalfunctionOct 22, 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), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS AND SEVEN OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEXT TWO SMART COILS IN THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COILS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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 12686022 ↗
• MalfunctionAug 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER . DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE THE NEXT TWO SMART COILS INTO A NEW MICROCATHETER, THE SMART COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310679 ↗
• MalfunctionAug 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER . DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE SMART COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE SMART COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE THE NEXT TWO SMART COILS INTO A NEW MICROCATHETER, THE SMART COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND THE SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310675 ↗
• MalfunctionAug 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS OF THE SAME SIZE 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 12259926 ↗
• MalfunctionJun 25, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RADIAL ARTERY USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO SMART COILS INTO THE ANEURYSM SUCCESSFULLY. ANOTHER SMART COIL WAS ADVANCED INTO THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN REMOVED THE HANDLE AND USED A NEW HANDLE TO DETACH THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH AND WAS REMOVED. NEXT, ANOTHER SMART COIL WAS ADVANCED; HOWEVER, THE PHYSICIAN HAD THE SAME ISSUE WITH THE SMART COIL AND THEREFORE, THE SMART COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN HAD DIFFICULTY DETACHING THE OTHER SMART COILS TOO, BUT HE WAS ABLE TO DETACH THEM MANUALLY. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12064694 ↗
• MalfunctionMay 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT SIDE PARAOPHTHALMIC ANEURYSM USING A PENUMBRA SMART COIL. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852447 ↗
• MalfunctionApr 30, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL 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 SUCCESSFULLY IMPLANTED SIX SMART COILS IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT SMART COIL THROUGH THE MIDDLE OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE SMART COIL WAS REMOVED AND ANOTHER SMART COIL WAS SUCCESSFULLY IMPLANTED INSTEAD. WHILE ATTEMPTING TO ADVANCE ANOTHER SMART COIL THROUGH THE MIDDLE 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 11758241 ↗
• MalfunctionMar 23, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) 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 SUCCESSFULLY IMPLANTED SEVEN NON-PENUMBRA COILS. NEXT, TWO SMART COILS WERE UNABLE TO ADVANCE INTO THE HUB OF THE MICROCATHETER AND BECAME STUCK IN THE GAP BETWEEN THE INTRODUCER SHEATH AND THE HUB. THEREFORE, THESE SMART COILS WERE REMOVED. UPON ANGIOGRAPHY, IT WAS REVEALED THAT THE TARGET LOCATION WAS SUFFICIENTLY PACKED; THEREFORE, THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558073 ↗
• MalfunctionMar 23, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) 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 SUCCESSFULLY IMPLANTED SEVEN NON-PENUMBRA COILS. NEXT, TWO SMART COILS WERE UNABLE TO ADVANCE INTO THE HUB OF THE MICROCATHETER AND BECAME STUCK IN THE GAP BETWEEN THE INTRODUCER SHEATH AND THE HUB. THEREFORE, THESE SMART COILS WERE REMOVED. UPON ANGIOGRAPHY, IT WAS REVEALED THAT THE TARGET LOCATION WAS SUFFICIENTLY PACKED; THEREFORE, THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558062 ↗
• MalfunctionJan 28, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TEN SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. AFTERWARDS, WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH, THE SMART COIL WAS STUCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, EIGHTEEN 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 11248281 ↗
• 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 (SMART COILS), NON-PENUMBRA COILS, A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO OTHER COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A SMART COIL PAST THE HUB OF THE MICROCATHETER, THE PHYSICIAN REPORTED THAT IT FELT TIGHT WHILE PUSHING THE COIL A FEW MILLIMETERS THROUGH THE HUB. IT WAS ALSO REPORTED THAT THE SMART COIL BECAME STUCK AND DID NOT ADVANCE PAST THE HUB. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ONE OTHER COIL, THE SAME MICROCATHETER, AND THE SAME BENCHMARK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10520890 ↗
• MalfunctionJun 10, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS STARTING POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10140935 ↗
• MalfunctionDec 19, 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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 9492688 ↗
• MalfunctionJul 19, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE WITHIN ITS 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 Consequences Or Impact To Patient

  MAUDE report 8807297 ↗
• MalfunctionMar 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CHOROIDAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS NOT ABLE TO ADVANCE THE SMART COIL INTO THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL AND ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED A SPACE BETWEEN THE TIP OF THE INTRODUCER SHEATH OF THE SMART COIL AND THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING A NEW SMART 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 8454190 ↗
• MalfunctionMar 26, 2019Failure to Advance; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Failure to Advance; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CHOROIDAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS NOT ABLE TO ADVANCE THE SMART COIL INTO THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL AND ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED A SPACE BETWEEN THE TIP OF THE INTRODUCER SHEATH OF THE SMART COIL AND THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING A NEW SMART 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 8454189 ↗
• MalfunctionFeb 21, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE TWO SMART COILS WITHIN THEIR INTRODUCER SHEATHS AND, THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW 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 8358352 ↗
• MalfunctionFeb 21, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE TWO SMART COILS WITHIN THEIR INTRODUCER SHEATHS AND, THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW 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 8358341 ↗
• MalfunctionJan 10, 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 SUCCESSFULLY PLACED TWO SMART 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 WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH AND THEREFORE, WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SMART 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 8235991 ↗
• MalfunctionJan 10, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE SMART COIL DISTAL DETACHMENT TIP (DDT) WAS PASSING THROUGH THE HUB OF THE MICROCATHETER AND THE SMART COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER BUT THE SAME ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. 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 8234159 ↗
• MalfunctionJan 10, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE SMART COIL DISTAL DETACHMENT TIP (DDT) WAS PASSING THROUGH THE HUB OF THE MICROCATHETER AND THE SMART COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER SMART COIL INTO THE MICROCATHETER BUT THE SAME ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. 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 8234154 ↗
• MalfunctionOct 25, 2018Failure 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 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH INTO A NON-PENUMBRA MICROCATHETER; 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 Consequences Or Impact To Patient

  MAUDE report 8007474 ↗
• MalfunctionOct 17, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN OPENED A NEW SMART COIL BUT IT WOULD NOT ADVANCE OUT OF ITS INTRODUCER AND INTO THE MICROCATHETER. AFTER TWO FAILED ATTEMPTS, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN OPENED ANOTHER SMART COIL BUT THE SAME ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A TWO 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 7975428 ↗
• MalfunctionSep 17, 2018Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING A SMART COIL WITHIN A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE MICROCATHETER AND SMART COIL WERE REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882414 ↗