Smart Coil 400SMTSTD0930Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00814548014364), received between Dec 1, 2017 and Sep 16, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL HANDLES (HANDLES). DURING THE PROCEDURE, FOUR SMART COILS WOULD NOT DETACH USING TWO HANDLES. IT WAS REPORTED THAT THE HANDLES CREATED SMALL SEPARATION OF THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE SMART COILS PUSHER ASSEMBLIES BUT THE SMART COILS WOULD NOT DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COILS IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND A THIRD HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484930 ↗
• MalfunctionSep 11, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE INITIAL POSITION. THE SMART COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER SMART COIL. HOWEVER, THE SAME ISSUE OCCURRED, AND THE SECOND SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED FOUR SMART COILS INDIVIDUALLY TO THE TARGET VESSEL. THE HANDLE TOOK TWO TO THREE ATTEMPTS TO DETACH THE FIRST, SECOND, AND THIRD SMART COILS, AND THE HANDLE WAS UNABLE TO DETACH THE FOURTH SMART COIL. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE FOURTH SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND ANOTHER HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10522704 ↗
• MalfunctionJan 10, 2018Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE SMART COIL APPROXIMATELY THREE QUARTERS INTO THE ANEURYSM AND SUBSEQUENTLY, THE SMART COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME MICROCATHETER WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178664 ↗
• MalfunctionDec 19, 2017Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ASCENDING AORTA USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE SMART COILS USING A NON-PENUMBRA MICROCATHETER, BUT ALSO FELT RESISTANCE ADVANCING FOUR SMART COILS OUT OF THE MICROCATHETER AND INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING DIFFICULTY SEEING WHEN THE SMART COILS EXITED THE MICROCATHETER, AND THEREFORE THE PHYSICIAN WAS UNSURE WHETHER THE RESISTANCE WAS CAUSED BY THE MICROCATHETER POSITIONING, A POSSIBLE KINK IN THE MICROCATHETER, OR WHETHER THE RESISTANCE WAS DUE TO THE SMART COILS. THE FOUR SMART COILS WERE THEREFORE RETRACTED, AND THE PROCEDURE WAS CONTINUED USING SHORTER SMART COILS. THE PROCEDURE WAS THEN COMPLETED USING A LANTERN DELIVERY MICROCATHETER AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131125 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING PENUMBRA SMART COILS (SMART COILS). AFTER THE SMART COILS WERE SUCCESSFULLY PLACED, THE HOSPITAL STAFF NOTICED A SMALL THROMBUS FORMED WITHIN THE P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY (PCA). THE THROMBUS WAS NOT FLOW LIMITING, AND THE PHYSICIAN TREATED IT WITH A HALF BOLUS OF INTEGRILIN, HOWEVER AFTER 10-15 MINUTES THE THROMBUS WAS STILL PRESENT. ANOTHER HALF BOLUS OF INTEGRILIN WAS ADMINISTERED, BUT WAS STILL INEFFECTIVE AT TREATING THE THROMBUS, AND THEREFORE THE DECISION WAS MADE TO ASPIRATE THE THROMBUS. THE PHYSICIAN USED A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) TO ATTEMPT TO REMOVE THE THROMBUS FROM THE P1 SEGMENT, HOWEVER THE PHYSICIAN WAS UNABLE TO REMOVE THE THROMBUS, AND THE OCCLUSION BECAME WORSE. THERE WAS STILL GOOD DISTAL FLOW THROUGH POSTERIOR COMMUNICATING ARTERY FROM THE ANTERIOR CIRCULATION. A SMALL DISSECTION IN THE MID-BASILAR ARTERY WAS THEN FOUND, WHICH WAS ALSO NOT FLOW LIMITING, AND WHICH WAS NOT RELATED TO THE SMART COIL SYSTEM. THE PATIENT WAS THEREFORE TREATED USING AN INTEGRILIN DRIP AND ASPIRIN WITHOUT STENT

  Patient problems: Thrombus

  MAUDE report 7076307 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING PENUMBRA SMART COILS (SMART COILS). AFTER THE SMART COILS WERE SUCCESSFULLY PLACED, THE HOSPITAL STAFF NOTICED A SMALL THROMBUS FORMED WITHIN THE P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY (PCA). THE THROMBUS WAS NOT FLOW LIMITING, AND THE PHYSICIAN TREATED IT WITH A HALF BOLUS OF INTEGRILIN, HOWEVER AFTER 10-15 MINUTES THE THROMBUS WAS STILL PRESENT. ANOTHER HALF BOLUS OF INTEGRILIN WAS ADMINISTERED, BUT WAS STILL INEFFECTIVE AT TREATING THE THROMBUS, AND THEREFORE THE DECISION WAS MADE TO ASPIRATE THE THROMBUS. THE PHYSICIAN USED A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) TO ATTEMPT TO REMOVE THE THROMBUS FROM THE P1 SEGMENT, HOWEVER THE PHYSICIAN WAS UNABLE TO REMOVE THE THROMBUS, AND THE OCCLUSION BECAME WORSE. THERE WAS STILL GOOD DISTAL FLOW THROUGH POSTERIOR COMMUNICATING ARTERY FROM THE ANTERIOR CIRCULATION. A SMALL DISSECTION IN THE MID-BASILAR ARTERY WAS THEN FOUND, WHICH WAS ALSO NOT FLOW LIMITING, AND WHICH WAS NOT RELATED TO THE SMART COIL SYSTEM. THE PATIENT WAS THEREFORE TREATED USING AN INTEGRILIN DRIP AND ASPIRIN WITHOUT STENT

  Patient problems: Thrombus

  MAUDE report 7076300 ↗