Smart Coil 400SMTSTD1160Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548014425), received between Dec 11, 2017 and Mar 8, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 8, 2018Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND THE SMART COIL BECAME STUCK APPROXIMATELY 20 CM FROM THE TIP OF THE MICROCATHETER; THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SMART COIL USING THE SAME MICROCATHETER, HOWEVER THE SAME INCIDENT OCCURRED. THE PHYSICIAN THEREFORE REMOVED THE SMART COIL, AND USED THE MICROCATHETER TO PLACE ANOTHER EMBOLIZATION SYSTEM. THE MICROCATHETER WAS THEN REMOVED, AND A NEW NON-PENUMBRA MICROCATHETER WAS PLACED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED TWO SMART COILS USING THE MICROCATHETER. NEXT, WHILE ADVANCING A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE SMART COIL MORE THAN ABOUT HALFWAY OUT OF THE TIP OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SMART COIL BY APPLYING MORE FORCE, AND CONSEQUENTLY THE SMART COIL PUSHER ASSEMBLY BROKE OUTSIDE OF THE PATIENT NEAR THE RHV. THE PHYSICIAN THEREFORE REMOVED THE PUSHER A

  Patient problems: Death; No Consequences Or Impact To Patient

  MAUDE report 7324654 ↗
• InjuryDec 11, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INTRA-CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRACT A SMART COIL INTO A NON-PENUMBRA MICROCATHETER FOR REPOSITIONING, THE SMART COIL UNINTENTIONALLY DETACHED OUTSIDE OF THE MICROCATHETER AND IN THE ANEURYSM. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE DETACHED SMART COIL, BUT THE SMART COIL FRAGMENTED INTO PIECES DURING THE ATTEMPT TO SNARE. MAJORITY OF THE COIL WAS REMOVED BY THE SNARE DEVICE. HOWEVER, SOME FRAGMENTS REMAINED OUTSIDE THE ANEURYSM INSIDE THE PATIENT¿S BODY. THE PROCEDURE THEN CONTINUED USING 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 7104779 ↗