Smart Coil 400SMTSFT0715Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00814548014722), received between Nov 21, 2016 and Oct 25, 2021 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2021Difficult to Advance; Difficult 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, TWO SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITION. THE FIRST SMART COIL WAS REMOVED FROM THE INTRODUCER SHEATH BY CUTTING OFF THE INTRODUCER SHEATH, THEN ADVANCED TO THE TARGET LOCATION, AND DETACHED INTO THE ANEURYSM. THE SECOND SMART COIL WAS UNABLE TO ADVANCE PAST THE ITS INITIAL POSITION AFTER MULTIPLE ATTEMPTS AND WAS REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE USING THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694978 ↗
• MalfunctionOct 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR INFERIOR CEREBELLAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITIONS OF THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661623 ↗
• MalfunctionSep 10, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL INTO THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE MICROCATHETER AND THE SMART COIL KICKED BACK. IT WAS REPORTED THAT THE SMART COIL WAS ABLE TO FORM IN THE ANEURYSM BUT THE PHYSICIAN DID NOT FEEL SAFE TO ADVANCE THE SMART COIL FURTHER. THEREFORE, THE SMART COIL WAS REMOVED INTACT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12456424 ↗
• MalfunctionAug 6, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN MANUALLY DETACHED THE SMART COIL; HOWEVER, THE DETACHED SMART COIL REMAINED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SMART COIL TO PUSH THE SMART COIL BACK INTO THE ANEURYSM. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THREE OTHER SMART COILS. THE THREE SMART COILS FAILED TO DETACH USING THE HANDLE. HOWEVER, THE PHYSICIAN MANUALLY DETACHED THE THREE SMART COILS INSIDE THE MICROCATHETER AND THEN USED THEIR RESPECTIVE PUSHER ASSEMBLIES TO PUSH THE SMART COILS BACK INTO THE ANEURYSM SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL 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

  MAUDE report 12291331 ↗
• InjuryJul 2, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT WAS IN A COMA BEFORE THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN USED A DUAL MICROCATHETER TECHNIQUE. A 7X15 SMART COIL WAS ADVANCED INTO THE TARGET LOCATION THROUGH THE FIRST MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN TRIED MULTIPLE TIMES TO DETACH THE SMART COIL, BUT THE SMART COIL WOULDN'T DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED WITH APPROXIMATELY 1CM INSIDE THE MICROCATHETER. AT THIS POINT, THE PHYSICIAN DECIDED TO PLACE THE 8X20 SMART COIL IN THE ANEURYSM THROUGH THE SECOND MICROCATHETER WITHOUT DETACHING IT. NEXT, HE DECIDED TO PUSH THE REST OF THE 7X15 SMART COIL USING THE PUSHER ASSEMBLY THROUGH THE FIRST MICROCATHETER. THE PHYSICIAN WAS ABLE TO PUSH 7X15 SMART COIL IN THE ANEURYSM; HOWEVER, A LOOP WAS SEEN. THE PHYSICIAN ASSUMED THAT LOOP CAME FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111462 ↗
• MalfunctionJun 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SMART COIL OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE SMART COIL WAS 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 11953378 ↗
• MalfunctionMay 17, 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 COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11833291 ↗
• MalfunctionJan 19, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO SMART COILS WERE DETACHED INTO THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE THIRD SMART COIL, IT DID NOT DETACH. AFTER THREE ATTEMPTS WERE MADE TO MANUALLY DETACH THE SMART COIL, IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING SIX NON-PENUMBRA COILS. 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 11198500 ↗
• MalfunctionSep 22, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WAS STUCK IN THE INTRODUCER SHEATH AND WOULD NOT ADVANCE FROM THE INITIAL POSITION. IT WAS REPORTED THAT THE PHYSICIAN MADE TWO UNSUCCESSFUL ATTEMPTS TO INSERT THE SMART COIL INTO THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWENTY OTHER 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 10571106 ↗
• MalfunctionJul 31, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE SMART COIL "FAILED TO DEPLOY" AFTER ADVANCING THROUGH A NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW SMART COIL, THE SAME HANDLE, AND THE SAME MICROCATHETER. THERE WAS NO REPORTED ISSUE WITH THE HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848642 ↗
• MalfunctionJun 28, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL; IT BECAME STUCK INSIDE OF THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE SMART COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744345 ↗
• MalfunctionApr 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS AND A NON-PENUMBRA STENT IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, EXPERIENCED RESISTANCE AND THE SMART COIL BECAME STUCK INSIDE OF THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED A KINK IN THE MICROCATHETER AND WAS UNABLE TO ADVANCE NEW SMART COILS AND OTHER ADDITIONAL COILS. THE ACCESS TO THE ANEURYSM WOULD BE LOST IF THE MICROCATHETER WAS TO BE REMOVED; THEREFORE, THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532496 ↗
• MalfunctionApr 19, 2019Failure 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 COIL). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS AND A NON-PENUMBRA STENT IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL THROUGH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL; HOWEVER, EXPERIENCED RESISTANCE AND THE SMART COIL BECAME STUCK INSIDE OF THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED A KINK IN THE MICROCATHETER AND WAS UNABLE TO ADVANCE NEW SMART COILS AND OTHER ADDITIONAL COILS. THE ACCESS TO THE ANEURYSM WOULD BE LOST IF THE MICROCATHETER WAS TO BE REMOVED; THEREFORE, THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532492 ↗
• MalfunctionApr 5, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE DISTAL TWO-THIRDS OF THE SMART COIL SEEMED STIFF AND UNABLE TO BEND WHILE BEING ADVANCED OUT OF THE NON-PENUMBRA MICROCATHETER AND INTO THE TARGET LOCATION, HOWEVER THE SMART COIL WAS SUCCESSFULLY PLACED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL, HOWEVER THE PROXIMAL END OF THIS SMART COIL ALSO SEEMED STIFF AND UNABLE TO BEND. WHILE PLACING THIS SMART COIL, THE TAIL OF THE FIRST SMART COIL SHIFTED, CAUSING IT PROTRUDE INTO THE ICA. THE PHYSICIAN WAS ABLE TO TRAP THE PROXIMAL END OF THE SMART COIL BETWEEN THE VESSEL WALL AND A NON-PENUMBRA STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399525 ↗
• InjuryJan 8, 2018Material Too Rigid or Stiff; Malposition of Device; Material Too Rigid or Stiff; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS. DURING THE PROCEDURE, TWO SMART COILS (F77124, C03494) WERE ADVANCED AND IMPLANTED USING A NON-PENUMBRA MICROCATHETER, AND AFTER BEING DETACHED, THE PROXIMAL ENDS OF THE COILS MIGRATED OUT OF THE ANEURYSM, SO THE SMART COILS WERE ONLY PARTIALLY WITHIN THE ANEURYSM. NEXT, TWO OTHER SMART COILS (F78441, F78758) FELT GRITTY AND WERE NOT ABLE TO BE ADVANCED INTO THE MICROCATHETER, AND THEREFORE THE SMART COILS WERE REMOVED. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL (F74006) OUT OF ITS INTRODUCER SHEATH, AND THEREFORE THE SMART COIL WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN WAS ABLE TO ADVANCE A SIXTH SMART COIL (F74006) THROUGH THE RHV, BUT WAS UNABLE TO ADVANCE IT INTO THE HUB OF THE MICROCATHETER, AND THEREFORE THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN WAS UNABLE TO ADVANCE THE SEVENTH SMART COIL (F73219) OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, AND THEREFORE THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL SMART COILS. THE PHYSICIAN ALSO DEPLOYED TWO STENTS INTO THE LEFT AND RIGHT POSTERIOR CEREBRAL ARTERY (PCA)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171928 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING EIGHT PENUMBRA SMART COILS (SMART COILS) WITH NO COMPLICATIONS. LATER THAT DAY, THE PATIENT WAS FOUND TO HAVE TRANSIENT EYE FLOATERS IN THE LEFT EYE OF MODERATE SEVERITY. A COMPUTED TOMOGRAPHY (CT) WAS TAKEN AND WAS NEGATIVE FOR STROKE. THE PHYSICIAN SUSPECTED THAT THE EYE FLOATERS MAY HAVE BEEN TRANSIENT DUE TO THE LARGER AMOUNT OF CONTRAST ADMINISTERED DURING THE PROCEDURE THAN NORMAL. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. ON (B)(6) 2017, THE PATIENT EXPERIENCED NEUROLOGICAL DECLINE OF RIGHT-SIDED WEAKNESS, RESULTING IN PROLONGED HOSPITALIZATION. A CT ANGIOGRAPHY WAS TAKEN, WHICH SHOWED SCATTERED PUNCTUATED INFARCTS THROUGHOUT THE BILATERAL FRONTAL AND PARIETAL LOBES SUGGESTIVE OF EMBOLIC DISEASE. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2017. THE REPORTED TRANSIENT EYE FLOATERS WAS ADJUDICATED BY THE PHYSICIAN TO BE POSSIBLY RELATED TO THE DISEASE STATE, PROCEDURE, AND THE SMART COIL SYSTEM. THE REPORTED NEUROLOGICAL DECLINE WAS ADJUDICATED BY THE PHYSICIAN TO BE UNRELATED TO THE DISEASE STATE, POSSIBLY RELATED

  Patient problems: Infarction, Cerebral; Vitreous Floaters; Weakness

  MAUDE report 6664804 ↗
• MalfunctionNov 21, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING ANOTHER MANUFACTURER¿S MICROCATHETER AND REALIZED THAT THE SIZE OF THE COIL DID NOT MATCH THE SIZE OF THE ANEURYSM. THEREFORE, THE SMART COIL WAS RETRACTED AND RE-SHEATHED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN REALIZED THAT THE COIL SIZE DID NOT MATCH THE SIZE OF THE ANEURYSM. THEREFORE, THE SMART COIL WAS RETRACTED AND RE-SHEATHED. IT WAS REPORTED THAT THE PHYSICIAN SOAKED THE SMART COILS IN HEPARINIZED SALINE AFTER THEY WERE RETRACTED. THEREAFTER, THE PHYSICIAN DEPLOYED AND DETACHED A NEW SMART COIL AND ANOTHER MANUFACTURER¿S COIL IN THE ANEURYSM USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO USE ONE OF THE PREVIOUS SMART COILS THAT WERE REMOVED FROM THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH. BOTH SMART COILS WERE THEN DISCARDED BEFORE BEING RETRIEVED AGAIN. HOWEVER, AFTER RETRIEVAL FROM THE GARBAGE, ONE OF THE SMART COILS WAS DETACHED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117029 ↗