Smart Coil 400SMTHXSFT0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00814548015590), received between Dec 14, 2017 and Dec 31, 2021 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETERS, AND A NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED NON-PENUMBRA COILS IN THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION 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 THE COIL WOULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, UPON RETRACTING, THE SMART COIL HAD UNINTENTIONALLY DETACHED AROUND THE MIDSHAFT OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13130525 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WITHOUT ANY PROCEDURAL COMPLICATIONS OR DEVICE MALFUNCTIONS. ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND AN ISCHEMIC STROKE IN THE IPSILATERAL M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS NOTED. SUBSEQUENTLY, THE PATIENT¿S BLOOD PRESSURE WAS MONITORED. THE PATIENT WAS ALSO ADMINISTERED MILD HEPARIN AND NO PROGRESSION OF THE STROKE WAS OBSERVED. THE PATIENT WAS IN STABLE CONDITION, INTUBATED AND ON ANALGESICS. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY WITH CLINICAL SEQUELAE. ON (B)(6) 2021, INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS UNRELATED TO THE SMART COILS AND PROBABLY RELATED TO THE INDEX PROCEDURE. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS POSSIBLY RELATED TO THE SMART COILS.

  Patient problems: Ischemia Stroke

  MAUDE report 12651449 ↗
• MalfunctionSep 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE ANEURYSM WAS BI-LOBED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO SMART COILS IN THE LARGER LOBE OF THE ANEURYSM USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND, WHILE POSITIONING THE SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO STOP COILING THE LARGER LOBE OF THE ANEURYSM. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SMART COIL IN THE SMALLER LOBE OF THE ANEURYSM USING THE HANDLE. WHILE ATTEMPTING TO DETACH ANOTHER SMART COIL IN THE TARGET LOCATION USING THE HANDLE, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REPOSITION THE SMART COIL. HOWEVER, WHILE REPOSITIONING, THE PHYSICIAN LOST ACCESS WITH THE MICROCATHETER. THEREFORE, THE SMART COIL WAS ALSO RETRAC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443630 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA)/ MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND PENUMBRA SMART COILS (SMART COILS). IT WAS REPORTED THE PATIENT HAD BEEN PREVIOUSLY TREATED FOR ANEURYSMS. DURING THE PROCEDURE, THE NEURON MAX WAS PLACED INTO THE CERVICAL RIGHT INTERNAL CAROTID ARTERY (ICA) USING THE ROADMAP TECHNIQUE, DOUBLE FLUSHED AND CONNECTED TO A CONTINUOUS HEPARINIZED SALINE INFUSION. THE PATIENT HAD MULTIPLE VASOSPASMS REQUIRING 10MG IA IN LEFT VERTEBRAL ARTERY AND 5MG IA VERAPAMIL IN RIGHT INTERNAL CAROTID ARTERY (ICA) AND AN ADDITIONAL 5MG. BALLOON ANGIOPLASTY WAS PERFORMED IN M1 SEGMENT DUE TO THE VASOSPASMS WHICH WERE RESOLVED ON THE SAME DAY. THE VASOSPASM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND TO THE NEURON MAX. DURING THE PROCEDURE, THE FIRST SMART COIL WAS SUCCESSFULLY IMPLANTED. WHILE PLACING THE SECOND SMART COIL THROMBUS FORMATION WAS NOTED. HALF CARDIAC BOLUS DOSE OF TIROFIBAN WAS ADMINISTERED, AND LATER ANOTHER HALF CARDIAC DOSE OF TIROFIBAN WAS ADMINISTERED. PATIENT WAS GIVEN TIROF

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 11845806 ↗
• MalfunctionJan 15, 2021Failure 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) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST MADE MULTIPLE ATTEMPTS TO ADVANCE THE SMART COIL WITHIN THE INTRODUCER SHEATH; HOWEVER, THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS FRICTION LOCK. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11179720 ↗
• MalfunctionOct 11, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) 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 INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER EIGHT ATTEMPTS. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE SMART COIL. THE PROCEDURE WAS COMPLETED USING OTHER 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 10660068 ↗
• MalfunctionOct 1, 2020Failure 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, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL IN THE TARGET VESSEL. NEXT, TWO SMART COILS WERE UNABLE TO ADVANCE PAST THE INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 10617708 ↗
• MalfunctionOct 1, 2020Failure 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, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL IN THE TARGET VESSEL. NEXT, TWO SMART COILS WERE UNABLE TO ADVANCE PAST THE INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 10617653 ↗
• MalfunctionAug 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE, THE PATIENT¿S VESSEL WAS PERFORATED USING A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO USE PENUMBRA SMART COILS (SMART COILS) TO STOP THE BLEEDING; HOWEVER, SIX SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE NEXT THREE SMART COILS WERE IMPLANTED IN THE TARGET LOCATION USING THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL USING THE HANDLE, IT WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS; THEREFORE, THIS SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING FIVE SMART 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 10354072 ↗
• MalfunctionAug 1, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE, THE PATIENT¿S VESSEL WAS PERFORATED USING A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO USE PENUMBRA SMART COILS (SMART COILS) TO STOP THE BLEEDING; HOWEVER, SIX SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE NEXT THREE SMART COILS WERE IMPLANTED IN THE TARGET LOCATION USING THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL USING THE HANDLE, IT WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS; THEREFORE, THIS SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING FIVE SMART 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 10354070 ↗
• MalfunctionAug 1, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY. DURING THE PROCEDURE, THE PATIENT¿S VESSEL WAS PERFORATED USING A NON-PENUMBRA GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO USE PENUMBRA SMART COILS (SMART COILS) TO STOP THE BLEEDING; HOWEVER, SIX SMART COILS WOULD NOT ADVANCE PAST THEIR INITIAL POSITIONS WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE SMART COILS WERE NOT USED IN THE PROCEDURE. THE NEXT THREE SMART COILS WERE IMPLANTED IN THE TARGET LOCATION USING THE PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). WHILE ATTEMPTING TO IMPLANT THE NEXT SMART COIL USING THE HANDLE, IT WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL WITHOUT SUCCESS; THEREFORE, THIS SMART COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING FIVE SMART 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 10354068 ↗
• MalfunctionNov 25, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN OPENED ANOTHER SMART COIL, AND IT WOULD NOT ADVANCE 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 9373279 ↗
• MalfunctionOct 9, 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 COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND REPORTED THAT THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH INTO THE NON-PENUMBRA MICROCATHETER. THE SMART COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. 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 9172670 ↗
• MalfunctionSep 10, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. A NEW SMART COIL WAS OPENED AND WAS ALSO UNABLE TO ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A THIRD SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981651 ↗
• MalfunctionSep 10, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. A NEW SMART COIL WAS OPENED AND WAS ALSO UNABLE TO ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A THIRD SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981650 ↗
• MalfunctionJun 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED EXTREME RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL, BUT THE SAME ISSUE OCCURRED AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A THIRD SMART COIL; HOWEVER, THE PHYSICIAN CONTINUED TO PUSH VERY HARD AND REPORTED THAT HE FELT IT ¿POPPED¿ FORWARD AND THE SMART COIL WAS SUCCESSFULLY PLACED IN THE TARGET VESSEL AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8720416 ↗
• MalfunctionJun 20, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED EXTREME RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL, BUT THE SAME ISSUE OCCURRED AND, THEREFORE, IT WAS REMOVED. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A THIRD SMART COIL; HOWEVER, THE PHYSICIAN CONTINUED TO PUSH VERY HARD AND REPORTED THAT HE FELT IT ¿POPPED¿ FORWARD AND THE SMART COIL WAS SUCCESSFULLY PLACED IN THE TARGET VESSEL AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8720412 ↗
• MalfunctionMar 12, 2019Unintended Collision; Unintended Collision

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (RMCA) USING PENUMBRA SMART COILS (SMART COILS). DURING IMPLANTATION OF A 1X1 SMART COIL, THE IMPLANTED 2X3 SMART COIL WAS PUSHED OUT OF THE TARGET VESSEL. THE 2X3 SMART COIL THEN MIGRATED OUT OF THE RMCA ANEURYSM INTO THE M3 SEGMENT OF THE MCA. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE 2X3 SMART COIL USING A SNARE DEVICE, THE COIL WAS LEFT IN THE M3, THE 1X1 SMART COIL WAS NOT USED AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413594 ↗
• MalfunctionJun 15, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER. THE SMART COIL WAS, THEREFORE, REMOVED, AND THE PROCEDURE WAS COMPLETED USING ALTERNATIVE DEVICES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606063 ↗
• MalfunctionMar 5, 2018Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Detachment Of Device Component; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) THEN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH THE BENCHMARK. WHILE ATTEMPTING TO ADVANCE A SMART COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE PHYSICIAN REALIZED THAT THE SMART COIL WOULD NOT FIT INTO THE VESSEL AND DECIDED TO REMOVE IT; HOWEVER, UPON RETRACTION THE SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND FLUSHED IT. THE PHYSICIAN THEN NOTICED THAT THE DETACHED COIL WAS NOT IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE BENCHMARK AND FLUSHED THE DETACHED COIL OUT. THE PROCEDURE WAS COMPLETED BY PLACING A STENT DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7313903 ↗
• MalfunctionDec 14, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COILS THROUGH A MICROCATHETER. ALTHOUGH THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT, MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. AS OF 14 DEC 2017, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117622 ↗