Penumbra System SCH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 00814548016139), received between Oct 15, 2015 and Dec 6, 2021 — classified as 295 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (265 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 295 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA STENT, AND A NON-PENUMBRA BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN PLACED A STENT THROUGH A BALLOON CATHETER IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE EXPANDED STENT VIA THE BALLOON CATHETER TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING TWO DIFFERENT HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER COILS, THE SAME MICROCATHETER, THE SAME GUIDE CATHETER, AND THE SAME BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934643 ↗
• MalfunctionDec 6, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GUIDE CATHETER, A NON-PENUMBRA STENT, AND A NON-PENUMBRA BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, NARROWED, AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN PLACED A STENT THROUGH A BALLOON CATHETER IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE EXPANDED STENT VIA THE BALLOON CATHETER TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING TWO DIFFERENT HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER COILS, THE SAME MICROCATHETER, THE SAME GUIDE CATHETER, AND THE SAME BALLOON CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934637 ↗
• MalfunctionDec 2, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COIL) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL 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 STILL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER SMART COIL. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH TWO DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12921118 ↗
• MalfunctionDec 2, 2021Mechanical Problem; Mechanical Problem

  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 A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MADE SEVERAL ATTEMPTS AND BROKE THE PUSHER ASSEMBLY 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

  MAUDE report 12919706 ↗
• MalfunctionNov 22, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED FOUR SMART COILS USING THE HANDLE AND TWO NON-PENUMBRA COILS IN THE TARGET VESSEL. AFTER ADVANCING ANOTHER SMART COIL INTO THE TARGET LOCATION, THE HANDLE FAILED TO DETACH THE COIL AFTER SEVERAL ATTEMPTS. THEREFORE, THE SMART COIL AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE OTHER COILS, THE SAME MICROCATHETER AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857582 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA 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 COILS IN THE TARGET LOCATION. AFTER ADVANCING A SMART COIL INTO THE TARGET LOCATION, THE HANDLE FAILED TO DETACH THE SMART COIL AFTER THREE ATTEMPTS. THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL MANUALLY BY HAND AND BY CUTTING THE PUSHER ASSEMBLY USING PEAN FORCEPS, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. AFTER REMOVAL OF THE PUSHER ASSEMBLY OF THE SMART COIL FROM THE HUB OF THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE SMART COIL HAD DETACHED AROUND THE HUB OF THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED AT THIS POINT SINCE THE ANEURYSM WAS SUFFICIENTLY PACKED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12847605 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN NON-PENUMBRA COILS AND THREE SMART COILS USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER TWO ATTEMPTS. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844455 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), PENUMBRA SMART COILS (SMART COIL), PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A SMART COIL IN THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED A PACKING COIL LP IN THE TARGET VESSEL USING A SECOND HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP ALSO FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP WAS REMOVED. THEN, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. IT WAS REPORTED THAT A SECOND ATTEMPT MADE TO DETACH THE PACKING COIL LP WITH THE FIRST HANDLE WAS ALSO UNSUCCESSFUL. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841364 ↗
• MalfunctionNov 19, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), PENUMBRA SMART COILS (SMART COIL), PACKING COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A SMART COIL IN THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED A PACKING COIL LP IN THE TARGET VESSEL USING A SECOND HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP ALSO FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PACKING COIL LP WAS REMOVED. THEN, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. IT WAS REPORTED THAT A SECOND ATTEMPT MADE TO DETACH THE PACKING COIL LP WITH THE FIRST HANDLE WAS ALSO UNSUCCESSFUL. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841354 ↗
• MalfunctionNov 18, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) 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 A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER 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 WAS UNSUCCESSFUL. 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 12834173 ↗
• MalfunctionNov 15, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817316 ↗
• MalfunctionNov 15, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SMART COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE NEXT SMART COIL INTO THE ANEURYSM THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN PUT THE DISTAL END OF THE MICROCATHETER AGAINST THE ANEURYSM AND PUSHED THE SMART COIL IN IT. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE SMART COIL AGAIN AFTER WITHDRAWING THE MICROCATHETER A LITTLE, BUT THE SMART COIL WOULD NOT DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 12817044 ↗
• MalfunctionNov 10, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12790676 ↗
• MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SMART COIL (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL IN THE TARGET VESSEL 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 WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING THE SMART COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED SMART COIL INTO THE ANEURYSM USING A WIRE. 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

  MAUDE report 12780291 ↗
• MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET LOCATION USING THE FIRST HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE FIRST HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE BUT HAD DIFFICULTY DETACHING. THE PHYSICIAN THEN USED HIS FINGERS TO MANUALLY DETACH THE COIL AND SUCCESSFULLY IMPLANTED THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778987 ↗
• MalfunctionNov 9, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET LOCATION USING THE FIRST HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL INTO THE TARGET LOCATION AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE FIRST HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER SMART COIL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE BUT HAD DIFFICULTY DETACHING. THE PHYSICIAN THEN USED HIS FINGERS TO MANUALLY DETACH THE COIL AND SUCCESSFULLY IMPLANTED THE SMART COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778877 ↗
• MalfunctionOct 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR GLUTEAL ARTERY USING A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), PENUMBRA SMART COILS (SMART COILS), A NON-PENUMBRA MICROCATHETER AND GUIDING SHEATH. IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A SMART COIL IN THE TARGET SITE. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH THE SMART COIL WITH THE HANDLE AFTER MULTIPLE ATTEMPTS; THE HANDLE WAS NOT CLICKING. THEREFORE, THE SMART COIL AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND NEW HANDLE. ON THE BACK TABLE, THE PHYSICIAN RETRACTED THE SLIDER ON THE HANDLE MULTIPLE TIMES, AND THE HANDLE WAS FUNCTIONAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701480 ↗
• MalfunctionOct 26, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701086 ↗
• MalfunctionOct 26, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701071 ↗
• MalfunctionOct 26, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, A 5F DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH FIVE OTHER SMART COILS. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO DETACH THE SMART COILS WITH THREE DIFFERENT HANDLES. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701069 ↗
• MalfunctionOct 25, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A NEW HANDLE TO SUCCESSFULLY DETACH THE SMART COIL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12695024 ↗
• MalfunctionOct 23, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST SMART COIL INTO THE TARGET VESSEL AND MADE FOUR ATTEMPTS TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE HANDLE DID NOT CLICK. THEREFORE, THE HANDLE AND THE SMART COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 12686756 ↗
• MalfunctionOct 20, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTRACRANIAL VESSELS USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667858 ↗
• MalfunctionOct 16, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACA) 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 LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE TWO OTHER ATTEMPTS, BUT THE SMART COIL WOULD NOT DETACH. NEXT, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT IT WAS UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE SMART COIL USING MEDICAL PLIERS, BUT THE SMART COIL DID NOT DETACH. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT THE PUSHER ASSEMBLY KEPT STRETCHING BUT THE SMART COIL DID NOT DETACH. THE PHYSICIAN THEN DECIDED TO REMOVE THE SMART COIL. UPON RETRACTING APPROXIMATELY THREE CENTIMETERS OF THE SMART COIL INTO THE MICROCATHETER, THE SMART COIL DETACHED. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY OF THE SMART COIL AND THEN USED THE GUIDEWIRE TO SUCCESSFULLY PUSH THE DETACHED SMART COIL INTO THE TARGET LOCATION. THE PROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643846 ↗
• MalfunctionOct 10, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPINAL ARTERY 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 A SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT, BUT THE SMART COIL WOULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN PULLED ON THE TAB WITH MEDICAL CLAMPS AND SUCCESSFULLY DETACHED 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

  MAUDE report 12602663 ↗