Penumbra System DH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI M424DH10), received between Aug 16, 2013 and May 14, 2021 — classified as 72 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (40 reports).

1 other recall cover devices cleared under the same FDA submission (K103305); they may or may not involve this specific model.

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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DETACH A PC400 USING THE HANDLE, THE COIL ALIGNMENT ZONE SEPARATED BUT THE COIL DID NOT DETACH. IT WAS REPORTED THAT THE CLICK OF THE HANDLE WAS NOT AUDIBLE. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO DETACH THE PC400 USING THE HANDLE; HOWEVER, THE PUSHER ASSEMBLY OF THE PC400 BECAME STUCK IN THE HANDLE. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PC400. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED ANOTHER PC400 IN THE TARGET VESSEL USING ANOTHER HANDLE. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT PC400 THROUGH THE MICROCATHETER, THE PC400 UNINTENTIONALLY DETACHED AND BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT. 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 11828683 ↗
• MalfunctionApr 7, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES), A RUBY COIL DETACHMENT HANDLE (HANDLE), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED A PC400 INTO THE TARGET LOCATION USING THE HANDLE. HOWEVER, THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400 THAT WAS STUCK IN THE HANDLE. AFTER THAT, THE SCRUB TECHNOLOGIST REMOVED THE PUSHER ASSEMBLY OF THE PC400 WITH THE HANDLE ATTACHED FROM THE PX SLIM. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER PC400 INTO THE TARGET LOCATION USING A SECOND HANDLE. HOWEVER, THE SAME ISSUE OCCURRED. THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400. SUBSEQUENTLY, THE SCRUB TECHNOLOGIST BROKE THE PUSHER ASSEMBLY OF THE PC400 AN INCH FROM THE HANDLE AND SET IT ASIDE. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER PC400 INTO THE TARGET LOCATION USING A THIRD HANDLE. HOWEVER, THE SAME ISSUE OCCURRED. THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400. CONSEQUENTLY, THE SCRUB TECHNOLOGIST WAS NOT ABLE TO PULL OUT THE PUSHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627630 ↗
• MalfunctionApr 7, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES), A RUBY COIL DETACHMENT HANDLE (HANDLE), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED A PC400 INTO THE TARGET LOCATION USING THE HANDLE. HOWEVER, THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400 THAT WAS STUCK IN THE HANDLE. AFTER THAT, THE SCRUB TECHNOLOGIST REMOVED THE PUSHER ASSEMBLY OF THE PC400 WITH THE HANDLE ATTACHED FROM THE PX SLIM. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER PC400 INTO THE TARGET LOCATION USING A SECOND HANDLE. HOWEVER, THE SAME ISSUE OCCURRED. THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400. SUBSEQUENTLY, THE SCRUB TECHNOLOGIST BROKE THE PUSHER ASSEMBLY OF THE PC400 AN INCH FROM THE HANDLE AND SET IT ASIDE. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER PC400 INTO THE TARGET LOCATION USING A THIRD HANDLE. HOWEVER, THE SAME ISSUE OCCURRED. THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400. CONSEQUENTLY, THE SCRUB TECHNOLOGIST WAS NOT ABLE TO PULL OUT THE PUSHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627626 ↗
• MalfunctionFeb 17, 2021Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS FISTULA (PAVF) USING RUBY COILS AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED SIX RUBY COILS IN THE TARGET LOCATION USING THE HANDLE. THEN, THE PHYSICIAN PLACED THE SEVENTH RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A NEW HANDLE TO DETACH THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD PACKING COILS AND THE SAME SECOND HANDLE. 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 11339656 ↗
• MalfunctionNov 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) AND PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL INTO THE TARGET LOCATION USING THE HANDLE. HOWEVER, THE SMART COIL PUSHER WIRE BECAME STUCK IN THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND SMART 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 10879551 ↗
• MalfunctionNov 17, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PARA-OPHTHALMIC GIANT INTRACRANIAL ANEURYSM (GIA) USING PENUMBRA COIL 400S (PC400), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED THREE PC400S INTO THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN PLACED AND DETACHED A FOURTH PC400 IN THE ANEURYSM USING THE HANDLE; HOWEVER, THE PUSHER ASSEMBLY OF THE PC400 BECAME JAMMED INSIDE THE HANDLE AND THE PHYSICIAN WAS UNABLE TO REMOVE IT. THEREFORE, THE HANDLE WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL PC400 AND A POD DETACHMENT HANDLE (HANDLE). 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 10854240 ↗
• MalfunctionFeb 28, 2020Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A RUBY COIL, A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH THE RUBY COIL USING THE HANDLE AFTER SEVERAL ATTEMPTS. THEREFORE, THE PHYSICIAN USED A HEMOSTAT FORCEPS TO PULL THE PUSHER ASSEMBLY AND DETACH THE COIL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9767841 ↗
• MalfunctionFeb 19, 2020Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE SINUS USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) AND PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A PC400 IN THE TARGET VESSEL USING THE HANDLE. HOWEVER, THE PUSHER ASSEMBLY OF THE PC400 BECAME STUCK IN THE HANDLE; THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE AND ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729751 ↗
• MalfunctionDec 9, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE INITIAL PC400S IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A NEW PC400 INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440585 ↗
• MalfunctionSep 25, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING A PENUMBRA COIL 400 (PC400) AND PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 THROUGH A NON-PENUMBRA MICROCATHETER AND INTO THE ABDOMINAL AORTIC ANEURYSM (AAA) SAC THROUGH THE TARGET VESSEL. THE PHYSICIAN THEN MADE FOUR ATTEMPTS TO DETACH THE PC400 USING THE HANDLE BUT WAS UNABLE TO DO SO. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE PC400 BUT ALSO WAS UNABLE TO DO SO. WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED, AND THE PC400 WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS, THE SAME MICROCATHETER, AND N-BUTYL CYANOACRYLATE (NBCA) INJECTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117688 ↗
• MalfunctionSep 10, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN DETACHED A PC400 USING THE HANDLE, HOWEVER, THE PHYSICIAN THEN FOUND THAT THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS STUCK IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. WHILE PREPARING ANOTHER PC400 FOR THE PROCEDURE, THE HOSPITAL STAFF FOUND THAT IT WAS KINKED WITHIN ITS PACKAGING. THE DAMAGE TO THIS PC400 WAS FOUND PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984700 ↗
• MalfunctionAug 14, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A PC400 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THE HANDLE. IT WAS REPORTED THAT THE HANDLE WAS DEPRESSED SEVERAL TIMES BEFORE THE FIRST PC400 DETACHED INTO THE VESSEL. THE PHYSICIAN THEN ADVANCED A SECOND PC400 INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, THE SAME PC400 AND ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895042 ↗
• MalfunctionAug 7, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400) AND PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PC400 COULD NOT BE DETACHED USING THE HANDLE. THEREFORE, THE PC400 WAS REMOVED. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE PC400 OUT OF PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PROCEDURE WAS COMPLETED USING A NEW PC400, SAME HANDLE AND SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869711 ↗
• MalfunctionJun 18, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERICALLOSAL ARTERY USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE PC400 IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE, BUT REPORTED THAT THE PC400 WOULD NOT DETACH AFTER SEVERAL ATTEMPTS. THE PC400 AND THE HANDLE WERE THEREFORE REMOVED AND WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER 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 8709525 ↗
• MalfunctionApr 24, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH A PC400 IN THE TARGET LOCATION USING THE HANDLE, DESPITE THE PROXIMAL DETACHMENT MARKER BEING SEPARATED. THE PHYSICIAN THEN WAS UNABLE TO REMOVE THE PROXIMAL END OF THE PUSHER ASSEMBLY FROM THE HANDLE. THEREFORE, THE PC400 AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547562 ↗
• MalfunctionMar 28, 2019Device Damaged Prior to Use; Difficult or Delayed Activation; Device Damaged Prior to Use; Difficult or Delayed Activation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE PHYSICIAN WAS TESTING THE PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) AND REPORTED THAT THE TRIGGER WAS SLOW AND DID NOT MAKE THE ''POPPING'' SOUND. THE ISSUE WITH THE HANDLE WAS FOUND PRIOR TO USE AND, THEREFORE, THE HANDLE WAS NOT USED IN THE PROCEDURE. SUBSEQUENTLY, THE PHYSICIAN LOST ACCESS TO THE TARGET VESSEL AND THE PROCEDURE WAS ENDED.

  Patient problems: No Patient Involvement

  MAUDE report 8459466 ↗
• MalfunctionMar 12, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CAROTID ARTERY (RCA) USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PENUMBRA SALES REPRESENTATIVE REMOVED THE HANDLE FROM ITS PACKAGING AND FOUND THAT THE TIP WAS BROKEN OFF FROM THE MAIN HANDLE. THE HANDLE WAS THEREFORE, NOT USED IN THE PROCEDURE. THE PROCEDURE AS COMPLETED USING A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413403 ↗
• MalfunctionFeb 5, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PC400 AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304790 ↗
• MalfunctionJan 24, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A POD DETACHMENT HANDLE (HANDLE) AND A POD6. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE POD6 IN THE TARGET VESSEL; HOWEVER, WAS UNABLE TO DETACH THE COIL USING THE HANDLE. A NEW HANDLE WAS USED TO SUCCESSFULLY DETACH THE POD6, AND THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS AND THE SAME NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8276495 ↗
• MalfunctionDec 21, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, UPON OPENING THE PACKAGING OF A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), THE HOSPITAL TECHNICIAN DISCOVERED THAT THE FUNNEL CAP HAD BROKEN OFF. THE DAMAGE TO THE HANDLE WAS NOTICED PRIOR TO USE; THEREFORE, THE HANDLE WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 8190325 ↗
• MalfunctionDec 6, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE DISTAL TIP OF A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) WAS DETACHED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED HANDLE WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 8139900 ↗
• MalfunctionNov 21, 2018Break; Break

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN FOUND THAT THE TIP OF A PENUMBRA COIL DETACHMENT HANDLE (HANDLE) HAD BROKEN OFF WHILE THE HANDLE WAS BEING REMOVED FROM ITS PACKAGING. THE DAMAGE TO THE HANDLE WAS FOUND PRIOR TO USE AND, THEREFORE, THE HANDLE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098013 ↗
• MalfunctionOct 25, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER PC400 WITHIN THE MICROCATHETER AND, THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO P400S. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER PC400, HOWEVER WAS UNABLE TO DETACH THE EMBOLIZATION COIL USING THE HANDLE. THE PHYSICIAN THEREFORE USED A NEW HANDLE TO SUCCESSFULLY DETACH THE COIL. THE PROCEDURE WAS THEN COMPLETED USING FIVE ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8007655 ↗
• MalfunctionOct 11, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE) PACKAGING AND NOTICED THAT THE FUNNEL CAP HAD BROKEN OFF. THE DAMAGE TO THE HANDLE WAS NOTICED PRIOR TO USE; THEREFORE, THE HANDLE WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 7958844 ↗
• MalfunctionOct 9, 2018Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A POD8 AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD8 INTO THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE POD8 FAILED TO DETACH. THE PHYSICIAN THEN MADE THREE TO FOUR ADDITIONAL ATTEMPTS BUT THE POD8 WOULD STILL NOT DETACH. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) WAS NOT SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE AND THE SAME POD8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103305. One submission often covers many models, so check the product and lot details in each record.

• Z-1906-2011 · Mar 4, 2011 · Terminated
  Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is in