Penumbra Coil 400 4002C2060Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI M4244002C20600), received between Dec 22, 2015 and Sep 16, 2021 — classified as 7 injuries, 26 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2021Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE. NEXT, THE PHYSICIAN THOUGHT THERE MUST BE SOME SLACK IN THE PX SLIM AND RELIEVED IT BY PULLING THE PX SLIM SLIGHTLY BACK; HOWEVER, NO SLACK WAS OBSERVED VIA FLUOROSCOPY. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED HALFWAY OUT THE DISTAL END OF THE PX SLIM WITH THAT PART OF THE COIL IN THE TARGET VESSEL. THEREFORE, THE PHYSICIAN SUCCESSFULLY REMOVED PART OF THE DETACHED PC400 USING A SNARE DEVICE, AND SOME WITH THE HELP OF ASPIRATION AND A STENT RETRIEVER. IT WAS REPORTED THAT WHILE REMOVING THE DETACHED PC400, THE PC400 BROKE INTO PIECES. NEXT, THE PHYSICIAN ADVANCED ANOTHER PC400 INTO THE TARGET VESSEL. WHILE FORMING THE PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE DETACHED PC400; HOWEVER, A STRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485674 ↗
• MalfunctionFeb 7, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE MICROCATHETER THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PC400. HOWEVER UPON RETRACTION, THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PC400 AND THEN REMOVED THE PC400. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER PC400; HOWEVER, THE SAME ISSUE OCCURRED, AND THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC 400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9682956 ↗
• MalfunctionSep 25, 2019Separation Failure; Premature Separation; Separation Failure; Premature Separation

  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 9117699 ↗
• MalfunctionJul 3, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 MORE THAN 50CM INTO THE (PX SLIM) AND, THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE SAME PC400, HOWEVER, THE SAME RESISTANCE WAS FELT. THE PROCEDURE WAS THEN CONTINUED USING A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8758045 ↗
• InjuryJul 2, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA COIL 400 (PC400), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), TWO NON-PENUMBRA MICROCATHETERS AND A NON-PENUMBRA BALLOON CATHETER. DURING THE PROCEDURE, A PC400 WAS PLACED IN THE ANEURYSM. THE PHYSICIAN NOTICED THERE WAS SIGNIFICANT HERNIATION INTO THE PARENT VESSEL LUMEN DUE TO THE WIDE NECK NATURE OF THE LESION. THEREFORE, THE PHYSICIAN DECIDED TO PROCEED WITH PIPELINE EMBOLIZATION SYSTEM PLACEMENT FIRST AND THE MICROCATHETER THAT WAS BEING USED WAS REMOVED. A DIFFERENT MICROCATHETER WAS THEN ADVANCED OVER AN EXCHANGE WIRE; HOWEVER, THE MICROCATHETER ABUTTED THE ANEURYSM ICA INTERFACE AND SUBSEQUENTLY, THE PHYSICIAN LOST ACCESS. WHILE ATTEMPTING TO REMOVE THE PC400, THE COIL BROKE INSIDE THE MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE COIL EXTENDED FROM THE ANEURYSM DOWN INTO THE ABDOMINAL REGION OF THE NEURON MAX. THE PHYSICIAN THEN USED A BALLOON CATHETER TO SUCCESSFULLY REMOVE THE DETACHED PC400 FROM THE PATIENT. IT WAS REPORTED THAT AT ONE POINT OF THE PROCEDURE THE PATIENT WAS GIVEN AN INFUSION OF INTRA-ARTERI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753262 ↗
• InjuryMay 22, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 APPROXIMATELY 45 CM OUT OF A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET VESSEL AND SUBSEQUENTLY DECIDED TO RETRACT THE PC400 TO RE-POSITION IT. WHILE ATTEMPTING TO RETRACT THE PC400 BACK INTO THE LANTERN, THE PHYSICIAN REALIZED THAT THE COIL HAD PREMATURELY DETACHED INTO THE PATIENT'S VESSEL. THE PHYSICIAN THEN CUT THE LANTERN AND INSERTED A SNARE IN ORDER TO RETRIEVE THE PC400. SUBSEQUENTLY, THE PC400 AND THE LANTERN WERE REMOVED TOGETHER FROM THE PATIENT AND THE DEVICES WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, TWO ADDITIONAL PC400 COILS, AND EIGHT OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633217 ↗
• MalfunctionApr 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TEN PC400S AND TWENTY NON-PENUMBRA COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING ANOTHER PC400 COIL A FEW CENTIMETERS INTO THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400 AND ENCOUNTERED RESISTANCE AGAIN WHEN THE PC400 WAS APPROXIMATELY 5 CM AWAY FROM THE TIP OF THE INTRODUCER SHEATH. THE PC400 WAS REMOVED FROM THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING EIGHT ADDITIONAL PC400 COILS, FIFTEEN OTHER COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565260 ↗
• MalfunctionApr 25, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PC400 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549296 ↗
• MalfunctionApr 12, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTIC DISSECTION USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH A NON-PENUMBRA GUIDE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN BECAME KINKED AT MULTIPLE LOCATIONS FROM THE DISTAL TIP. THE PHYSICIAN CONTINUED TO USE THE SAME MICROCATHETER AND SUCCESSFULLY PLACED A PC400 IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO INSERT A NEW PC400 INTO THE MICROCATHETER; HOWEVER, EXPERIENCED RESISTANCE AND, THE PHYSICIAN DECIDED TO RETRACT THE PC400. WHILE RETRACTING THE PC400, IT INADVERTENTLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE GUIDE CATHETER AND THE LANTERN CONTAINING THE DETACHED PC400 AND INSERTED A NEW GUIDE CATHETER AND A NEW LANTERN. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING NEW SMART COILS AND ADDITIONAL SIXTEEN OTHER COILS WITH THE SAME MICROCATHETER AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511151 ↗
• MalfunctionJan 10, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX PC400S IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE LANTERN, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AT THE TIP OF THE INTRODUCER SHEATH AND THE PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S, A PENUMBRA SMART COIL (SMART COIL) AND OTHER COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8238351 ↗
• MalfunctionOct 19, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE PC400S AND 130 NON-PENUMBRA COILS USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE MICROCATHETER, THE PC400 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 13 ADDITIONAL PC400S AND 31 OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7987285 ↗
• MalfunctionOct 12, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR PC400S USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 MORE THAN 10 CM INTO THE LANTERN. THE PC400 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7963378 ↗
• MalfunctionAug 10, 2018Stretched; Failure to Advance; Stretched; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO POD COILS AND FIVE PC400S IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW PC400 OUT OF INTRODUCER SHEATH AND INTO SALINE, THE PC400 WOULD NOT ADVANCE. SUBSEQUENTLY, THE PC400 ADVANCED OUT OF ITS INTRODUCER SHEATH BUT WAS ELONGATED APPROXIMATELY THREE CENTIMETERS FROM ITS DISTAL TIP; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL PC400, OTHER COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Patient Involvement

  MAUDE report 7773515 ↗
• MalfunctionJul 30, 2018Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARCUATE AORTA USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO INSERT A NEW PC400 INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE HUB OF THE PX SLIM AND SUBSEQUENTLY, THE PC400 BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT OTHER PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732501 ↗
• MalfunctionJan 8, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400''S (PC400S). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER IN THE CELIAC ARTERY, THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) TOWARD THE TARGET VESSEL. NEXT, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL PC400 IN THE TARGET VESSEL USING THE LANTERN. AFTER THAT, THE PHYSICIAN FLUSHED THE LANTERN, THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE LANTERN; HOWEVER, THE PC400 WOULD NOT EXIT THE TIP OF THE LANTERN. THE PHYSICIAN DID NOT MENTION FEELING ANY RESISTANCE PRIOR TO THE PC400 BECOMING STUCK. THE PHYSICIAN THEN REPOSITIONED THE TIP OF THE LANTERN AND RE-ATTEMPTED TO ADVANCE THE PC400 OUT OF THE TIP OF THE LANTERN; HOWEVER, THE PC400 WOULD NOT ADVANCE AND COULD ONLY BE RETRACTED. THEREFORE, THE PC400 WAS REMOVED AND ADVANCED OUT OF ITS INTRODUCER SHEATH AND INTO SALINE TO CHECK FOR DAMAGES BUT NO ABNORMALITIES WERE OBSERVED. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO ADVANCE THE SAME PC400 THROUGH THE LANTERN BUT THE SAME ISSUE OCCURRED. THUS, THE PC400 WAS REMOVED AND A NEW PC400 W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7173700 ↗
• MalfunctionDec 28, 2017Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). IT WAS REPORTED THAT THE PATIENT¿S VESSEL WAS SLIGHTLY CALCIFIED AND WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN FELT A STRONG TOUCH OF "SCRATCHING" AND WAS UNABLE TO ADVANCE A PC400 MORE THAN ABOUT 30 CM INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM); THEREFORE, THE PX SLIM WAS REMOVED WITH THE PC400 INSIDE. THE PC400 WAS REMOVED FROM WITHIN THE PX SLIM, AND THE PROCEDURE WAS THEN COMPLETED USING SIX NEW PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7152749 ↗
• MalfunctionDec 6, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 MORE THAN FIVE CENTIMETERS OUT OF THE TIP OF THE PX SLIM AND INTO THE PATIENT. THE PHYSICIAN THEREFORE REMOVED THE PC400 AND COMPLETED THE PROCEDURE USING NEW COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7087664 ↗
• MalfunctionDec 5, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS FISTULA (P-AVF) USING PENUMBRA COILS 400 (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA DIAGNOSTIC CATHETER THROUGH A NON-PENUMBRA BALLOON GUIDING CATHETER. NEXT, THE PHYSICIAN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH THE NON-PENUMBRA DIAGNOSTIC CATHETER AND NON-PENUMBRA BALLOON GUIDING CATHETER TOWARD THE TREATMENT SITE. THE PHYSICIAN THEN ADVANCED 14 PC400S IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE SAME MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE PC400 BECAME KINKED; THEREFORE, IT WAS REMOVED AND A NEW PC400 WAS PLACED INSTEAD. THE PROCEDURE WAS COMPLETED USING EIGHT PC400S, AND TWO NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084038 ↗
• MalfunctionSep 27, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SHUNT ROUTE (BETWEEN THE SPLENIC VEIN AND THE RENAL VEIN) USING PENUMBRA COILS 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 30 CENTIMETERS INTO THE PX SLIM; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE PX SLIM AND RE-ATTEMPTED TO ADVANCE THE PC400; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THEREFORE, THE COIL WAS REMOVED. AFTER THAT, THE PHYSICIAN OPENED A NEW PC400, ADVANCED IT INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY BROKE THE PC400 PUSHER ASSEMBLY AND MANUALLY DETACHED THE COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S, THE SAME PX SLIM AND A NEW HANDLE WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6898951 ↗
• MalfunctionSep 27, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SHUNT ROUTE (BETWEEN THE SPLENIC VEIN AND THE RENAL VEIN) USING PENUMBRA COILS 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 30 CENTIMETERS INTO THE PX SLIM; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE PX SLIM AND RE-ATTEMPTED TO ADVANCE THE PC400; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THEREFORE, THE COIL WAS REMOVED. AFTER THAT, THE PHYSICIAN OPENED A NEW PC400, ADVANCED IT INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY BROKE THE PC400 PUSHER ASSEMBLY AND MANUALLY DETACHED THE COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S, THE SAME PX SLIM AND A NEW HANDLE WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6898942 ↗
• MalfunctionJun 30, 2017Detachment Of Device Component; Premature Activation; Difficult or Delayed Activation; Detachment Of Device Component; Premature Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400'S (PC400'S). IT WAS REPORTED THAT THE PATIENT HAD EXCESSIVELY TORTUOUS VESSELS AND MORE TIME WAS NEEDED TO ACCESS THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE TARGET VESSEL, THEN DEPLOYED AN INITIAL PC400 AND ATTEMPTED TO DETACH IT USING A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). HOWEVER, UPON MANIPULATION, A DULL SOUND WAS HEARD FROM THE HANDLE AND IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE ON THE PC400 PUSHER ASSEMBLY WAS NOT SEPARATED PROPERLY. NEXT, THE PHYSICIAN WIPED THE ALIGNMENT ZONE AND MADE ANOTHER ATTEMPT TO DETACH THE PC400 USING THE HANDLE BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN APPLIED FORCE IN AN ATTEMPT TO MANUALLY DETACH THE PC400 WHILE SIMULTANEOUSLY PULLING THE SLIDER ON THE HANDLE; HOWEVER, THE PC400 DID NOT DETACH. THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE AND TESTED THE DETACHMENT MECHANISM TO MAKE SURE THAT IT CLICKED. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE PC400 USING THE NEW HANDLE BUT WAS STILL UNSUCCESSFUL AND DECIDED TO RETRACT THE COIL. WHILE THE PC400 WAS BEING RETRACTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680622 ↗
• MalfunctionApr 6, 2017Out-Of-Box Failure; Defective Device; Material Protrusion/Extrusion; Out-Of-Box Failure; Defective Device; Material Protrusion/Extrusion

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT THE TIP OF A PENUMBRA COIL 400 (PC400) WAS ALREADY EXPOSED UPON REMOVAL OF THE INTRODUCER SHEATH FROM THE DISPENSER HOOP. WHILE THE PC400 PUSHER ASSEMBLY WAS BEING ADVANCED, IT WAS OBSERVED THAT THE PC400 WAS ALREADY DETACHED INSIDE ITS INTRODUCER SHEATH. THEREFORE, THE PC400 WAS NOT USED FOR THE PROCEDURE AND DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING NEW PC400''S AND ADDITIONAL COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6468224 ↗
• MalfunctionFeb 10, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CERVICAL SPINAL DURAL ARTERIOVENOUS FISTULA (AVF) AT THE C2 LEVEL USING PENUMBRA COIL 400''S (PC400¿S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 INTO THE TARGET VESSEL USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK DC) BUT WAS UNABLE TO DETACH THE COIL USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AS OF (B)(6) 2017, THE PATIENT IS DOING OK, WALKING AGAIN AND ALMOST BACK TO NORMAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6322092 ↗
• MalfunctionJan 4, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX PC400'S INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). NEXT, THE PHYSICIAN OPENED A NEW PC400, REMOVED THE PC400 PUSHER ASSEMBLY AND NOTICED THAT THE INTRODUCER SHEATH REMAINED INSIDE THE PACKAGING HOOP. THE PACKAGING HOOP WAS FLUSHED TO REMOVE THE INTRODUCER SHEATH AND THE PC400 WAS ABLE TO BE RESHEATHED BACK INTO ITS INTRODUCER SHEATH. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PC400 THROUGH THE PX SLIM BUT WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE CONTINUED USING NEW PC400'S. AFTER FLUSHING THE PX SLIM, THE PHYSICIAN ATTEMPTED TO ADVANCE A TWELFTH PC400 THROUGH THE PX SLIM BUT WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE PHYSICIAN RETRACTED THE PC400; HOWEVER, WHILE THE COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED INSIDE ITS INTRODUCER SHEATH. THE DETACHED PC400 WAS REMOVED INSIDE ITS SHEATH AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6224070 ↗
• InjuryNov 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT INTERNAL CAROTID ARTERY (ICA) PROCEDURE USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, WHILE ADVANCING THE 28TH PC400 THROUGH THE PX SLIM DELIVERY CATHETER (PX SLIM) THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM IN ORDER TO REMOVE THE DETACHED PC400. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND A NEW PC400. AFTER THE PROCEDURE, THE PATIENT¿S CONDITION WORSENED AND A COMPUTERIZED TOMOGRAPHY (CT) CONFIRMED THAT THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) WHICH WAS BELIEVED TO BE FROM THE ANEURYSM. IT IS UNKNOWN WHAT CAUSED THIS SAH. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO EMBOLIZE THE PARENT VESSEL USING NON-PENUMBRA COILS IN ORDER TO TREAT THIS SAH; THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT¿S CONDITION WAS STABILIZED.

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 6130421 ↗