Penumbra Coil 400 4004C0513Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI M4244004C05130), received between Sep 3, 2015 and Sep 22, 2023 — classified as 1 death, 5 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S, A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S INTO THE TARGET LOCATION USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED WHEN THE COIL WAS PARTIALLY WITHIN THE PX SLIM AND PARTIALLY WITHIN THE VESSEL. THEREFORE, THE PHYSICIAN USED A STENT RETRIEVER TO ASSIST WITH THE REMOVAL OF THE PC400. THE PROCEDURE WAS COMPLETED USING A NEW PC400, THE SAME PX SLIM, THE SAME NEURON 070, AND THE SAME NEURON MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804207 ↗
• MalfunctionAug 4, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 OUT OF THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE PC400 WOULD NO LONGER ADVANCE. THE PHYSICIAN FOUND THAT THE PC400 WAS UNINTENTIONALLY DETACHED PARTIALLY INSIDE THE PX SLIM AND PARTIALLY INSIDE THE TARGET LOCATION. THEREFORE, A SNARE WAS USED TO REMOVE THE PC400 FROM THE PATIENT. THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM IN ORDER TO USE A NON-PENUMBRA SYSTEM TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME NEURON MAX AND A NON-PENUMBRA MICROCATHETER TO IMPLANT TEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466398 ↗
• InjuryJun 4, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SEVEN PC400S. WHILE ATTEMPTING TO PLACE THE EIGHTH PC400, THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITION AND THEREFORE, RETRACTED THE COIL. UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED AND WAS REMOVED USING A STENT RETRIEVER. THE PROCEDURE ENDED AT THIS POINT, AS VERY GOOD STASIS WAS OBSERVED IN THE ANEURYSM, INDICATING GOOD NECK COVERAGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939504 ↗
• MalfunctionJun 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE LANTERN AND A NON-PENUMBRA GUIDE CATHETER WERE PLACED INTO THE TARGET VESSEL. UPON ADVANCEMENT OF THE PC400 COIL OVER THE HUB OF THE LANTERN, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE AND DECIDED TO FLUSH THE LANTERN. HOWEVER, WHEN THE PC400 WAS ADVANCED AGAIN, THE SAME RESISTANCE OCCURRED. THE PHYSICIAN THEN DECIDED TO REMOVE THE PC400 AND THE LANTERN AND COMPLETED THE PROCEDURE USING A NEW LANTERN AND THREE ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737222 ↗
• MalfunctionMay 28, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400S (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), IT UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 AND SUCCESSFULLY FLUSHED OUT THE COIL. THE PROCEDURE WAS COMPLETED USING A NEW PC400 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 8646553 ↗
• MalfunctionApr 18, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE I ENDOLEAK USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PC400S IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW PC400, THE PHYSICIAN NOTICED THE COIL WOULD NOT FIT DUE TO THE PACKAGING DENSITY OF THE TARGET VESSEL AND, THEREFORE, THE PC400 WAS RETRACTED. WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED AT THE PROXIMAL END OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE PC400 AND SAFELY PULLED OUT THE COIL. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING NEW PC400S 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 8525868 ↗
• MalfunctionApr 5, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED FIVE PC400S INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE SIXTH PC400, IT WAS REPORTED THAT IT WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THE PC400 WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489259 ↗
• MalfunctionJul 24, 2018Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER TOWARD THE INTERNAL ILIAC ARTERY OF THE CONTRALATERAL SIDE FROM THE FEMORAL ARTERY. WHILE ADVANCING A GUIDEWIRE THROUGH A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY 30 CENTIMETERS FROM THE TIP OF THE LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A PC400 THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED APPROXIMATELY 30 CENTIMETERS FROM THE TIP OF THE LANTERN AND THE PC400 BECAME STUCK. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW THE PC400; HOWEVER, THE PC400 UNRAVELED AND UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7716490 ↗
• MalfunctionMay 3, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A PC400, HOWEVER, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER AFTER BEING REPOSITIONED MULTIPLE TIMES. THE PHYSICIAN, THEREFORE, REMOVED THE MICROCATHETER WITH THE PC400 INSIDE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7484823 ↗
• MalfunctionMar 30, 2018Detachment Of Device Component; Retraction Problem; Physical Resistance; Detachment Of Device Component; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR PC400'S USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 PAST THE MIDDLE OF THE PX SLIM, AND THEREFORE THE PHYSICIAN RETRACTED THE PC400. UPON REMOVAL OF THE PUSHER ASSEMBLY, THE PHYSICIAN FOUND THAT THE PC400 HAD UNINTENTIONALLY DETACHED WITHIN THE PX SLIM, AND THEREFORE THE PX SLIM WAS REMOVED WITH THE PC400 INSIDE. IT WAS NOTICED THAT THE PX SLIM WAS SLIGHTLY KINKED, AND THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7385088 ↗
• MalfunctionMar 1, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE PC400¿S AND FOUR NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE HALF WAY THROUGH THE MICROCATHETER AND THE PC400 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE PC400. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND FIVE ADDITIONAL PC400¿S. THERE WAS NO REPORT OF AN ADVERSE EFFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7306729 ↗
• MalfunctionFeb 16, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE PC400S SLIGHTLY PROXIMAL AT THE DISTAL BIFURCATION OF THE RIGHT IIA ANEURYSM USING THE LANTERN. WHILE ADVANCING A NEW PC400 THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE PC400 WAS UNABLE TO FULLY ADVANCE OUT OF THE LANTERN AND BECAME STUCK. UPON ATTEMPTING TO RETRACT THE PC400, IT UNINTENTIONAL DETACHED WITHIN THE LANTERN. THE LANTERN WAS THEREFORE REMOVED, AND THE PHYSICIAN PULLED THE PC400 OUT, AND THEN REINSERTED THE SAME LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400, HOWEVER THE PC400 WAS UNABLE TO ADVANCE AND BECAME STUCK AGAIN. UPON ATTEMPTING TO RETRACT THE PC400 IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PC400 INSIDE, AND COMPLETED THE PROCEDURE USING A NEW MICROCATHETER AND A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7277525 ↗
• MalfunctionDec 21, 2017Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY USING PENUMBRA COIL 400''S (PC400'S). IT WAS NOTED THAT THE PATIENT HAD SLIGHT CALCIFICATION. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FOUR INITIAL PC400'S INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE TWO NEW PC400'S INTO THE PX SLIM, THE PHYSICIAN CONNECTED THE INTRODUCER SHEATH WITH THE HUB OF THE PX SLIM AND ADVANCED THE COILS APPROXIMATELY TWENTY TO THIRTY CENTIMETERS INTO PX SLIM. THE PHYSICIAN THEN FELT SCRATCHING AND WAS UNABLE TO ADVANCE THE PC400'S FURTHER. IT WAS ALSO REPORTED THAT ONE OF THE PC400'S UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED, THEN THE DETACHED COIL WAS REMOVED FROM THE PX SLIM. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND FOURTEEN NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139693 ↗
• MalfunctionDec 21, 2017Detachment Of Device Component; Failure to Advance; Material Integrity Problem; Detachment Of Device Component; Failure to Advance; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY USING PENUMBRA COIL 400'S (PC400'S). IT WAS NOTED THAT THE PATIENT HAD SLIGHT CALCIFICATION. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FOUR INITIAL PC400'S INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE TWO NEW PC400'S INTO THE PX SLIM, THE PHYSICIAN CONNECTED THE INTRODUCER SHEATH WITH THE HUB OF THE PX SLIM AND ADVANCED THE COILS APPROXIMATELY TWENTY TO THIRTY CENTIMETERS INTO PX SLIM. THE PHYSICIAN THEN FELT SCRATCHING AND WAS UNABLE TO ADVANCE THE PC400'S FURTHER. IT WAS ALSO REPORTED THAT ONE OF THE PC400'S UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED, THEN THE DETACHED COIL WAS REMOVED FROM THE PX SLIM. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND FOURTEEN NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139660 ↗
• MalfunctionOct 20, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERY ANEURYSM USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING A PC400 APPROXIMATELY 10 CM FROM THE TIP OF A NON-PENUMBRA MICROCATHETER AND THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6966021 ↗
• MalfunctionOct 18, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) TO TREAT A PELVIC TUMOR USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN COAXIALLY ADVANCED A NON-PENUMBRA CATHETER AND MICROCATHETER TOWARD THE TARGET TREATMENT PORTION OF THE IIA. WHILE ATTEMPTING TO ADVANCE TWO PC400S THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE FROM THE BEGINNING OF THE INSERTION; THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958504 ↗
• MalfunctionOct 18, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) TO TREAT A PELVIC TUMOR USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN COAXIALLY ADVANCED A NON-PENUMBRA CATHETER AND MICROCATHETER TOWARD THE TARGET TREATMENT PORTION OF THE IIA. WHILE ATTEMPTING TO ADVANCE TWO PC400S THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE FROM THE BEGINNING OF THE INSERTION; THEREFORE, THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6958500 ↗
• MalfunctionJul 10, 2017Detachment Of Device Component; Device Operates Differently Than Expected; Detachment Of Device Component; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA MICROCATHETER TOWARDS THE TARGET PAVM, THEN DEPLOYED AND DETACHED TWO PC400'S. WHILE ATTEMPTING TO DEPLOY A NEW PC400 INTO THE PAVM, THE PHYSICIAN DID NOT LIKE THE SHAPE THAT THE COIL WAS TAKING AND BEGAN MANIPULATING IT. AFTER SEVERAL ATTEMPTS OF ADVANCING AND RETRACTING THE COIL, THE PHYSICIAN NOTICED THAT THE COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN ATTACHED A SYRINGE TO THE BACK OF THE MICROCATHETER AND PULLED NEGATIVE PRESSURE BACK. THE MICROCATHETER CONTAINING THE PC400 WAS THEN REMOVED. THEREAFTER, THE MICROCATHETER WAS FLUSHED AND USED TO COMPLETE THE PROCEDURE WITH NEW PC400'S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6699296 ↗
• MalfunctionJun 27, 2017Device Handling Problem; Device Handling Problem

  WHILE PREPARING A PENUMBRA COIL 400 (PC400) FOR A COIL EMBOLIZATION PROCEDURE, THE RADIOLOGIC TECHNOLOGIST INADVERTENTLY DROPPED THE PC400 ONTO THE FLOOR PRIOR TO INSERTING IT INTO THE MICROCATHETER. THE PC400 WAS DROPPED PRIOR TO ITS USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Patient Involvement

  MAUDE report 6672200 ↗
• MalfunctionApr 7, 2017Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VEIN USING PENUMBRA COIL 400''S (PC400¿S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PC400; HOWEVER, STRONG RESISTANCE WAS FELT AND TO AVOID UNINTENTIONAL DETACHMENT, THE PHYSICIAN ATTEMPTED TO CONTINUE ADVANCING THE PC400. DUE TO STRONG RESISTANCE, THE PC400 WOULD NOT ADVANCE FURTHER. SUBSEQUENTLY, THE PC400 PUSHER ASSEMBLY BECAME KINKED AND THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PXSLIM CONTAINING THE DETACHED COIL, FLUSHED THE COIL OUT AND REINSERTED THE PX SLIM INTO THE PATIENT'S BODY. THE PROCEDURE WAS THEN COMPLETED USING A NEW PC400 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 6473126 ↗
• InjuryMar 14, 2017Migration or Expulsion of Device; Material Protrusion/Extrusion; Unintended Movement; Migration or Expulsion of Device; Material Protrusion/Extrusion; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400''S (PC400'S). AFTER DEPLOYING AND DETACHING THE LAST PC400 OF THE PROCEDURE, THE PHYSICIAN REMOVED THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) OUT OF THE PATIENT AND SUBSEQUENTLY, THE END OF THE PC400 MIGRATED DOWN INTO THE PARENT ARTERY. THE PHYSICIAN THEN ATTEMPTED TO USE A STENT DEVICE BUT WAS UNABLE TO SUCCESSFULLY PLACE IT. THEREFORE, THE PHYSICIAN LEFT THE SINGLE LOOP OF THE PC400 PROTRUDING OUT OF THE ANEURYSM SINCE HE DID NOT BELIEVE THAT IT WOULD CAUSE ANY PROBLEMS. THE PATIENT WAS THEN PLACED ON PLAVIX AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 6404321 ↗
• MalfunctionDec 6, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A PANCREATIC FISTULA USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE PC400 IN THE FISTULA USING ANOTHER MANUFACTURER BALLOON CATHETER WITH NO ISSUES. WHILE ATTEMPTING TO ADVANCE THE FOURTH PC400 THROUGH THE BALLOON CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 BECAME STUCK AND UNABLE TO ADVANCE. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME BALLOON CATHETER AND NEW PC400'S. THE PHYSICIAN REPORTED FLUSHING BETWEEN EACH COIL AND NOT USING A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6149384 ↗
• 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 6130538 ↗
• 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 6130536 ↗
• 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 6130535 ↗