Penumbra Coil 400 4004C1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI M4244004C10300), received between Dec 22, 2015 and Aug 27, 2019 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 INTO THE TARGET VESSEL WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN NOTICED THAT IT HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PC400 HAD DETACHED PARTIALLY IN THE TARGET VESSEL AND PARTIALLY WITHIN THE PX SLIM. THE PHYSICIAN THEN PUSHED THE REMAINING PART OF THE PC400 OUT OF THE PX SLIM AND INTO THE TARGET VESSEL USING THE DETACHED PUSHER ASSEMBLY. THE PC400 WAS IMPLANTED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8937526 ↗
• MalfunctionJun 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PC400 WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW PC400S AND A POD PACKING COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744442 ↗
• MalfunctionDec 10, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING THE FIRST PC400 COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER WHEN IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PC400 AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148668 ↗
• MalfunctionDec 10, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE HUB OF THE MICROCATHETER AND THE PC400 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S 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 8148201 ↗
• MalfunctionNov 13, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), DESPITE MULTIPLE ATTEMPTS TO ADVANCE IT. THE PHYSICIAN THEREFORE REMOVED THE LANTERN AND THE PC400. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE PC400 WAS FRACTURED AND THE LANTERN WAS KINKED. THE PROCEDURE WAS COMPLETED USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8066326 ↗
• MalfunctionSep 14, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE JUST BEFORE THE SMART COIL CAME OUT THE TIP OF THE PX SLIM; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PC400; THEREFORE, THE PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, OTHER COILS AND FOUR NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877649 ↗
• MalfunctionSep 14, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE JUST BEFORE THE SMART COIL CAME OUT THE TIP OF THE PX SLIM; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PC400; THEREFORE, THE PX SLIM AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM, OTHER COILS AND FOUR NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877632 ↗
• MalfunctionMay 8, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400¿S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY CALCIFIED. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE MICROCATHETER AND THE PC400 BECAME STUCK AND COULD NOT BE PUSHED OUT; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT OTHER PC400¿S 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 7496670 ↗
• MalfunctionMar 29, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS AND A PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PC400 THROUGH THE MICROCATHETER, AND THEREFORE THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE PC400 WAS ELONGATED AND KINKED. A NEW PC400 WAS THEN SUCCESSFULLY PLACED. THE PHYSICIAN THEN FELT RESISTANCE ADVANCING ANOTHER PC400 WITHIN THE MICROCATHETER, HOWEVER UPON RETRACTION TO REMOVE THE PC400, THE PHYSICIAN FOUND THAT THE PC400 HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED WITH MICROCATHETER WITH THE PC400 INSIDE, AND THEN REINSERTED THE SAME MICROCATHETER. THE PROCEDURE WAS COMPLETED 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 7383805 ↗
• MalfunctionMar 29, 2018Kinked; Stretched; Physical Resistance; Kinked; Stretched; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS AND A PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PC400 THROUGH THE MICROCATHETER, AND THEREFORE THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE PC400 WAS ELONGATED AND KINKED. A NEW PC400 WAS THEN SUCCESSFULLY PLACED. THE PHYSICIAN THEN FELT RESISTANCE ADVANCING ANOTHER PC400 WITHIN THE MICROCATHETER, HOWEVER UPON RETRACTION TO REMOVE THE PC400, THE PHYSICIAN FOUND THAT THE PC400 HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED WITH MICROCATHETER WITH THE PC400 INSIDE, AND THEN REINSERTED THE SAME MICROCATHETER. THE PROCEDURE WAS COMPLETED 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 7383804 ↗
• MalfunctionJan 20, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400''S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY CURVED. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE PC400''S INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND THE HANDLE. THE PHYSICIAN THEN ADVANCED A NEW PC400 (LOT #F72631) INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. AFTER FOUR TO FIVE FAILED ATTEMPTS, THE PC400 WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE BY DEPLOYING AND DETACHING TEN ADDITIONAL PC400''S USING THE SAME PX SLIM AND HANDLE. WHILE ATTEMPTING TO ADVANCE A NEW PC400 (LOT #F68287) THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE ABOUT HALF WAY THROUGH THE PX SLIM AND DECIDED TO FORCEFULLY REMOVE THE PC400. THE PROCEDURE WAS THEN COMPLETED USING FOURTEEN ADDITIONAL PC400S, TWO SMART COILS, THE SAME PX SLIM AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7208716 ↗
• MalfunctionJan 3, 2018Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COILS 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 HALF WAY THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE PC400 BECAME STUCK WHEN IT WAS ABOUT TO EXIT THE TIP OF THE MICROCATHETER; THEREFORE, MICROCATHETER AND PC400 WERE REMOVED ALTOGETHER. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND FOUR ADDITIONAL PC400S WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162330 ↗
• MalfunctionDec 19, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER PC400 THROUGH THE MIDDLE OF THE MICROCATHETER AND THE PC400 BECAME STUCK AND UNABLE TO ADVANCE; THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE PC400 INSIDE. THE PHYSICIAN THEN INSERTED A NEW NON-PENUMBRA MICROCATHETER AND SUCCESSFULLY DEPLOYED AND DETACHED TWO PC400S. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN WHILE ADVANCING ANOTHER PC400 THROUGH THE MIDDLE OF THE MICROCATHETER, AND THE PC400 BECAME STUCK AND UNABLE TO ADVANCE; THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE PC400 INSIDE. THE PHYSICIAN THEN REMOVED THE PC400 FROM THE MICROCATHETER AND REINSERTED THE SAME MICROCATHETER. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL PC400S AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129378 ↗
• MalfunctionDec 19, 2017Stretched; Physical Resistance; Mechanical Jam; Stretched; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER IN THE LEFT BRACHIAL ARTERY, THEN ADVANCED A NON-PENUMBRA MICROCATHETER TOWARD THE TREATMENT SITE. THE PHYSICIAN THEN PLACED TWO NON-PENUMBRA COILS AND SIX PC400S IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 HALFWAY THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE PC400 BECAME STUCK WHEN IT WAS SLIGHTLY ADVANCED OUT OF THE TIP OF THE MICROCATHETER AND BECAME UNRAVELED IN THE MICROCATHETER WHILE BEING RETRACTED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND THE PC400 ALTOGETHER. THE PC400 WAS THE REMOVED AND THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED USING A NEW PC400 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 7129198 ↗
• MalfunctionOct 19, 2017Unraveled Material; Physical Resistance; Device Operates Differently Than Expected; Unraveled Material; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT SUBCLAVIAN ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER AND MICROCATHETER IN THE TARGET VESSEL THEN PLACED A NON-PENUMBRA COIL IN THE ANEURYSM. WHILE ATTEMPTING TO PLACE A PC400 IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE COIL WAS NOT TAKING ITS INTENDED SHAPE. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE AND RETRACT THE PC400 AND SUBSEQUENTLY, THE PC400 BECAME UNRAVELED. 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 AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT AND THE PHYSICIAN ADVANCED A NEW PC400 INTO THE ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE PC400 USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). WITHOUT REALIZING THAT THE PC400 FAILED TO DETACH, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400 PUSHER ASSEMBLY; HOWEVER, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE PC400 WAS STILL ATTACHED TO ITS PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN DECIDE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6962143 ↗
• MalfunctionOct 4, 2017Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A PULMONARY ARTERIOVENOUS FISTULA (P-AVF) USING A PENUMBRA COIL 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MICROCATHETER TOWARD THE TREATMENT SITE. PRIOR TO INSERTING A PC400 IN THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE COIL WAS BEING ADVANCED OUT OF ITS INTRODUCER SHEATH. THE PHYSICIAN DECIDED TO RETRACT THE PC400 BACK INTO ITS INTRODUCER SHEATH; HOWEVER, THE PC400 WAS ENTRAPPED AND WOULD NOT RETRACT. THEREFORE, THE PC400 WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6914143 ↗
• MalfunctionSep 5, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE FOURTH PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 PUSHER ASSEMBLY ONLY A COUPLE OF CENTIMETERS INTO THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN RE-ATTEMPTED TO ADVANCE THE PC400 INTO THE MICROCATHETER; HOWEVER, THE COIL WOULD NOT ADVANCE. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PC400S 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 6843163 ↗
• MalfunctionAug 31, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COIL 400''S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER AND MICROCATHETER TOWARDS THE TREATMENT SITE OF THE TARGET VESSEL. NEXT, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AS ANCHORING COILS AND TWO ADDITIONAL PC400''S TO FILL THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A THIRD PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED SUBTLE RESISTANCE AROUND THE HUB OF THE MICROCATHETER AND SUBSEQUENTLY, THE PC400 BECAME STUCK INSIDE THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE PC400; HOWEVER, UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL AND FLUSHED THE COIL OUT. THEREAFTER, THE MICROCATHETER WAS FLUSHED AGAIN AND USED WITH NINE ADDITIONAL COILS TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836322 ↗
• MalfunctionAug 8, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400''S (PC400''S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA MICROCATHETER TOWARDS THE IIA, THEN INTRODUCED THE PC400 INTRODUCER SHEATH INTO THE HUB OF THE MICROCATHETER AND SEATED IT IN THE HUB TAPER. WHILE ATTEMPTING TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL ANY FURTHER THROUGH ITS SHEATH. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THREE NEW PC400''S AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6774333 ↗
• MalfunctionFeb 7, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING AN ABDOMINAL AORTIC ANEURYSM COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WAS UNABLE TO ADVANCE PAST 20 CM FROM THE PROXIMAL END OF THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED AND CLEANED UP. THE PHYSICIAN THEN RE-ATTEMPTED TO ADVANCE THE SAME PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS EXPERIENCED AGAIN AT THE SAME POINT. THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM, TWO NON-PENUMBRA COILS, AND THREE NEW PC400S. IT SHOULD BE NOTED THAT THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE AND FLUSHED THE PX SLIM AFTER EACH COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6309227 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE LEFT PERIOPHTHALMIC ARTERY USING PENUMBRA COIL 400 (PC400'S) WITH NO COMPLICATIONS DURING THE PROCEDURE. HOWEVER, SIX HOURS POST-PROCEDURE, THE PATIENT DEVELOPED APHASIA, WHICH PROGRESSED TO RIGHT-SIDED WEAKNESS. A FOLLOW-UP ANGIOGRAPHY WAS PERFORMED AND SHOWED DECREASE BLOOD FLOW INTO THE MIDDLE CEREBRAL ARTERY (MCA) AND A THROMBUS IN THE M3 BRANCH OF THE LEFT INTERNAL CAROTID ARTERY (LICA) WAS NOTICED. THEREFORE, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE, WHICH PARTIALLY REMOVED THE THROMBUS; HOWEVER, A FRAGMENT OF THE THROMBUS WENT DOWNSTREAM AND COULD NOT BE REMOVED. THE PATIENT WAS STILL ADMITTED IN THE HOSPITAL. AS OF (B)(6) 2016, THE PATIENT WAS IN STABLE CONDITION. THIS SERIOUS ADVERSE EVENT WAS REPORTED AS AN ISCHEMIC STROKE AND WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE PC400'S, THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM MALFORMATION.

  Patient problems: Dysphasia; Thrombus; Weakness

  MAUDE report 5975442 ↗
• MalfunctionJun 29, 2016Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) BEFORE A STENT-GRAFTING USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE PATIENT, THEN PLACED A POD6 COIL AND ANOTHER MANUFACTURER'S COIL INTO THE SUPERIOR GLUTEAL ARTERY (SGA) FOLLOWED BY ANOTHER POD6 COIL AND ANOTHER COIL FROM THE OTHER MANUFACTURER INTO THE INFERIOR GLUTEAL ARTERY (IGA). AFTER DEPLOYING AND DETACHING ANOTHER POD6 COIL IN THE MAIN VESSEL OF THE IIA, THE PHYSICIAN DEPLOYED A PC400 COIL IN THE IIA BUT WAS UNABLE TO DETACH THE COIL. THEREFORE, THE PC400 COIL WAS RETRACTED; HOWEVER, WHILE THE COIL WAS BEING RETRACTED FROM IIA, IT UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PX SLIM CONTAINING THE DETACHED PC400 COIL WAS REMOVED FROM THE PATIENT AND THE PC400 COIL WAS THEN REMOVED FROM THE PX SLIM. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL, ANOTHER COIL FROM THE OTHER MANUFACTURER 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 5758820 ↗
• InjuryMay 9, 2016Detachment Of Device Component; Entrapment of Device; Physical Resistance; Detachment Of Device Component; Entrapment of Device; Physical Resistance

  THE PATIENT WAS UNDERGOING A POST PNEUMONECTOMY COIL EMBOLIZATION PROCEDURE IN THE LEFT PULMONARY ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN FIRST DELIVERED ANOTHER MANUFACTURER'S COILS INTO THE ANEURYSM USING ANOTHER MANUFACTURER'S MICROCATHETER. THE PHYSICIAN THEN SWITCHED OUT THE MICROCATHETER FOR A PX SLIM. WHILE ADVANCING A PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON ATTEMPTING TO ADVANCE AND RETRACT THE PC400 COIL, IT UNINTENTIONALLY DETACHED. THE REMAINING PORTION OF THE PC400 COIL INSIDE THE PX SLIM WAS OBSERVED AROUND THE INFERIOR VENA CAVA (IVC) PASSING AFTER THE CHAMBER ON THE RIGHT SIDE OF THE HEART. THE PHYSICIAN REMOVED THE PC400 COIL PUSHER ASSEMBLY FROM THE PATIENT AND ATTEMPTED TO FLUSH THE REMAINING PORTION OF THE PC400 COIL INTO THE TARGET VESSEL USING A SYRINGE BUT WAS UNABLE TO. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PX SLIM AND THE DETACHED PC400 COIL AT THE SAME TIME BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN INSERTED ANOTHER MANUFACTURER'S MICROCATHETER INTO THE PX SLIM NEAR THE END PORTION OF THE DETACHED PC400 COIL AND ATTEM

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

  MAUDE report 5642675 ↗
• MalfunctionJan 11, 2016Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON HEPATIC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DELIVERED TWO COMPETITOR'S COILS INTO THE ANEURYSM USING A DIAGNOSTIC CATHETER, ANOTHER MANUFACTURER'S MICROCATHETER AND ANOTHER MANUFACTURER'S SELECTIVE CATHETER. THE PHYSICIAN THEN REMOVED THE SELECTIVE CATHETER AND ATTEMPTED TO DELIVER A PC400 COIL INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE PC400 COIL OUT OF THE MICROCATHETER. THE PHYSICIAN RE-POSITIONED THE MICROCATHETER BUT WAS STILL UNABLE TO ADVANCE THE PC400 COIL OUT. THE PC400 COIL WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5359065 ↗
• MalfunctionDec 22, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 COIL OUT OF ITS ORANGE INTRODUCER SHEATH AND INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN REMOVED THE PC400 COIL, REINSERTED THE INTRODUCER SHEATH INTO THE HUB OF THE PX SLIM AND MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 COIL THROUGH THE PX SLIM; HOWEVER, THE PC400 COIL WOULD NOT ADVANCE AT ALL AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5321426 ↗