Penumbra Coil 400 4002C1857Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI M4244002C18570), received between Jan 8, 2016 and Apr 6, 2022 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 USING THE PX SLIM INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. WHILE ATTEMPTING TO RETRACT THE PC400, THE PC400 UNINTENTIONALLY DETACHED WITH THE TAIL OF THE PC400 COMING OUT OF THE ANEURYSM. THE PC400 WAS LEFT IN THE ANEURYSM. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NEW PC400 TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW PC400S, THE SAME PX SLIM, AND A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031831 ↗
• MalfunctionFeb 25, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COILS 400 (PC400S), A REUSED PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A PC400 (32MM X 60CM) THROUGH A REUSED PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE DETACHED PC400 WAS REMOVED USING A BALLOON CATHETER AND THE PHYSICIAN ALSO REMOVED THE PX SLIM. NEXT, THE PHYSICIAN PLACED ANOTHER PC400 IN THE TARGET LOCATION SUCCESSFULLY USING A NEW PX SLIM. NEXT, WHILE ADVANCING ANOTHER PC400 (28MM X 60CM) TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITH HALF OF THE PC400 IN THE TARGET LOCATION AND THE OTHER HALF OF THE PC400 IN THE PX SLIM. THE PHYSICIAN WAS UNABLE TO REMOVE THE DETACHED PC400 DUE TO THE PC400 BEING TANGLED WITH THE PREVIOUS PLACED PC400. THEREFORE, THE DETACHED PC400 WAS LEFT IN THE PATIENT¿S VESSEL. AFTERWARDS, WHILE ADVANCING ANOTHER PC400 (24MM X 57CM) TO THE TARGET LOCATION, THE PC400 STRETCHED. SUBSEQUENTLY, THE PC4

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11377660 ↗
• MalfunctionMay 17, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400S (PC400) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE PC400 AND THE 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 8620942 ↗
• MalfunctionMar 28, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 WOULD NOT ADVANCE BEYOND THE MID SHAFT OF THE PX SLIM. THE PC400 AND PX SLIM WERE THEN REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461195 ↗
• MalfunctionOct 25, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  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 8007645 ↗
• MalfunctionAug 1, 2018Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400S). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO PLACE A PC400 IN THE TARGET VESSEL, THE PC400 WAS DEVIATING FROM THE TREATMENT SITE. THEREFORE, THE PHYSICIAN ATTEMPTED TO PUSH AND PULL THE PC400 THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE PC400 DID NOT ADVANCE SMOOTHLY AND SUBSEQUENTLY UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7741343 ↗
• MalfunctionJul 16, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PENUMBRA COIL 400 (PC400). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS AND 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 WITH ONE LOOP OF THE PC400 PROTRUDING OUT OF THE TIP OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN ATTEMPTED TO PULL AND PUSH THE PC400 SEVERAL TIMES; HOWEVER, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7692574 ↗
• MalfunctionFeb 2, 2018Separation Failure; Device Operates Differently Than Expected; Separation Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC VEIN USING PENUMBRA COILS 400 (PC400S), A POD8 AND PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED EIGHT PC400S AND THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ADVANCED A NEW PC400 (F66239) IN THE TARGET VESSEL USING THE SAME LANTERN AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. AFTER TWO TO THREE FAILED ATTEMPTS, THE PHYSICIAN MANUALLY BENT THE COILS PUSHER ASSEMBLY AND ATTEMPTED TO MANUALLY DETACH IT; HOWEVER, THE PC400 WOULD NOT DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING EIGHT ADDITIONAL PC400S AND TWO NON-PENUMBRA COILS. WHILE ATTEMPTING TO ADVANCE A NEW PC400 (F70755) THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MIDDLE OF THE LANTERN AND THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN DECIDED TO USE A POD8; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE POD8 WAS REMOVED. THE PROCEDURE WAS COMPLETED ADDITIONAL COILS, A NEW HANDLE AND THE SAME LA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7235856 ↗
• 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 7173725 ↗
• MalfunctionJun 13, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE TARGET VESSEL, THEN DEPLOYED AND DETACHED TWO PC400'S AND THREE NON-PENUMBRA COILS. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF THE TIP OF THE PX SLIM. THEREFORE, THE PHYSICIAN RETRACTED THE PC400, FLUSHED THE PX SLIM AND THEN MADE ANOTHER ATTEMPT TO ADVANCE THE COIL. HOWEVER, RESISTANCE WAS MET AGAIN AND THE PC400 WAS REMOVED. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME 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 6638893 ↗
• MalfunctionMay 19, 2017Detachment Of Device Component; Separation Failure; Detachment Of Device Component; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S). IT WAS NOTED THAT THE PATIENT HAD A TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 (F65128) INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ATTEMPTED TO DETACH THE PC400 USING A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE); HOWEVER, THE PC400 FAILED TO DETACH. IT WAS NOTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE PUSHER ASSEMBLY ONLY SHOWED A SMALL GAP OF 0.5 CM. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE PX SLIM; HOWEVER, IT DID NOT IMPROVE THE SITUATION; THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400. UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM AND THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED PC400 INTO THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED THE SECOND PC400 (F67056) INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN ENCOUNTERED THE SAME DIFFICULTY WHILE ATTEMPTING TO DETACH THE PC400 USING THE SAME HANDLE. REPOSITIONING THE PX SLIM DID NOT HELP. THE PC400 WAS THEN MANUALLY DETACHED IN THE ANEURYSM. IT WAS REPORTED THAT WHEN MANUALLY DETACHING THIS PC400, RESISTANCE WAS E

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6578409 ↗
• MalfunctionApr 24, 2017Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING A PC400 25 CM INTO THE PX SLIM; CONSEQUENTLY, THE PC400 BECAME STUCK IN THE PX SLIM. THE PHYSICIAN THEREFORE, REMOVED THE PX SLIM WITH THE PC400 INSIDE, AND COMPLETED THE PROCEDURE USING A NEW PC400 AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6517328 ↗
• 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 PARAOPHTHALAMIC 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 5975339 ↗
• MalfunctionAug 5, 2016Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA)-POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED A STEAM-SHAPING OF A PX SLIM DELIVERY MICROCATHETER (PX SLIM) BEFORE ADVANCING IT TO THE RIGHT PORTION OF THE ANEURYSM. ALTHOUGH TORTUOSITY WAS NOTED IN THE TARGET VESSEL, THE PX SLIM WAS ABLE TO SMOOTHLY ADVANCE TO THE TARGET VESSEL WITH NO ISSUES NOTICED. THE PHYSICIAN THEN DEPLOYED AND DETACHED FOUR PC400 COILS INTO THE TARGET VESSEL USING THE PX SLIM. WHILE THE PHYSICIAN WAS ADVANCING THE FIFTH PC400 COIL INTO THE PX SLIM, THE COIL BECAME STUCK AND ABOUT TEN CENTIMETERS OF COIL WOULD NOT ADVANCE IN. THE PHYSICIAN REMOVED THE PC400 COIL SUCCESSFULLY AND ADVANCED A NEW PC400 COIL THROUGH THE PX SLIM WITH NO ISSUES. AFTER ADJUSTING THE DEFLECTION ON THE PREVIOUS PC400 COIL INTRODUCER SHEATH AND CONFIRMING NO DAMAGES TO IT, THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 COIL INTO THE PX SLIM; HOWEVER, THE COIL BECAME STUCK AT THE SAME LOCATION IN THE PX SLIM. THEREFORE, THE PC400 COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING EIGHT NEW PC400 COILS AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5851210 ↗
• MalfunctionApr 13, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A FISTULA USING PENUMBRA COILS 400 (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A PC400 COIL THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). UPON RETRACTING THE PC400 COIL PUSHER ASSEMBLY, THE PHYSICIAN NOTICED THAT THE PC400 COIL HAD UNINTENTIONALLY DETACHED IN THE HUB OF THE PX SLIM AND IT WAS REMOVED. WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, IT UNINTENTIONALLY DETACHED AND WAS PUSHED IN THE ANEURYSM USING A GUIDE WIRE. THE PROCEDURE WAS COMPLETED USING SIX NEW PC400 COILS WITH 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 5575386 ↗
• MalfunctionFeb 19, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY (SGA) AND INFERIOR GLUTEAL ARTERY (IGA) USING PENUMBRA COIL 400 COILS (PC400 COILS) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A PC400 COIL AND TWO OTHER MANUFACTURERS' COILS INTO THE ANEURYSM USING A PX SLIM. THE PHYSICIAN THEN SWITCHED TO A SECOND PX SLIM IN ORDER TO AVOID ANY FOREIGN MATTER INSIDE THE CATHETER AND PERFORMED AN EMBOLIZATION PROCEDURE USING N-BUTYL-2-CYANOACRYLATE, NBCA, AN EMBOLIC MATERIAL. THE PHYSICIAN FLUSHED A THIRD PX SLIM AND ATTEMPTED TO DELIVER A PC400 COIL INTO THE ANEURYSM; HOWEVER, RESISTANCE WAS MET WHILE ADVANCING THE PC400 COIL THROUGH THE PX SLIM. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO ADVANCE THE PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN REMOVED BOTH DEVICES FROM THE PATIENT AND COMPLETED THE PROCEDURE USING A NEW 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 5448871 ↗
• InjuryJan 19, 2016Detachment Of Device Component; Failure to Advance; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FOUR PC400 COILS INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND OTHER MANUFACTURERS' DEVICES. WHILE ADVANCING A FIFTH PC400 COIL INTO THE ANEURYSM, THE PHYSICIAN FELT AN "ENTRAPMENT" AND WAS UNABLE TO ADVANCE THE TIP OF THE PC400 COIL ANY FURTHER INTO THE ANEURYSM. THE PHYSICIAN THEN PULLED BACK ON THE PC400 PUSHER ASSEMBLY ABOUT TEN TIMES IN AN ATTEMPT TO RETRACT THE PC400 COIL FROM THE PX SLIM; HOWEVER, THE TIP OF THE PC400 COIL UNINTENTIONALLY DETACHED. THE PX SLIM AND THE OTHER MANUFACTURERS' DEVICES WERE REMOVED. THE PHYSICIAN THEN REINSERTED THE OTHER MANUFACTURER'S SHEATH AND REQUIRED A SNARE DEVICE TO RETRIEVE THE DETACHED TIP OF PC400 COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING EIGHT NEW PC400 COILS 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 5378203 ↗
• MalfunctionJan 8, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING A PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FIFTEEN PC400 COILS INTO THE ANEURYSM. THE PHYSICIAN THEN REMOVED A NEW PC400 COIL FROM ITS PACKAGING. WHILE ADVANCING THIS PC400 COIL OUT OF ITS ORANGE-COLORED INTRODUCER SHEATH, THE PHYSICIAN NOTICED THAT THE PC400 COIL PUSHER ASSEMBLY WAS KINKED. THE KINKED PUSHER ASSEMBLY WAS FOUND PRIOR TO USE. THEREFORE, THE PC400 COIL WAS NOT USED FOR THE PROCEDURE AND DID NOT ENTER THE PATIENT'S BODY. THE PHYSICIAN CONTINUED THE PROCEDURE USING A NEW PC400 COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5355799 ↗