Penumbra Coil 400 4002C1040Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI M4244002C10400), received between Aug 26, 2015 and Feb 5, 2024 — classified as 5 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (34 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COIL 400S (PC400S) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 INTO THE TARGET LOCATION. THE PHYSICIAN CONTINUED TO EXPERIENCE RESISTANCE WHILE ADVANCING THE PC400 INTO THE TARGET LOCATION AND DECIDED TO REMOVE THE PC400. WHILE ATTEMPTING TO REMOVE THE PC400, ONLY THE PUSHER ASSEMBLY CAME OUT AND THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS SLOWLY REMOVED FROM THE PATIENT. THE PC400 WAS THEN REMOVED FROM THE MICROCATHETER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18643716 ↗
• MalfunctionMay 24, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED 2 PC400S IN THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING THE 3RD PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE DETACHED PC400. THE PC400 WAS FLUSHED OUT OF THE PX SLIM AND THE PX SLIM WAS REINSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489603 ↗
• MalfunctionMar 25, 2021Stretched; Failure to Advance; Physical Resistance/Sticking; Stretched; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVERAL PC400S INTO THE TARGET LOCATION USING THE MICROCATHETER. THEN, WHILE ADVANCING ANOTHER PC400 THROUGH THE MICROCATHETER, THE PC400 BECAME STUCK AND APPROXIMATELY, ONLY ONE CENTIMETER OF THE PC400 WOULD EXIT THE DISTAL END OF THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE REMOVING THE PC400. SUBSEQUENTLY, THE PC400 WAS REMOVED WITH DIFFICULTY AND IT WAS ALSO REPORTED THAT THE PC400 BECAME STRETCHED DURING REMOVAL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572016 ↗
• MalfunctionDec 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN WAS TREATING A LARGE ANEURYSM IN THE PCA WITH PC400S. WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 BECAME STUCK IN THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11095120 ↗
• MalfunctionMar 31, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A MID-BASILAR ARTERY ANEURYSM USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S IN THE ANEURYSM USING THE PX SLIM AND NEURON MAX. THE PHYSICIAN THEN ATTEMPTED TO PLACE THE THIRD PC400 INTO THE ANEURYSM BUT WAS UNSUCCESSFUL; THEREFORE, THE PHYSICIAN REDUCED THE SLACK OF THE PX SLIM AND ATTEMPTED AGAIN TO PLACE THE PC400 BUT WAS ALSO UNSUCCESSFUL; THEREFORE, THE PC400 WAS REMOVED. UPON REMOVAL OF THE PC400, IT WAS NOTICED THAT THERE WAS A LOT OF CLOT ON THE PC400; THEREFORE, THE PC400 WAS RINSED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PC400 THROUGH THE PX SLIM BUT THE PX SLIM GOT KICKED OUT OF PLACED. THE PX SLIM WAS THEN SECURED BACK INTO PLACED AND THE PHYSICIAN ATTEMPTED AGAIN TO PLACE THE PC400 INTO THE ANEURYSM BUT WAS UNSUCCESSFUL. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS 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 9907866 ↗
• MalfunctionSep 9, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR PC400¿S IN THE SUPERIOR GLUTEAL ARTERY USING A LANTERN. IT WAS ALSO REPORTED THAT THE PHYSICIAN MANAGED TO ADVANCE THE FOUR PC400¿S AGAINST RESISTANCE IN THE LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW PC400 AS THE FIFTH COIL, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AT THE END OF THE MICROCATHETER AND DECIDED TO DETACH THE COIL. THE PHYSICIAN THEN ATTEMPTED TO PUSH OUT THE PC400 USING A NON-PENUMBRA GUIDEWIRE AND FLUSHING THE MICROCATHETER, HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE LANTERN WAS REMOVED WITH THE PC400 INSIDE. THE PROCEDURE WAS COMPLETED USING NEW PC400¿S AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8978047 ↗
• MalfunctionAug 14, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8895050 ↗
• MalfunctionJul 10, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED A LANTERN DELIVERY MICROCATHTER (LANTERN) AND SOON AFTER ADVANCING THE FIRST PC400, RESISTANCE WAS EXPERIENCED AND KINKED THE DELIVERY PUSHER; THEREFORE, THE PC 400 WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING TEN OTHER PC400S 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 8778596 ↗
• MalfunctionApr 17, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A PC400 PAST THE HUB OF THE LANTERN. WHILE RETRACTING THE PC400, IT WAS REPORTED THAT IT UNINTENTIONALLY DETACHED WITHIN THE HUB OF THE LANTERN. THE PC400 WAS THEN REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER PC400, AND REPORTED THAT THE PC400 WAS UNABLE TO ADVANCE PAST THE INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THIS PC400 WAS ALSO REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PC400 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 8522418 ↗
• MalfunctionMar 20, 2019Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC AORTA (TA) AND THE LEFT SUBCLAVIAN ARTERY (SCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN STENTED THE TA AND ADVANCED A NON-PENUMBRA MICROCATHETER INTO THE SCA. THE PHYSICIAN THEN SUCCESSFULLY PLACED THREE COMPETITORS'' COILS INTO THE SCA. WHEN ATTEMPTING TO ADVANCE THE FOURTH COIL, A PC400, THROUGH THE MICROCATHETER, THE PHYSICIAN REPORTED FEELING RESISTANCE AT THE PROXIMAL PART AND IT COULD NOT ADVANCE MORE THAN 5 CM PAST THE HUB. WHILE WITHDRAWING THE PC400 IN AN ATTEMPT TO RE-ADVANCE IT, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE PC400 COIL BY HAND AND IT WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436490 ↗
• InjuryFeb 27, 2019Premature Separation; Premature Separation

  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 PLACED TWO PC400S IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA CATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE LANTERN, THE PC400 UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY AND MIGRATED INTO THE EXTERNAL ILIAC ARTERY (EIA). THE PHYSICIAN WAS ABLE TO REMOVE THE DETACHED PC400. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING FIVE RUBY 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 8373920 ↗
• MalfunctionFeb 15, 2019Premature 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 INTRODUCED A NON-PENUMBRA GUIDE CATHETER FROM THE FEMORAL ARTERY AND PLACED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A PC400 IN THE TARGET VESSEL AND FORMED FOUR LOOPS. WHILE ATTEMPTING TO PULL THE PC400 IN ORDER TO REPOSITION IT, THE PC400 UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM AND PC400 PUSHER ASSEMBLY, THEN REMOVED THE GUIDE CATHETER AND THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE CATHETER, THE SAME PX SLIM AND FIVE ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8344531 ↗
• MalfunctionOct 25, 2018Failure to Advance; Material Deformation; Material Twisted/Bent; Failure to Advance; Material Deformation; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN AND, THEREFORE, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE TIP OF THE INTRODUCER SHEATH WAS KINKED, AND THERE WAS A SLIGHT DISTORTION IN THE COIL. THE PROCEDURE WAS THEN COMPLETED USING NEW PC400S 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 8006832 ↗
• MalfunctionAug 9, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A BALLOON-OCCLUDED RETROGRADE TRANSFEMORAL OBLITERATION (BRTO) PROCEDURE USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE FIRST PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 OUT OF INTRODUCER SHEATH AND INTO SALINE, THE PHYSICIAN EXPERIENCED RESISTANCE NEAR THE TIP OF THE INTRODUCER SHEATH AND THE PC400 WOULD NOT COME OUT; THEREFORE, THE PC400 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE OTHER 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 7769809 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURE ANEURYSM USING PENUMBRA COILS 400 (PC400S) WITH NO ISSUES. THE NEXT DAY, THE PATIENT HEALTH STATUS DECLINED. A COMPUTERIZED TOMOGRAPHY/COMPUTERIZED TOMOGRAPHY ANGIOGRAM (CT/CTA) THEN MAGNETIC RESONANCE IMAGING (MRI) WERE ORDERED. THE PATIENT REMAINS WEAK ON RIGHT SIDE AND SOMNOLENT. ACCORDING TO THE PHYSICIAN, THE MRI WITH LEFT SIDE INFRACT THAT APPEARED MORE WATERSHED. THE CTA WAS CLEAR BEYOND THE COIL MASS. THE MAGNETIC RESONANCE ANGIOGRAPHY (MRA) SHOWED SOME NARROWING NEAR THE COIL MASS WHICH IS PARTIALLY ARTIFACT BUT OVERALL LOOKS PATENT. THE PATIENT IS ALREADY ON ACETYLSALICYLIC ACID (ASA) AND HAD HEPARIN DURING CASE. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2018. AS OF (B)(6) 2018, THE EVENT WAS STILL CONSIDERED UNRESOLVED. THE LEFT CEREBRAL WATERSHED STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE PC400 SYSTEM AND THE PROCEDURE.

  Patient problems: Ischemia; Lethargy; Weakness

  MAUDE report 7707481 ↗
• MalfunctionJun 14, 2018Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WAS UNABLE TO ADVANCE; THEREFORE IT WAS REMOVED. NEXT, THE PHYSICIAN RE-ATTEMPTED TO ADVANCE THE SAME PC400; HOWEVER, RESISTANCE WAS EXPERIENCED AGAIN AND, CONSEQUENTLY, THE PC400 PUSHER ASSEMBLY BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE LANTERN, HOWEVER, THE SAME RESISTANCE WAS EXPERIENCED AGAIN. THE PHYSICIAN THEREFORE REMOVED THE PC400, THE LANTERN, AND THE NON-PENUMBRA SHEATH. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE TIP OF THE LANTERN WAS SLIGHTLY DAMAGED. NEST, THE PHYSICIAN INSERTED A NEW CATHETER AND A NON-PENUMBRA MICROCATHETER INTO THE TARGET LOCATION AND ATTEMPTED TO ADVANCE THE SAME PC400. DESPITE EXPERIENCING RESISTANCE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DEPLOY AND DETACH THE PC400. THE PROCEDURE WAS THEN COMPLETED USING 10 ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601344 ↗
• MalfunctionApr 25, 2018Bent; Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE USING PENUMBRA COILS 400 (PC400¿S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE HOSPITAL FELLOW WAS TOO AGGRESSIVE AND INADVERTENTLY BENT THE PC400 PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT ANOTHER PC400 PUSHER ASSEMBLY WAS ALSO BENT WHILE ADVANCING THE PC400 THROUGH THE PX SLIM; THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING ADDITIONAL COILS. AROUND THE 30TH COIL, IT WAS REPORTED THAT BLOOD MIGHT HAVE GOTTEN INSIDE THE HANDLE AND ITS THE TRIGGER BECAME A BIT STICKY; THEREFORE, THE HANDLE WAS SET ASIDE. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM, A NEW HANDLE AND ADDITIONAL PC400'S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7461639 ↗
• MalfunctionMar 28, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S USING THE LANTERN. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER PC400 THROUGH THE LANTERN, AND THEREFORE ATTEMPTED TO RETRACT THE PC400. THE PC400 UNINTENTIONALLY DETACHED WHILE BEING RETRACTED, AND THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PC400 INSIDE. THE SAME LANTERN WAS THEN RE-ADVANCED, AND THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER PC400 THROUGH IT. THE PHYSICIAN AGAIN FELT RESISTANCE ADVANCING, BUT WAS ABLE TO PLACE AND DETACH THE PC400 IN THE TARGET LOCATION. THE LANTERN WAS THEN REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, TEN 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 7378594 ↗
• InjuryJan 3, 2018Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND UNABLE TO ADVANCE ANOTHER PC400 FULLY THROUGH THE MICROCATHETER. THE PHYSICIAN CONTINUED TO ATTEMPT TO ADVANCE THE SAME PC400, AND CONSEQUENTLY, THE PUSHER WIRE OF THE PC400 BECAME KINKED AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO USE A GUIDEWIRE TO ADVANCE THE DETACHED PC400, HOWEVER WAS UNABLE TO AND THEREFORE REMOVED THE MICROCATHETER AND 4F SHEATH, LEAVING THE PC400 WITHIN THE NON-PENUMBRA 5F CATHETER. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE PC400 FROM WITHIN THE CATHETER, HOWEVER WAS UNABLE TO, AND THEREFORE RE-ATTEMPTED TO ADVANCE THE DETACHED PC400 USING THE SNARE DEVICE. THE PHYSICIAN WAS THEN ABLE TO PUSH THE PC400 FORWARD AND DELIVER IT INTO THE TARGET ANEURYSM. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, SHEATH, AND CATHETER, AND THREE ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162181 ↗
• 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 7129333 ↗
• MalfunctionDec 6, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; 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) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE PX SLIM INTO THE DISTAL END OF THE RIGHT IIA (SUPERIOR GLUTEAL ARTERY AND BIFURCATION OF INFERIOR GLUTEAL ARTERY), THEN DEPLOYED AND DETACHED SIX PC400'S INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE COIL WAS ADVANCED MIDWAY THROUGH THE PX SLIM. SUBSEQUENTLY, THE PC400 PUSHER ASSEMBLY BECAME KINKED WHEN THE PHYSICIAN USED A LITTLE FORCE IN AN ATTEMPT TO ADVANCE THE COIL FURTHER. THEREFORE, THE PHYSICIAN REMOVED BOTH THE PX SLIM AND THE PC400 FROM THE PATIENT¿S BODY. THE PROCEDURE WAS THEN COMPLETED USING A NEW PX SLIM AND THREE ADDITIONAL PC400''S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089265 ↗
• MalfunctionDec 5, 2017Failure 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 COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR PC400S USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE HUB OF THE MICROCATHETER, DESPITE MULTIPLE ATTEMPTS. THE PHYSICIAN THEREFORE REMOVED THE PC400 AND COMPLETED THE PROCEDURE USING NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7084042 ↗
• MalfunctionNov 9, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX PC400S USING A LANTERN. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE LANTERN AND, THEREFORE, THE LANTERN WAS REMOVED WITH THE PC400 INSIDE. THE PHYSICIAN PREPARED A NEW LANTERN AND A NEW COIL FOR USE, HOWEVER THEN DECIDED THAT THE EXISTING COIL MASS WAS SUFFICIENT AND THE BLOOD FLOW WAS COMPLETELY OCCLUDED, THEREFORE, THE DEVICES WERE NOT USED AND THE PROCEDURE THEN ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7016368 ↗
• MalfunctionAug 4, 2017Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA COIL 400S (PC400'S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL PC400 INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PC400 PUSHER ASSEMBLY FROM THE HANDLE BUT WAS UNABLE TO DO SO. THEREFORE, THE HANDLE WAS REMOVED WITH THE PUSHER ASSEMBLY STILL STUCK INSIDE. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL PC400'S, A NEW HANDLE, 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 6769201 ↗
• MalfunctionJun 22, 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 PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE A PC400 THROUGH IT. HOWEVER, WHILE ADVANCING THE COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN MET RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PC400 WAS THEN REMOVED AND A NEW PC400 WAS OPENED AND PLACED INTO THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A NEW PC400 INTO THE PX SLIM BUT WAS UNABLE TO REMOVE THE COIL''S INTRODUCER SHEATH FROM THE PROXIMAL END OF THE PUSHER ASSEMBLY. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW PC400''S 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 6662051 ↗