Penumbra Coil 400 4006C0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI M4244006C04080), received between Sep 30, 2015 and Feb 4, 2023 — classified as 1 death, 10 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO PC400S INTO THE ANEURYSM USING THE PX SLIM. THE PHYSICIAN THEN ADVANCED THE THIRD PC400 INTO THE ANEURYSM AND DETACHED IT. SUBSEQUENTLY, IT WAS NOTICED THAT PART OF THE THIRD PC400 WAS NO LONGER INSIDE THE ANEURYSM. THEREFORE, THE PHYSICIAN PUSHED THE PC400 BACK INTO THE ANEURYSM USING THE PX SLIM. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY IMPLANTED A FOURTH PC400. NEXT, THE FIFTH PC400 WAS OPENED, AND IT WAS THEN NOTICED THAT THE DISTAL MARKER ON THE PC400 WAS MISSING. HOWEVER, THE PHYSICIAN SUCCESSFULLY PLACED THE FIFTH PC400 IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING A SIXTH 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 16301351 ↗
• MalfunctionJul 2, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PC400 IN THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING THE NEXT PC400 THROUGH THE PX SLIM, THE PC400 BECAME STUCK; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE RETRACTING THE PC400, THE PX SLIM BROKE APPROXIMATELY 30 CENTIMETERS FROM ITS HUB. IT WAS REPORTED THAT THE REST OF THE PX SLIM REMAINED WITHIN THE NON-PENUMBRA CATHETER. THEREFORE, THE PHYSICIAN PULLED THE CATHETER WITH THE BROKEN PX SLIM TOGETHER. 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 10222624 ↗
• MalfunctionDec 23, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE COIL. HOWEVER, DURING RETRACTION, THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED AND THE PC400 WAS FLUSHED OUT. 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 9510985 ↗
• MalfunctionSep 5, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING PENUMBRA COIL 400S AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400 COILS INTO THE TARGET LOCATION USING THE LANTERN. DURING ADVANCEMENT OF THE NEXT PC400 THROUGH THE MIDDLE OF THE LANTERN, IT WAS REPORTED THAT THE PC400 UNINTENTIONALLY DETACHED. THE LANTERN AND PC400 WERE REMOVED TOGETHER FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE LANTERN WAS BROKEN AT THE PROXIMAL PART. THEREFORE, THE DEVICES WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR NEW PC400 COILS 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 8967163 ↗
• MalfunctionSep 4, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE POD COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE HUB OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PC400 WAS REMOVED, AND THE LANTERN WAS FLUSHED. THE PHYSICIAN THEN ENCOUNTERED RESISTANCE AGAIN WHILE ATTEMPTING TO RE-ADVANCE THE PC400 THROUGH THE HUB OF THE LANTERN; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 8962989 ↗
• MalfunctionJul 10, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE PC400 COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW PC400, THE LANTERN KICKED OUT OF THE TARGET LOCATION; THEREFORE, PHYSICIAN REMOVED THE PC400 IN ORDER TO REPOSITION THE LANTERN. WHILE RETRACTING THE PC400 INTO THE LANTERN DURING AN ATTEMPT TO REPOSITION, THE PC400 UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL, THEN REMOVED THE COIL OUT AND REINSERTED THE LANTERN INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400¿S 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 8775556 ↗
• MalfunctionJun 28, 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). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AT THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PC400 COMPLETELY INTACT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400¿S, OTHER COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745660 ↗
• MalfunctionJun 28, 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 (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AT THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PC400 COMPLETELY INTACT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400¿S, OTHER COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8745656 ↗
• MalfunctionJun 18, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 IN THE MIDDLE OF THE LANTERN; THEREFORE, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE PC400 ¿STRETCHED¿ WHILE BEING REMOVED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN, FIVE PC400S AND ONE OTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707301 ↗
• MalfunctionApr 24, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, PRIOR TO ADVANCEMENT INTO THE PATIENT, THE PHYSICIAN WAS EXAMINING A PC400 IN SALINE SOLUTION AND FOUND THAT THE COIL WAS STRAIGHT AND WAS NOT COILING. IT WAS ALSO REPORTED THAT THE PC400 WAS DEFORMED. THE PC400 COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8547459 ↗
• MalfunctionFeb 5, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PC400 AND 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 8304780 ↗
• MalfunctionJan 3, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 WAS STUCK AT THE HUB OF THE MICROCATHETER AND WOULD NOT ADVANCE FURTHER; THEREFORE, IT 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 8215317 ↗
• MalfunctionDec 26, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS FISTULA USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE INSERTING A PC400 INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PC400. HOWEVER, UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE DETACHED COIL INTO THE TARGET VESSEL USING THE PUSHER ASSEMBLY; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND EIGHT ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197078 ↗
• MalfunctionNov 19, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA STENT DEVICE FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. NEXT, THE PHYSICIAN PLACED A NON-PENUMBRA MICROCATHETER AND SEVEN PC400S IN THE TARGET VESSEL. WHILE ATTEMPTING TO INSERT ANOTHER PC400 INTO THE 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 THREE 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 8085952 ↗
• MalfunctionNov 12, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE TIP OF THE MICROCATHETER AND THE PC400 WOULD NOT ADVANCE FURTHER TO EXIT THE MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS ENDED AT THIS POINT WITH NO OTHER COILS USED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059715 ↗
• InjuryJul 24, 2018Break; Unraveled Material; Material Deformation; Break; Unraveled Material; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400S (PC400S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND ONE PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE RETRACTING A NEW PC400 FOR REPOSITIONING, THE COIL UNRAVELED; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, WHILE WITHDRAWING THE PC400, IT BECAME ELONGATED IN THE PATIENT¿S BODY. THE PHYSICIAN WAS ABLE TO REMOVE MOST OF THE PC400 BUT SUSPECTED THAT A SMALL AMOUNT OF THE ELONGATED PART OF THE PC400 BROKE AND REMAINED IN THE PATIENT¿S BODY. SUBSEQUENTLY, THROMBUS FORMED AND THEREFORE, THE PHYSICIAN USED A NON-PENUMBRA CATHETER TO REMOVE THE THROMBUS. THE PROCEDURE WAS COMPLETED BY PRESSING THE SUSPECTED REMAINING PIECE OF THE COIL TO THE VESSEL WITH A STENT GRAFT, PREVENTING THE COIL FROM FLOATING IN THE PATIENT¿S BODY.

  Patient problems: Thrombus

  MAUDE report 7716330 ↗
• MalfunctionJun 6, 2018Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A POD COIL IN THE TARGET VESSEL USING A PX SLIM MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO INSERT A PC400 INTO THE PX SLIM, THE PHYSICIAN NOTICED THAT THE COIL DID NOT ADVANCE INTO THE MICROCATHETER. THE PHYSICIAN THEN LOOKED AROUND AND NOTICED THAT THE EMBOLIZATION COIL WAS ON THE GROUND. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400, OTHER COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7575928 ↗
• MalfunctionApr 24, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A POD COIL AND TWO PC400S USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ADVANCED ANOTHER PC400 INTO THE LANTERN, AND ATTEMPTED TO REMOVE THE INTRODUCER SHEATH FROM THE PROXIMAL END OF THE PUSHER ASSEMBLY OF THE PC400. HOWEVER, THE PUSHER ASSEMBLY WAS STUCK WITHIN THE FRICTION LOCK ON THE INTRODUCER SHEATH AND COULD NOT BE REMOVED. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PC400 INSIDE, AND THEN REINSERTED THE SAME LANTERN. 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 7456811 ↗
• MalfunctionFeb 14, 2018Failure to Advance; Physical Resistance; Material Integrity Problem; Failure to Advance; Physical Resistance; Material Integrity Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING POD4'S, PENUMBRA COIL 400'S (PC400'S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AN INITIAL POD4 THROUGH THE LANTERN AND ATTEMPTED TO DEPLOY THE COIL IN THE TARGET VESSEL; HOWEVER, THE POD4 WAS NOT COILING PROPERLY AND WAS REMOVED. WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE SAME LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE NEAR THE HUB OF THE LANTERN AND DECIDED TO REMOVE THE PC400. THE PC400 WAS THEN VISUALLY INSPECTED IN A TRAY FILLED WITH SALINE AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN; HOWEVER, RESISTANCE WAS STILL ENCOUNTERED SO THE PC400 WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED THE INITIAL POD4 THROUGH THE LANTERN AND INTO THE TARGET VESSEL BUT THE COIL DID NOT COIL PROPERLY AND WAS REMOVED. IN THE END, THE IMA WAS NOT EMBOLIZED WITH COILS AND STENT GRAFTING WAS PERFORMED. IT WAS REPORTED THAT THE LANTERN, POD4 AND PC400 WERE SLIGHTLY DAMAGED BUT THE SPECIFIC DETAILS ARE UNKNOWN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7272262 ↗
• MalfunctionJan 5, 2018Stretched; Device Handling Problem; Stretched; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY FOUR COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN PLACED A NEW NON-PENUMBRA MICROCATHETER AND SUCCESSFULLY PLACED ONE PC400. THE PHYSICIAN THEN ATTEMPTED TO PLACE A SECOND PC400, HOWEVER WHILE ADVANCING AND RETRACTING THE PC400 MULTIPLE TIMES TO REPOSITION THE PC400, THE PC400 BEGAN TO STRETCH. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE PC400 INSIDE, AND THEN COMPLETED THE PROCEDURE USING THE FIRST 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 7168262 ↗
• MalfunctionDec 19, 2017Separation Failure; Difficult or Delayed Activation; Separation Failure; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO POD COILS AND PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AFTER THAT, THE PHYSICIAN ADVANCED A NEW PC400 IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. IT WAS REPORTED THAT THE PET LOCK WAS SEPARATED ABOUT TWO MILLIMETERS. AFTER SEVERAL FAILED ATTEMPTS, A NEW HANDLE WAS OPENED AND THE PC400 WAS SUCCESSFULLY DETACHED. THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING ADDITIONAL COILS. WHILE ATTEMPTING TO ADVANCE A NEW PC400 AS THE 27TH COIL THROUGH THE PX SLIM, THE PC400 WOULD NOT ADVANCE FURTHER AFTER REACHING ALMOST THE DISTAL TIP OF THE PX SLIM. THEREFORE, IT WAS REMOVED, FLUSHED WITH SALINE AND RE-INSERTED INTO THE PX SLIM; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129820 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400''S (PC400'S) WITH NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2017, THE PATIENT PRESENTED AT THE HOSPITAL WITH A RIGHT ARM AND LEG SENSATION CHANGE. THE RIGHT ARM SENSATION RESOLVED SPONTANEOUSLY; HOWEVER, THE PATIENT HAD DECREASED SENSATION BELOW THE KNEE AND A COLD FEELING WAS PRESENT. THE PATIENT'S NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE AT BASELINE WAS A 3. THE RESULTS OF THE COMPUTERIZED TOMOGRAPHY (CT) HEAD AND COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE NEGATIVE AT BASELINE. THE PATIENT WAS GIVEN INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV-TPA) AND THE SYMPTOMS RESOLVED ON (B)(6) 2017. THE REPORTED FOCAL NEUROLOGICAL DEFICIT WAS ADJUDICATED TO BE AN ADVERSE EVENT THAT WAS POSSIBLY RELATED TO THE PC400 BUT UNRELATED TO THE PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7033403 ↗
• MalfunctionOct 27, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SINGLE CARDIAC VENTRICLE DEFECT USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A PC400 THROUGH THE HUB OF THE MICROCATHETER AND THEREFORE; THE PC400 WAS REMOVED. THE PHYSICIAN RE-ATTEMPTED TO ADVANCE THE PC400 SEVERAL TIMES, HOWEVER WAS UNABLE TO ADVANCE THE PC400 INTO THE MICROCATHETER. THE PROCEDURE WAS THEREFORE 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 6983406 ↗
• MalfunctionMay 22, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400(PC400S). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS USING A PC400 WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 UNINTENTIONALLY DETACHED IN THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM WITH THE DETACHED PC400 INSIDE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583542 ↗
• InjuryNov 29, 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 6131917 ↗