Penumbra Coil 400 4002C0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI M4244002C08300), received between Sep 3, 2015 and Jun 27, 2019 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2019Material Frayed; Unraveled Material; Material Frayed; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CLEFT USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ADVANCING A PC400 INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN VISUALIZED BY FLUOROSCOPY THAT THE PC400 BECAME FRAYED AND UNRAVELED. THE PC400 WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL PC400S 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 8739773 ↗
• MalfunctionMay 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400 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 8612084 ↗
• MalfunctionApr 30, 2019Failure to Advance; Failure to Advance

  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 THREE PC400S AND TWO OTHER COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE TIP OF THE LANTERN AND, THEREFORE, THE LANTERN WAS REMOVED WITH THE PC400 INSIDE. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN AND COMPLETED THE PROCEDURE 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 8565261 ↗
• MalfunctionAug 27, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT PULMONARY ARTERY USING PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT¿S VESSELS WERE MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH THE TIP OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400. WHILE RETRACTING, THE PC400 UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY AND, THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE DETACHED PC400 INSIDE. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, A NEW PC400, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7819182 ↗
• MalfunctionJun 29, 2018Detachment Of Device Component; Kinked; Detachment Of Device Component; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY (SPA)/ COMMON HEPATIC ARTERY (CHA) USING POD6S AND A PENUMBRA COIL 400 (PC400). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A POD6 INTO THE HUB OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE POD6 INTRODUCER SHEATH; THEREFORE, THE PHYSICIAN REMOVED THE POD6 AND SOAKED IT IN A SALINE TREY. THE PHYSICIAN THEN ATTEMPTED AGAIN TO ADVANCE THE POD6 INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE POD6 BECAME STUCK AT THE SAME POSITION IN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE MICROCATHETER, THE PC400 PUSHER BECAME KINKED AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED IN THE MICROCATHETER. IT WAS REPORTED THAT THE PROXIMAL END OF THE PC400 WAS APPROXIMATELY FIVE CENTIMETERS INTO THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE PC400 PUSHER ASSEMBLY, THE DETACHED COIL AND REMOVED THE COIL. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, FOUR POD COILS, ONE PENUMBRA SMART COIL (SMART COIL) AND FOUR OTHERS COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651785 ↗
• InjuryJun 29, 2018Detachment Of Device Component; Detachment Of Device Component

  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 ONE RUBY COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE A PC400, HOWEVER, WHILE RETRACTING TO REPOSITION THE PC400, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE VESSEL. THE PHYSICIAN THEREFORE USED A SNARE DEVICE TO REMOVE THE DETACHED COIL, AND THEN COMPLETED THE PROCEDURE USING ADDITIONAL COILS, NEW RUBY 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 7651616 ↗
• MalfunctionApr 10, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400¿S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL TIP OF THE LANTERN AND THE PC400 WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE SAME POSITION AND PC400 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING 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 7412357 ↗
• MalfunctionMar 5, 2018Detachment Of Device Component; Kinked; Device Damaged Prior to Use; Detachment Of Device Component; Kinked; Device Damaged Prior to Use

  WHILE PREPARING A NEW PENUMBRA COIL 400 (PC400) ON THE BACK TABLE FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT THE PC400 WAS ALREADY DETACHED UPON REMOVAL FROM ITS PACKAGING HOOP. ADDITIONALLY, THE PC400 PUSHER ASSEMBLY BECAME KINKED UPON RETRACTING THE COIL BACK INTO ITS PACKAGING HOOP. THE PC400 BECAME DETACHED AND THE PUSHER ASSEMBLY BECAME DAMAGED PRIOR TO USE. THEREFORE, THE PC400 WAS NOT USED IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Patient Involvement

  MAUDE report 7314903 ↗
• MalfunctionJan 19, 2018Failure 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 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 MORE THAN ABOUT 10 CM INTO A NON-PENUMBRA MICROCATHETER, AND THEREFORE THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL NINE 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 7208297 ↗
• MalfunctionNov 14, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A THORACIC ARTERY ANEURYSM USING A PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES) AND PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA STENT GRAFT TOWARD THE TREATMENT SITE, THEN ADVANCED A NON-PENUMBRA SUPPORT MICROCATHETER INTO THE LEFT SUBCLAVIAN ARTERY. AFTER THAT, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS AND FIVE PC400S IN THE TARGET VESSEL. THEREAFTER, THE PHYSICIAN ADVANCED A NEW PC400 IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. THEREFORE, THE PHYSICIAN TRIED TO ADJUST THE POSITION OF THE PC400 BY USING THE PUSH AND PULL TECHNIQUE. WHILE ATTEMPTING TO PUSH AND RETRACT THE PC400, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE PC400 UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL FROM THE PATIENT¿S BODY AND FLUSHED TO COIL OUT. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER IN TARGET VESSEL AND THE PROCEDURE WAS COMPLETED USING THREE OTHER 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 7030939 ↗
• MalfunctionOct 19, 2017Detachment Of Device Component; Positioning Failure; Detachment Of Device Component; Positioning Failure

  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 6962230 ↗
• MalfunctionOct 5, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HEPATIC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 THROUGH THE HUB OF A NON-PENUMBRA MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS USING THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400, HOWEVER AGAIN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THROUGH THE HUB OF THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE PC400 AND MICROCATHETER, AND FLUSHED THE MICROCATHETER. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND RE-ATTEMPTED TO ADVANCE THE TWO PC400S, BUT WAS STILL UNABLE TO. THE PROCEDURE WAS THEREFORE COMPLETED USING THE SAME MICROCATHETER, NEW 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 6917894 ↗
• MalfunctionFeb 2, 2017Peeled/Delaminated; Failure to Advance; Physical Resistance; Peeled/Delaminated; 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 DEPLOYED AND DETACHED TWO PC400''S INTO THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FLUSHED THE PX SLIM AND ATTEMPTED TO ADVANCE A NEW PC400 THROUGH IT. HOWEVER, THE PX SLIM KICKED BACK AND THE PHYSICIAN LOST ACCESS TO THE TARGET VESSEL. THEREFORE, THE PC400 WAS RETRACTED. THE PHYSICIAN THEN ATTEMPTED TO RESHEATH THE PC400 BACK INTO ITS INTRODUCER SHEATH BUT ENCOUNTERED RESISTANCE WAS UNABLE TO RESHEATH THE COIL. UPON INSPECTION OF THE PC400, THE PHYSICIAN NOTICED THAT THE BLACK COATING OF THE ALIGNMENT ZONE WAS PEELED OFF AND MOVED PROXIMAL FROM ITS APPROPRIATE POSITION. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND FLUSHED THE PX SLIM AFTER PLACING EACH COIL DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6296023 ↗
• MalfunctionJan 17, 2017Detachment Of Device Component; Positioning Failure; Device Operates Differently Than Expected; Detachment Of Device Component; Positioning Failure; Device Operates Differently Than Expected

  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 DEPLOYED AND DETACHED SEVEN PC400''S INTO THE IIA USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) WITHOUT AN ISSUE. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE EIGHTH PC400 INTO THE TARGET VESSEL; HOWEVER, THE COIL DID NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE PHYSICIAN MANIPULATED THE PX SLIM IN ORDER TO RETRACT AND ADVANCE THE PC400 SEVERAL TIMES. AFTER MANIPULATING THE DEVICES FOR SOME TIME, THE PHYSICIAN DID NOT ENCOUNTER RESISTANCE BUT NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED. BECAUSE MORE THAN HALF OF THE COIL WAS LEFT INSIDE THE PX SLIM, THE PHYSICIAN CAREFULLY REMOVED THE PX SLIM CONTAINING THE DETACHED PC400 AND COMPLETED THE PROCEDURE USING THE SAME PX SLIM AND A NEW PC400. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND FLUSHED THE PX SLIM BETWEEN EACH COIL USED DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6257521 ↗
• MalfunctionJan 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING VARICOSE VEINS USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE PC400S AND NON-PENUMBRA COILS IN THE TARGET VESSELS THROUGH A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING AN ADDITIONAL PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME NON-PENUMBRA MICROCATHETER. IN ADDITION, THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6241757 ↗
• InjurySep 28, 2016Detachment Of Device Component; Kinked; Physical Resistance; Detachment Of Device Component; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH ANOTHER MANUFACTURER'S MICROCATHETER. CONSEQUENTLY, THE PC400 BECAME KINKED AND UNINTENTIONALLY DETACHED INSIDE THE PATIENT'S BODY. THE PHYSICIAN REQUIRED A SNARE DEVICE TO RETRIEVE THE DETACHED COIL. THE PHYSICIAN SUBSEQUENTLY HALTED THE PROCEDURE AND POSTPONED IT UNTIL THE FOLLOWING WEEK. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV); HOWEVER, CONTINUOUS FLUSH WAS NOT MAINTAINED. THE SUBSEQUENT PROCEDURE WAS SUCCESSFULLY COMPLETED USING PC400, POD COILS AND ANOTHER MANUFACTURER'S MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5983915 ↗
• MalfunctionAug 2, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN INITIALLY DELIVERED TWO COILS FROM ANOTHER MANUFACTURER AND TWO PC400 COILS INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER. WHILE ADVANCING A NEW PC400 COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 COIL BECAME STUCK AROUND THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400 COIL; HOWEVER, WHILE THE COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN FLUSHED THE PC400 COIL OUT OF THE MICROCATHETER USING A SYRINGE AND THEN ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE MICROCATHETER. HOWEVER, THE NEW PC400 COIL BECAME STUCK AROUND THE TIP OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER THEN RETRACTED THE PC400 COIL FROM IT AND COMPLETED THE PROCEDURE USING ANOTHER MANUFACTURERS' 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 5842002 ↗
• InjuryJul 6, 2016Stretched; Material Deformation; Mechanical Jam; Stretched; Material Deformation; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A RUPTURED CAROTID TERMINUS ANEURYSM USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED AN INITIAL PC400 COIL INTO THE ANEURYSM USING THE PX SLIM. AFTER APPROXIMATELY FIFTY PERCENT OF A SECOND PC400 COIL WAS DEPLOYED INTO THE ANEURYSM, IT WAS NOTICED THAT THE COIL WAS NOT MOVING WHEN THE PC400 COIL PUSHER ASSEMBLY WAS BEING MANIPULATED (ADVANCED AND RETRACTED). NO RESISTANCE WAS OBSERVED WHILE ADVANCING THIS SECOND PC400 COIL. THE PHYSICIAN DID NOTICE THAT THE PX SLIM WAS POSITIONED INSIDE THE ANEURYSM AND BEGAN TO PREPARE AN OCCLUSION BALLOON SYSTEM TO BE PLACED AT THE ANEURYSM NECK IN ORDER TO SUPPORT THE PX SLIM. DURING THIS PROCESS, THE HOSPITAL STAFF ATTEMPTED TO CHANGE OUT THE FLUSH BAG, WHICH WAS CONNECTED TO THE PX SLIM. HOWEVER, WHILE THE FLUSH BAG WAS BEING CHANGED, THE LINE WAS PULLED WHICH CAUSED THE PX SLIM TO BE DISPLACED OUTSIDE OF ITS PREVIOUS POSITION. THIS MOVEMENT MADE IT IMPOSSIBLE TO PUSH ADDITIONAL COILS INTO THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO USE ANOTHER MANUFACTURER'S RETRI

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

  MAUDE report 5774021 ↗
• MalfunctionJun 30, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT A PC400 PUSHER ASSEMBLY WAS FOUND BENT WHILE REMOVING IT FROM THE PACKAGING. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5761633 ↗
• MalfunctionFeb 12, 2016Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN LEFT INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S CATHETER TOWARD THE TARGET VESSEL AND THEN ADVANCED THE PX SLIM THROUGH THE CATHETER. WHILE A PC400 COIL WAS ADVANCED APPROXIMATELY 10 CENTIMETERS FROM THE TIP OF THE PX SLIM, THE OTHER MANUFACTURER'S CATHETER KICKED BACK. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE PC400 COIL FROM THE PX SLIM BUT UNSUCCESSFUL DUE TO RESISTANCE FELT ON THE PC400 COIL PUSHER ASSEMBLY. AFTER SEVERAL ATTEMPTS WERE MADE TO WITHDRAW THE PC400 COIL, IT UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN REMOVED THE OTHER MANUFACTURER'S CATHETER AND THE PX SLIM CONTAINING THE PC400 COIL FROM THE PATIENT AND COMPLETED THE PROCEDURE USING A NEW PX SLIM, THREE NEW PC400 COILS AND ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5434611 ↗
• MalfunctionFeb 10, 2016Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE AT IPSI-LATERAL LIMB IN THE LEFT INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING AND RETRACTING A PC400 COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PC400 COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE PC400 COIL AND THE MICROCATHETER FROM THE PATIENT AND COMPLETED THE PROCEDURE USING A NEW PC400 COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5429556 ↗
• InjuryDec 28, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR BASILAR ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS. HOWEVER, AFTER THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED MODERATE HYDROCEPHALUS. A VENTRICULOSTOMY WAS PERFORMED AND THE EVENT WAS RESOLVED ON (B)(6) 2012. THE REPORTED MODERATE HYDROCEPHALUS WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH POSSIBLE RELATIONSHIP TO THE PC400 COILS, PROBABLE RELATIONSHIP TO ANGIOGRAPHIC PROCEDURE AND DEFINITE RELATIONSHIP TO THE ANEURYSM STATE.

  Patient problems: Hydrocephalus

  MAUDE report 5331281 ↗
• MalfunctionSep 3, 2015Difficult or Delayed Positioning

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A PENUMBRA COIL 400 (PC400) COILS AND A PENUMBRA COIL 400 DETACHMENT HANDLE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED THE FIRST PC400 COIL USING THE DETACHMENT HANDLE. THE PHYSICIAN ADVANCED A SECOND PC400 COIL INTO THE ANEURYSM; HOWEVER, IT WOULD NOT DETACH USING THE DETACHMENT HANDLE. THE PC400 COIL WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN REQUIRED MULTIPLE ATTEMPTS TO MANUALLY DETACH IT OUTSIDE THE PATIENT. THE PHYSICIAN USED A THIRD PC400 COIL WHICH HE WAS UNABLE TO DETACH USING THE DETACHMENT HANDLE, BUT WAS ABLE TO MANUALLY DETACH FROM THE PUSHER WIRE INTO THE ANEURYSM. THE PROCEDURE CONTINUED USING A NEW (FOURTH) PC400 COIL AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5054671 ↗