Penumbra Coil 400 4004J25Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI M4244004J250), received between Oct 10, 2015 and Mar 14, 2022 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT TRANSVERSE SINUS USING PENUMBRA COIL 400S (PC400), A NEURON 6F 070 DELIVERY CATHETER (NEURON 070), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE NEURON 070 INTO THE PATIENT, THEN ADVANCED THE PX SLIM THROUGH THE NEURON 070. WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN INADVERTENTLY ADVANCED THE PC400 IN THE WRONG CHANNEL OF THE VESSEL; THEREFORE THE PHYSICIAN DECIDED TO PULL BACK AND REPOSITION THE PC400. HOWEVER, WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PAC400 COIL, THE SAME NEURON 070 AND PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13755305 ↗
• MalfunctionApr 1, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA COILS 400 (PC400) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH A LANTERN. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602739 ↗
• MalfunctionAug 2, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA COILS 400 (PC400) AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE PC400S IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A NEW PC400 COIL IN THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY FIVE CENTIMETERS FROM THE PROXIMAL END; THEREFORE, THE PC400 REMOVED. DURING A SECOND ATTEMPT TO ADVANCE THE SAME PC400, RESISTANCE WAS FELT; THEREFORE, THE PC400 WAS REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ADVANCED ANOTHER PC400 AGAINST RESISTANCE; HOWEVER, THE COIL WAS PLACED SUCCESSFULLY IN THE TARGET VESSEL. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN. THE PROCEDURE WAS COMPLETED USING A PC400 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 8856296 ↗
• MalfunctionOct 10, 2018Failure 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, THE PHYSICIAN SUCCESSFULLY PLACED FOUR PC400S AND A POD COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE MIDDLE OF ITS INTRODUCER SHEATH, DESPITE ADVANCING AND RETRACTING THE PC400 MULTIPLE TIMES. THE PHYSICIAN THEREFORE REMOVED THE PC400, AND THE PROCEDURE WAS COMPLETED USING NEW 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 7954457 ↗
• MalfunctionAug 15, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SINUS TRANSVERSUS USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVEN COILS IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ADVANCED A NEW PC400 INTO THE TARGET VESSEL BUT DID NOT LIKE THE COIL POSITION; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-INTRODUCE THE SAME PC400, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE PC400 WOULD NOT ADVANCE INTO THE PX SLIM; THEREFORE, IT WAS REMOVED. IT REPORTED THAT THE PHYSICIAN DID NOT RINSE THE PC400 IN SALINE PRIOR TO RE-USING IT. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER PC400 IN THE TARGET VESSEL USING THE SAME PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 INTO THE PX SLIM BUT THE PC400 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING EIGHT 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 7785829 ↗
• InjuryJun 19, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 UNINTENTIONALLY DETACHED IN THE PATIENT'S BODY. THEREFORE, THE PHYSICIAN USED TWO NON-PENUMBRA STENT RETRIEVER DEVICES TO REMOVE THE DETACHED PC00 FROM THE PATIENT. THERE WAS NO NOTED DAMAGE TO THE PX SLIM AFTER REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613678 ↗
• MalfunctionFeb 23, 2018Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING PENUMBRA COILS 400 (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A POD PACKING COIL (PODJ) IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A PC400 INTO THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PC400 INTRODUCER SHEATH WAS THIN AND THE COIL WOULD NOT ADVANCE OUT OF THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE PC400 INTRODUCER SHEATH AND ATTEMPTED TO LOAD THE PC400 INTO THE PREVIOUSLY USED PODJ INTRODUCER SHEATH; HOWEVER, THE PC400 BECAME DETACHED IN THE PROCESS. SUBSEQUENTLY, THE PC400 WAS SET ASIDE AND THE PHYSICIAN OPENED A NEW PC400. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 INTO THE PX SLIM, THE PC400 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7292367 ↗
• MalfunctionFeb 23, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT VERTEBRAL ARTERY USING PENUMBRA COILS 400 (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A POD PACKING COIL (PODJ) IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A PC400 INTO THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PC400 INTRODUCER SHEATH WAS THIN AND THE COIL WOULD NOT ADVANCE OUT OF THE SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE PC400 INTRODUCER SHEATH AND ATTEMPTED TO LOAD THE PC400 INTO THE PREVIOUSLY USED PODJ INTRODUCER SHEATH; HOWEVER, THE PC400 BECAME DETACHED IN THE PROCESS. SUBSEQUENTLY, THE PC400 WAS SET ASIDE AND THE PHYSICIAN OPENED A NEW PC400. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 INTO THE PX SLIM, THE PC400 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7292365 ↗
• MalfunctionJul 3, 2017Bent; Detachment Of Device Component; Device Damaged Prior to Use; Bent; Detachment Of Device Component; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE TECHNICIAN OPENED THE PACKAGING OF THE PENUMBRA COIL 400 (PC400) AND IT WAS NOTICED THAT THE PC400 PUSHER ASSEMBLY WAS BENT IN HALF AND THE PC400 WAS DETACHED FROM ITS PUSHER ASSEMBLY. THE PC400 WAS REMOVED FROM ITS DISPENSER HOOP AND CONFIRMED TO BE DETACHED. THE DETACHED PC400 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400 WITHOUT ANY ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 6684709 ↗
• MalfunctionFeb 6, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 AS THE THIRD COIL INTO A PX SLIM DELIVERY MICROCATHETER(PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE INTO THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED FROM THE ROTATING HEMOSTASIS VALVE (RHV) AND THE INTRODUCER SHEATH WAS INSPECTED. THE PHYSICIAN OBSERVED NO ABNORMALITY AND RE-ATTEMPTED TO ADVANCE THE PC400 INTO THE PX SLIM; HOWEVER, THE PC400 WOULD NOT ADVANCE INTO THE PX SLIM AND THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN USED AN RHV AND MAINTAINED CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6306072 ↗
• MalfunctionDec 19, 2016Physical Resistance; Detachment of Device or Device Component; Physical Resistance; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (P-COM) USING PENUMBRA COILS 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 INTO THE TARGET VESSEL USING THE PX SLIM; HOWEVER, DUE TO STRONG FRICTION IN THE PX SLIM, THE PC400 FAILED TO DETACH. THEREFORE, THE PX SLIM AND PC400 WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER¿S COILS AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6186412 ↗
• InjuryNov 28, 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 6130558 ↗
• InjuryNov 28, 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 6130531 ↗
• InjuryNov 28, 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 6130530 ↗
• InjuryNov 28, 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 6130528 ↗
• InjuryNov 28, 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 6130527 ↗
• MalfunctionJan 5, 2016Failure to Advance; Physical Resistance; Difficult to Advance; Failure to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ARTERIOVENOUS FISTULA (AVF) IN THE LEFT GLUTEAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN USED ANOTHER MANUFACTURER'S MICROCATHETER ALONG WITH N-BUTYL CYANOACRYLATE (NBCA) TO PERFORM AN EMBOLIZATION. A NEW MICROCATHETER WAS THEN OPENED AND TWO NEW PC400 COILS WERE DEPLOYED AND DETACHED INTO THE AVF. NEXT, THE PHYSICIAN ADVANCED A NEW PC400 COIL INTO THE MICROCATHETER; HOWEVER, IT BECAME STUCK AND WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE PC400 COIL FROM THE PATIENT AND ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE MICROCATHETER; HOWEVER, THIS PC400 COIL ALSO BECAME STUCK AND WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE PC400 COIL AND THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL COILS NEEDED. A FINAL ANGIOGRAPHY WAS PERFORMED, WHICH DID NOT REVEAL ANY ABNORMAL BLOOD FLOW. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5345416 ↗
• MalfunctionJan 5, 2016Failure to Advance; Physical Resistance; Difficult to Advance; Failure to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR AN ARTERIOVENOUS FISTULA (AVF) IN THE LEFT GLUTEAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN USED ANOTHER MANUFACTURER'S MICROCATHETER ALONG WITH N-BUTYL CYANOACRYLATE (NBCA) TO PERFORM AN EMBOLIZATION. A NEW MICROCATHETER WAS THEN OPENED AND TWO NEW PC400 COILS WERE DEPLOYED AND DETACHED INTO THE AVF. NEXT, THE PHYSICIAN ADVANCED A NEW PC400 COIL INTO THE MICROCATHETER; HOWEVER, IT BECAME STUCK AND WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE PC400 COIL FROM THE PATIENT AND ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE MICROCATHETER; HOWEVER, THIS PC400 COIL ALSO BECAME STUCK AND WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE PC400 COIL AND THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL COILS NEEDED. A FINAL ANGIOGRAPHY WAS PERFORMED, WHICH DID NOT REVEAL ANY ABNORMAL BLOOD FLOW. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5345409 ↗
• MalfunctionOct 10, 2015Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400 (PC400 COIL). DURING THE PROCEDURE, THE PC400 COIL UNINTENTIONALLY DETACHED WHILE BEING DEPLOYED IN THE ANEURYSM. A STENT RETRIEVER DEVICE WAS USED TO REMOVE THE PC400 COIL FROM THE PATIENT. THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW PC400 COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5142452 ↗