Penumbra Coil 400 4004C0615Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI M4244004C06150), received between Sep 30, 2015 and Sep 26, 2024 — classified as 9 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT VERTEBRAL ARTERY USING A PENUMBRA COIL 400 (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE PC400 THROUGH THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PC400 AND EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PC400 BECAME STUCK AND UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE PC400 FROM THE PATIENT. THE PHYSICIAN DECIDED TO USE SMALLER DIAMETER COILS TO CONTINUE THE PROCEDURE AND THEREFORE, DISCONTINUED USE OF THE PX SLIM. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313324 ↗
• MalfunctionAug 9, 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 (IIA) USING PENUMBRA COIL 400S (PC400) AND POD PACKING COILS (POD PC). 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 RESISTANCE APPROXIMATELY 20 CENTIMETERS FROM THE PROXIMAL END OF THE MICROCATHETER. THEREFORE, THE PC400 WAS REMOVED AND SUCCESSFULLY PLACED A NEW PC400 IN THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A POD PC, HOWEVER, EXPERIENCED THE SAME RESISTANCE APPROXIMATELY 20 CENTIMETERS FROM THE PROXIMAL END OF THE MICROCATHETER AND, THEREFORE, THE POD PC AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW POD PCS 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 8879015 ↗
• MalfunctionJun 10, 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, WHILE ATTEMPTING TO PLACE A PC400 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DETERMINED THAT THE PC400 WOULD NOT FIT WELL IN THE VESSEL AND DECIDED TO REMOVE IT. HOWEVER, WHILE WITHDRAWING THE PC400, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND TWO OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682743 ↗
• MalfunctionMay 10, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, IT WAS REPORTED THAT THREE PC400S DID NOT TAKE THEIR INTENDED SHAPE AND, THEREFORE, THE PC400S WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW PC400S AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8599828 ↗
• MalfunctionApr 17, 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) AND A LANTERN DELIVERY MICROCATHETER. 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 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 8522421 ↗
• MalfunctionDec 5, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS AND THREE PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A PC400 OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER AND, THEREFORE, THE PC400 WAS REMOVED. 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 8135842 ↗
• MalfunctionSep 25, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED PC400S IN THE TARGET LOCATION USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A PC400 WITHIN ITS INTRODUCER SHEATH AND, 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 7907181 ↗
• 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) 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 7707544 ↗
• MalfunctionMar 8, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL ARTERY USING PENUMBRA COILS 400 (PC400¿S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN MENTIONED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED MIDWAY IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, ADDITIONAL PC400¿S AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7325368 ↗
• MalfunctionOct 18, 2017Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  WHILE PREPARING FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING OF THE FIRST PENUMBRA COIL 400 (PC400) AND THEN ATTEMPTED TO REMOVE THE COIL FROM ITS DISPENSER; HOWEVER, THE PC400 WAS ALREADY EXPOSED AND HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PC400 WAS NOT USED IN THE PROCEDURE AND DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PC400.

  Patient problems: No Patient Involvement

  MAUDE report 6958449 ↗
• MalfunctionJul 11, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CAROTID TERMINUS USING PENUMBRA COIL 400'S (PC400'S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 INTO THE TARGET VESSEL BUT WAS UNABLE TO DETACH THE COIL USING THE HANDLE. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6703893 ↗
• MalfunctionJul 3, 2017Detachment Of Device Component; Device Damaged Prior to Use; Out-Of-Box Failure; Detachment Of Device Component; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COILS 400 (PC400'S. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX PC400'S IN THE TARGET VESSEL. WHILE REMOVING A NEW PC400 FROM ITS PACKAGING HOOP, THE PHYSICIAN NOTICED THAT THE PC400 WAS ALREADY OUTSIDE OF ITS INTRODUCER SHEATH. UPON PULLING BACK THE PC400 PUSHER ASSEMBLY, THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. THE DAMAGED PC400 WAS THEN SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6684046 ↗
• MalfunctionMay 15, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR TIP USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED EIGHT PC400'S INTO THE PATIENT USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM. THEREFORE, THE PC400 WAS REMOVED AND 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 6566851 ↗
• MalfunctionMar 10, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA USING PENUMBRA COILS 400 (PC400¿S) AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE INITIAL PC400S THROUGH A PX SLIM WITHOUT A ROTATING HEMOSTASIS VALVE (RHV) AND CONTINUOUS FLUSH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND PC400S WERE REMOVED. THE PHYSICIAN THEN OPENED A NEW PX SLIM AND ATTEMPTED TO ADVANCE NEW PC400S; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400S WOULD NOT ADVANCE THROUGH THE NEW PX SLIM. THEREFORE, THE PC400S WERE REMOVED. IT WAS REPORTED THAT AFTER CONNECTING THE PX SLIM WITH A RHV, A FLUSH LINE AND HOLDING THE HUB OF THE PX SLIM STRAIGHT, THE PROCEDURE WAS COMPLETED USING 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 6395026 ↗
• MalfunctionJan 25, 2017Positioning Failure; Physical Resistance; Difficult to Advance; Positioning Failure; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROPER HEPATIC ARTERY USING PENUMBRA COIL 400''S (PC400'S). THE PHYSICIAN CONFIRMED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND THAT THERE WAS NO EXCESSIVELY HIGH ANGULATION. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY DEPLOYED AND DETACHED TWO PC400'S IN THE LEFT GASTRIC ARTERY. THE PHYSICIAN THEN PLACED ANOTHER MANUFACTURER'S BALLOON CATHETER IN THE DISTAL PORTION OF THE PROPER HEPATIC ARTERY. NEXT, A PX SLIM DELIVERY MICROCATHETER (PX SLIM) WAS ADVANCED TOWARDS THE TARGET VESSEL AND A PC400 WAS THEN DEPLOYED AND DETACHED. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE. AFTER THE COIL BEGAN TAKING SHAPE, THE PHYSICIAN FELT RESISTANCE AND DECIDED TO RETRACT THE COIL. WHILE ATTEMPTING TO RETRACT THE PC400, THE PHYSICIAN ALSO ENCOUNTERED RESISTANCE. THEREFORE, THE PX SLIM CONTAINING THE COIL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN FLUSHED THE PX SLIM AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW PC400 AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED A CONTINUOUS FLUSH THROUGHOUT THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6277072 ↗
• MalfunctionJan 16, 2017Detachment Of Device Component; Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Detachment Of Device Component; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COILS 400 (PC400'S). DURING THE PROCEDURE, AFTER ADVANCING AND DEPLOYING A PC400 IN THE ANEURYSM, THE PHYSICIAN DECIDED TO REPOSITION IT. WHILE ATTEMPTING TO REPOSITION THE PC400, THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN ATTEMPTED TO USE SALINE TO FLUSH THE DETACHED PC400 INTO THE ANEURYSM; HOWEVER, IT WAS UNSUCCESSFUL AND THE PC400 MIGRATED OUT OF THE ANEURYSM AND PARTIALLY OCCLUDED THE MCA. NEXT,THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DETACHED PC400 FROM THE MCA; HOWEVER, RETRIEVAL OF THE DETACHED PC400 WAS UNSUCCESSFUL AS WELL. THEREFORE, THE PROCEDURE WAS ENDED AT THIS POINT, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH HEMODYNAMIC INSTABILITY. THE PATIENT CONTINUES WITH VENTILATOR SUPPORT AND IS UNDER SEDATION, AND IS CONSIDERED STABLE AND HAS PNEUMONIA AS OF (B)(6) 2017.

  Patient problems: Device Embedded In Tissue or Plaque; Sedation; Ventilator Dependent

  MAUDE report 6255038 ↗
• MalfunctionJan 13, 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 400''S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO STANDARD PC400'S INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SOFT PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER ADVANCING THE COIL TWENTY CENTIMETERS FROM THE HUB OF THE MICROCATHETER AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE PC400 WAS REMOVED AND ANOTHER NEW SOFT PC400 WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AGAIN AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE SOFT PC400 WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW STANDARD PC400 AND THE SAME MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH BUT DID FLUSH THE MICROCATHETER BEFORE EACH PC400 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 6251649 ↗
• 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 6130522 ↗
• 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 6130514 ↗
• 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 6130507 ↗
• 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 6130499 ↗
• 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 6130489 ↗
• MalfunctionNov 4, 2016Retraction Problem; Physical Resistance; Mechanical Jam; Retraction Problem; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVF) USING PENUMBRA COIL 400¿S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA ANGIOGRAPHIC BALLOON CATHETER INTO THE PULMONARY ARTERY AND THEN ADVANCED A NON-PENUMBRA CATHETER AND GUIDE WIRE TOWARD THE FEEDER. THE ANGIOGRAPHIC BALLOON CATHETER WAS THEN INFLATED AND A PC400 WAS DEPLOYED AND DETACHED INTO THE TARGET VESSEL. WHILE ADVANCING A NEW PC400 THROUGH THE CATHETER, THE PHYSICIAN FELT GRADUAL RESISTANCE AND SUBSEQUENTLY, THE PC400 BECAME STUCK INSIDE THE CATHETER. THE PHYSICIAN THEN ATTEMPTED TO RE-SHEATH THE PC400 BY PULLING IT BACK; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PC400 WOULD NOT RETRACT BACK INTO ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER WITH THE PC400 STILL INSIDE. AFTER THE DEVICES WERE REMOVED FROM THE PATIENT, THE PHYSICIAN REMOVED THE PC400 FROM THE CATHETER; HOWEVER, THE PC400 BECAME UNRAVELED. THE PHYSICIAN THEN INSPECTED THE CATHETER BY ADVANCING A GUIDE WIRE THROUGH IT AND FOUND NO ISSUES. THEREAFTER, THE CATHETER WAS REINSERTED INTO THE PATIENT AND A NEW PC400 WAS DEPLOYED AND DETACHED INTO THE TARGE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6080266 ↗
• MalfunctionAug 4, 2016Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) THROUGH ANOTHER MANUFACTURER'S ANGIOGRAPHIC CATHETER, TOWARDS THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE A PC400 COIL THROUGH THE PX SLIM; HOWEVER, THE PHYSICIAN EXPERIENCED DIFFICULTY AND THE PC400 COIL WAS UNABLE TO ADVANCE. THEREFORE, THE PHYSICIAN REMOVED THE PC400 COIL AND CONTINUED THE PROCEDURE BY SUCCESSFULLY DEPLOYING AND DETACHING TWO NEW PC400 COILS INTO THE TARGET VESSEL USING THE SAME PX SLIM. THE PX SLIM WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S COILS AND THE ANGIOGRAPHIC CATHETER. THE PHYSICIAN DID NOT USE THE PX SLIM WITH THE OTHER MANUFACTURER'S COILS BECAUSE IT WAS NOT COMPATIBLE WITH THE COILS. THERE WERE NO ISSUES WITH THE PX SLIM DURING THE PROCEDURE. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5847459 ↗
• MalfunctionJul 20, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE LEFT ICA AND THEN PLACED ANOTHER MANUFACTURER'S STENT DEVICE IN THE NECK PORTION OF THE ANEURYSM. WHILE USING THE JAILING TECHNIQUE TO PERFORM THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 COIL APPROXIMATELY TEN CENTIMETERS THROUGH THE PX SLIM AND THEN MET RESISTANCE. THEREFORE, THE PHYSICIAN REMOVED THE PC400 COIL AND CONTINUED THE PROCEDURE BY DEPLOYING AND DETACHING THIRTEEN PC400 COILS INTO THE ANEURYSM USING THE SAME PX SLIM. WHILE ATTEMPTING TO DELIVER A NEW PC400 COIL, THE PHYSICIAN MET RESISTANCE AFTER THE COIL WAS SLIGHTLY ADVANCED OUT OF THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE COIL BUT ALSO MET RESISTANCE. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE PX SLIM CONTAINING THE PC400 COIL; HOWEVER, THE COIL UNINTENTIONALLY DETACHED AROUND THE COMMON CAROTID ARTERY AND MIGRATED TOWARDS THE DISTAL VESSELS. CONSEQUENTLY, THE PHYSICIAN REQUIRED A SNARE DEVICE TO RETRIEVE THE DETACHED PC400 COIL FROM THE PATIENT. THE PROCEDU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5810565 ↗