Penumbra Coil 400 4004C0820Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI M4244004C08200), received between Sep 3, 2015 and May 23, 2024 — classified as 8 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ILIAC ANEURYSM USING PENUMBRA COIL 400S (PC400S) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE PC400 HAD UNINTENTIONALLY DETACHED. THEREFORE, THE DETACHED PC400 AND THE MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT. THE PC400 WAS THEN REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386340 ↗
• MalfunctionOct 7, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A PENUMBRA COIL 400 (PC400). DURING THE PROCEDURE, AFTER ADVANCING PART OF THE PC400 INTO THE TARGET VESSEL, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A STENT RETRIEVER TO REMOVE THE DETACHED PC400. THE PX SLIM WAS THEN REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17892604 ↗
• MalfunctionJan 12, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY USING PENUMBRA COIL 400 (PC400S), NON-PENUMBRA COILS (COOK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THEN, WHILE ADVANCING A PC400 TO THE TARGET VESSEL USING THE MICROCATHETER, THE PC400 UNINTENTIONALLY DETACHED WITH PART OF THE PC400 IN THE MICROCATHETER AND THE OTHER PART IN THE TARGET VESSEL. THEREFORE, THE PHYSICIAN INFLATED A BALLOON CATHETER AND THEN USED A GUIDEWIRE TO SUCCESSFULLY PUSH THE DETACHED PC400 INSIDE THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL, MEDICAL GLUE AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238664 ↗
• MalfunctionJan 27, 2020Stretched; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SIGMOID SINUS USING PENUMBRA COILS 400 (PC400S), POD PACKING COILS (POD PCS), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN ATTEMPTED TO REMOVE THE INTRODUCER SHEATH OF THE PC400, BUT THE PUSHER ASSEMBLY OF THE PC400 STRETCHED; THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE AND PLACED ANOTHER PC400 INTO THE TARGET VESSEL. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE THE POD PC THROUGH THE PX SLIM INTO THE TARGET VESSEL, THE PUSHER ASSEMBLY OF THE POD PC APPEARED KINKED AND ITS INTRODUCER SHEATH ¿CRIMPED"; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PC 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 9633867 ↗
• MalfunctionMay 23, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE PC400S USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PC400 THROUGH THE MIDDLE OF ITS INTRODUCER SHEATH AND, THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING TWO NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635865 ↗
• MalfunctionApr 24, 2019Fracture; Fracture

  THE PATIENT WAS UNDERGOING A VARICOCELE COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO INSERT A PC400 INTO THE MICROCATHETER, HOWEVER, THE PHYSICIAN NOTICED THAT THE PUSHER ASSEMBLY OF THE PC400 WAS FRACTURED 20CM FROM THE PROXIMAL END, DESPITE THERE BEING NO RESISTANCE WHILE ADVANCING. THEREFORE, THE PC400 WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544850 ↗
• MalfunctionApr 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEINS USING PENUMBRA COIL 400'S (PC400'S). IT SHOULD BE NOTED THAT THE TARGET VESSEL WAS ACCESSED VIA THE RIGHT FEMORAL ARTERY (FA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE FIRST PC400 INTO THE TARGET VESSEL AND DECIDED TO RETRACT THE COIL TO REPOSITION IT. IT WAS THEN REPORTED THAT THE PC400 WOULD "NOT COME WITH THE DELIVERY PUSHER". THE PC400 AND LANTERN WERE THEN REMOVED FROM THE PATIENT AND THE PC400 WAS REMOVED FROM THE LANTERN. NO ADDITIONAL INFORMATION REGARDING THE ISSUE WITH THE PC400 IS AVAILABLE. THE SAME LANTERN WAS THEN RE-ADVANCED INTO THE TARGET VESSEL AND THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL PC400'S AND SIX NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522767 ↗
• MalfunctionFeb 21, 2019Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY (SA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 THROUGH THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER WITH THE PC400 INSIDE AND CONSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PC400 WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS THEN COMPLETED USING THE SAME MICROCATHETER AND A NEW PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360010 ↗
• MalfunctionNov 17, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR COMMUNICATING ARTERY (PCA) USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED APPROXIMATELY ONE CENTIMETER OF A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE RETRACTING THE PC400 BACK INTO THE MICROCATHETER FOR RE-POSITIONING, THE PC400 UNINTENTIONALLY DETACHED WITHIN PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED WITH THE DETACHED PC400 INSIDE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8082379 ↗
• MalfunctionSep 26, 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 NINE COILS AND FOUR PC400S USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE HUB OF THE MICROCATHETER AND, THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7911111 ↗
• MalfunctionSep 25, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY FIVE CENTIMETERS FROM THE MICROCATHETER'S DISTAL TIP AND THE PC400 WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE PHYSICIAN RETRACTED THE PC400 INTO ITS INTRODUCER SHEATH AND ATTEMPTED TO ADVANCE IT IN SALINE. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AFTER ADVANCING THREE LOOPS OF THE PC400 OUT OF ITS INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING A NEW PC400, ADDITIONAL 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 7908330 ↗
• MalfunctionSep 17, 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 USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE FIFTH PC400 THROUGH THE HUB OF THE MICROCATHETER. THE PC400 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW PC400S 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 7882762 ↗
• MalfunctionSep 17, 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 A COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882540 ↗
• MalfunctionSep 5, 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 A PC400 USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH ITS INTRODUCER SHEATH AND, THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW PC400 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846926 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURE ANEURYSM USING PENUMBRA COILS 400 (PC400S) WITH NO ISSUES. THE NEXT DAY, THE PATIENT HEALTH STATUS DECLINED. A COMPUTERIZED TOMOGRAPHY/COMPUTERIZED TOMOGRAPHY ANGIOGRAM (CT/CTA) THEN MAGNETIC RESONANCE IMAGING (MRI) WERE ORDERED. THE PATIENT REMAINS WEAK ON RIGHT SIDE AND SOMNOLENT. ACCORDING TO THE PHYSICIAN, THE MRI WITH LEFT SIDE INFRACT THAT APPEARED MORE WATERSHED. THE CTA WAS CLEAR BEYOND THE COIL MASS. THE MAGNETIC RESONANCE ANGIOGRAPHY (MRA) SHOWED SOME NARROWING NEAR THE COIL MASS WHICH IS PARTIALLY ARTIFACT BUT OVERALL LOOKS PATENT. THE PATIENT IS ALREADY ON ACETYLSALICYLIC ACID (ASA) AND HAD HEPARIN DURING CASE. THE PATIENT WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2018. AS OF 03-JUL-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 7707606 ↗
• MalfunctionFeb 16, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE PC400S SLIGHTLY PROXIMAL AT THE DISTAL BIFURCATION OF THE RIGHT IIA ANEURYSM USING THE LANTERN. WHILE ADVANCING A NEW PC400 THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE PC400 WAS UNABLE TO FULLY ADVANCE OUT OF THE LANTERN AND BECAME STUCK. UPON ATTEMPTING TO RETRACT THE PC400, IT UNINTENTIONAL DETACHED WITHIN THE LANTERN. THE LANTERN WAS THEREFORE REMOVED, AND THE PHYSICIAN PULLED THE PC400 OUT, AND THEN REINSERTED THE SAME LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400, HOWEVER THE PC400 WAS UNABLE TO ADVANCE AND BECAME STUCK AGAIN. UPON ATTEMPTING TO RETRACT THE PC400 IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PC400 INSIDE, AND COMPLETED THE PROCEDURE USING A NEW MICROCATHETER AND A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7277522 ↗
• MalfunctionJan 24, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING PENUMBRA COIL 400'S (PC400S). IT WAS REPORTED THAT THE PATIENT HAD MODERATELY TORTUOUS VESSELS. DURING THE PROCEDURE, THE WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH ITS INTRODUCER SHEATH AND INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN ENCOUNTERED RESISTANCE BUT CONTINUED TO ADVANCE THE COIL; HOWEVER, THE PC400 WAS UNABLE TO ADVANCE ANY FURTHER AND DID NOT REACH THE HUB OF THE MICROCATHETER. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A FOUR NEW PC400'S, SEVEN ADDITIONAL 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 7216962 ↗
• MalfunctionAug 22, 2017Failure to Advance; Physical Resistance; Defective Device; Failure to Advance; Physical Resistance; Defective Device

  PRIOR TO ADVANCING A PENUMBRA COIL 400 (PC400) THROUGH THE NON-PENUMBRA MICROCATHETER AND INTO THE PATIENT, THE PHYSICIAN WANTED TO MAKE SURE THAT THE PC400 WAS WORKING PROPERLY AND ATTEMPTED TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE TIP OF THE COIL WAS UNABLE TO EXIT THE INTRODUCER SHEATH. THEREFORE, THE PC400 WAS SET ASIDE AND DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A TOTAL OF (B)(4) PC400'S.

  Patient problems: No Patient Involvement

  MAUDE report 6811348 ↗
• MalfunctionJul 5, 2017Break; Separation Failure; Physical Resistance; Break; Separation Failure; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400'S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS A BIT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER IN THE CELIAC ARTERY, THEN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) TOWARD THE TREATMENT SITE. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO PC400'S IN THE TARGET VESSEL USING A PENUMBRA COIL 400 DETACHMENT HANDLE (DH1). WHILE ATTEMPTING TO DETACH A NEW PC400 USING THE SAME DH1, THE PHYSICIAN EXPERIENCED DIFFICULTY AND THE PC400 FAILED TO DETACH. IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE BUT THE PC400 WOULD NOT DETACH. THEREFORE, THE PHYSICIAN ATTEMPTED TO PULL THE PULL WIRE WITH A FORCEPS AND RE-ATTEMPTED TO DETACH THE PC400; HOWEVER, THE PC400 WOULD STILL NOT DETACH. IT WAS ALSO REPORTED THAT THE PC400 PULL WIRE BECAME FRACTURED IN THE MIDDLE. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687220 ↗
• MalfunctionJun 21, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC ARTERY USING PENUMBRA COIL 400''S (PC400'S) AND TWO PENUMBRA COIL DETACHMENT HANDLES (DH1''S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) TOWARDS THE TARGET VESSEL, THEN DEPLOYED AND DETACHED THREE PC400''S USING THE FIRST DH1. NEXT, THE PHYSICIAN DEPLOYED A NEW PC400 INTO THE TARGET VESSEL AND THEN ATTEMPTED TO DETACH IT USING THE SAME DH1. HOWEVER, AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE DH1 AND DECIDED TO OPEN A NEW DH1; HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO DETACH THE PC400 WITH THIS SECOND DH1. THEREFORE, THE PC400 WAS RETRACTED AND THE PROCEDURE WAS COMPLETED USING A NEW PC400, THE SAME PX SLIM AND THE SECOND DH1. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6659331 ↗
• MalfunctionMay 22, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING PENUMBRA COIL 400 (PC400S). DURING THE PROCEDURE, AFTER SUCCESSFULLY DEPLOYING AND DETACHING NON-PENUMBRA COILS AND PC400S USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE A 6TH PC400 THROUGH THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. HOWEVER WHILE ADVANCING, THE PHYSICIAN EXPERIENCED A STRONG RESISTANCE AND WAS UNABLE TO ADVANCE; CONSEQUENTLY, THE PUSHER WIRE BECAME KINKED AND THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND AN ADDITIONAL PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6583524 ↗
• MalfunctionMar 30, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A PC400 INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF THE TIP OF ITS INTRODUCER SHEATH. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 6446836 ↗
• MalfunctionMar 22, 2017Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A PC400 IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ADVANCED ANOTHER PC400 IN THE TARGET VESSEL USING THE SAME PX SLIM; HOWEVER, WHILE MANIPULATING THE PX SLIM AND THE PC400 IN THE PATIENT¿S BODY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE PC400 APPEARED TO BE LENGTHENED. IT WAS CONFIRMED THAT THE PC400 BECAME UNRAVELED IN THE PATIENT¿S BODY; THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO GRAB THE PX SLIM AND REMOVE THE UNRAVELED PC400. THE PHYSICIAN THEN TOOK AN ANGIOGRAPHY WHICH REVEALED THAT THE BLOOD FLOW HAD DECREASED; THEREFORE, THE PROCEDURE WAS COMPLETED AT THIS POINT. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USED A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN CONTINUOUS FLUSH THROUGHOUT THE PROCEDURE; HOWEVER, MANUAL FLUSH WAS PERFORMED AFTER EACH COIL INSERTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424478 ↗
• MalfunctionFeb 28, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CORONARY ARTERY USING PENUMBRA COIL 400''S (PC400''S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 APPROXIMATELY FORTY TO FIFTY CENTIMETERS THROUGH THE INTRODUCER SHEATH AND TOWARDS THE PX SLIM DELIVERY MICROCATHETER (PX SLIM) BUT THEN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE PC400 WAS RESHEATHED BACK INTO ITS INTRODUCER SHEATH AND THE PHYSICIAN CONFIRMED THAT THE COIL COULD BE ADVANCED AND RETRACTED THROUGH ITS INTRODUCER SHEATH. THEREAFTER, THE PX SLIM WAS FLUSHED WITH A SYRINGE AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE SAME PC400. HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE PC400 AT THE SAME LOCATION. 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 6366806 ↗
• MalfunctionDec 9, 2016Out-Of-Box Failure; Defective Device; Material Protrusion/Extrusion; Out-Of-Box Failure; Defective Device; Material Protrusion/Extrusion

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT APPROXIMATELY HALF OF A PENUMBRA COIL 400 (PC400) WAS ALREADY OUT OF ITS INTRODUCER UPON REMOVAL FROM THE DISPENSER HOOP. WHILE ATTEMPTING TO RE-SHEATH THE PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO RE-SHEATH THE COIL. THE DEFECTIVE PC400 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SIX NEW PC400'S.

  Patient problems: No Patient Involvement

  MAUDE report 6159089 ↗