Penumbra Coil 400 4006C0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI M4244006C03060), received between Dec 17, 2015 and Sep 4, 2020 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (9 reports).

1 other recall cover devices cleared under the same FDA submission (K103305); they may or may not involve this specific model.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA COILS 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT WAS IN POOR CONDITION PRIOR TO THE PROCEDURE; THE PATIENT HAD A BLEED AND AN ARTERIOVENOUS (AV) FISTULA. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE IN THE INTRODUCER SHEATH AND WAS STUCK AT THE FRICTION LOCK. SUBSEQUENTLY, THE SMART COIL WAS REMOVED, AND THE PHYSICIAN IMPLANTED ANOTHER SMART COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED IN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 10497405 ↗
• InjuryDec 2, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERIES (PCOM) USING PENUMBRA COILS 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE PC400S IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT PC400 THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 UNINTENTIONALLY DETACHED WITH THE MAJOR PART HANGING IN THE VESSEL; THEREFORE, THE PHYSICIAN SUCCESSFULLY USED A STENT RETRIEVER DEVICE TO REMOVE THE DETACHED PC400, AND THE PX SLIM WAS REMOVED. THE PHYSICIAN THEN CONTINUED THE PROCEDURE AND PLACED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO PACK THE ANEURYSM WITH A PENUMBRA SMART COIL (SMART COIL). HOWEVER, THERE WAS NO SPACE LEFT IN THE ANEURYSM TO INSERT THE SMART COIL, AND THEREFORE, THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396749 ↗
• MalfunctionOct 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S), A POD4 AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE MICROCATHETER KICKED OUT OF PLACE. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND REPOSITIONED THE LANTERN. WHILE ATTEMPTING TO ADVANCE THE SAME PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE AND THEREFORE, THE PC400 WAS REMOVED. IT WAS REPORTED THAT FLUSHING THE MICROCATHETER DID NOT RESOLVE THE RESISTANCE ISSUE. NEXT, THE PHYSICIAN ADVANCED A POD4 AND ATTEMPTED TO DETACH THE COIL USING A HANDLE; HOWEVER, THE POD4 FAILED TO DETACH AND, THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE POD4 ALIGNMENT ZONE WAS NOT DIVIDED IN HALF. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S WITH THE SAME HANDLE AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214988 ↗
• MalfunctionAug 2, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) USING PENUMBRA COIL 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED EIGHT PC400S IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW PC400, THE MICROCATHETER KICKED OUT OF THE TARGET VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND REPOSITIONED THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE SAME PC400, HOWEVER, IT BECAME STUCK AND WAS UNABLE TO ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 8855740 ↗
• MalfunctionMay 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST PC400 THROUGH THE MICROCATHETER. THE PC400 COIL WAS THEREFORE REMOVED AND THE PROCEDURE WAS COMPLETED USING THREE PENUMBRA SMART COILS (SMART COILS) AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615428 ↗
• MalfunctionApr 24, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A PC400 IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH A PC400 IN THE TARGET LOCATION USING THE HANDLE, DESPITE THE PROXIMAL DETACHMENT MARKER BEING SEPARATED. THE PHYSICIAN THEN WAS UNABLE TO REMOVE THE PROXIMAL END OF THE PUSHER ASSEMBLY FROM THE HANDLE. THEREFORE, THE PC400 AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 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 8547563 ↗
• MalfunctionMar 28, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE RUBY COILS AT THE TARGET VESSEL USING A LANTERN. NEXT, THE PHYSICIAN REMOVED THE LANTERN AND PLACED A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN AND ATTEMPTED TO ADVANCE A PENUMBRA COIL 400 (PC400); HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN WAS FOUND TO BE KINKED APPROXIMATELY 5 MILLIMETERS FROM THE DISTAL TIP. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE COIL. WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED AT THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND ATTEMPTED TO ADVANCE A NEW PC400; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED COIL OUT OF THE LANTERN AND INTO THE TARGET LOCATION. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS WITH 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 8458841 ↗
• MalfunctionMar 28, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (DAVF) USING PENUMBRA SMART COILS (SMART COILS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE RUBY COILS AT THE TARGET VESSEL USING A LANTERN. NEXT, THE PHYSICIAN REMOVED THE LANTERN AND PLACED A SMART COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN AND ATTEMPTED TO ADVANCE A PENUMBRA COIL 400 (PC400); HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN WAS FOUND TO BE KINKED APPROXIMATELY 5 MILLIMETERS FROM THE DISTAL TIP. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE COIL. WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED AT THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND ATTEMPTED TO ADVANCE A NEW PC400; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED COIL OUT OF THE LANTERN AND INTO THE TARGET LOCATION. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SMART COILS WITH 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 8458823 ↗
• MalfunctionAug 8, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED 8 PC400S IN THE TARGET LOCATION USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND 20 CM FROM THE LANTERN PROXIMAL TIP; THEREFORE, THE LANTERN CONTAINING THE PC400 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN FLUSHED AND RINSED THE PC400 AND ATTEMPTED TO ADVANCE IT AGAIN; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING TWO NEW 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 7765158 ↗
• InjuryMay 18, 2018Break; Inadequacy of Device Shape and/or Size; Physical Resistance; Break; Inadequacy of Device Shape and/or Size; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA COILS 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE LAST PC400 THROUGH THE PX SLIM. AFTER ADVANCING PART OF THE PC400 INTO THE ANEURYSM, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO LONG AND DECIDED TO REMOVE IT. HOWEVER, WHILE RETRACTING THE PC400 INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 BROKE IN TWO PIECES AND APPROXIMATELY THREE CENTIMETERS OF THE COIL¿S TAIL WENT DOWN INTO THE POSTERIOR CEREBRAL ARTERY (PCA). THE REST OF THE PC400 WAS REMOVED WITH ITS PUSHER ASSEMBLY AND THE PROCEDURE WAS ENDED AT THAT POINT AS THE PHYSICIAN DID NOT HAVE A SNARE DEVICE TO REMOVE THE PART OF THE COIL THAT WAS PROTRUDING IN THE PCA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527555 ↗
• MalfunctionFeb 22, 2018Fracture; Physical Resistance; Fracture; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN EH MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPEREINCED RESISTANCE WHILE ADVANCING A LANTERN THROUGH A NON-PENUMBRA CATHETER, HOWEVER WAS ABLE TO CONTINUE TO ADVANCE IT. AFTER THE LANTERN HAD BEEN ADVANCED OUT OF THE TIP OF THE CATHETER HOWEVER, THE PHYSICIAN WAS UNABLE TO MANIPULATE IT, AND THEREFORE THE LANTERN WAS REMOVED. IT WAS REPORTED THAT THE TIP OF THE LANTERN WAS COMPRESSED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW LANTERN AND SUCCESSFULLY DEPLOYED AND DETACHED A PC400. WHILE ATTEMPTING TO ADVANCE AND DEPLOY A NEW PC400, THE PHYSICIAN SAW THAT UNDER THE FLUOROSCOPY IMAGE THAT THE SECOND PC400 BECAME FRACTURED AFTER REPOSITIONING IT SEVERAL TIMES AGAINST SLIGHT RESISTANCE. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PC400 INSIDE. THE PROCEDURE ENDED AT THIS POINT BECAUSE THE TARGET LOCATION WAS SUFFICIENTLY EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7289143 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7033558 ↗
• MalfunctionOct 25, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Detachment of Device or Device Component; Device Damaged Prior to Use; Out-Of-Box Failure; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT LUMBAR ARTERY USING PENUMBRA COIL 400'S (PC400'S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT A PC400 HAD UNINTENTIONALLY DETACHED WITHIN THE PACKAGING HOOP WHEN TAKING IT OUT FOR THE PROCEDURE. THE DAMAGE TO THE PC400 OCCURRED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ADVANCED A NEW PC400 THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), HOWEVER THE PHYSICIAN WAS UNABLE TO DETACH THE PC400 USING THE HANDLE, DESPITE ATTEMPTING TO DETACH IT MULTIPLE TIMES. THE PHYSICIAN THEREFORE MANUALLY DETACHED THE PC400. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978401 ↗
• MalfunctionSep 26, 2017Break; Failure to Advance; Physical Resistance; Break; 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) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS USING THE PX SLIM. THE PHYSICIAN THEN FELT RESISTANCE ADVANCING A PC400 THROUGH THE PX SLIM, AND THE PC400 BECAME STUCK. THE PHYSICIAN ATTEMPTED TO FORCEFULLY RETRACT THE PC400; CONSEQUENTLY, THE PC400 COIL BROKE. THE PHYSICIAN THEREFORE REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW 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 6895441 ↗
• InjuryMar 2, 2017Detachment Of Device Component; Unraveled Material; Physical Resistance; Detachment Of Device Component; Unraveled Material; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAJOR AORTO-PULMONARY COLLATERAL ARTERY USING PENUMBRA COILS 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S 4F CATHETER IN THE TARGET VESSEL, ADVANCED A PX SLIM THROUGH IT AND DEPLOYED AND DETACHED A PC400 IN THE TARGET VESSEL. WHILE PLACING A NEW PC400, THE PX SLIM FELL OUT OF THE TREATMENT SITE; THEREFORE, THE PHYSICIAN ATTEMPTED TO PUSH IT BACK INTO THE TREATMENT SITE; HOWEVER, IT WAS UNSUCCESSFUL. UPON ATTEMPTING TO RETRACT THE PC400, THE PHYSICIAN EXPERIENCED A SLIGHT RESISTANCE BUT KEPT ON PULLING THE PC400. CONSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED, AND UNRAVELED WITH ABOUT TWO CENTIMETERS PROTRUDING FROM THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PX SLIM WITH THE DETACHED PC400; HOWEVER, THE PC400 SLIPPED OUT THE PX SLIM AND INTO THE 4F CATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO PULL THE DETACHED PC400 OUT WITH THE GUIDEWIRE BUT IT WAS UNSUCCESSFUL AND THE PC400 BECAME STUCK INSIDE THE 4F CATHETER. THE PHYSICIAN WAS FINALLY ABLE TO REMOVE THE DETACHED PC400 FRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6374901 ↗
• MalfunctionMar 2, 2017Separation Failure; Device Operates Differently Than Expected; Separation Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COILS 400 (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A POD4 AND TWO PC400'S IN THE TARGET VESSEL USING A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH A NEW PC400 (FOURTH COIL OF THE PROCEDURE) USING THE SAME HANDLE DESPITE MULTIPLE ATTEMPTS; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, THE SAME HANDLE, 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 6373261 ↗
• MalfunctionNov 15, 2016Difficult or Delayed Activation; Physical Resistance; Difficult to Advance; Difficult or Delayed Activation; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROPER HEPATIC ARTERY USING PENUMBRA COIL 400S (PC400''S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURERS 4-FRENCH SHEPHERD HOOK CATHETER INTO THE CELIAC ARTERY AND THEN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) THROUGH THE CATHETER TOWARD THE TARGET VESSEL. WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE; HOWEVER, THE PX SLIM CAME OUT OF THE TARGET VESSEL. THEREFORE, THE PHYSICIAN RETRACTED AND RE-SHEATHED THE PC400 BACK INTO ITS INTRODUCER SHEATH. THE PHYSICIAN THEN RE-ADVANCED THE PX SLIM TOWARD THE TARGET VESSEL AND RE-ATTEMPTED TO ADVANCE THE PREVIOUS PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PC400 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PC400 WAS REMOVED AND A NEW PC400 WAS OPENED. THE PHYSICIAN DEPLOYED AND DETACHED THE NEW PC400 INTO THE ANEURYSM USING THE PX SLIM. THE PHYSICIAN THEN REDEPLOYED AND DETACHED THE PREVIOUS PC400 INTO THE ANEURYSM USING THE SAME PX SLIM TO COMPLETE THE PROCEDURE. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6105047 ↗
• MalfunctionJul 22, 2016Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DELIVERED THREE COILS FROM ANOTHER MANUFACTURER AND A PC400 COIL INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE, REMOVED THE PC400 COIL. THE PHYSICIAN THEN REMOVED THE MICROCATHETER FROM THE PATIENT AND NOTICED THAT THE PREVIOUSLY REMOVED PC400 COIL HAD UNINTENTIONALLY DETACHED AND WAS STILL CONTAINED AROUND THE HUB OF THE MICROCATHETER. THE PHYSICIAN INDICATED THAT HE DID NOT EXPERIENCE ANY RESISTANCE WHILE REMOVING THE PC400 COIL. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL AND A NEW MICROCATHETER FROM THE OTHER MANUFACTURER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5817512 ↗
• InjuryJul 20, 2016Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; 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: Thrombosis

  MAUDE report 5810556 ↗
• MalfunctionJul 20, 2016Stretched; Physical Resistance; Stretched; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A FEW PC400 COILS INTO THE PATIENT USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS ONLY ABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH BUT NOT INTO THE PX SLIM. THEREFORE, THE PC400 COIL WAS REMOVED AND ADDITIONAL PC400 COILS WERE DEPLOYED AND DETACHED INTO THE PATIENT. WHILE ADVANCING ANOTHER NEW PC400 COIL THROUGH THE SAME PX SLIM, THE PHYSICIAN EXPERIENCED FRICTION AND DECIDED TO RETRACT THE COIL. WHILE THE PHYSICIAN WAS RETRACTING THE PC400 COIL, IT BECAME STRETCHED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL PC400 COILS AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND ALSO MAINTAINED A CONTINUOUS FLUSH THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5808661 ↗
• MalfunctionJun 21, 2016Detachment Of Device Component; Physical Resistance; Mechanical Jam; Detachment Of Device Component; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED OTHER MANUFACTURERS'' GUIDE CATHETER AND MICROCATHETER COAXIALLY INTO THE PATIENT AND THEN DEPLOYED AND DETACHED SIX PC400 COILS IN THE SUPERIOR GLUTEAL ARTERY AND THREE PC400 COILS IN THE INFERIOR GLUTEAL ARTERY. THE PHYSICIAN THEN IMPLANTED ANOTHER MANUFACTURER¿S COIL INTO THE ILIOLUMBAR ARTERY. THEREAFTER, THE MICROCATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND ANOTHER MICROCATHETER FROM THE SAME MANUFACTURER WAS INSERTED INTO THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A PC400 COIL THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THEREFORE, THE COIL WAS RETRACTED. THE PHYSICIAN ADJUSTED THE POSITION OF THE CATHETERS AND THEN MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 COIL. HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE COIL BECAME STUCK INSIDE THE MICROCATHETER. UPON RETRACTING THE PC400 COIL PUSHER ASSEMBLY, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT AND THEN RETRACTED THE PC400 COIL FROM IT. THE PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5740219 ↗
• MalfunctionDec 17, 2015Detachment Of Device Component; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT INTERNAL THORACIC ARTERY USING PENUMBRA COIL 400 COILS (PC 400 COILS). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A PC400 COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER AS IT WOULD NOT ADVANCE PASS THE MIDDLE OF THE MICROCATHETER AND WAS REMOVED. WHILE THE PC400 COIL WAS BEING REMOVED FROM THE PATIENT, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT AND FLUSHED THE DETACHED PC400 COIL OUT OF IT. THE PROCEDURE WAS THEN COMPLETED USING A NEW PC400 COIL 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 5309079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103305. One submission often covers many models, so check the product and lot details in each record.

• Z-1906-2011 · Mar 4, 2011 · Terminated
  Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is in