Penumbra Coil 400 4002C1660Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI M4244002C16600), received between Aug 28, 2015 and Sep 16, 2021 — classified as 4 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (30 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 47 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400 (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE. NEXT, THE PHYSICIAN THOUGHT THERE MUST BE SOME SLACK IN THE PX SLIM AND RELIEVED IT BY PULLING THE PX SLIM SLIGHTLY BACK; HOWEVER, NO SLACK WAS OBSERVED VIA FLUOROSCOPY. SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED HALFWAY OUT THE DISTAL END OF THE PX SLIM WITH THAT PART OF THE COIL IN THE TARGET VESSEL. THEREFORE, THE PHYSICIAN SUCCESSFULLY REMOVED PART OF THE DETACHED PC400 USING A SNARE DEVICE, AND SOME WITH THE HELP OF ASPIRATION AND A STENT RETRIEVER. IT WAS REPORTED THAT WHILE REMOVING THE DETACHED PC400, THE PC400 BROKE INTO PIECES. NEXT, THE PHYSICIAN ADVANCED ANOTHER PC400 INTO THE TARGET VESSEL. WHILE FORMING THE PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE DETACHED PC400; HOWEVER, A STRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485679 ↗
• MalfunctionJul 23, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE ABDOMINAL AORTA USING PC400 COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE PUSHING A PC400 COIL THROUGH THE INTRODUCER SHEATH AND INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 COIL STOPPED ADVANCING IN THE PX SLIM. THEREFORE, THE PC400 COIL AND PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317799 ↗
• MalfunctionAug 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD4 AND A PC400 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A NEW PC400 WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. 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 8865878 ↗
• MalfunctionAug 2, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING THE PC400 APPROXIMATELY HALF WAY INTO THE TARGET VESSEL AND THE OTHER HALF INSIDE THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED AND NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO NEW PC400 COILS, THREE POD PACKING COILS (POD PC), TWO NON-PENUMBRA 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 8856332 ↗
• MalfunctionJun 27, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY (SA) USING PENUMBRA COIL 400S (PC400) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW PC400, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY 60 CENTIMETERS FROM THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO RETRACT THE PC400; CONSEQUENTLY, THE PUSHER ASSEMBLY KINKED UPON REMOVAL AND, THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE PC400. THE PHYSICIAN THEN NOTICED THE PC400 HAD DETACHED INSIDE OF THE MICROCATHETER OUTSIDE OF THE PATIENT AND, THEREFORE, THE LANTERN WAS FLUSHED TO SUCCESSFULLY REMOVE THE DETACHED COIL. THE PHYSICIAN THEN INTRODUCED THE SAME LANTERN; HOWEVER, EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A NEW PC400 AND, THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME PC400, ADDITIONAL 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 8741043 ↗
• MalfunctionMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED THIRTY SEVEN PC400S AND THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN ADVANCED A NEW PC400 THROUGH THE LANTERN, BUT RETRACTED THE PC400 INTO ITS INTRODUCER SHEATH IN ORDER TO REPOSITION IT. THE PHYSICIAN THEN EXPERIENCED RESISTANCE JUST AFTER RE-ADVANCING THE PC400 WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S, OTHER COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633736 ↗
• MalfunctionMay 14, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN RENAL ARTERY USING PENUMBRA COILS 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN PLACED A PC400 IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA GUIDE CATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER PC400 INTO THE MICROCATHETER, BUT THE SAME ISSUE OCCURRED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S WITH THE SAME LANTERN AND GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8610108 ↗
• MalfunctionJan 10, 2019Failure 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 ADVANCED THREE COILS THROUGH A NON-PENUMBRA MICROCATHETER INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A PC400 AS THE FOURTH COIL, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE PC400 BEYOND ITS STARTING POSITION WITHIN THE INTRODUCER SHEATH. THE PC400 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE OTHER PC400S AND ANOTHER COIL, WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8238429 ↗
• MalfunctionDec 11, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR ENDOLEAK TYPE II ABDOMINAL AORTIC ANEURYSM (AAA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND WAS UNABLE TO ADVANCE A PC400 THROUGH THE MICROCATHETER. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL, A SMART COIL, AND A PC400, WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8151116 ↗
• MalfunctionOct 3, 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 FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 THROUGH THE TIP OF ITS INTRODUCER SHEATH AND INTO THE HUB OF A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THEREFORE, THE PC400 WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW 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 7932574 ↗
• MalfunctionSep 5, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERIOVENOUS FISTULA USING PENUMBRA COILS 400 (PC400S) AND A PENUMBRA COILS 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE BLACK ALIGNMENT ZONE (PET LOCK) WAS NOT SEPARATED. THE PHYSICIAN THEN MADE A FEW MORE ATTEMPTS BUT THE PC400 STILL DID NOT DETACH. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SAME PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848776 ↗
• MalfunctionAug 20, 2018Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE DISTAL TIP OF THE PX SLIM AND, THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER PC400, HOWEVER, RESISTANCE WAS AGAIN FELT WHILE TRYING TO ADVANCE PAST THE TIP OF THE PX SLIM. THE PHYSICIAN ATTEMPTED TO REMOVE THE PC400, HOWEVER, WHILE RETRACTING, THE PC400 BEGAN TO UNRAVEL. THE PHYSICIAN, THEREFORE, REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PROCEDURE WAS THEN COMPLETED USING 18 ADDITIONAL COILS, A 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 7798318 ↗
• MalfunctionAug 20, 2018Physical 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 A RUBY COIL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE DISTAL TIP OF THE PX SLIM AND, THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER PC400, HOWEVER, RESISTANCE WAS AGAIN FELT WHILE TRYING TO ADVANCE PAST THE TIP OF THE PX SLIM. THE PHYSICIAN ATTEMPTED TO REMOVE THE PC400, HOWEVER, WHILE RETRACTING, THE PC400 BEGAN TO UNRAVEL. THE PHYSICIAN, THEREFORE, REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PROCEDURE WAS THEN COMPLETED USING 18 ADDITIONAL COILS, A 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 7798316 ↗
• MalfunctionJun 25, 2018Failure 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 COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MIDDLE OF THE MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE SAME POSITION AND THE PC400 BECAME STUCK. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND THE PROCEDURE WAS COMPLETED USING OTHER 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 7634300 ↗
• MalfunctionJun 7, 2018Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A COLLAGEN EMBOLIC AGENT IN THE TARGET LOCATION USING THE PX SLIM. THE PHYSICIAN THEN FLUSHED THE PX SLIM WITH SALINE AND ATTEMPTED TO ADVANCE A PC400 THROUGH THE MICROCATHETER; HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE PC400 OUT OF THE TIP OF THE PX SLIM. THE PHYSICIAN THEREFORE REMOVED THE PC400 AND ADVANCED A GUIDEWIRE THROUGH THE PX SLIM, HOWEVER RESISTANCE WAS FELT AT THE TIP OF THE PX SLIM. THE PHYSICIAN THEREFORE REMOVED THE PX SLIM AND COMPLETED THE PROCEDURE USING A NEW PX SLIM AND NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7580618 ↗
• MalfunctionApr 4, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA COILS 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST PC400 INTO THE ANEURYSM, THE PC400 MIGRATED DOWN INTO THE PARENT VESSEL; THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PC400. WHILE ATTEMPTING TO RETRACT THE PC400, IT UNINTENTIONALLY DETACHED WITH APPROXIMATELY FOUR CENTIMETERS OF THE COIL OUTSIDE OF THE PX SLIM. THEREFORE, THE PHYSICIAN ATTACHED A SYRINGE TO THE BACK OF THE PX SLIM AND APPLIED SUCTION TO SUCCESSFULLY REMOVE THE PX SLIM AND DETACHED PC400 TOGETHER. UPON REMOVAL OF THE PX SLIM, IT WAS NOTICED THAT THE PX SLIM WAS BROKEN AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH, A NEW PX SLIM AND ADDITIONAL PC400¿S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7397470 ↗
• MalfunctionApr 4, 2018Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FEMORAL ARTERY USING PENUMBRA COILS 400 (PC400¿S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AFTER REACHING THE TARGET VESSEL, THE PHYSICIAN USED THE HANDLE TO DETACH THE PC400. UPON REMOVAL OF THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PC400 RETURNED WITH THE PX SLIM AND THAT THE PC400 WAS NOT DETACHED. THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396121 ↗
• MalfunctionApr 4, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR PC400S USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE PROXIMAL SHAFT OF THE LANTERN, AND THEREFORE THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR NEW PC400S, ADDITIONAL COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395675 ↗
• MalfunctionFeb 2, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC VEIN USING PENUMBRA COILS 400 (PC400S), A POD8 AND PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED EIGHT PC400S AND THREE NON-PENUMBRA COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ADVANCED A NEW PC400 (F66239) IN THE TARGET VESSEL USING THE SAME LANTERN AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. AFTER TWO TO THREE FAILED ATTEMPTS, THE PHYSICIAN MANUALLY BENT THE COILS PUSHER ASSEMBLY AND ATTEMPTED TO MANUALLY DETACH IT; HOWEVER, THE PC400 WOULD NOT DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE CONTINUED USING EIGHT ADDITIONAL PC400S AND TWO NON-PENUMBRA COILS. WHILE ATTEMPTING TO ADVANCE A NEW PC400 (F70755) THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MIDDLE OF THE LANTERN AND THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN DECIDED TO USE A POD8; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE POD8 WAS REMOVED. THE PROCEDURE WAS COMPLETED ADDITIONAL COILS, A NEW HANDLE AND THE SAME LA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7235879 ↗
• MalfunctionDec 19, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO POD COILS AND PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AFTER THAT, THE PHYSICIAN ADVANCED A NEW PC400 IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PC400 FAILED TO DETACH. IT WAS REPORTED THAT THE PET LOCK WAS SEPARATED ABOUT TWO MILLIMETERS. AFTER SEVERAL FAILED ATTEMPTS, A NEW HANDLE WAS OPENED AND THE PC400 WAS SUCCESSFULLY DETACHED. THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING ADDITIONAL COILS. WHILE ATTEMPTING TO ADVANCE A NEW PC400 AS THE 27TH COIL THROUGH THE PX SLIM, THE PC400 WOULD NOT ADVANCE FURTHER AFTER REACHING ALMOST THE DISTAL TIP OF THE PX SLIM. THEREFORE, IT WAS REMOVED, FLUSHED WITH SALINE AND RE-INSERTED INTO THE PX SLIM; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7129849 ↗
• MalfunctionDec 11, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA STENT IN THE TARGET VESSEL USING THE TRANS-CELL TECHNIQUE. AFTER THAT, THE PHYSICIAN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) TO THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A PC400; HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, THREE ADDITIONAL COILS AND TWO POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104612 ↗
• MalfunctionNov 14, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENORENAL SHUNT TO TREAT A HEPATIC ENCEPHALOPATHY USING PENUMBRA COILS 400 (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED TWO PC400'S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX 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 7031315 ↗
• MalfunctionNov 8, 2017Mechanical Problem; Failure to Advance; Physical Resistance; Mechanical Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO PC400S OUT OF THEIR INTRODUCER SHEATHS AND INTO THE LANTERN. THE PC400S WERE ABLE TO ADVANCE TWO OR THREE CENTIMETERS, BUT THEN BECAME STUCK WITHIN THEIR INTRODUCER SHEATHS. THE TWO PC400S AND THE LANTERN WERE THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011890 ↗
• MalfunctionJul 20, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) TOWARDS THE TARGET VESSEL AND ATTEMPTED TO ADVANCE AN INITIAL PC400 THROUGH IT. WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER THE COIL ADVANCED APPROXIMATELY TEN CENTIMETERS THROUGH THE PX SLIM. THEREFORE, THE PC400 WAS RETRACTED AND THE PX SLIM WAS FLUSHED. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE PC400 THROUGH THE PX SLIM BUT RESISTANCE WAS ENCOUNTERED AGAIN. SUBSEQUENTLY, THE PC400 WAS REMOVED AND A NEW PC400 WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE SAME LOCATION IN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE PC400 WAS REMOVED, THE PX SLIM WAS FLUSHED AND THE PC400 WAS RINSED OFF WITH SALINE IN A TRAY. THE PHYSICIAN THEN REINSERTED THE PX SLIM INTO THE PATIENT AND MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 THROUGH BUT WAS UNSUCCESSFUL. THEREFORE, THE PC400 WAS REMOVED AND PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME PX S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6728239 ↗
• MalfunctionJul 20, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) TOWARDS THE TARGET VESSEL AND ATTEMPTED TO ADVANCE AN INITIAL PC400 THROUGH IT. WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AFTER THE COIL ADVANCED APPROXIMATELY TEN CENTIMETERS THROUGH THE PX SLIM. THEREFORE, THE PC400 WAS RETRACTED AND THE PX SLIM WAS FLUSHED. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE PC400 THROUGH THE PX SLIM BUT RESISTANCE WAS ENCOUNTERED AGAIN. SUBSEQUENTLY, THE PC400 WAS REMOVED AND A NEW PC400 WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE SAME LOCATION IN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE PC400 WAS REMOVED, THE PX SLIM WAS FLUSHED AND THE PC400 WAS RINSED OFF WITH SALINE IN A TRAY. THE PHYSICIAN THEN REINSERTED THE PX SLIM INTO THE PATIENT AND MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 THROUGH BUT WAS UNSUCCESSFUL. THEREFORE, THE PC400 WAS REMOVED AND PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME PX S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6728007 ↗