Penumbra Coil 400 4002C1245Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI M4244002C12450), received between Sep 24, 2015 and May 14, 2021 — classified as 2 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (39 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DETACH A PC400 USING THE HANDLE, THE COIL ALIGNMENT ZONE SEPARATED BUT THE COIL DID NOT DETACH. IT WAS REPORTED THAT THE CLICK OF THE HANDLE WAS NOT AUDIBLE. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO DETACH THE PC400 USING THE HANDLE; HOWEVER, THE PUSHER ASSEMBLY OF THE PC400 BECAME STUCK IN THE HANDLE. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PC400. NEXT, THE PHYSICIAN SUCCESSFULLY DETACHED ANOTHER PC400 IN THE TARGET VESSEL USING ANOTHER HANDLE. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT PC400 THROUGH THE MICROCATHETER, THE PC400 UNINTENTIONALLY DETACHED AND BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828680 ↗
• InjuryAug 22, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) TO TREAT A PSEUDO-ANEURYSM USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO COILS. WHILE INTRODUCING A PC400 TO THE TARGET VESSEL, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE BEFORE IT PREMATURELY DETACHED. IT WAS REPORTED THAT ONE THIRD OF THE COIL WAS IN THE ANEURYSM AND THE REST WAS CONTAINED IN THE PX SLIM. THEREFORE, THE PHYSICIAN USED A NON-PENUMBRA STENT RETRIEVER AND A NON-PENUMBRA DEVICE TO SUCCESSFULLY RETRIEVE THE PC400. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA STENT DEVICE 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 10440538 ↗
• MalfunctionFeb 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PC400 THROUGH THE PX SLIM; THEREFORE, IT 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 9679684 ↗
• MalfunctionAug 16, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400¿S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH A PX SLIM, AND WHEN THE PHYSICIAN PULLED THE PUSHER ASSEMBLY THE PC400 UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE SAME PX SLIM; HOWEVER, THE PHYSICIAN EXPERIENCED THE SAME RESISTANCE AND SUBSEQUENTLY THE PUSHER ASSEMBLY WAS KINKED. THE PHYSICIAN REMOVED THE PC400 AND THE PX SLIM. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH A NEW PX SLIM; HOWEVER, THE PHYSICIAN EXPERIENCED THE SAME RESISTANCE AND SUBSEQUENTLY THE PUSHER ASSEMBLY WAS ALSO KINKED. THE PHYSICIAN REMOVED THE PC400. THE PROCEDURE WAS COMPLETED USING THE PX SLIM AND NINE PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903071 ↗
• MalfunctionAug 1, 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 A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PC400, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY 15 CENTIMETERS PAST THE HUB OF THE LANTERN. IT WAS REPORTED THAT THE PHYSICIAN FLUSHED THE MICROCATHETER TO BREAK RESISTANCE, HOWEVER, WAS UNSUCCESSFUL. THEREFORE, THE LANTERN AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW PC400S 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 8853307 ↗
• MalfunctionJul 19, 2019Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A PENUMBRA COIL 400 (PC400) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MIDDLE OF THE LANTERN; THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE PC400. HOWEVER, WHILE RETRACTING THE PC400, IT BECAME STUCK IN THE LANTERN; THEREFORE, THE PHYSICIAN REMOVED THE LANTERN WITH THE PC400 TOGETHER. WHILE ATTEMPTING TO REMOVE THE PC400 FROM THE LANTERN OUTSIDE OF THE PATIENT¿S BODY, THE PC400 BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER CATHETER AND COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807094 ↗
• MalfunctionJun 28, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A 45-DEGREE TIP LANTERN IN THE TARGET LOCATION AND ATTEMPTED TO ADVANCE TWO PC400S THROUGH IT. HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING EACH COIL THROUGH THE ANGLED DISTAL TIP OF THE LANTERN. THE PHYSICIAN THEN REMOVED THE PC400S AND LANTERN AND INSERTED A NEW LANTERN WITH A STRAIGHT TIP. UPON REMOVAL OF THE PC400S AND THE LANTERN IT WAS NOTED THAT THE PC400S HAD THE OFFSET COIL WINDS AND THE TIP OF THE LANTERN HAD STRETCHED AND NARROWED. THE PROCEDURE WAS THEN COMPLETED USING THE NEW LANTERN, RUBY COILS, AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744760 ↗
• MalfunctionJun 28, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A 45-DEGREE TIP LANTERN IN THE TARGET LOCATION AND ATTEMPTED TO ADVANCE TWO PC400S THROUGH IT. HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING EACH COIL THROUGH THE ANGLED DISTAL TIP OF THE LANTERN. THE PHYSICIAN THEN REMOVED THE PC400S AND LANTERN AND INSERTED A NEW LANTERN WITH A STRAIGHT TIP. UPON REMOVAL OF THE PC400S AND THE LANTERN IT WAS NOTED THAT THE PC400S HAD THE OFFSET COIL WINDS AND THE TIP OF THE LANTERN HAD STRETCHED AND NARROWED. THE PROCEDURE WAS THEN COMPLETED USING THE NEW LANTERN, RUBY COILS, AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744745 ↗
• MalfunctionMay 21, 2019Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A PENUMBRA COILS 400S (PC400) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE TWO PC400S (LOT #''S F80233 AND F83390) PAST THE DISTAL TIP OF A LANTERN AND, THEREFORE, THE PC400S WERE REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN REMOVED THE LANTERN AND FOUND THE DISTAL TIP TO BE OVALIZED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE TWO PC400 (LOT #¿S F80233 AND F83390) AGAIN WITH A NEW LANTERN; HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE FIRST PC400 (LOT # F80233) IN THE MICROCATHETER AND THE SECOND PC400 (LOT # F83390) WAS UNABLE TO ADVANCE WITHIN ITS INTRODUCER SHEATH AND, THEREFORE BOTH PC400S WERE REMOVED. IT WAS REPORTED THAT THE PROXIMAL SIDE OF THE SECOND PC400 (LOT # F83390) WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING NEW PC400S WITH THE SECOND 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 8628016 ↗
• MalfunctionMay 21, 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 A PENUMBRA COILS 400S (PC400) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE TWO PC400S (LOT #''S F80233 AND F83390) PAST THE DISTAL TIP OF A LANTERN AND, THEREFORE, THE PC400S WERE REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN REMOVED THE LANTERN AND FOUND THE DISTAL TIP TO BE OVALIZED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE TWO PC400 (LOT #¿S F80233 AND F83390) AGAIN WITH A NEW LANTERN; HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE FIRST PC400 (LOT # F80233) IN THE MICROCATHETER AND THE SECOND PC400 (LOT # F83390) WAS UNABLE TO ADVANCE WITHIN ITS INTRODUCER SHEATH AND, THEREFORE BOTH PC400S WERE REMOVED. IT WAS REPORTED THAT THE PROXIMAL SIDE OF THE SECOND PC400 (LOT # F83390) WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING NEW PC400S WITH THE SECOND 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 8627582 ↗
• MalfunctionFeb 21, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400) AND A VELOCITY DELIVERY MICROCATHETER (VELOCITY). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE PC400 PAST THE DISTAL TIP OF THE VELOCITY, 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 8360599 ↗
• MalfunctionDec 17, 2018Failure 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 A PENUMBRA COILS 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE PC400 IN THE TARGET VESSEL. WHILE ATTEMPTING TO INSERT A NEW PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE HUB OF THE MICROCATHETER AND THE COIL WOULD NOT ADVANCE FURTHER; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND ADDITIONAL COILS 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 8169219 ↗
• MalfunctionDec 13, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 WITHIN ITS INTRODUCER SHEATH. 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 8160240 ↗
• MalfunctionNov 23, 2018Failure to Advance; Failure to Advance

  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 PC400S USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE HUB OF THE MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW PC400S AND ADDITIONAL COILS 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 8100111 ↗
• MalfunctionNov 21, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PULMONARY ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND ONE PC400 IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO INSERT ANOTHER PC400 INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW 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 8097963 ↗
• MalfunctionNov 15, 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 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 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 8073275 ↗
• MalfunctionOct 23, 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 COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE PC400S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE TIP OF THE PC400 INTRODUCER SHEATH AND THE PC400 WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE SUBSEQUENT PC400. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING 20 OTHER PC400S AND THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997548 ↗
• MalfunctionSep 28, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE THE PC400 AND LANTERN WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING NEW PC400S 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 7920467 ↗
• MalfunctionSep 19, 2018Collapse; Failure to Advance; Physical Resistance/Sticking; Collapse; 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 SEVEN PC400S USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER PC400 THROUGH THE MIDDLE OF THE MICROCATHETER AND, THEREFORE, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE EMBOLIZATION COIL WAS DISTORTED AND COMPRESSED AT THE TIP. 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 7890320 ↗
• MalfunctionSep 6, 2018Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Failure to Advance; Deformation Due to Compressive Stress; 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 OUT OF ITS INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER. THE PC400 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW PC400S AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE PC400 WAS COMPRESSED ON THE DISTAL TIP OF THE EMBOLIZATION COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852417 ↗
• MalfunctionAug 29, 2018Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  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 A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN ATTEMPTED TO RETRACT AND REMOVE THE PC400, HOWEVER, THE PHYSICIAN FELT RESISTANCE AND THE PC400 THEN UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN THEREFORE REMOVED THE PX SLIM WITH THE PC400 INSIDE. THE PROCEDURE WAS COMPLETED USING THE SAME 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 7831114 ↗
• MalfunctionAug 20, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MIDDLE OF THE MICROCATHETER AND THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400, EIGHT RUBY COILS AND THE SAME MICROCATHETER. IT WAS REPORTED THAT THE SURFACE OF THE MICROCATHETER WAS ROUGH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799768 ↗
• MalfunctionAug 9, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A RETROGRADE TRANSVENOUS COIL EMBOLIZATION WITH BALLOON OBSTRUCTION COIL USING A PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE USING THE FIRST PC400; HOWEVER, THE PC400 WAS ABLE TO BE DEPLOYED AND DETACHED IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT ABOUT 2CM FROM THE DISTAL TIP OF THE MICROCATHETER; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER TREATMENT METHOD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7769870 ↗
• MalfunctionJun 11, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS FISTULA (P-AVF) USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND FIVE PC400¿S IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE NEW PC400 INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400¿S, 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 7589694 ↗
• MalfunctionMay 31, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE DEPLOYING A PC400 IN THE TARGET VESSEL, THE LANTERN DELIVERY MICROCATHETER (LANTERN) KICKED OUT OF THE ANEURYSM; THEREFORE, THE PHYSICIAN REMOVED THE PC400 IN ORDER TO REPOSITION THE LANTERN. WHILE ATTEMPTING TO REINSERT THE PC400 INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AROUND THE PROXIMAL END OF THE LANTERN AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL, REMOVED THE COIL OUT AND REINSERTED THE LANTERN INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400¿S 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 7559031 ↗