Penumbra Coil 400 4002C1450Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI M4244002C14500), received between Aug 13, 2015 and Mar 27, 2020 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (28 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, A PC400 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892256 ↗
• MalfunctionOct 22, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT GASTRIC VARICES (GV) USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221925 ↗
• MalfunctionSep 6, 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 COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A THIRD PC400 OVER THE HUB OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PHYSICIAN FLUSHED THE LANTERN AND THE PC400. HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN WHEN TRYING TO RE-ADVANCE THE PC400; THEREFORE, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE BLOOD CLOT MAY HAVE BEEN ATTACHED TO THE PC400. THE PROCEDURE WAS COMPLETED USING FOUR OTHER 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 8972026 ↗
• MalfunctionJul 11, 2019Failure to Advance; Contamination /Decontamination Problem; Physical Resistance/Sticking; Failure to Advance; Contamination /Decontamination Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 IN THE HUB OF A LANTERN DELIVERY MICROCATHETER (LANTERN). ANOTHER UNSUCCESSFUL ATTEMPT WAS MADE TO ADVANCE THE PC400 INTO THE LANTERN; THEREFORE, THE PC400 WAS REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE USING FOUR OTHER COILS AND THE SAME LANTERN. IT WAS NOTED THAT THE PHYSICIAN FOUND AN UNKNOWN WIRE COMING FROM THE COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8780559 ↗
• 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 8610107 ↗
• MalfunctionFeb 26, 2019Failure to Fold; Failure to Advance; Physical Resistance/Sticking; Failure to Fold; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARIX USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), HOWEVER, THE PC400 WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN THEN REMOVED THE PC400 FROM THE PATIENT AND SET IT ASIDE FOR LATER USE. A POD12 COIL WAS THEN SUCCESSFULLY ADVANCED INTO THE TARGET VESSEL USING THE SAME LANTERN. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE PC400, BUT REPORTED FEELING RESISTANCE DURING ADVANCEMENT. IT WAS ALSO REPORTED THAT THE PC400 WOULD ONLY ADVANCE A FEW CENTIMETERS OUT OF ITS INTRODUCER SHEATH. THE PC400 WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PC400S AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370466 ↗
• MalfunctionFeb 15, 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 (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA GUIDE CATHETER AND A LANTERN IN THE TARGET VESSEL. WHILE INSERTING THE PC400 IN THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 BECAME STUCK AND WOULD NOT ADVANCE FURTHER; THEREFORE, THE LANTERN AND PC400 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A PX SLIM DELIVERY 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 8344612 ↗
• MalfunctionJan 11, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT PULMONARY ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A PC400 IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, RESISTANCE WAS ENCOUNTERED APPROXIMATELY TWO CENTIMETERS THROUGH THE LANTERN AND THE PC400 WOULD NOT ADVANCE FURTHER. 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 8239862 ↗
• MalfunctionDec 20, 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) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 OUT OF THE TIP OF THE LANTERN. THE PHYSICIAN THEN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED WITH THE PC400 INSIDE UNDER NEGATIVE PRESSURE. IT WAS REPORTED THAT THE TIP OF THE LANTERN WAS COLLAPSED. THE PROCEDURE WAS THEN COMPLETED USING PENUMBRA SMART COILS, 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 8186184 ↗
• MalfunctionNov 1, 2018Defective Device; Defective Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN NOTICED AFTER DEPLOYING THE FIRST PC400 USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) THAT THE SIZE OF THE COIL DID NOT FIT IN THE TARGET VESSEL. HE RETRACTED THE FIRST PC400 AND DEPLOYED THE SECOND PC400 BUT AFTER 10 CM OF THE COIL WAS DEPLOYED FROM THE PX SLIM THE PHYSICIAN EXPERIENCED RESISTANCE AND RETRACTED THE COIL OUT OF THE PATIENT¿S BODY. IT WAS NOTICED THAT 3 CM OF THE SR WIRE WAS EXPOSED FROM THE PROXIMAL END OF THE COIL AND THE TIP OF COIL WAS DISTORTED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL NINE PC400 AND THREE NON-PENUMBRA 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 8030379 ↗
• MalfunctionSep 14, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE HUB OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE, REMOVED THE PC400. THE PROCEDURE WAS COMPLETED USING FIVE OTHER 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 7878164 ↗
• MalfunctionSep 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM) USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM); THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PC400 WOULD NOT ADVANCE MORE THAN HALF WAY IN THE PX SLIM. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400S AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847671 ↗
• 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 7769878 ↗
• MalfunctionJun 25, 2018Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  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 7634298 ↗
• MalfunctionMay 25, 2018Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A PC400 INTO THE MICROCATHETER, THE PC400 DETACHED IN ITS INTRODUCER SHEATH; 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 7545065 ↗
• MalfunctionMar 9, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400''S (PC400¿S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE AN INITIAL PC400 INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MICROCATHETER AND DECIDED TO REMOVE THE COIL. A SECOND PC400 WAS OPENED; HOWEVER, THE SAME RESISTANCE WAS EXPERIENCED. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND SUCCESSFULLY COMPLETED THE PROCEDURE USING FIVE NEW PC400''S, TWO ADDITIONAL COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7327699 ↗
• MalfunctionJan 4, 2018Failure to Advance; Physical Resistance; 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 COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A PC400, HOWEVER FELT RESISTANCE THAT BECAME STRONGER THE MORE THE PC400 WAS ADVANCED. THE PHYSICIAN EVENTUALLY WAS UNABLE TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, AND THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING FOUR ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7165922 ↗
• MalfunctionDec 27, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 HALF WAY THROUGH THE PX SLIM AND THE PHYSICIAN DECIDED TO RETRACT THE PC400. HOWEVER, WHILE RETRACTING THE PC400, RESISTANCE WAS ENCOUNTERED AGAIN AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED AFTER BEING RETRACTED FIVE CENTIMETERS INTO ITS INTRODUCER SHEATH. THEREFORE, THE DETACHED COIL WAS REMOVED FROM THE ROTATING HEMOSTASIS VALVE (RHV) OF THE PX SLIM AND THE PROCEDURE WAS COMPLETED USING SIXTEEN 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 7150001 ↗
• MalfunctionDec 5, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER IN THE LEFT BRACHIAL ARTERY, THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) COAXIALLY TOWARD THE TREATMENT SITE. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO PC400S IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN THEN WAS UNABLE TO ADVANCE THE PC400 MORE THAN 4-5 CM OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, AND THEREFORE THE PC400 WAS RE-SHEATHED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SAME PC400 AGAIN, HOWEVER WAS UNABLE TO. THE PHYSICIAN THEREFORE REMOVED THE PC400 AND LANTERN, AND COMPLETED THE PROCEDURE USING A NEW LANTERN AND NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7083966 ↗
• MalfunctionNov 15, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 SUDDENLY STOPPED A FEW CENTIMETERS FROM THE HUB OF THE PX SLIM; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SOAKED THE PC400 IN A SALINE BATH AND RE-ATTEMPTED TO INSERT THE PC400 INTO THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PC400 STOPPED AGAIN AFTER BEING ADVANCED A FEW CENTIMETERS PASS THE HUB OF THE PX SLIM. THEREFORE, IT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING TWO OTHER PC400S, TWO POD 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 7035658 ↗
• MalfunctionOct 27, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  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 SUCCESSFULLY DEPLOYED AND DETACHED FIVE PC400S IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ATTEMPTING TO ADVANCE ANOTHER PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WAS UNABLE TO ADVANCE ANY FURTHER. THE PHYSICIAN THEN ATTEMPTED TO FORCEFULLY ADVANCE THE PC400 COIL THROUGH THE MIDDLE OF THE PX SLIM AND CONSEQUENTLY, THE PC400 PUSHER WIRE BECAME KINKED. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM WITH THE PC400 INSIDE, AND THEN REMOVED THE PC400 FROM THE PX SLIM. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985116 ↗
• MalfunctionSep 15, 2017Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRACT A PC400 INTRODUCER SHEATH FROM THE PUSHER ASSEMBLY UPON ADVANCING THE PC400 INTO A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 PUSHER ASSEMBLY BECAME KINKED. ANTICIPATING THAT THE PC400 MIGHT HAVE UNINTENTIONALLY DETACHED, THE PHYSICIAN REMOVED THE PC400. IT WAS REPORTED THAT THE PHYSICIAN DID NOT MENTION RESISTANCE WHILE ATTEMPTING TO RETRACT THE PC400 INTRODUCER SHEATH AND THAT THE PC400 WAS STILL ATTACHED TO ITS PUSHER ASSEMBLY AFTER REMOVAL. 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 6870341 ↗
• MalfunctionJul 14, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC ARTERY USING PENUMBRA COIL 400''S (PC400¿S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL PC400 INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER. AFTER INTRODUCING THE INTRODUCER SHEATH OF A NEW PC400 THROUGH THE HUB OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE PHYSICIAN REMOVED THE PC400 AND WAS ABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH. WHILE ATTEMPTING TO RE-ADVANCE THE PC400 INTO THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400 WOULD NOT ADVANCE. THEREFORE, THE PC400 WAS REMOVED AND A NEW PC400 WAS OPENED AND PLACED INTO THE TARGET VESSEL WITHOUT ANY ISSUES. WHILE ATTEMPTING TO ADVANCE A NEW PC400 INTO THE MICROCATHETER, THE PHYSICIAN MET RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL INTO THE MICROCATHETER. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS 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 6715924 ↗
• MalfunctionJun 22, 2017Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) INTO THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE A PC400 THROUGH IT. HOWEVER, WHILE ADVANCING THE COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN MET RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PC400 WAS THEN REMOVED AND A NEW PC400 WAS OPENED AND PLACED INTO THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A NEW PC400 INTO THE PX SLIM BUT WAS UNABLE TO REMOVE THE COIL'S INTRODUCER SHEATH FROM THE PROXIMAL END OF THE PUSHER ASSEMBLY. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW 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 6662059 ↗
• MalfunctionJun 6, 2017Failure to Advance; Physical Resistance; Device Operates Differently Than Expected; Failure to Advance; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED EXCESSIVE RESISTANCE AND THE PC400 WAS UNABLE TO ADVANCE FURTHER THAN HALFWAY IN THE MICROCATHETER. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL PC400S AND THE SAME MICROCATHETER WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616235 ↗