Penumbra Coil 400 4002C2860Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI M4244002C28600), received between Jul 20, 2016 and Jan 27, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2023Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING A PENUMBRA COIL 400 (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PX SLIM OVER THE GUIDEWIRE INTO THE VENOUS POUCH. IT WAS REPORTED THAT AFTER EXCESSIVE MANIPULATION THE PHYSICIAN PERFORATED THE MID-SHAFT OF THE PX SLIM WITH THE GUIDEWIRE; HOWEVER, THE PROCEDURE CONTINUED WITH THE SAME PX SLIM. WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 EMBOLIZATION COIL WAS DAMAGED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE PC400 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16260236 ↗
• MalfunctionOct 14, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO RE-POSITION THE FIRST PC400, THE COIL UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN PROCEEDED TO PUSH THE REMAINING COIL INTO THE TARGET LOCATION USING THE PUSHER WIRE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12637505 ↗
• MalfunctionSep 9, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT MULTIPLE ANEURYSMS IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S), VASCULAR PLUGS, A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO VASCULAR PLUGS INTO THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ADVANCING A PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PC400. HOWEVER, UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER VASCULAR PLUG, A PC400, THE SAME MICROCATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450679 ↗
• MalfunctionFeb 25, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COILS 400 (PC400S), A REUSED PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE ADVANCING A PC400 (32MM X 60CM) THROUGH A REUSED PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE DETACHED PC400 WAS REMOVED USING A BALLOON CATHETER AND THE PHYSICIAN ALSO REMOVED THE PX SLIM. NEXT, THE PHYSICIAN PLACED ANOTHER PC400 IN THE TARGET LOCATION SUCCESSFULLY USING A NEW PX SLIM. NEXT, WHILE ADVANCING ANOTHER PC400 (28MM X 60CM) TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITH HALF OF THE PC400 IN THE TARGET LOCATION AND THE OTHER HALF OF THE PC400 IN THE PX SLIM. THE PHYSICIAN WAS UNABLE TO REMOVE THE DETACHED PC400 DUE TO THE PC400 BEING TANGLED WITH THE PREVIOUS PLACED PC400. THEREFORE, THE DETACHED PC400 WAS LEFT IN THE PATIENT¿S VESSEL. AFTERWARDS, WHILE ADVANCING ANOTHER PC400 (24MM X 57CM) TO THE TARGET LOCATION, THE PC400 STRETCHED. SUBSEQUENTLY, THE PC4

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11377655 ↗
• MalfunctionDec 9, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE INITIAL PC400S IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A NEW PC400 INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE PC400 FAILED TO DETACH. 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 9440589 ↗
• MalfunctionJun 18, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY (RA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PC400 WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO FLUSH THE PC400 SYSTEM, BUT THE PC400 REMAINED STUCK IN ITS INTRODUCER SHEATH. THE PC400 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOURTEEN ADDITION PC400 COILS AND THREE OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707484 ↗
• 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 7997543 ↗
• MalfunctionSep 20, 2018Defective Device; Defective Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SEVERE TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A PC400 USING A NON-PENUMBRA MICROCATHETER, HOWEVER, WHILE ADVANCING THE PC400, THE MICROCATHETER MIGRATED. THE PHYSICIAN THEN PULLED BACK THE PC400 AND MADE SEVERAL ATTEMPTS TO REPOSITION THE MICROCATHETER, BUT WAS UNSUCCESSFUL; THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE PC400 INSIDE. ON THE BACK TABLE, IT WAS NOTICED THAT THE PC400 WAS DAMAGED. THE PHYSICIAN THEN PLACED A PX SLIM DELIVERY MICROCATHETER AND COMPLETED THE PROCEDURE USING NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895008 ↗
• MalfunctionSep 17, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PC400S USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE THIRD PC400 THROUGH THE END OF THE PX SLIM. THE PC400 WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING 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 7882722 ↗
• MalfunctionSep 5, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS USING A LANTERN DELIVERY MICROCATHETER. THE PHYSICIAN THEN ADVANCED A PC400 TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE, HOWEVER, THE PC400 DID NOT DETACH DESPITE MAKING TWO ATTEMPTS. THE PHYSICIAN OPENED A NEW HANDLE AND THEN SUCCESSFULLY DETACHED THE PC400 IN THE TARGET LOCATION. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER PC400, HOWEVER, WHILE MANIPULATING THE PC400 WITHIN THE MICROCATHETER, THE PC400 UNINTENTIONALLY DETACHED. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE DETACHED COIL INSIDE. THE PHYSICIAN THEN RE-INSERTED THE SAME LANTERN AND COMPLETED THE PROCEDURE WITH ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848532 ↗
• MalfunctionMar 22, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COILS 400 (PC400¿S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND SLIGHTLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED FIVE PC400¿S 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 DISTAL TIP OF THE PC400¿S INTRODUCER SHEATH AND THE PC400 WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED ADDITIONAL PC400¿S 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 7363224 ↗
• MalfunctionJan 17, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY AND PULMONARY ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY TEN CENTIMETERS INTO THE LANTERN AND THE COIL WOULD NOT ADVANCE FURTHER. AFTER MAKING TWO UNSUCCESSFUL ATTEMPTS, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH THE TWO OTHER PC400S. THE PROCEDURE WAS COMPLETED USING 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 7202120 ↗
• MalfunctionJan 17, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY AND PULMONARY ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY TEN CENTIMETERS INTO THE LANTERN AND THE COIL WOULD NOT ADVANCE FURTHER. AFTER MAKING TWO UNSUCCESSFUL ATTEMPTS, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH THE TWO OTHER PC400S. THE PROCEDURE WAS COMPLETED USING 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 7202114 ↗
• MalfunctionJan 17, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY AND PULMONARY ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL APPROXIMATELY TEN CENTIMETERS INTO THE LANTERN AND THE COIL WOULD NOT ADVANCE FURTHER. AFTER MAKING TWO UNSUCCESSFUL ATTEMPTS, THE PC400 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH THE TWO OTHER PC400S. THE PROCEDURE WAS COMPLETED USING 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 7202103 ↗
• MalfunctionOct 5, 2017Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A LANTERN TO THE SPLENIC ARTERY THROUGH A NON-PENUMBRA CATHETER. THEN PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PC400 MORE THAN APPROXIMATELY 30CM INTO THE LANTERN; THEREFORE, THE LANTERN WAS REMOVED WITH THE PC400 INSIDE. THE PHYSICIAN THEN PLACED A NEW LANTERN AND RE-ATTEMPTED TO PLACE THE SAME PC400. THE PHYSICIAN FELT A STRONG RESISTANCE WHILE INSERTING THE PC400 INTO THE LANTERN, BUT WAS ABLE TO SUCCESSFULLY PLACE THE PC400. THE PROCEDURE WAS THEN COMPLETED USING AN ADDITIONAL PC400 AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6917746 ↗
• MalfunctionMar 8, 2017Detachment Of Device Component; Physical Resistance; Device Operates Differently Than Expected; Detachment Of Device Component; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT RENAL ARTERY USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED A SLIGHT RESISTANCE BUT CONTINUED TO ADVANCE THE PC400. AFTER ADVANCING THE PC400 INTO THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE PC400 WAS NOT COILING PROPERLY; THEREFORE, THE PHYSICIAN DECIDED TO RETRACT IT. HOWEVER, UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM WITH THE DETACHED PC400 INSIDE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND MICROCATHETER. THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MECHANICALLY AND CONTINUOUSLY FLUSHED THE MICROCATHETER THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6387717 ↗
• MalfunctionFeb 21, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERIOVENOUS FISTULA (AVF) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE FIRST PC400, THE PHYSICIAN DEPLOYED ABOUT FIFTEEN CENTIMETERS OF THE COIL INTO THE TARGET VESSEL AND THEN ENCOUNTERED RAPID BLOOD FLOW FROM THE SHUNT, WHICH PUSHED THE COIL ASIDE. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400 IN ORDER TO REPOSITION THE BALLOON CATHETER. WHILE MANIPULATING THE PC400 SO THAT IT COULD BE RETRACTED BACK INTO THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PC400 FROM THE PATIENT AND THEN FLUSHED THE COIL OUT OF THE MICROCATHETER WITH SALINE. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA 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 6347996 ↗
• MalfunctionNov 22, 2016Detachment Of Device Component; Physical Resistance; Mechanical Jam; Detachment Of Device Component; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT SUBCLAVIAN ARTERY ANEURYSM USING PENUMBRA COIL 400¿S (PC400). DURING THE PROCEDURE, THE PHYSICIAN INSERTED AN ANGIOGRAPHIC CATHETER INTO THE RIGHT SUBCLAVIAN ARTERY BY THE RIGHT BRACHIAL ARTERY APPROACH, AND THEN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN HAD ALREADY PLACED THREE PIECES OF STENTS FROM THE RIGHT SUBCLAVIAN ARTERY THROUGH THE RIGHT COMMON CAROTID ARTERY OVER THE TARGET TREATMENT PORTION. WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND UPON ATTEMPTING TO RETRACT THE PC400, IT UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED WITH THE DETACHED PC400 COIL AND THE PC400 WAS FLUSHED OUT. THE PHYSICIAN THEN RE-INSERTED THE PX SLIM IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A NEW PC400 THROUGH; HOWEVER, RESISTANCE WAS EXPERIENCED AGAIN. THEREFORE, THE PC400 WAS RETRACTED AND RE-SHEATHED, AND THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND THE PREVIOUS PC400 WITHOUT FURTHER ISSUE. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6123300 ↗
• MalfunctionAug 17, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, WHILE IN USE WITH ANOTHER MANUFACTURER'S MICROCATHETER, A PC400 UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PC400 AS WELL AS OTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5884653 ↗
• MalfunctionJul 20, 2016Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY FOR AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) TOWARDS A SAC IN THE RIGHT PULMONARY AVM AND THEN DEPLOYED AND DETACHED TEN PC400 COILS INTO THE PATIENT. WHILE ATTEMPTING TO ADVANCE THE ELEVENTH PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN HAD DIFFICULTY AFTER THE COIL WAS ADVANCED APPROXIMATELY HALF WAY THROUGH THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 COIL FROM THE PATIENT'S BODY. WHILE THE DEVICES WERE OUTSIDE OF THE PATIENT, THE PHYSICIAN CONFIRMED THAT THERE WERE NO VISUAL DAMAGES TO THE PX SLIM AND ATTEMPTED TO ADVANCE THE PC400 COIL THROUGH THE PX SLIM BUT WAS STILL UNABLE TO. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE SAME PX SLIM WHILE STILL OUTSIDE OF THE PATIENT'S BODY AND FOUND THAT THE COIL ADVANCED THROUGH SUCCESSFULLY. THEREFORE, THE PHYSICIAN ADJUSTED THE PX SLIM TO DECREASE DEFLEXION, FLUSHED ITS INNER LUMEN AND THEN CHECKED IT AGAIN FOR KINKS. THE PX SLIM WAS REINSERTED INTO THE PATIENT AND THE PROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5810422 ↗