Penumbra Coil 400 4002C3260Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI M4244002C32600), received between Sep 10, 2015 and Feb 25, 2021 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 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 11377652 ↗
• MalfunctionMar 12, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING A PENUMBRA COIL 400 (PC400) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 IN THE TARGET VESSEL USING A PX SLIM; HOWEVER, THE PC400 WOULD NOT TAKE ITS INTENDED SHAPE OR SIT PROPERLY. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THE PC400 HAD STRETCHED. THEREFORE, 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 Consequences Or Impact To Patient

  MAUDE report 9826198 ↗
• MalfunctionAug 6, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, WHILE ADVANCING THE FIRST PC400 AT THE END OF A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400, FOUR 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 8865883 ↗
• MalfunctionJul 17, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 (PC400) COILS 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 DELIVERY PUSHER 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 DELIVERY PUSHER WAS KINKED. THE PHYSICIAN REMOVED THE PC400 AND THE PX SLIM. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM AND NINE PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799397 ↗
• MalfunctionJul 17, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  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 8799385 ↗
• MalfunctionSep 5, 2018Difficult or Delayed Activation; Difficult or Delayed Separation; Difficult or Delayed Activation; Difficult or Delayed 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 7848524 ↗
• MalfunctionApr 30, 2018Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE I ENDOLEAK OF AAA USING PENUMBRA COILS 400 (PC400¿S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE FIRST PC400 THROUGH A NON-PENUMBRA MICROCATHETER, THE PC400 BECAME STUCK APPROXIMATELY ONE CENTIMETER FROM THE DISTAL TIP OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED AND INSPECTED. THE PC400 WAS THEN RE-ADVANCED INTO THE MICROCATHETER; HOWEVER, THE PC400 BECAME STUCK AGAIN AT THE SAME POSITION. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER PC400, SIX SMART COILS, A NON-PENUMBRA 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 7473574 ↗
• MalfunctionDec 11, 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). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS MILDLY TORTUOUS, BUT NO CALCIFICATION, STENOSIS OR CONSTRICTION WAS OBSERVED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA DIAGNOSTIC CATHETER TOWARDS THE TARGET VESSEL THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH THE DIAGNOSTIC CATHETER. WHILE ATTEMPTING TO ADVANCE THE FIRST PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE LANTERN AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE PC400 WAS REMOVED FROM THE LANTERN AND A NEW PC400 WAS OPENED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH THIS SUBSEQUENT PC400 AND THEREFORE, THE COIL WAS REMOVED FROM THE LANTERN. AFTER THAT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A NEW PC400 INTO THE TARGET VESSEL USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE LANTERN AGAIN AND THEREFORE, THE PC400 WAS REMOVED. THE LANTERN WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106583 ↗
• MalfunctionDec 11, 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). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS, BUT NO CALCIFICATION, STENOSIS OR CONSTRICTION WAS OBSERVED. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA DIAGNOSTIC CATHETER TOWARDS THE TARGET VESSEL THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH THE DIAGNOSTIC CATHETER. WHILE ATTEMPTING TO ADVANCE THE FIRST PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE LANTERN AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE PC400 WAS REMOVED FROM THE LANTERN AND A NEW PC400 WAS OPENED. IT WAS REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH THIS SUBSEQUENT PC400 AND THEREFORE, THE COIL WAS REMOVED FROM THE LANTERN. AFTER THAT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A NEW PC400 INTO THE TARGET VESSEL USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER PC400 THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE MIDWAY THROUGH THE LANTERN AGAIN AND THEREFORE, THE PC400 WAS REMOVED. THE LANTERN WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING THE DIA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106469 ↗
• MalfunctionNov 7, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400 WOULD NOT ADVANCE. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM AND PC400. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND TEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006906 ↗
• MalfunctionNov 7, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400 WOULD NOT ADVANCE. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM AND PC400. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND TEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7006901 ↗
• MalfunctionMay 2, 2017Physical Resistance; Device Operates Differently Than Expected; Electrical Overstress; Physical Resistance; Device Operates Differently Than Expected; Electrical Overstress

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A PC400 THROUGH ITS INTRODUCER SHEATH AND INTO THE PX SLIM DELIVERY MICROCATHETER (PX SLIM); THEREFORE, 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 Consequences Or Impact To Patient

  MAUDE report 6537084 ↗
• MalfunctionNov 29, 2016Failure to Advance; Physical Resistance; Material Deformation; Failure to Advance; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) TO TREAT PELVIC ARTERIOVENOUS MALFORMATIONS (AVM'S) USING PENUMBRA COIL 400''S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S MICROCATHETER TOWARD THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE AN INITIAL PC400 THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO RETRACT THE COIL. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AT THE SAME POSITION. THEREFORE, THE PC400 COIL WAS REMOVED AND A NEW PC400 WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE SAME POSITION IN THE MICROCATHETER. THEREFORE, BOTH THE PC400 AND MICROCATHETER WERE REMOVED. THEREAFTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND NEW PC400'S AND RUBY COILS. IT SHOULD BE NOTED THAT THE TWO ORIGINAL PC400'S WERE NOT ADVANCED THROUGH THE PX SLIM BECAUSE THE TIP OF THOSE COILS BECAME DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6130979 ↗
• MalfunctionNov 29, 2016Failure to Advance; Physical Resistance; Material Deformation; Failure to Advance; Physical Resistance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) TO TREAT PELVIC ARTERIOVENOUS MALFORMATIONS (AVM'S) USING PENUMBRA COIL 400'S (PC400'S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S MICROCATHETER TOWARD THE TARGET VESSEL AND THEN ATTEMPTED TO ADVANCE AN INITIAL PC400 THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO RETRACT THE COIL. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT TO ADVANCE THE PC400 THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AT THE SAME POSITION. THEREFORE, THE PC400 COIL WAS REMOVED AND A NEW PC400 WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW PC400 THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AT THE SAME POSITION IN THE MICROCATHETER. THEREFORE, BOTH THE PC400 AND MICROCATHETER WERE REMOVED. THEREAFTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND NEW PC400'S AND RUBY COILS. IT SHOULD BE NOTED THAT THE TWO ORIGINAL PC400'S WERE NOT ADVANCED THROUGH THE PX SLIM BECAUSE THE TIP OF THOSE COILS BECAME DAMAGED. I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6130973 ↗
• MalfunctionJun 23, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400) WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, AFTER DEPLOYING TWO LOOPS OF A PC400 IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THE PC400 WAS UNABLE TO ADVANCE ANY FURTHER. WHILE ATTEMPTING TO RETRACT THE PC400 BACK INTO THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PC400 AND PX SLIM WERE REMOVED FROM THE PATIENT. THE PX SLIM WAS REINSERTED IN THE PATIENT AND AFTER FLUSHING CONTROL CONTRAST, THE PHYSICIAN NOTICED THE PX SLIM WAS BROKEN BETWEEN THE HUB AND THE STRAIN RELIEF. THE PX SLIM WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING 10 ADDITIONAL PC400 COILS WITH ANOTHER MANUFACTURER'S MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5746762 ↗
• MalfunctionMay 9, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DELIVERED TWO PC400 COILS IN THE ANEURYSM USING ANOTHER MANUFACTURER'S MICROCATHETER. THE PHYSICIAN THEN ADVANCED A NEW PC400 COIL THROUGH THE MICROCATHETER AND WHILE REPOSITIONING THE PC400 COIL IN THE ANEURYSM, IT UNINTENTIONALLY DETACHED. THE DETACHED PC400 COIL WAS THEN PUSHED INTO THE ANEURYSM USING THE PC400 COIL PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING FOUR NEW PC400 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 5641959 ↗
• MalfunctionMar 23, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE FIRST PC400 COIL INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). PRIOR TO INSERTING THE SECOND PC400 COIL INTO THE PATIENT, THE PHYSICIAN EXAMINED THE COIL AND FOUND THAT IT WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN DID NOT USE THE PC400 COIL FOR THE PROCEDURE AND CONTINUED BY SUCCESSFULLY PLACING ADDITIONAL PC400 COILS USING THE SAME PX SLIM. BEFORE INSERTING THE THIRTEENTH PC400 COIL INTO THE PATIENT, THE PHYSICIAN EXAMINED THE COIL AND FOUND THAT IT WAS ALSO STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH, SIMILAR TO THE SECOND PC400 COIL. THEREFORE, THE THIRTEENTH COIL WAS NOT USED FOR THE PROCEDURE. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW PC400 COIL AND THE SAME PX SLIM.

  Patient problems: No Patient Involvement

  MAUDE report 5521590 ↗
• MalfunctionMar 23, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE FIRST PC400 COIL INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). PRIOR TO INSERTING THE SECOND PC400 COIL INTO THE PATIENT, THE PHYSICIAN EXAMINED THE COIL AND FOUND THAT IT WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN DID NOT USE THE PC400 COIL FOR THE PROCEDURE AND CONTINUED BY SUCCESSFULLY PLACING ADDITIONAL PC400 COILS USING THE SAME PX SLIM. BEFORE INSERTING THE THIRTEENTH PC400 COIL INTO THE PATIENT, THE PHYSICIAN EXAMINED THE COIL AND FOUND THAT IT WAS ALSO STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH, SIMILAR TO THE SECOND PC400 COIL. THEREFORE, THE THIRTEENTH COIL WAS NOT USED FOR THE PROCEDURE. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE USING A NEW PC400 COIL AND THE SAME PX SLIM.

  Patient problems: No Patient Involvement

  MAUDE report 5521566 ↗
• MalfunctionSep 10, 2015Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COIL 400 (PC400) COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN SUCCESSFULLY DETACHED THE FIRST 3 PC400 COILS INTO THE ANEURYSM. WHILE ADVANCING THE 4TH PC400 COIL THROUGH THE PX SLIM, IT BECAME STUCK AND WOULD NOT ADVANCE. THE PHYSICIAN REMOVED THE PC400 COIL FROM THE PATIENT AND CONTINUED THE PROCEDURE USING NEW PC400 COILS. WHEN ADVANCING THE 10TH PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PC400 WAS STUCK; THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND IRRIGATED IT WITH SALINE BEFORE ATTEMPTING TO ADVANCE IT THROUGH THE PX SLIM AGAIN. UPON INSERTION, THE PC400 COIL WOULD NOT ADVANCE FROM THE INTRODUCER SHEATH. THE PHYSICIAN REMOVED THE PC400 COIL FROM THE PATIENT AND SUCCESSFULLY CONTINUED THE PROCEDURE USING NEW PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5068837 ↗