Penumbra Coil 400Recalls & reported problems across all models

We found 120 models of Penumbra Coil 400 by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 842 adverse event reports in the FDA's MAUDE database, received between Aug 13, 2015 and Sep 12, 2025 — classified as 4 deaths, 143 injuries, 695 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (328 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Penumbra Coil 400 problems

Penumbra Coil 400 models

120 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Penumbra Coil 400 4002C1245

  DEVICE, NEUROVASCULAR EMBOLIZATION
  61 reports
• Penumbra Coil 400 4002C1040

  DEVICE, NEUROVASCULAR EMBOLIZATION
  52 reports
• Penumbra Coil 400 4002C1660

  DEVICE, NEUROVASCULAR EMBOLIZATION
  47 reports
• Penumbra Coil 400 4002C1450

  DEVICE, NEUROVASCULAR EMBOLIZATION
  40 reports
• Penumbra Coil 400 4006C0408

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death39 reports
• Penumbra Coil 400 4004C0820

  DEVICE, NEUROVASCULAR EMBOLIZATION
  36 reports
• Penumbra Coil 400 4002C2060

  DEVICE, NEUROVASCULAR EMBOLIZATION
  33 reports
• Penumbra Coil 400 4004C0513

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death32 reports
• Penumbra Coil 400 4004C0615

  DEVICE, NEUROVASCULAR EMBOLIZATION
  30 reports
• Penumbra Coil 400 4004C1030

  DEVICE, NEUROVASCULAR EMBOLIZATION
  25 reports
• Penumbra Coil 400 4002C0830

  DEVICE, NEUROVASCULAR EMBOLIZATION
  23 reports
• Penumbra Coil 400 4006C0306

  DEVICE, NEUROVASCULAR EMBOLIZATION
  22 reports
• Penumbra Coil 400 4002C2860

  DEVICE, NEUROVASCULAR EMBOLIZATION
  20 reports
• Penumbra Coil 400 4002C3260

  DEVICE, NEUROVASCULAR EMBOLIZATION
  19 reports
• Penumbra Coil 400 4004J25

  DEVICE, NEUROVASCULAR EMBOLIZATION
  19 reports
• Penumbra Coil 400 4002C1857

  DEVICE, NEUROVASCULAR EMBOLIZATION
  18 reports
• Penumbra Coil 400 4006U0204

  DEVICE, NEUROVASCULAR EMBOLIZATION
  14 reports
• Penumbra Coil 400 4002C2457

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• Penumbra Coil 400 4004C0720

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death11 reports
• Penumbra Coil 400 4002C0720

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• Penumbra Coil 400 4002C0935

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• Penumbra Coil 400 4002C1557

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Penumbra Coil 400 4002C0620

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• Penumbra Coil 400 4002C2260

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• Penumbra Coil 400 4004C0715

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• Penumbra Coil 400 4002C0925

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• Penumbra Coil 400 4004J15

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• Penumbra Coil 400 4006C0202

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• Penumbra Coil 400 4006C0203

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• Penumbra Coil 400 4006C0204

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• Penumbra Coil 400 4006C0406

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• Penumbra Coil 400 4002C1145

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4002C1348

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4004C0412

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4004C0925

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4004C1135

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4006C0304

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4006C0410

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4006U0201

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4006U0203

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Penumbra Coil 400 4002C0312

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• Penumbra Coil 400 4002C0820

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• Penumbra Coil 400 4002C1235

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• Penumbra Coil 400 4004C0306

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• Penumbra Coil 400 4004C0509

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• Penumbra Coil 400 4006C0410-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 400PAC40

  Device, Vascular, For Promoting Embolization
  3 reports
• Penumbra Coil 400 400PAC60

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4002C0306

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4002C0310

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4002C0510

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4002C0610

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4002C0715

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C0406

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C0408

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C0610

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C0815

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C0830

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C1335

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004C1440

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4004J7

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4006C0303

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4006C0308

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4006U0305

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4006U0408

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Penumbra Coil 400 4006C0406-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C0615-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C0720-A

  Device, Vascular, For Promoting Embolization
  2 reports
• Penumbra Coil 400 4004C0820-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4002C1857-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4002C2060-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006U0304-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 400PAC50

  Device, Vascular, For Promoting Embolization
  2 reports
• Penumbra Coil 400 4002C0408

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4002C0512

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4002C0615

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4002C1030

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death2 reports
• Penumbra Coil 400 4002C1135

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4002C1335

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C0310

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C0710

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C0935

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C1020

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C1235

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004C1845

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4004J10

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006C0305

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006C0404

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006U0202

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006U0306

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006U0308

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Penumbra Coil 400 4006C0202-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4006C0303-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4006C0306-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4006C0308-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4006C0404-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4004C0408-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4004C0513-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4004C0610-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Penumbra Coil 400 4004C0815-A

  Device, Vascular, For Promoting Embolization
  1 report

Recent Penumbra Coil 400 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING PAC400 COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PAC400 COILS INTO THE TARGET VESSEL USING THE PX SLIM. WHILE ADVANCING ANOTHER PAC400 COIL INTO THE TARGET VESSEL, THE COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE VESSEL. THEREFORE, THE DETACHED PAC400 COIL WAS REMOVED USING A SNARE DEVICE AND A GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PAC400 COILS AND TWO PX SLIMS. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED THE PXSLIM 45 DEGREE TO A STRAIGHT IN ORDER TO REACH A DIFFERENT PART OF THE CCF. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043522 ↗
• MalfunctionJul 25, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE FOR A CAROTID ARTERY DISSECTION USING PAC400 COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PAC400 TO THE TARGET LOCATION, THE PAC400 UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DETACHED COIL WAS PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE CAROTID ARTERY. THE COIL PUSHER ASSEMBLY WAS USED TO PUSH THE REST OF THE PAC400 COIL OUT OF THE PX SLIM INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED WITH MORE PAC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22616618 ↗
• MalfunctionJul 3, 2025Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VENOUS SINUS USING A PAC400 COIL AND AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25). DURING THE PROCEDURE, WHILE ADVANCING THE PAC400 COIL THROUGH THE ACCESS25, THE PHYSICIAN NOTICED THAT THE PAC400 COIL PUSHER ASSEMBLY KINKED. THE PAC400 COIL THEN UNINTENTIONALLY DETACHED WITHIN THE ACCESS25. THE ACCESS25 CONTAINING THE DETACHED PAC400 COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PAC400 COIL AND ANOTHER ACCESS25. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398446 ↗
• MalfunctionJun 27, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARTERIOVENOUS (AV) FISTULA ARTERY USING PENUMBRA COILS 400 (PC400), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 TO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN DETERMINED THE PC400 WAS UNDERSIZED AND DECIDED TO RESHEATH THE PC400. THE PC400 BECAME KNOTTED AND WHILE RETRACTING, THE EMBOLIZATION COIL DETACHED. MANUAL SUCTION AND DUAL SNARES WERE USED TO ATTEMPT TO REMOVE THE EMBOLIZATION COIL WITHOUT SUCCESS. THE PHYSICIAN DECIDED TO LEAVE THE EMBOLIZATION COIL IN THE INTERNAL ILIAC VEIN. IT WAS REPORTED THAT THE EMBOLIZATION COIL MIGRATED TO THE LUNG. NO INTERVENTION WAS PERFORMED TO REMOVE THE EMBOLIZATION COIL. THERE WERE NO ADDITIONAL ADVERSE EVENTS CAUSED BY LEAVING THE DETACHED COIL IN LUNG. THE PHYSICIAN ADVANCED ANOTHER PC400 INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE PC400 USING A HANDLE. THE PUSHER ASSEMBLY OF THE PC400 HAD SEPARATED, BUT THE EMBOLIZATION COIL DID NOT DETACH. THE PHYSICIAN THEN PUSHED THE PC400 INTO THE TARGET LOCATION USING THE PUSHER ASSEMBLY AND IT EV

  Patient problems: Foreign Body In Patient

  MAUDE report 22344509 ↗
• MalfunctionMar 12, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOMM) USING A PENUMBRA COIL 400 (PC400), A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND AN ACCESS25 DELIVERY MICROCATHETER (ACCESS25). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE PC400 NINE TIMES USING THE HANDLE, BUT THE PC400 WOULD NOT DETACH. IT WAS REPORTED THAT THE PC400 PUSHER ASSEMBLY DETACHMENT ZONE WAS STUCK IN THE HANDLE AND COULD NOT BE REMOVED. THE PHYSICIAN THEN PULLED THE PC400 PUSHER ASSEMBLY DETACHMENT ZONE WITH THE HANDLE ATTACHED TO MANUALLY DETACH THE PC400 WITHOUT SUCCESS. THE PC400 WAS THEN ADVANCED AND RETRACTED WITHIN THE ACCESS25, BUT THE PC400 WOULD NOT DETACH. THE PHYSICIAN ADVANCED AND RETRACTED THE ACCESS25 TO REPOSITION, BUT THE PC400 WOULD NOT DETACH. AFTER MULTIPLE ATTEMPTS TO DETACH THE PC400, THE PHYSICIAN DECIDED TO REMOVE THE PC400. WHILE RETRACTING THE PC400, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE ACCESS25. THE PHYSICIAN THEN USED THE PC400 PUSHER ASSEMBLY TO GENTLY PUSH THE DETACHED PC400 INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL PC400S, ANOTHER HANDLE, AND THE SAME ACCESS25. THERE WAS NO RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590417 ↗
• MalfunctionJan 24, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PAC400 COIL, A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE), AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE PAC400 INTO THE TARGET LOCATION USING THE HANDLE. WHILE ADVANCING A SECOND PAC400 COIL TO THE TARGET LOCATION, THE SECOND PAC400 UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE DETACHED PAC400. THE PROCEDURE WAS COMPLETED USING A THIRD PAC400, THE SAME HANDLE, 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 21233066 ↗
• MalfunctionSep 26, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT VERTEBRAL ARTERY USING A PENUMBRA COIL 400 (PC400), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A NON-PENUMBRA LONG SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE PC400 THROUGH THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PC400 AND EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PC400 BECAME STUCK AND UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE PC400 FROM THE PATIENT. THE PHYSICIAN DECIDED TO USE SMALLER DIAMETER COILS TO CONTINUE THE PROCEDURE AND THEREFORE, DISCONTINUED USE OF THE PX SLIM. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20313324 ↗
• MalfunctionMay 23, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PORTAL ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A PC400 INTO THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED ANOTHER PC400 INTO THE TARGET LOCATION; HOWEVER, WHILE ATTEMPTING TO REPOSITION THE PC400, THE COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN REMOVED THE DETACHED PC400 USING A STENT RETRIEVER. THE PROCEDURE WAS COMPLETED USING ANOTHER PC400, A PAC400, 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 19386624 ↗
• MalfunctionMay 23, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ILIAC ANEURYSM USING PENUMBRA COIL 400S (PC400S) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400S INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT PC400, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED UNDER FLUOROSCOPY THAT THE PC400 HAD UNINTENTIONALLY DETACHED. THEREFORE, THE DETACHED PC400 AND THE MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT. THE PC400 WAS THEN REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19386340 ↗
• MalfunctionMay 2, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PC400 INTO THE CAROTID SINUS AND NOTICED THAT THE PC400 WAS OVERSIZED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE PC400, THE PC400 UNINTENTIONALLY DETACHED, WITH PART OF THE COIL WITHIN THE MICROCATHETER AND THE OTHER PART IN THE MID-AORTA. THE PHYSICIAN THEN USED A SNARE TO RETRIEVE THE DETACHED PC400. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL PC400S 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 19235032 ↗
• MalfunctionFeb 5, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING PENUMBRA COIL 400S (PC400S) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A PC400 INTO THE TARGET LOCATION. THE PHYSICIAN CONTINUED TO EXPERIENCE RESISTANCE WHILE ADVANCING THE PC400 INTO THE TARGET LOCATION AND DECIDED TO REMOVE THE PC400. WHILE ATTEMPTING TO REMOVE THE PC400, ONLY THE PUSHER ASSEMBLY CAME OUT AND THE PHYSICIAN NOTICED THAT THE PC400 HAD UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS SLOWLY REMOVED FROM THE PATIENT. THE PC400 WAS THEN REMOVED FROM THE MICROCATHETER. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18643716 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN ORIGIN OF THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PC400 AND REPORTED THAT THE COIL UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 AND FLUSHED THE COIL OUT OF THE PX SLIM USING A THREE ML SYRINGE.THE PHYSICIAN THEN RE-INTRODUCED THE SAME PX SLIM INTO THE TARGET LOCATION AND ATTEMPTED TO IMPLANT ANOTHER PC400. WHILE RETRACTING THE PC400 FOR RE-POSITIONING, THE PCOM DISSECTED CAUSING THROMBOSIS OF THE ANEURYSM AND PART OF THE PCOM. THEREFORE, THE PC400 WAS REMOVED INTACT. THE PHYSICIAN THEN ADMINISTERED AN ANTIPLATELET DRUG. THE PROCEDURE WAS ENDED AT THIS POINT.

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 18509139 ↗
• MalfunctionJan 12, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN ORIGIN OF THE POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA COIL 400S (PC400S), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PC400 AND REPORTED THAT THE COIL UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE PX SLIM CONTAINING THE PC400 AND FLUSHED THE COIL OUT OF THE PX SLIM USING A THREE ML SYRINGE. THE PHYSICIAN THEN RE-INTRODUCED THE SAME PX SLIM INTO THE TARGET LOCATION AND ATTEMPTED TO IMPLANT ANOTHER PC400. WHILE RETRACTING THE PC400 FOR RE-POSITIONING, THE PCOM DISSECTED CAUSING THROMBOSIS OF THE ANEURYSM AND PART OF THE PCOM. THEREFORE, THE PC400 WAS REMOVED INTACT. THE PHYSICIAN THEN ADMINISTERED AN ANTIPLATELET DRUG. THE PROCEDURE WAS ENDED AT THIS POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509138 ↗
• MalfunctionDec 9, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A PAC400 COIL AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL IN THE TARGET LOCATION USING THE RUBY COIL DETACHMENT HANDLE (HANDLE). THE PAC400 WAS THEN ADVANCED THROUGH THE PX SLIM UP THE RIGHT VERTEBRAL AND DOWN THE LEFT VERTEBRAL ARTERY TO THE TARGET LOCATION AND THE PHYSICIAN NOTICED THAT THE PAC400 HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PAC400 WAS NOT SECURE IN THE TARGET VESSEL. A SNARE DEVICE WAS USED TO RETRIEVE THE PAC400. THE PROCEDURE WAS COMPLETED AT THIS POINT AND THE PHYSICIAN DECIDED NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298354 ↗
• MalfunctionDec 4, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400S (PC400S) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE FLUOROSCOPY IMAGING REVEALED THAT THE PC400 HAD UNINTENTIONALLY DETACHED INSIDE THE MIDDLE OF THE PX SLIM. THE PHYSICIAN ATTEMPTED TO FLUSH THE PC400 OUT OF PX SLIM USING A 3 ML SYRINGE WITHOUT SUCCESS. THEREFORE, THE PX SLIM CONTAINING THE PC400 WAS REMOVED FROM THE PATIENT AND THE COIL WAS SUCCESSFULLY FLUSHED OUT OF THE PX SLIM ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM, ANOTHER PC400, AND A LIQUID EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256594 ↗

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