POD RBYPOD8Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI M424RBYPOD80), received between Aug 21, 2015 and Jun 25, 2025 — classified as 90 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A POD PACKING COIL (PACKING COIL), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH ANOTHER POD COIL AND A PACKING COIL. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED POD COIL AND PACKING COIL RESPECTIVELY. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325650 ↗
• MalfunctionNov 14, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRACHIAL VEIN TO TREAT AN ARTERIOVENOUS FISTULA (AVF) USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE DISTAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. AFTERWARDS, THE PHYSICIAN PERFORMED AN ANGIOGRAM WHICH SHOWED GOOD BLOOD FLOW IN THE AVF. THE PHYSICIAN THEN DECIDED NOT TO BLOCK THE BRACHIAL VEIN AND 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 15794455 ↗
• MalfunctionAug 18, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE POD COIL. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE POD COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A RUBY 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 12339804 ↗
• MalfunctionAug 2, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT VARICOSE VEINS USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE POD COIL UNINTENTIONALLY DETACHED. HOWEVER, THE PHYSICIAN WAS ABLE TO IMPLANT THE POD COIL INTO THE TARGET VESSEL BY FLUSHING THE LANTERN AND USING THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE AFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264523 ↗
• MalfunctionApr 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING THE POD COIL APPROXIMATELY HALFWAY INTO THE LANTERN, THE POD COIL WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO ADVANCE THE POD COIL; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, A RUBY COIL, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616788 ↗
• MalfunctionJun 3, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING POD COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET VESSEL USING THE MICROCATHETER; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE POD COIL AND WANTED TO PLACE IT MORE DISTAL TO THE ANEURYSM. WHILE RETRACTING THE POD COIL TO REPOSITION THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE POD COIL WAS FLUSHED OUT. WHILE ADVANCING A NEW POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER PRIOR TO EXITING THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 10117072 ↗
• MalfunctionMar 5, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VARIX USING A POD8, NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED COILS IN THE TARGET VESSEL USING THE DIAGNOSTIC CATHETER. THE MICROCATHETER THEN WAS ADVANCED THROUGH THE DIAGNOSTIC CATHETER. NEXT, WHILE ADVANCING THE POD8 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD8 BECAME STUCK; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE MICROCATHETER HAD KINKED; THEREFORE, IT WAS ALSO REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795762 ↗
• MalfunctionNov 13, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING POD8S. DURING THE PROCEDURE, A POD8 WAS UNABLE TO ADVANCE PAST THE TIP OF THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD8S AND PENUMBRA COIL 400S (PC400S). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318261 ↗
• MalfunctionOct 11, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC VEIN USING POD8S AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD8 THROUGH THE LANTERN, THE HOSPITAL NURSE EXPERIENCED RESISTANCE, AND THE POD8 UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD8 WAS REMOVED, AND THE POD8 WAS FLUSHED OUT. UPON REMOVAL, THE LANTERN WAS NOTICED TO BE KINKED AND THEREFORE, IT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER PENUMBRA COILS AND ANOTHER LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179595 ↗
• MalfunctionOct 8, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING POD8S AND RUBY COILS. IT WAS NOTICED THAT THE PATIENT HAD AN ACUTE ANGLE INTO THE HYPOGASTRIC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA GUIDE CATHETER IN THE TARGET VESSEL AND THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) OVER A NON-PENUMBRA GUIDEWIRE INTO THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED A POD8 THROUGH THE LANTERN; HOWEVER, AFTER ADVANCING APPROXIMATELY HALF OF THE POD8 OUT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD8 BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE POD8; HOWEVER, WHILE RETRACTING THE POD8, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD8 AND THEN REMOVED THE POD8. WHILE ADVANCING A NEW POD8 THROUGH THE SAME LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, AFTER ADVANCING APPROXIMATELY 75 PERCENT OF THE POD8 OUT OF THE LANTERN, THE POD8 UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD8 AND THEN REMOVED THE POD8. IT WAS ALSO REPORTED THAT THE PHYSICIAN IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169855 ↗
• MalfunctionOct 8, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING POD8S AND RUBY COILS. IT WAS NOTICED THAT THE PATIENT HAD AN ACUTE ANGLE INTO THE HYPOGASTRIC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA GUIDE CATHETER IN THE TARGET VESSEL AND THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) OVER A NON-PENUMBRA GUIDEWIRE INTO THE ANEURYSM. NEXT, THE PHYSICIAN ADVANCED A POD8 THROUGH THE LANTERN; HOWEVER, AFTER ADVANCING APPROXIMATELY HALF OF THE POD8 OUT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD8 BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE POD8; HOWEVER, WHILE RETRACTING THE POD8, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD8 AND THEN REMOVED THE POD8. WHILE ADVANCING A NEW POD8 THROUGH THE SAME LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, AFTER ADVANCING APPROXIMATELY 75 PERCENT OF THE POD8 OUT OF THE LANTERN, THE POD8 UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD8 AND THEN REMOVED THE POD8. IT WAS ALSO REPORTED THAT THE PHYSICIAN IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169849 ↗
• MalfunctionOct 3, 2019Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PCS) AND A POD8. WHILE REMOVING A POD PC FROM ITS PACKAGING HOOP, THE PUSHER WIRE BECAME KINKED. THE POD PC WAS DAMAGED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN SUCCESSFULLY PLACED SIX POD PCS IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. UPON ADVANCEMENT OF A POD8, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO ADJUST THE MICROCATHETER AND RE-ADVANCE THE POD8. WHEN THE PHYSICIAN HAD RE-ADVANCED THE POD8 APPROXIMATELY HALFWAY OUT OF THE MICROCATHETER, THE PUSHER WIRE KINKED AND BROKE AND THE POD8 UNINTENTIONALLY DETACHED. THE POD8 AND MICROCATHETER WERE THEN REMOVED TOGETHER FROM THE PATIENT AND WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, A POD6, AND POD PC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9154373 ↗
• MalfunctionAug 27, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A POD8. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD8 WOULD NOT ADVANCE INTO THE HUB OF A NON-PENUMBRA MICROCATHETER; THEREFORE, THE POD8 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 8936814 ↗
• MalfunctionJul 24, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT IPOGASTRIC ARTERY USING POD8. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE POD8 INTO A NON-PENUMBRA MICROCATHETER; CONSEQUENTLY, THE POD8 BECAME STUCK AND WAS UNABLE TO ADVANCE ANY FURTHER; THEREFORE THE POD8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO RUBY 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 8821315 ↗
• MalfunctionJun 14, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD8S. DURING THE PROCEDURE, WHILE ADVANCING A POD8 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE POD8 UNINTENTIONALLY DETACHED WITHIN 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 A NEW POD8 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 8700847 ↗
• MalfunctionMay 3, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD6'S AND POD8'S. IT SHOULD BE NOTED THAT THE TARGET ARTERY WAS DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD8 INTO A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO IMPLANT THE POD8, IT WAS REPORTED THAT THE POD8 WOULD NOT ANCHOR OR TAKE ITS INTENDED SHAPE AND BEGAN TO FLOW DOWN THE ARTERY. THE POD8 WAS THEN RE-SHEATHED AND REMOVED FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE AND SUCCESSFULLY IMPLANTED A POD6. HOWEVER, WHILE ATTEMPTING TO IMPLANT THE NEXT COIL, A POD PACKING COIL (POD PC), IT WAS REPORTED THAT THE POD PC MADE CONTACT WITH THE POD6 COIL PACK. AS A RESULT, THE POD6 MIGRATED OUT OF THE TARGET VESSEL TO AN UNDESIRED LOCATION. THE POD PC WAS SUBSEQUENTLY REMOVED AND THE PHYSICIAN USED A SNARE TO RETRIEVE THE POD6 FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING RUBY 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 8577822 ↗
• MalfunctionApr 9, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD8S. WHILE PREPARING TO ADVANCE THE POD8 INTO THE PATIENT, THE PHYSICIAN FLUSHED THE POD8 WITH SALINE AND ADVANCED AND RETRACTED IT WITHIN ITS SHEATH. WHILE RETRACTING THE POD8 BACK TO ITS INITIAL POSITION, THE PHYSICIAN REPORTED EXPERIENCING RESISTANCE. THE POD8 THEN INADVERTENTLY DETACHED WITHIN THE SHEATH. THE ISSUE WITH THE POD8 WAS FOUND PRIOR TO USE AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL POD8 COILS AND ONE NON-PENUMBRA COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8496220 ↗
• MalfunctionMar 19, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INFERIOR MESENTERIC ARTERY (RIMA) USING A POD6, POD8 AND A POD PACKING COIL (POD PC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD6 AND POD8 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, BOTH COILS WOULD NOT TAKE THEIR INTENDED SHAPE. THEREFORE, THE POD6 AND POD8 WERE REMOVED. AFTER THAT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL AND A POD PC IN THE TARGET VESSEL. HOWEVER, AFTER PERFORMING AN ANGIOGRAPHIC RUN, THE PHYSICIAN NOTICED THAT PART OF THE POD PC MIGRATED OUT OF THE VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE POD PC. THE PROCEDURE WAS COMPLETED AT THIS POINT AND NO ADDITIONAL COILS WERE PLACED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8434905 ↗
• MalfunctionNov 1, 2018Failure to Fold; Inadequacy of Device Shape and/or Size; Failure to Advance; Failure to Fold; Inadequacy of Device Shape and/or Size; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD8S, POD PACKING COILS (PODJS), AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A POD8, HOWEVER, IT WAS NOT TAKING ITS INTENDED SHAPE. THE PHYSICIAN REMOVED THE POD8 AND ADVANCED THE LANTERN MORE DISTAL, HOWEVER THE PHYSICIAN THEN WAS UNABLE TO ADVANCE THE POD8 OUT OF ITS INTRODUCER SHEATH. THE PHYSICIAN THEREFORE REMOVED THE POD8 AND WAS ABLE TO SUCCESSFULLY PLACE A NEW POD8 IN THE TARGET VESSEL. IT WAS NOTICED THAT THE LANTERN BECAME KINKED AFTER DEPLOYING THE POD8 AND THEREFORE, THE LANTERN WAS REMOVED AND REPLACED WITH A NEW LANTERN. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE NEW LANTERN INTO THE NON-PENUMBRA CATHETER; THEREFORE, IT WAS REMOVED AND ANOTHER LANTERN WAS OPENED. AFTERWARDS, A PODJ WAS SELECTED, HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE IT OUT OF ITS INTRODUCER SHEATH. A KINK WAS FOUND IN THE INTRODUCER SHEATH AND, THEREFORE, THE PODJ WAS REMOVED. ANOTHER PODJ WAS SELECTED AND SUCCESSFULLY IMPLANTED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A NEW RUBY COIL; HOWEVER, WHILE ATTEMPTING TO LOAD IT INTO THE MICROCATHETER, THE ASSISTING SURG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8030315 ↗
• MalfunctionOct 23, 2018Device Damaged Prior to Use; Premature Separation; Device Damaged Prior to Use; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD8. DURING THE PROCEDURE, THE HOSPITAL STAFF REMOVED A POD8 FROM ITS PACKAGING HOOP AND ADVANCED THE COIL OUT OF ITS INTRODUCER SHEATH OUTSIDE OF THE PATIENT. THE PHYSICIAN THEN NOTICED THAT THE POD8 HAD DETACHED WITHIN THE PACKAGING HOOP. THE DAMAGE TO THE POD8 WAS FOUND PRIOR TO USE AND, THEREFORE, THE POD8 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD8.

  Patient problems: No Patient Involvement

  MAUDE report 7997474 ↗
• MalfunctionOct 9, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A POD8 AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD8 INTO THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE POD8 FAILED TO DETACH. THE PHYSICIAN THEN MADE THREE TO FOUR ADDITIONAL ATTEMPTS BUT THE POD8 WOULD STILL NOT DETACH. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) WAS NOT SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE AND THE SAME POD8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949597 ↗
• MalfunctionSep 14, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD8S. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A POD8 THROUGH ITS INTRODUCER SHEATH AND INTO A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD8, RUBY 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 7878678 ↗
• MalfunctionSep 14, 2018Failure to Advance; Device Handling Problem; Physical Resistance/Sticking; Failure to Advance; Device Handling Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD8. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD8 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD8 WOULD NOT PROPERLY ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THE MICROCATHETER AND POD8 WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND RUBY COILS. IT WAS REPORTED THAT THE NON-PENUMBRA MICROCATHETER THAT THE PHYSICIAN WAS USING WAS INCOMPATIBLE WITH THE POD8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877890 ↗
• MalfunctionAug 22, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A POD8 AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A POD8 INTO THE TARGET VESSEL USING A LANTERN, THE POD8 UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THREE RUBY COILS. IT IS UNKNOWN WHETHER OR NOT THE FIRST LANTERN WAS DAMAGED AFTER REMOVAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7806134 ↗
• MalfunctionAug 13, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD8S. DURING THE PROCEDURE, WHILE ADVANCING A POD8 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AT ABOUT 10CM FROM THE LANTERN¿S DISTAL TIP; THEREFORE, THE POD8 WAS REMOVED. UPON REMOVAL, THE PHYSICIAN INSPECTED THE POD8 AND ATTEMPTED TO ADVANCE IT THROUGH THE LANTERN AGAIN; HOWEVER, THE POD8 BECAME STUCK AT THE SAME POSITION IN THE LANTERN. THEREFORE, THE POD8 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 7778404 ↗