POD RBYPOD8-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 00814548019635), received between Jul 25, 2018 and May 21, 2026 — classified as 3 injuries, 192 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (123 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 195 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A GUIDE CATHETER (038), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. THE PHYSICIAN ADVANCED THE LANTERN AND GUIDE CATHETER TO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A POD COIL, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE POD COIL. AFTER RETRACTING THE COIL'S PUSHER ASSEMBLY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE EMBOLIZATION COIL DETACHED WITHIN THE MID-SHAFT OF THE LANTERN. THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE DETACHED EMBOLIZATION COIL OUT OF THE LANTERN. THE PHYSICIAN DECIDED TO OPEN A NEW POD COIL. WHILE REMOVING THE COIL FROM ITS PACKAGING HOOP, THE POD COIL PUSHER ASSEMBLY WAS NOTICED TO BE KINKED. THE POD COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW POD COIL AND THE SAME GUIDE CATHETER AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240106 ↗
• MalfunctionApr 22, 2026Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER. DESPITE THE RESISTANCE, THE PHYSICIAN CONTINUED ADVANCING THE POD COIL, WHICH RESULTED IN A KINK AND SUBSEQUENT FRACTURE OF THE PUSHER ASSEMBLY. THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND A NEW MICROCATHETER (UNKNOWN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953251 ↗
• InjuryJan 12, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A POD COIL. THE POD COIL WAS REMOVED. WHILE REPOSITIONING THE NEXT POD COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED IN THE PATIENT'S VESSEL. A SNARE DEVICE WAS USED TO ATTEMPT TO REMOVE THE DETACHED EMBOLIZATION COIL WITHOUT SUCCESS. NO ADDITIONAL INFORMATION WAS PROVIDED ON HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24039108 ↗
• MalfunctionDec 23, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL VESSEL USING POD PACKING COILS (PACKING COILS), A POD COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE PACKING COILS IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING THE LAST POD COIL INTO THE TARGET LOCATION, THE POD COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE TAIL END OF DETACHED POD COIL WAS STILL INSIDE OF THE LANTERN. THE PHYSICIAN USED SALINE TO PUSH THE DETACHED POD COIL OUT FROM THE LANTERN, BUT THE POD COIL MIGRATED INTO THE AORTA. THEREFORE, A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE DETACHED POD COIL, AND NO PART OF THE POD COIL WAS LEFT IN THE PATIENT. THE PROCEDURE HAD 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 23878574 ↗
• MalfunctionDec 12, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL SYSTEM USING A POD COIL, NON-PENUMBRA COILS, POD PACKING COILS (PACKING COIL), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE NON-PENUMBRA COILS AND TWO PACKING COILS INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCE THE POD COIL AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. IT WAS REPORTED THAT THE MICROCATHETER MAY HAVE BEEN KINKED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE AFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796740 ↗
• MalfunctionDec 11, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE LANTERN WAS REMOVED CONTAINING THE DETACHED POD COIL AND THE COIL WAS FLUSHED OUT FROM THE LANTERN. THE PHYSICIAN REINSERTED THE LANTERN BACK INTO THE TARGET VESSEL. WHILE ADVANCING A NEW POD COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED, AND THE LANTERN WAS REMOVED CONTAINING THE DETACHED POD COIL. THE LANTERN WAS FLUSHED AND THE DETACHED POD COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23780240 ↗
• MalfunctionDec 11, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE LANTERN WAS REMOVED CONTAINING THE DETACHED POD COIL AND THE COIL WAS FLUSHED OUT FROM THE LANTERN. THE PHYSICIAN REINSERTED THE LANTERN BACK INTO THE TARGET VESSEL. WHILE ADVANCING A NEW POD COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED, AND THE LANTERN WAS REMOVED CONTAINING THE DETACHED POD COIL. THE LANTERN WAS FLUSHED AND THE DETACHED POD COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23780229 ↗
• MalfunctionOct 21, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL IN THE MID-SHAFT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON ATTEMPTING TO RETRACT THE POD COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED, AND THE DETACHED POD COIL WAS FLUSHED OUT OF THE LANTERN. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23350316 ↗
• MalfunctionSep 15, 2025Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE HYPOGASTRIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL HALFWAY OUT OF THE LANTERN, THE POD COIL UNRAVELED AND UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN ADVANCED A GUIDEWIRE TO TRAP THE DETACHED POD COIL. THE LANTERN CONTAINING THE DETACHED POD COIL AND THE GUIDEWIRE WERE REMOVED. AFTER REMOVAL OF THE DETACHED POD COIL, THE GUIDEWIRE, AND THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WAS DAMAGED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL AND ANOTHER LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059248 ↗
• 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 22325603 ↗
• MalfunctionJun 3, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER, THE POD COIL BECAME STUCK IN THE DISTAL LENGTH OF THE MICROCATHETER. UPON ATTEMPTING TO RETRIEVE THE POD COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT, AND THE POD COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 22137486 ↗
• MalfunctionJan 21, 2025Fracture; Physical Resistance/Sticking; Premature Separation; Fracture; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, POD PACKING COILS (PACKING COIL), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING THE FIRST POD COIL INTO THE MICROCATHETER. THE POD COIL THEN BECAME STUCK IN THE MID-SHAFT OF THE MICROCATHETER, AND WOULD NOT ADVANCE FURTHER. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS THEN FLUSHED AND THE POD COIL WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING TWO POD COILS, THREE PACKING COILS, 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 21203587 ↗
• MalfunctionNov 22, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN BEGAN RETRACTING THE POD COIL, AND, SUBSEQUENTLY, POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. TO REMOVE THE POD COIL, THE PHYSICIAN PULLED NEGATIVE PRESSURE WITH A SYRINGE UNTIL THE POD COIL WAS VISIBLE, AND THE COIL WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 20765055 ↗
• MalfunctionSep 13, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN AROUND A BEND IN THE PATIENT'S ANATOMY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE POD COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER POD 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 20209698 ↗
• MalfunctionApr 29, 2024Unraveled Material; Difficult or Delayed Separation; Unraveled Material; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD COILS, A POD DETACHMENT HANDLE (HANDLE), AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE COIL WITH THE HANDLE; HOWEVER, THE POD COIL WOULD NOT DETACH. WHILE RETRACTING, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE POD COIL. IT WAS NOTED THAT THE POD COIL STARTED UNRAVELING WHILE BEING REMOVED. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203795 ↗
• MalfunctionMar 21, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN KICKED OUT OF THE TARGET VESSEL OUTFLOW. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE LANTERN BACK INTO THE TARGET VESSEL; HOWEVER, THE LANTERN LOOPED IN THE ANEURYSM BEFORE GOING INTO THE OUTFLOW. THE PHYSICIAN THEN PULLED THE LANTERN BACK TO STRAIGHTEN IT OUT. WHILE ATTEMPTING TO ADVANCE THE POD COIL OUT OF THE DISTAL END OF THE LANTERN, THE PHYSICIAN NOTICED THAT THE POD COIL WAS STUCK AND DECIDED TO REMOVE IT. UPON REMOVAL, IT WAS NOTICED THAT ONLY THE PUSHER ASSEMBLY OF THE POD COIL WAS REMOVED AND THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND A SECOND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947565 ↗
• MalfunctionMar 4, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE POD COIL PAST THE MID-SHAFT OF THE MICROCATHETER AND DECIDED TO REMOVE THE COIL. SUBSEQUENTLY, UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL POD COILS, FOUR NON-PENUMBRA COILS, 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 18828028 ↗
• MalfunctionFeb 21, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, POD PACKING COILS (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO POD COILS AND THREE POD PCS INTO THE TARGET VESSEL USING THE LANTERN. AFTER ADVANCING A SMALL PART OF ANOTHER POD COIL OUT OF THE LANTERN, THE POD COIL WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN DECIDED TO REMOVE THE POD COIL AND WHILE REMOVING, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS THEN FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, THREE POD PCS, 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 18754561 ↗
• MalfunctionDec 6, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A SPLENORENAL SHUNT USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE DISTAL END IF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE ATTEMPTING TO PULL THE POD COIL BACK, THE POD COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 18279758 ↗
• MalfunctionOct 3, 2023Failure to Fold; Physical Resistance/Sticking; Premature Separation; Failure to Fold; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY (SGA) AND THE INFERIOR GLUTEAL ARTERY (IGA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD COIL INTO THE TARGET VESSEL USING THE LANTERN, BUT THE POD COIL WAS NOT TAKING IT¿S INTENDED SHAPE. THE PHYSICIAN DECIDED TO REMOVE THE POD COIL AND, WHILE RETRACTING THE POD COIL, THE PHYSICIAN NOTICED THAT THE POD COIL HAD STOPPED MOVING AND THAT THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17864276 ↗
• MalfunctionSep 15, 2023Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER WITH SALINE TO PUSH THE DETACHED POD COIL INTO THE VESSEL AND THE COIL WAS SUCCESSFULLY IMPLANTED. NEXT, WHILE ADVANCING ANOTHER POD COIL, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 17760825 ↗
• MalfunctionSep 15, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER WITH SALINE TO PUSH THE DETACHED POD COIL INTO THE VESSEL AND THE COIL WAS SUCCESSFULLY IMPLANTED. NEXT, WHILE ADVANCING ANOTHER POD COIL, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 17760788 ↗
• MalfunctionAug 18, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT PUDENDAL VEIN USING POD COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA GLIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE PATIENT''S VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE GLIDE CATHETER, THE MICROCATHETER, AND THE POD COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, A NEW NON-PENUMBRA MICROCATHETER, AND THE SAME GLIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577946 ↗
• MalfunctionAug 18, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL MIDWAY THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO FIX THE POD COIL BUT WERE UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED POD COIL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17577845 ↗
• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE POD COIL WAS ADVANCED THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE POD COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING POD PACKING COILS (POD PC), 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 17243003 ↗