POD RBYPOD4-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00814548019598), received between Jul 11, 2018 and Oct 22, 2025 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (31 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC 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 IN THE MID-SHAFT OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON ATTEMPTING TO RETRACT THE POD COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT, AND THE DETACHED POD COIL WAS FLUSHED OUT OF THE MICROCATHETER. 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 23358397 ↗
• MalfunctionDec 27, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028075 ↗
• MalfunctionNov 22, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) 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 MID-SHAFT OF THE MICROCATHETER, THE POD COIL BECAME STUCK. THE PHYSICIAN THEN DECIDED TO REMOVE THE POD COIL AND WHILE RETRACTING, THE POD COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED. ON THE BACK TABLE, THE POD COIL WAS FLUSHED OUT OF THE MICROCATHETER. 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 18194032 ↗
• MalfunctionJan 19, 2023Break; Unraveled Material; Migration; Break; Unraveled Material; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN PLACED ANOTHER POD COIL IN THE VESSEL AND THEN REMOVED THE MICROCATHETER AND CATHETER. SUBSEQUENTLY, A FLUOROSCOPY WAS PERFORMED, AND THE PHYSICIAN NOTICED THE TAIL END OF THE POD COIL (POD4) WAS DISLODGED AND MIGRATED INTO THE HEPATIC ARTERY. THE FOLLOWING DAY, THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE POD COIL THAT MIGRATED INTO THE HEPATIC ARTERY. HOWEVER, WHILE SNARING THE TIP OF THE POD COIL, THE PHYSICIAN NOTICED THE POD COIL BROKE AND STARTED TO UNRAVEL. IT WAS REPORTED THAT SMALL STRANDS OF THE POD COIL WERE BEING PULLED OUT AND MAJORITY OF THE STRANDS WERE REMOVED USING THE SNARE, BUT A SMALL RESIDUAL STRAND REMAINED IN THE VESSEL THAT EXTENDS TO THE ILIAC. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT AND THE PATIENT WAS SENT TO UNDERGO A COMPUTED TOMOGRAPHY (CT). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16211419 ↗
• MalfunctionOct 21, 2022Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL 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 THE POD COIL BECAME STUCK AND WOULD NOT ADVANCE WITHIN THE MICROCATHETER. SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE POD COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 15649742 ↗
• MalfunctionMay 3, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN 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 THE POD COIL BECAME STUCK INSIDE THE MICROCATHETER. SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 14270293 ↗
• MalfunctionNov 23, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE POD COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE POD COIL FAILED TO DETACH. IT WAS NOTICED THAT THE BLACK ALIGNMENT ZONE ON THE POD COIL WAS SEPARATED; HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE POD COIL STILL DID NOT DETACH. AFTERWARDS, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE POD COIL BY PULLING THE WIRE MULTIPLE TIMES. IT WAS REPORTED THAT TWO OTHER PENUMBRA COILS HAD DIFFICULTY DETACHING WITH THE HANDLE; HOWEVER, THE COILS WERE ABLE TO DETACH ON THE SECOND ATTEMPT. THE PROCEDURE WAS COMPLETED USING MORE RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863530 ↗
• MalfunctionOct 6, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN MULTIPLE TIBIAL DEVELOPMENTAL VENOUS ANOMALY (DVA) COLLATERAL VESSELS USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN DELIVERED SIX COILS TO THE TARGET LOCATIONS. WHILE DELIVERING THE NEXT POD COIL, THE PHYSICIAN REALIZED THERE WAS NOT ENOUGH LANDING ZONE TO FULLY DEPLOY THE POD COIL AND OPTED TO RETRACT IT. THE POD COIL STOPPED TRACKING HALFWAY THROUGH THE INTRODUCER SHEATH. ANOTHER ATTEMPT WAS MADE AGAIN TO RETRACT THE POD COIL INTO THE INTRODUCER SHEATH; HOWEVER, THE HOSPITAL TECH BENT THE PUSHER ASSEMBLY. THIS CAUSED THE POD COIL AND INTRODUCER SHEATH TO STAY STUCK IN THEIR POSITION. SINCE THE PHYSICIAN HAD OPTED TO RECAPTURE PRIOR TO COMPLICATION, THEY REMOVED THE POD COIL OUT OF INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING TWO NEW COILS 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 12583578 ↗
• MalfunctionSep 3, 2021Break; Retraction Problem; Physical Resistance/Sticking; Break; Retraction Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERY (RIMA) USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A POD COIL WAS ADVANCED INTO THE MICROCATHETER AND BECAME STUCK MIDWAY. THE HOSPITAL TECHNOLOGIST ATTEMPTED TO PULL THE POD COIL BACK INTO THE INTRODUCER SHEATH, BUT THE POD COIL WAS UNABLE TO COMPLETELY RETRACT OUT OF THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE INTRODUCER SHEATH TO FIND THE POD COIL STUCK IN THE MICROCATHETER, HANGING HALFWAY OUT AND DETACHED FROM THE PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN PULLED THE DETACHED POD COIL OUT OF THE MICROCATHETER BY HAND. IT WAS REPORTED THE MICROCATHETER MAY NOT HAVE BEEN FLUSHED PRIOR TO INTRODUCING THE POD COIL. 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 12424871 ↗
• MalfunctionAug 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FLUSHED A POD COIL PRIOR TO ADVANCING BUT THE POD COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, 13 RUBY 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 12379814 ↗
• MalfunctionJul 30, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH; CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE POD COIL HAD BENT. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256666 ↗
• MalfunctionJul 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING POD COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST POD COIL THROUGH ITS INTRODUCER SHEATH, AND REPORTED THAT IT BECAME STUCK WHEN THE DISTAL TIP OF THE COIL REACHED THE DISTAL TIP OF ITS INTRODUCER SHEATH. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO RUBY 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 12186889 ↗
• MalfunctionJul 17, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN NON-PENUMBRA COILS AND THREE RUBY COILS. WHILE ATTEMPTING TO ADVANCE A POD COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE POD COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY WITHIN THE INTRODUCER SHEATH. THEREFORE, THE POD COIL AND ITS INTRODUCER SHEATH WERE REMOVED FROM THE HUB OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, FOUR RUBY COILS, FIVE OTHER 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 12186067 ↗
• MalfunctionJul 14, 2021Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A VARICOCELE USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL INTO THE LANTERN, THE RADIOLOGY TECHNICIAN NOTICED A KINK ON THE PUSHER ASSEMBLY OF THE POD COIL. THE RADIOLOGY TECHNICIAN THEN ATTEMPTED TO SLOWLY ADVANCE THE POD COIL; HOWEVER, THE KINK BECAME WORSE. THEREFORE, IT WAS DECIDED TO REMOVE THE POD COIL. UPON RETRACTION, IT WAS NOTICED THAT THE POD COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY. THE PHYSICIAN WAS ABLE TO PULL THE DETACHED POD COIL FROM THE ROTATING HEMOSTASIS VALVE (RHV) BY HAND. 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 12169673 ↗
• MalfunctionJun 14, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ACCESSORY RENAL ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER ADVANCING A POD COIL JUST PAST THE HUB OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS RETRACTED AND 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 11994417 ↗
• MalfunctionMay 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE THE BRACHIAL BRANCH USING A POD COIL, RUBY COILS, AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. NEXT, THE POD COIL BECAME STUCK WHILE ADVANCING THROUGH THE LANTERN; THEREFORE, THE POD COIL AND LANTERN WERE REMOVED. THE PHYSICIAN INSERTED A NEW LANTERN INTO THE TARGET LOCATION, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE AND THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821836 ↗
• MalfunctionMay 10, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER . IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 11798804 ↗
• MalfunctionMar 27, 2021Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A POD COIL IN THE TARGET LOCATION. WHEN THE PHYSICIAN ADVANCED THE NEXT POD COIL IN THE LANTERN, THE PHYSICIAN FELT RESISTANCE, AND THE PUSHER ASSEMBLY OF THE POD COIL BECAME KINKED. THEREFORE, THE POD COIL WAS REMOVED. IT WAS REPORTED THE POD COIL WAS FOUND DETACHED ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, THREE PENUMBRA COILS 400 (PC400S), 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 11579471 ↗
• MalfunctionMar 19, 2021Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE TARGET ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SIZING ISSUES WITH OTHER PENUMBRA COILS; THEREFORE, THESE COILS WERE NOT IMPLANTED AND WERE REMOVED FROM THE PROCEDURE. WHILE IMPLANTING THE FIRST POD COIL, IT WOULD NOT FORM IN THE VESSEL. THE PHYSICIAN DECIDED TO REMOVE THE POD COIL AND, WHILE RETRACTING THE COIL BACK INTO THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. AFTER REMOVING THE POD COIL, THE PHYSICIAN ATTEMPTED TO IMPLANT A RUBY COIL AND REPORTED THAT THE COIL ALSO DID NOT FORM IN THE VESSEL. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL. THE PHYSICIAN WAS UNABLE TO RETRACT THE RUBY COIL BACK INTO THE MICROCATHETER AT FIRST, BUT EVENTUALLY DID AND SUBSEQUENTLY REMOVED THE RUBY COIL FROM THE PROCEDURE. THE PROCEDURE CONTINUED WITH OTHER PENUMBRA COILS; HOWEVER, THE PHYSICIAN EXPERIENCED SIZING ISSUES WITH THESE COILS. THEREFORE, THE PENUMBRA COILS WITH SIZING ISSUES WERE NOT IMPLANTED AND WERE REMOVED FROM TH

  Patient problems: Perforation of Vessels

  MAUDE report 11531994 ↗
• MalfunctionMar 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL BRANCH ARTERY USING POD COILS, POD PACKING COILS (POD PCS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE TECHNOLOGIST EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE MIDDLE OF THE MICROCATHETER. THE POD COIL WAS RETRACTED AND RE-ADVANCED, BUT THE ISSUE WAS NOT RESOLVED. THEREFORE, THE POD COIL WAS REMOVED. NEXT, THE PHYSICIAN WAS ADVANCING A POD PC APPROXIMATELY ONE THIRD OF THE WAY THROUGH THE MICROCATHETER WHEN THE PUSHER WIRE BECAME KINKED. NO RESISTANCE WAS REPORTED. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL (4MM) AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11414835 ↗
• MalfunctionJan 11, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCE RESISTANCE IN THE MIDDLE OF THE LANTERN AND THE POD COIL WOULD NOT ADVANCE ANY FURTHER. CONSEQUENTLY, THE PHYSICIAN KINKED THE POD COIL; THEREFORE, 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; No Consequences Or Impact To Patient

  MAUDE report 11149062 ↗
• MalfunctionDec 21, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE OCCLUDED VESSEL MEASURED 4CM, AND A POD4 WAS SELECTED. DURING THE PROCEDURE, THE POD4 SEEMED OVERSIZED. WHEN THE PHYSICIAN ATTEMPTED TO RECAPTURE THE POD4, THE POD4 UNINTENTIONALLY DETACHED IN THE PATIENT. THE PHYSICIAN THEN PUSHED THE POD4 INTO THE SPLENIC ARTERY TO PREVENT THE POD4 FROM MOVING INTO THE AORTA. THE PROCEDURE WAS COMPLETED USING A POD3 AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11051647 ↗
• MalfunctionDec 10, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A POD COIL AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL IN THE VEIN, THE PHYSICIAN EXPERIENCED RESISTANCE PRIOR TO DETACHING THE POD COIL. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE POD COIL TO GET A DENSER PACK. HOWEVER, WHILE ATTEMPTING TO WITHDRAW THE POD COIL, THE POD COIL WAS NOT COMING BACK WITH THE PUSHER ASSEMBLY AND THE COIL HAD UNINTENTIONALLY DETACHED IN THE VEIN. IT WAS REPORTED THAT THE PHYSICIAN DETERMINED THE POD COIL WAS SAFE AND DECIDED TO LEAVE THE COIL IN PLACE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10985264 ↗
• MalfunctionNov 13, 2020Failure 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 INFERIOR GLUTEAL ARTERY USING A POD COIL, A NON-PENUMBRA COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL THROUGH THE LANTERN INTO THE TARGET VESSEL. AFTER ADVANCING APPROXIMATELY FIVE TO FIFTEEN CENTIMETERS OF THE POD COIL INTO THE VESSEL, THE PHYSICIAN NOTICED THAT THE POD COIL COULD NOT BE FORMED AS EXPECTED. NEXT, AFTER ADVANCING AND RETRACTING THE POD COIL THREE TIMES, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY NOTICED UNDER FLUOROSCOPY THAT THE POD COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE POD COIL WAS REMOVED. THE PHYSICIAN THEN REINSERTED THE LANTERN INTO THE PATIENT¿S BODY AND COMPLETED USING ANOTHER COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10840673 ↗
• MalfunctionOct 27, 2020Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD COIL. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO RE-SHEATH A POD COIL AND THEREFORE, IT WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

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

  MAUDE report 10741240 ↗