POD RBYPOD6Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI M424RBYPOD60), received between Aug 14, 2015 and May 22, 2024 — classified as 4 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (45 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 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Failure 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 SPLENIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE DEVICE INTO THE MICROCATHETER. THE PHYSICIAN DECIDED TO REMOVE THE COIL. AFTER REMOVAL, THE PHYSICIAN NOTICED THAT THE POD COIL WAS DETACHED. THEREFORE, THE POD COIL WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL DETAILS WERE PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377297 ↗
• MalfunctionMay 2, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN 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 INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND A NEW LANTERN. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE DEFICIENCY OR DAMAGE TO THE FIRST LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14261711 ↗
• MalfunctionJan 6, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER AND INTO THE TARGET LOCATION WITH APPROXIMATELY ONE CENTIMETER OF THE POD COIL IN THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD COIL. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED IN THE RIGHT RENAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DETACHED POD COIL. NEXT, THE PHYSICIAN ADVANCED A NEW POD COIL THROUGH THE MICROCATHETER AND INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED, AND THE POD COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD COIL. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED IN THE AORTA. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DETACHED POD COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL AND A NEW MICRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180191 ↗
• MalfunctionJan 6, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER AND INTO THE TARGET LOCATION WITH APPROXIMATELY ONE CENTIMETER OF THE POD COIL IN THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD COIL. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED IN THE RIGHT RENAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DETACHED POD COIL. NEXT, THE PHYSICIAN ADVANCED A NEW POD COIL THROUGH THE MICROCATHETER AND INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED, AND THE POD COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD COIL. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED IN THE AORTA. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DETACHED POD COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL AND A NEW MICRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180188 ↗
• MalfunctionMay 18, 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 RENAL ARTERY USING POD COILS, A POD PACKING COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD COIL AND A POD PACKING COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER POD COIL THROUGH THE MICROCATHETER, THE POD COIL BECAME STUCK, AND THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11841590 ↗
• MalfunctionMay 4, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A NON-PENUMBRA SHEATH . IT WAS NOTED THAT VASCULAR ACCESS WAS SLIGHTLY DIFFICULT. DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED THE LANTERN INTO THE SHEATH TO THE TARGET LOCATION. WHILE ADVANCING A FEW CENTIMETERS OF A POD COIL THROUGH THE DISTAL TIP OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE POD COIL WOULD NOT ADVANCE FURTHER. THEREFORE, THE POD COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE A NEW POD COIL, RESISTANCE WAS EXPERIENCED; HOWEVER, THE PHYSICIAN WAS ABLE TO PLACE THE POD COIL INTO THE TARGET VESSEL SUCCESSFULLY. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN DUE TO THE RESISTANCE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA 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 11773600 ↗
• MalfunctionApr 23, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11712666 ↗
• MalfunctionFeb 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OFF OF A FISTULA USING POD COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET THE POD8 TO ANCHOR PROPERLY IN THE TARGET VESSEL. THE POD8 WAS RETRACTED AND RE-ADVANCED BUT THE SAME ISSUE OCCURRED. NEXT, THE PHYSICIAN ATTEMPTED TO USE A POD6 BUT THIS COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE POD6 WAS REMOVED AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN MADE ANOTHER ATTEMPT WITH THE SAME POD6 WITHOUT SUCCESS. THEREFORE, THE POD6 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER POD6, THE SAME MICROCATHETER, THE SAME CATHETER, AND THE SAME SHEATH. 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 11364676 ↗
• MalfunctionSep 2, 2020Physical Resistance/Sticking; 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 ADVANCING THE POD COIL AT THE DISTAL END OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; 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 Consequences Or Impact To Patient

  MAUDE report 10485535 ↗
• MalfunctionJul 16, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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 TWO POD COILS SEPARATELY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PUSHER ASSEMBLIES OF THE POD COILS WERE INADVERTENTLY BENT. THEREFORE, THE POD COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286814 ↗
• MalfunctionJul 16, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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 TWO POD COILS SEPARATELY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PUSHER ASSEMBLIES OF THE POD COILS WERE INADVERTENTLY BENT. THEREFORE, THE POD COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286813 ↗
• MalfunctionMar 19, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL 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 INSIDE THE LANTERN. THEREFORE, THE LANTERN 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 LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9856876 ↗
• MalfunctionDec 12, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD6. DURING THE PROCEDURE, WHILE ADVANCING THE POD6 THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD6 UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN PULLED THE DETACHED POD6 FROM THE HUB OF THE MICROCATHETER AND SUCCESSFULLY REMOVED THE COIL. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457996 ↗
• MalfunctionSep 26, 2019Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A POD6. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT THE POD6 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE POD6 WAS NOT PLACED IN THE DESIRED POSITION; THEREFORE, THE PHYSICIAN RE-SHEATHED THE POD6 IN ORDER TO RE-POSITION IT. WHILE RE-ADVANCING THE POD6 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY 1/3 OF THE POD6 INTO THE MICROCATHETER AND REALIZED THAT THE POD6 PUSHER ASSEMBLY WAS KINKED. SUBSEQUENTLY, THE POD6 UNINTENTIONALLY DETACHED WITH APPROXIMATELY 2/3 OF THE POD6 STILL WITHIN THE INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN REMOVED THE INTRODUCER SHEATH WITH THE DETACHED POD6 FROM THE HUB OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126651 ↗
• MalfunctionAug 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING POD6S. DURING THE PROCEDURE, THE PHYSICIAN BEGAN ADVANCING THE POD6 AND ENCOUNTERED RESISTANCE AT THE HUB OF THE NON-PENUMBRA MICROCATHETER. THE POD6 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER POD6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893816 ↗
• MalfunctionJul 19, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING POD6S. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A POD6 PAST THE DISTAL END OF THE INTRODUCER SHEATH AND, THEREFORE, THE POD6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD6 AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805840 ↗
• MalfunctionJun 11, 2019Premature Separation; Premature Separation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED TWO POD6S INTO SALINE TO CHECK THEIR SHAPES ON THE BACK TABLE. HOWEVER, WHILE RETRACTING THE POD6S BACK INTO THEIR INTRODUCER SHEATHS, BOTH POD6S DETACHED FROM THEIR PUSHER ASSEMBLIES. THE DAMAGE TO THE POD6S OCCURRED PRIOR TO USE AND, THEREFORE, THE POD6S WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER POD PACKING COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8688992 ↗
• MalfunctionJun 11, 2019Premature Separation; Premature Separation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN ADVANCED TWO POD6S INTO SALINE TO CHECK THEIR SHAPES ON THE BACK TABLE. HOWEVER, WHILE RETRACTING THE POD6S BACK INTO THEIR INTRODUCER SHEATHS, BOTH POD6S DETACHED FROM THEIR PUSHER ASSEMBLIES. THE DAMAGE TO THE POD6S OCCURRED PRIOR TO USE AND, THEREFORE, THE POD6S WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER POD PACKING COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8688991 ↗
• MalfunctionJun 5, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD6. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE POD6 PAST THE HUB OF THE NON-PENUMBRA MICROCATHETER AND WAS UNABLE TO ADVANCE THE COIL ANY FURTHER. THEREFORE, THE POD6 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 Consequences Or Impact To Patient

  MAUDE report 8672624 ↗
• InjuryMay 3, 2019Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD6S AND POD8S. 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 8577826 ↗
• 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 8434907 ↗
• MalfunctionJan 3, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD6S. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO POD6S THROUGH A NON-PENUMBRA MICROCATHETER. THEREFORE, THE POD6S WERE REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS, NEW COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212660 ↗
• MalfunctionJan 3, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD6S. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO POD6S THROUGH A NON-PENUMBRA MICROCATHETER. THEREFORE, THE POD6S WERE REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS, NEW COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212654 ↗
• MalfunctionNov 28, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD6S. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A POD8 AS THE FIRST COIL IN THE OUTFLOW VESSEL WITH A NON-PENUMBRA MICROCATHETER; HOWEVER, THE POD8 DID NOT TAKE ITS INTENDED SHAPE. IT WAS REPORTED THAT THE POD8 WAS OVERSIZED AND THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A POD6 INTO THE OUTFLOW VESSEL USING THE SAME MICROCATHETER; HOWEVER, THE BASE CATHETER BEING USED COULD NOT BE STABILIZED; THEREFORE, THE POD6 WAS RETRACTED AND FLUSHED. WHEN THE POD6 WAS ADVANCED AGAIN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD6 WOULD NOT ADVANCE PAST THE INTRODUCER SHEATH. THEREFORE, THE POD6 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL POD6S, RUBY COILS, NON-PENUMBRA EMBOLIC AGENTS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111654 ↗
• MalfunctionOct 19, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD6S. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A POD6 ABOUT 15 CM FROM THE TIP OF A NON-PENUMBRA MICROCATHETER AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE POD6 BROKE. THE POD6 WAS THEN REMOVED. THE PROCEDURE THEN ATTEMPTED TO PLACE ANOTHER POD6, HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE POD6 THOUGH THE HUB OF THE MICROCATHETER. THEREFORE, THE POD6 WAS REMOVED. THE PROCEDURE THEN 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 7985707 ↗