POD RBYPOD12-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00814548019666), received between Jun 21, 2018 and Mar 25, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE POD COIL THROUGH THE PROXIMAL LENGTH OF THE LANTERN. THE PHYSICIAN DECIDED TO CONTINUE ADVANCING THE POD COIL TO THE TARGET LOCATION. WHILE THE PHYSICIAN WAS RETRACTING THE POD COIL INTO THE LANTERN TO REPOSITION IT, THE POD COIL FRACTURED. THE FRACTURED COIL WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING POD PACKING COILS (PACKING 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 24693253 ↗
• MalfunctionSep 10, 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 A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK WITHIN THE MID-SHAFT OF THE LANTERN. THE PHYSICIAN ATTEMPTED TO PUSH AND PULL THE POD COIL, BUT THE POD COIL WOULD NOT MOVE. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. IT WAS REPORTED THAT UPON FLUSHING THE POD COIL OUT OF THE LANTERN ON THE BACK TABLE, THE PHYSICIAN FOUND THAT THE POD COIL HAD UNINTENTIONALLY DETACHED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 20184414 ↗
• MalfunctionAug 29, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VEIN USING POD COILS, RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, NINE RUBY COILS AND THREE POD COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT TWO OF THE IMPLANTED POD COILS WERE ADVANCED THROUGH AGAINST RESISTANCE WITHIN THE LANTERN. WHILE ADVANCING ANOTHER POD COIL THROUGH THE DISTAL END OF THE LANTERN, THE POD COIL BECAME STUCK. THE PHYSICIAN THEN DECIDED TO REMOVE THE POD COIL; HOWEVER, UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NINE POD PACKING COILS (POD PC) AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642464 ↗
• MalfunctionMar 27, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A POD PACKING COIL (PODJ), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA 5F CATHETER, A NON-PENUMBRA 8F SHEATH, A NON-PENUMBRA 16F SHEATH AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS WITH EXTREME ANGULATION. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 16F SHEATH OVER THE GUIDEWIRE IN THE PATIENT AND USED IT TO MAKE THE LEFT COMMON ILIAC ARTERY STRAIGHT. THE PHYSICIAN THEN ADVANCED THE 5F CATHETER OVER THE LANTERN THROUGH THE 8F SHEATH INTO THE TARGET LOCATION. NEXT, WHILE ADVANCING A POD COIL THROUGH THE LANTERN THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK AT THE PROXIMAL END OF THE LANTERN. SUBSEQUENTLY, THE NURSE ACCIDENTLY TOUCHED THE PROXIMAL END OF THE PUSHER ASSEMBLY OF THE POD COIL AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. AFTERWARDS, WHILE RE-ADVANCING THE LANTERN THROUGH THE DISTAL END OF THE 16F SHEATH AND CROSSING OVER THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE MID-SHAFT OF THE LA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623931 ↗
• MalfunctionMar 27, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A POD PACKING COIL (PODJ), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA 5F CATHETER, A NON-PENUMBRA 8F SHEATH, A NON-PENUMBRA 16F SHEATH AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS WITH EXTREME ANGULATION. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 16F SHEATH OVER THE GUIDEWIRE IN THE PATIENT AND USED IT TO MAKE THE LEFT COMMON ILIAC ARTERY STRAIGHT. THE PHYSICIAN THEN ADVANCED THE 5F CATHETER OVER THE LANTERN THROUGH THE 8F SHEATH INTO THE TARGET LOCATION. NEXT, WHILE ADVANCING A POD COIL THROUGH THE LANTERN THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK AT THE PROXIMAL END OF THE LANTERN. SUBSEQUENTLY, THE NURSE ACCIDENTLY TOUCHED THE PROXIMAL END OF THE PUSHER ASSEMBLY OF THE POD COIL AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. AFTERWARDS, WHILE RE-ADVANCING THE LANTERN THROUGH THE DISTAL END OF THE 16F SHEATH AND CROSSING OVER THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE MID-SHAFT OF THE LAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623922 ↗
• MalfunctionNov 27, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING POD COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE POD COIL WOULD NOT ANCHOR AND KEPT RUNNING DOWN THE VESSEL. THEREFORE, THE POD COIL WAS REMOVED. 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 12879930 ↗
• MalfunctionJul 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING A POD COIL APPROXIMATELY A FEW INCHES INTO THE MICROCATHETER, THE PHYSICIAN NOTICED THE POD COIL BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, IT WAS REMOVED. 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 12176683 ↗
• MalfunctionJun 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH A LANTERN THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE POD COIL. UPON RETRACTION, IT WAS NOTICED THAT THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD COIL AND THEN FLUSHED THE POD COIL. IT WAS ALSO REPORTED THAT THE PUSHER ASSEMBLY OF THE POD COIL HAD BECOME KINKED. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SECOND POD COIL THROUGH THE SAME LANTERN; HOWEVER, THE POD COIL WAS SUCCESSFULLY PLACED IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING TWO POD PACKING COILS (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 12087390 ↗
• MalfunctionJun 29, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH A LANTERN THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE POD COIL. UPON RETRACTION, IT WAS NOTICED THAT THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD COIL AND THEN FLUSHED THE POD COIL. IT WAS ALSO REPORTED THAT THE PUSHER ASSEMBLY OF THE POD COIL HAD BECOME KINKED. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SECOND POD COIL THROUGH THE SAME LANTERN; HOWEVER, THE POD COIL WAS SUCCESSFULLY PLACED IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING TWO POD PACKING COILS (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 12087326 ↗
• MalfunctionJun 15, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD COILS, A RUBY COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING THE POD COIL APPROXIMATELY HALFWAY INTO THE LANTERN, THE HOSPITAL TECHNICIAN KINKED THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. NEXT, THE HOSPITAL TECHNICIAN INSERTED A RUBY COIL INTO THE LANTERN; HOWEVER, AFTER ADVANCING THE RUBY COIL APPROXIMATELY HALFWAY INTO THE LANTERN, THE SAME ISSUE OCCURRED. THE HOSPITAL TECHNICIAN KINKED THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW POD COILS AND POD PACKING COILS ALONG WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005609 ↗
• MalfunctionJun 10, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA CATHETER. IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, A POD COIL WOUND ITSELF WHEN MOVING FORWARD IN THE HUB OF THE LANTERN, AND THE PHYSICIAN RE-SHEATHED THE COIL. THE PUSHER ASSEMBLY WAS STUCK WHEN ATTEMPTING TO RE-ADVANCE, AND A PART OF THE PUSHER ASSEMBLY WAS BENT. THEREFORE, THE COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, THIRTY-ONE 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 11975107 ↗
• MalfunctionMay 6, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS, POD COILS, PACKING COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS COILING SEPARATE BRANCHES OFF THE PORTAL VEIN AND SUCCESSFULLY IMPLANTED FIVE PENUMBRA COILS WITHIN VARIOUS BRANCHES. SUBSEQUENTLY, WHEN ADVANCING THE SIXTH COIL, A POD COIL, THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO PULL THE POD COIL OUT AND REALIZED THE POD COIL HAD UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED, AND THE POD COIL WAS FLUSHED OUT OF THE MICROCATHETER WITH A SYRINGE OF HEPARINIZED SALINE. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, PACKING 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 11786571 ↗
• MalfunctionApr 22, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE POD COIL WAS RUNNING IN THE VESSEL AND WOULD NOT ANCHOR. THE POD COIL WAS DETERMINED TO BE TOO LARGE AND WAS BEING RE-SHEATHED WHEN THE COIL DETACHED INSIDE ITS INTRODUCER SHEATH. THEREFORE, THE POD COIL WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SMALLER 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 11709142 ↗
• MalfunctionMar 23, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ESOPHAGEAL VEIN USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE INSERTING A POD COIL INTO THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, IT 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 11558153 ↗
• MalfunctionJul 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER; 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 Consequences Or Impact To Patient

  MAUDE report 10340105 ↗
• MalfunctionApr 16, 2020Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING POD COILS, POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL APPROXIMATELY 10 CENTIMETERS INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE POD COIL WAS REMOVED AND FLUSHED. THE PHYSICIAN THEN ATTEMPTED TO RE-ADVANCE THE POD COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. SUBSEQUENTLY, 12 MILLIMETERS FROM THE PROXIMAL END OF THE PUSHER ASSEMBLY OF THE POD COIL STRETCHED AND THE PUSHER ASSEMBLY BROKE OUTSIDE OF THE PATIENT PRIOR TO ADVANCING THROUGH LANTERN. THEREFORE, THE POD COIL WAS REMOVED. IT WAS REPORTED THAT THE PUSHER ASSEMBLY BROKE BUT REMAINED INTACT. THE PROCEDURE WAS COMPLETED USING A POD COIL, THREE POD PCS 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 9967700 ↗
• MalfunctionJun 27, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD8 AND A POD12. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN USING THE POD8 AND THE POD12 AND WAS UNABLE TO ADVANCE EITHER COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN). THE COILS WERE THEREFORE REMOVED AND WERE NOT USED IN THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739821 ↗
• MalfunctionMar 2, 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 POD10 COILS AND POD12 COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A POD10 INTO A NON-PENUMBRA MICROCATHETER AND REPORTED THAT IT WAS UNABLE TO ADVANCE BEYOND THE HUB. THE POD10 WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. A DIFFERENT POD10 WAS OPENED AND INSERTED THROUGH THE MICROCATHETER BUT DEEMED TOO SMALL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A POD12 INTO THE MICROCATHETER AND EXPERIENCED RESISTANCE. IT WAS ALSO REPORTED THAT THE POD12 WAS UNABLE TO ADVANCE BEYOND THE HUB OF THE MICROCATHETER. CONSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE POD12. UPON REMOVAL, THE POD12 COIL PARTIALLY BROKE OFF FROM ITS PUSHER WIRE AND WAS THEN FULLY REMOVED. A POD14 WAS THEN CHOSEN AND SUCCESSFULLY ADVANCED THROUGH THE MICROCATHETER BUT WAS DEEMED TOO LARGE AND WAS NOT USED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384465 ↗
• MalfunctionNov 1, 2018Inadequacy of Device Shape and/or Size; Material Deformation; Inadequacy of Device Shape and/or Size; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD12, POD PACKING COILS (PODJS) AND RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A POD12 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DETERMINED THAT THE POD12 WAS OVERSIZED AND THEREFORE, IT WAS REMOVED. THE POD12 PUSHER ASSEMBLY THEN BECAME KINKED WHEN THE HOSPITAL TECHNOLOGIST SUBMERGED IT INTO SALINE TO FLUSH IT. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN. NEXT, THE PHYSICIAN IMPLANTED A POD10 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A PODJ THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PUSHER ASSEMBLY OF THE PODJ BECAME KINKED ON THE BACK END OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN IMPLANTED ANOTHER PODJ IN THE TARGET VESSEL WITH NO ISSUES. WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED, WITH SOME OF THE RUBY COIL IN THE PATIENT'' BODY. THEREFORE, THE PHYSICIAN USED MANUAL ASPIRATION TO PULL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028915 ↗
• MalfunctionAug 2, 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 POD12S. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD12 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE, THE POD12 WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO RINSE THE POD12 IN A BOWL OF SALINE; HOWEVER, THE POD12 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER POD12 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 7745106 ↗
• MalfunctionJun 21, 2018Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY BENT THE POD12 AS THE POD12 WAS CAUGHT ON THE PATIENT DRAPE UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE POD12 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD12.

  Patient problems: No Patient Involvement

  MAUDE report 7626529 ↗