POD RBYPOD10-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00814548019659), received between Jul 18, 2018 and Apr 22, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (40 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. WHILE RETRACTING A POD COIL FOR RE-POSITIONING IN THE TARGET VESSEL, THE COIL UNINTENTIONALLY DETACHED IN AN UNWANTED PART OF THE SPLENIC ARTERY. HOWEVER, THE PHYSICIAN DECIDED IT WAS NOT NECESSARY TO RETRIEVE THE POD COIL. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETER.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958705 ↗
• MalfunctionMar 19, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT 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 AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE LANTERN WAS ADVANCED INTO THE TARGET VESSEL. WHILE ADVANCING AND RETRACTING THE POD COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TEN PENUMBRA COILS INCLUDING A NEW POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643914 ↗
• MalfunctionJan 14, 2026Physical Resistance/Sticking; 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. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL IN THE MICROCATHETER, THE POD COIL BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE POD COIL, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED FROM THE PATIENT, AND THE POD COIL WAS SUBSEQUENTLY REMOVED FROM THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, POD PACKING 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 24076048 ↗
• MalfunctionNov 14, 2025Material 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 COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE NURSE EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ATTEMPTED TO PULL BACK THE POD COIL INTRODUCER SHEATH, AND IT WAS NOTED THAT THE PUSHER ASSEMBLY WAS ALSO BEING RETRACTED. THE PHYSICIAN THEN NOTICED THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE LANTERN CONTAINING THE DETACHED POD COIL WAS THEN REMOVED FROM THE PATIENT. THE POD COIL AND THE LANTERN WERE NO LONGER USED IN THE PROCEDURE. 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 23562809 ↗
• MalfunctionMay 6, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PORTAL VEIN VARICES USING A POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA GLIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE COIL WOULD NOT EXIT THE LANTERN. THE PHYSICIAN TRIED TO REMOVE THE POD COIL, BUT IT BECAME STUCK. THE PHYSICIAN ATTEMPTED TO REMOVE THE POD COIL WITH HEMOSTATS BY PINING THE COIL WIRE WITHIN THE GLIDE CATHETER, HOWEVER, THE COIL'S PUSHER WIRE FRACTURED AND THE POD COIL DETACHED WITHIN THE LANTERN. THEREFORE, THE GLIDE CATHETER AND LANTERN CONTAINING THE POD COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW LANTERN AND ANOTHER POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973369 ↗
• MalfunctionFeb 26, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUBCLAVIAN ARTERY USING A POD COIL, POD PACKING COILS (PACKING COIL), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE POD COIL INTO THE TARGET LOCATION. TO ACHIEVE BETTER PACKING, THE PHYSICIAN REPOSITIONED THE LANTERN MULTIPLE TIMES. WHILE ADVANCING AND RETRACTING THE POD COIL, THE POD COIL UNINTENTIONALLY DETACHED. THE POD COIL WAS REMOVED FROM THE PATIENT. THE SAME ISSUE OCCURRED WITH THREE ADDITIONAL POD PACKING COILS. OUT OF THE FOUR DETACHED COILS, THREE COILS WERE DETACHED IN THE LANTERN AND WERE REMOVED BY REMOVING THE LANTERN FROM THE PATIENT. IT WAS REPORTED THAT ONE OF THE FOUR COILS DETACHED PARTIALLY IN THE VESSEL AND PARTIALLY IN THE MICROCATHETER AND THAT COIL WAS SNARED OUT. IT IS UNKNOWN WHICH OF THE FOUR DETACHED COILS WAS SNARED OUT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA 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 21472175 ↗
• MalfunctionDec 6, 2024Physical 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 HIGHLY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL, THE PHYSICIAN FELT RESISTANCE IN THE MID-SHAFT OF THE MICROCATHETER. WHEN ATTEMPTING TO RETRACT THE POD COIL, THE PHYSICIAN FELT RESISTANCE AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER AT THE MID-SHAFT. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE POD COIL WAS THEN FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING NINE RUBY COILS, ONE POD PACKING COIL (PACKING COIL), TEN 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 20859767 ↗
• MalfunctionSep 30, 2024Break; Physical Resistance/Sticking; Premature Separation; Break; 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 NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL STOPPED ADVANCING. THE PHYSICIAN CONTINUED TO ADVANCE THE POD COIL AGAINST RESISTANCE; HOWEVER, THE POD COIL WAS UNABLE TO ADVANCE PAST THE MID-SHAFT OF THE MICROCATHETER. WHILE ATTEMPTING TO PUSH THE POD COIL, THE PHYSICIAN FRACTURED THE PUSHER ASSEMBLY OF THE POD COIL. WHILE REMOVING THE FRACTURED PUSHER ASSEMBLY OF THE POD COIL, THE PHYSICIAN NOTICED THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS REPORTED THAT THE DETACHED POD COIL WAS FLUSHED OUT OF THE MICROCATHETER. 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 20340090 ↗
• MalfunctionAug 4, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING POD COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST POD COIL AND VISUALIZED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE POD COIL HAD BECOME UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER, BEFORE REACHING THE TARGET LOCATION, AND HAD MOVED INTO THE PATIENT'S ANATOMY AS THE PHYSICIAN HAD CONTINUED TO ADVANCE IT. THE POD COIL DID NOT DETACH IN THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO LEAVE THE COIL IN THE PATIENT. NEXT, THE SAME ISSUE OCCURRED WITH A SECOND POD COIL. THE SECOND POD COIL DID NOT DETACH IN THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO LEAVE THE POD COIL IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A THIRD POD COIL AND A RUBY COIL DETACHMENT HANDLE (HANDLE). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902430 ↗
• MalfunctionAug 4, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING POD COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST POD COIL AND VISUALIZED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE POD COIL HAD BECOME UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER, BEFORE REACHING THE TARGET LOCATION, AND HAD MOVED INTO THE PATIENT'S ANATOMY AS THE PHYSICIAN HAD CONTINUED TO ADVANCE IT. THE POD COIL DID NOT DETACH IN THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO LEAVE THE COIL IN THE PATIENT. NEXT, THE SAME ISSUE OCCURRED WITH A SECOND POD COIL. THE SECOND POD COIL DID NOT DETACH IN THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO LEAVE THE POD COIL IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A THIRD POD COIL AND A RUBY COIL DETACHMENT HANDLE (HANDLE). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19902429 ↗
• MalfunctionJun 17, 2024Break; Physical Resistance/Sticking; Premature Separation; Break; 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). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH ITS INTRODUCER SHEATH BUT CONTINUED TO ADVANCE THE POD COIL. WHILE ADVANCING THE POD COIL THROUGH THE PROXIMAL LENGTH OF THE LANTERN, THE POD COIL BECAME STUCK WITHIN THE LANTERN AND THE POD COIL PUSHER ASSEMBLY FRACTURED. THE PHYSICIAN THEN FOUND THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. THE POD COIL WAS THEN FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA 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 19554914 ↗
• MalfunctionMar 13, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING POD COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED AND BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED POD COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND POD PACKING COIL (POD PC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899336 ↗
• MalfunctionMar 1, 2024Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY AND THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE DETACHED POD COIL WAS CONTAINED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE DETACHED POD COIL OUT FROM THE MICROCATHETER. 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 18821024 ↗
• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL SPLENIC ARTERY USING A POD COIL, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT AND REPOSITION THE POD COIL. SUBSEQUENTLY, UPON RETRACTING THE POD COIL, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE PATIENT''S VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE POD COIL. 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 17242108 ↗
• MalfunctionMay 26, 2023Physical 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. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. 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 THREE 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 17014127 ↗
• MalfunctionMay 19, 2023Physical 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, A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. HOWEVER, THE PHYSICIAN CONTINUED TO ADVANCE THE POD COIL AGAINST RESISTANCE AND THE POD COIL BECAME STUCK WITH A FEW CENTIMETERS OF THE POD COIL OUTSIDE OF THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO REMOVE THE POD COIL AND WHILE RETRACTING THE POD COIL, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, FOUR ADDITIONAL 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 16967874 ↗
• MalfunctionJan 6, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING THE POD COIL INTO THE TARGET LOCATION, THE PHYSICIAN RETRACTED THE POD COIL TO REPOSITION IT WITHIN THE VESSEL. SUBSEQUENTLY, WHEN THE PHYSICIAN WENT TO RE-ADVANCE THE POD COIL, THE PHYSICIAN NOTICED THE COIL HAD DETACHED WITHIN THE VESSEL. IT WAS ALSO REPORTED THAT THE POD COIL HAD DETACHED CLOSE ENOUGH TO THE TARGET LOCATION AND THE PHYSICIAN DETERMINED IT WAS SAFE TO LEAVE THE DETACHED POD COIL IN PLACE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16113103 ↗
• MalfunctionDec 27, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ESOPHAGEAL VARICES USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY KINKED THE PUSHER ASSEMBLY OF THE POD COIL. CONSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA 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 16051571 ↗
• MalfunctionNov 19, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AN ANGIOGRAPHIC CATHETER, AND A NON-PENUMBRA GUIDE SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED AN EMBOLIC DEVICE INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN BEGAN TO EMBOLIZE ANOTHER PART OF THE TARGET VESSEL WITH A POD COIL, THREE NON-PENUMBRA COILS, AND TWO POD PACKING COILS (POD PCS). AFTER ADVANCING ANOTHER POD COIL INTO THE TARGET LOCATION, THE COIL UNINTENTIONALLY DETACHED WHEN IT WAS ADVANCED APPROXIMATELY ONE THIRD OF THE WAY OUTSIDE OF THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE DETACHED POD COIL BY PINCHING THE GUIDE SHEATH WITH FORCEPS AND REMOVING THE GUIDE SHEATH, LANTERN, AND POD COIL TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A STENT GRAFT WITHOUT ADDITIONAL COIL EMBOLIZATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829865 ↗
• MalfunctionAug 13, 2022Physical 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 LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN TO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, WHILE RETRACTING THE PUSHER ASSEMBLY OF THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN ALSO EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. 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 15222667 ↗
• MalfunctionJul 5, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL ARTERY USING POD COILS, A NON-PENUMBRA MICROCATHETER, AND A CATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS, CALCIFIED, AND STENOSED. DURING THE PROCEDURE, THE PHYSICIAN INJECTED AN EMBOLIC AGENT THROUGH A NON-PENUMBRA MICROCATHETER BEFORE EXCHANGING THE MICROCATHETER FOR A NEW ONE. WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. AFTER THE POD COIL WAS ADVANCED INTO THE TARGET LOCATION, THE MICROCATHETER SLIPPED OUT OF POSITION. RESISTANCE WAS ENCOUNTERED WHILE RETRACTING THE POD COIL AND, SUBSEQUENTLY, THE MICROCATHETER WAS RE-POSITIONED. THE PHYSICIAN WAS PREPARING TO RE-ADVANCE THE POD COIL AND NOTICED THAT THE COIL WAS UNINTENTIONALLY DETACHED AND CONTAINED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS, A NEW NON-PENUMBRA MICROCATHETER, AND MORE OF THE EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916817 ↗
• MalfunctionJan 13, 2022Physical 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, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE POD COIL AND, SUBSEQUENTLY, THE COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN. THE LANTERN CONTAINING THE POD COIL WAS THEN REMOVED FROM THE PATIENT. ON THE BACK TABLE, THE PHYSICIAN NOTICED THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, POD COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER POD COIL, TWO POD PACKING COILS (POD PCS), AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252853 ↗
• MalfunctionNov 9, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN MADE SEVERAL ATTEMPTS TO IMPLANT THE FIRST POD COIL INTO THE TARGET VESSEL AND REPORTED THAT IT WOULD NOT FIT. WHILE RETRACTING THE POD COIL THROUGH THE MIDDLE OF THE LANTERN, RESISTANCE WAS ENCOUNTERED AND THE POD COIL DETACHED. 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 BY RE-INSERTING THE SAME LANTERN AND IMPLANTING A NON-PENUMBRA POD COIL AND FOUR OTHER NON-PENUMBRA PUSHABLE COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783685 ↗
• MalfunctionOct 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA CATHETER, AND NON-PENUMBRA CATHETER. IT WAS REPORTED THE PATIENT ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS ADVANCING THE FIRST POD COIL, THE POSITION OF THE CATHETER WAS INADVERTENTLY MOVED. THE PHYSICIAN THEN RETRIEVED THE POD COIL INTO ITS INTRODUCER SHEATH. WHEN RE-ADVANCING THE POD COIL INTO THE HUB OF THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY REMOVED THE POD COIL. IT WAS REPORTED THE ROTATING HEMOSTASIS VALVE (RHV) WAS NOT TIGHT. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, POD PACKING COIL (POD PC), 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 12692757 ↗
• MalfunctionOct 19, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT VARICES OFF THE SPLENIC VEIN USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE PUSHING A POD COIL AS THE FIRST COIL INTO THE VESSEL, THE POD COIL HAD UNINTENTIONALLY DETACHED EARLY IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 12661721 ↗