POD RBYPODJ5-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00814548017631), received between Aug 30, 2018 and Jun 27, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD PACKING COIL (PACKING COIL), RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE TARGET VESSEL. THE PACKING COIL WAS ADVANCED TO THE TARGET LOCATION. WHILE REPOSITIONING, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED AND FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL OF THE SAME SIZE, 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 22351841 ↗
• MalfunctionMay 6, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY (CIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, POD PACKING COILS (PACKING COILS), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE MIDSHAFT OF THE LANTERN IN MULTIPLE PLACES. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER CONTAINING THE FRACTURED LANTERN. THE PHYSICIAN THEN IMPLANTED THREE RUBY COILS IN THE TARGET LOCATION USING A NEW LANTERN. THE PHYSICIAN THEN FLUSHED THE LANTERN. WHILE ADVANCING A PACKING COIL THROUGH THE LANTERN AND INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PACKING COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEN USED ANOTHER PACKING COIL TO PUSH THE DETACHED PACKING COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED AFTER PLACING THE PACKING COIL USING THE SECOND LANTERN 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 19250859 ↗
• MalfunctionNov 16, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A POD PACKING COILS (POD PC), A NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A POD PC (B)(4) THROUGH THE NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE POD PC WAS UNABLE TO REACH THE TARGET VESSEL AND UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED, AND THE POD PC WAS REMOVED FROM THE MICROCATHETER. THE PHYSICIAN THEN REINSERTED THE MICROCATHETER INTO THE PATIENT AND ATTEMPTED TO ADVANCE ANOTHER POD PC (B)(4); HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE DETACHED POD PC AND MICROCATHETER WERE REMOVED TOGETHER. THE PHYSICIAN THEN INSERTED A LANTERN INTO THE PATIENT AND ATTEMPTED TO ADVANCE A POD PC (B)(4) THROUGH THE LANTERN. HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE POD PC UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED, AND THE POD PC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151611 ↗
• MalfunctionAug 23, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (POD PC), AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD PC TO THE TARGET LOCATION USING THE MICROCATHETER. IT WAS REPORTED THAT THE POD PC WAS LOOSELY PACKING IN THE TARGET VESSEL AND THE POD PC WAS NOTED TO BE DETACHED. THE POD PC MIGRATED TO ANOTHER BRANCH OF THE VESSEL DUE TO THE BLOOD FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608546 ↗
• MalfunctionNov 17, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (POD PC), POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE POD PCS AND POD COILS IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN ADVANCED AND DETACHED ANOTHER POD PC IN THE TARGET LOCATION. SUBSEQUENTLY, WHILE REMOVING THE PUSHER ASSEMBLY OF THE POD PC, THE PHYSICIAN NOTICED THE PUSHER ASSEMBLY HAD BROKEN OFF WITHIN THE LANTERN AND BECAME STUCK. THEREFORE, THE LANTERN CONTAINING THE BROKEN PUSHER ASSEMBLY OF THE POD PC WAS REMOVED. IT WAS REPORTED AFTER REMOVING THE LANTERN, THE HOSPITAL TECHNOLOGIST NOTICED THE LANTERN WAS STIFF WHERE THE PUSHER ASSEMBLY HAD BROKEN OFF AND BECAME STUCK. THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. NEXT, THE PHYSICIAN INSERTED A NEW LANTERN INTO THE PATIENT AND THEN ADVANCED THE NEXT POD PC THROUGH THE LANTERN. WHILE ATTEMPTING TO FORM THE POD PC IN THE DESIRED LOCATION, THE COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE POD PC DETACHED IN THE DESIRED LOCATION; THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH AND SECURE THE POD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820323 ↗
• MalfunctionNov 4, 2022Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COIL (POD PCS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD PC OUT FROM THE INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PHYSICIAN NOTICED THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS BENT. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. HOWEVER, WHILE REMOVING THE COIL, THE PUSHER ASSEMBLY OF THE POD PC BROKE AND A PORTION OF THE PUSHER ASSEMBLY WITH THE INNER FILAMENT WIRE CAME OUT. CONSEQUENTLY, THE POD PC HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN INJECTED SALINE TO PUSH THE DETACHED POD PC OUT OF THE MICROCATHETER AND INTO THE VESSEL. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL 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 15730522 ↗
• MalfunctionNov 18, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICOCELE VEIN USING POD PACKING COILS (POD PCS) AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE POD PC. WHILE ATTEMPTING TO ADVANCE THE NEXT POD PC THROUGH THE MIDDLE OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED AND THE COIL WOULD NOT ADVANCE. THE PHYSICIAN REMOVED AND RE-INSERTED THE SAME POD PC; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SMALLER 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 12836869 ↗
• MalfunctionNov 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ARTERY OFF THE SUPERIOR MESENTERIC ARTERY (SMA) USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE PARTIALLY ADVANCING A POD PC INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 12834044 ↗
• MalfunctionSep 30, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING POD PACKING COILS (POD PC), RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS AND FOUR POD PCS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER POD PC; HOWEVER, THE POD PC WAS STUCK AND WOULD NOT ADVANCE OUT ITS INTRODUCER SHEATH. THEREFORE, THE POD PC WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW POD PC IN VESSEL USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN ADVANCED THE LAST POD PC INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE POD PC FAILED TO DETACH. THEREFORE, THE POD PC WAS REMOVED. THE PHYSICIAN WAS SATISFIED WITH THE PACKING DENSITY AND DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558703 ↗
• MalfunctionSep 30, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING POD PACKING COILS (POD PC), RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS AND FOUR POD PCS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER POD PC; HOWEVER, THE POD PC WAS STUCK AND WOULD NOT ADVANCE OUT ITS INTRODUCER SHEATH. THEREFORE, THE POD PC WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW POD PC IN VESSEL USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN ADVANCED THE LAST POD PC INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE POD PC FAILED TO DETACH. THEREFORE, THE POD PC WAS REMOVED. THE PHYSICIAN WAS SATISFIED WITH THE PACKING DENSITY AND DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558688 ↗
• MalfunctionSep 28, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS, POD PACKING COILS (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL AND THE PUSHER ASSEMBLY OF THE POD PC KINKED WHILE ADVANCING THE COILS THROUGH THEIR INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL AND THE POD PC WERE REMOVED. IT WAS REPORTED THAT BOTH THE COILS WERE ABLE TO ADVANCE PAST THEIR INITIAL POSITION. THE PROCEDURE WAS COMPLETED USING TWO RUBY COILS, ONE 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 12543620 ↗
• MalfunctionMay 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE PULMONARY ARTERY USING POD PACKING COILS (POD PCS). IT WAS REPORTED THE PATIENT HAD A PREVIOUS EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE POD PC IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO USE ANOTHER POD PC (F100414) AND BENT THE PUSHER ASSEMBLY. THE POD PC WAS THEN REMOVED. NEXT, THE PHYSICIAN OPENED ANOTHER POD PC (C11947). THE LANTERN WAS NOT STAYING IN THE PULMONARY ARTERY BRANCH AND WAS UNABLE TO ADVANCE BACK INTO THE TARGET LOCATION WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE POD PC. THE POD PC WAS THEN REMOVED, AND THE PHYSICIAN DECIDED NOT TO USE ADDITIONAL COILS. THERE WAS NO FLOW THROUGH THE COIL, AND THE PHYSICIAN WAS SATISFIED. 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 11868214 ↗
• MalfunctionApr 13, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING POD PACKING COILS (POD PCS). DURING THE PROCEDURE, A POD PC STARTED TO LOSE PLACEMENT PRIOR TO DETACHING DUE TO THE VELOCITY OF THE BLOOD FLOW. THEREFORE, THE POD PC 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 11660216 ↗
• MalfunctionMar 4, 2021Material Deformation; Material Deformation

  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 11414862 ↗
• MalfunctionDec 31, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A POD PC WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD PACKING COIL. 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 11102169 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690903 ↗
• MalfunctionOct 16, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), POD COILS, RUBY COIL DETACHMENT HANDLES (HANDLES) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED FIVE RUBY COILS, TWO POD PCS, AND TWO POD COILS INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH THEM USING TWO DIFFERENT HANDLES; HOWEVER, THE RUBY COILS, POD PCS AND POD COILS FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE FIVE RUBY COILS, TWO POD PCS AND TWO POD COILS. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

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

  MAUDE report 10690868 ↗
• MalfunctionSep 8, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE A POD PC OUT OF ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PACKING COIL AND 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 10505196 ↗
• MalfunctionSep 4, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL THORACIC ARTERY USING A POD PACKING COIL (POD PC), LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA COILS, NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE COILS IN THE TARGET VESSEL USING THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE MICROCATHETER WAS REMOVED AND REPLACED WITH THE LANTERN. WHILE ADVANCING THE POD PC THROUGH THE MID-SHAFT OF THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE LANTERN AND POD PC WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL OTHER COILS AND THE INITIAL NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10494851 ↗
• MalfunctionSep 3, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL SUPERIOR MESENTERIC ARTERY (SMA) USING POD PACKING COILS (POD PCS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE POD PC WOULD NOT SHAPE AS INTENDED. THEREFORE, THE POD PC WAS REMOVED FROM THE PATIENT AND RINSED WITH SALINE ON THE BACK TABLE. THE PHYSICIAN IMPLANTED A RUBY COIL BEFORE MAKING A SECOND AND FINAL ATTEMPT TO IMPLANT THE SAME POD PC. THE POD PC STILL DID NOT TAKE THE DESIRED SHAPE; HOWEVER, THE PHYSICIAN NOTICED THAT THE BLEED WAS SUCCESSFULLY EMBOLIZED. THEREFORE, THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491355 ↗
• MalfunctionAug 7, 2020Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING POD PACKING COILS (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN HAD A DIFFICULT TIME ADVANCING THE POD PC. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PACKING 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 10381243 ↗
• MalfunctionJan 29, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING TWO RUBY COILS AND A POD PC THROUGH THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COILS AND POD PC WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 9643657 ↗
• MalfunctionMay 30, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COIL (POD PC). DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A POD PC, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE POD PC THROUGH THE MICROCATHETER AND, THEREFORE, IT 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 Patient Involvement

  MAUDE report 8655334 ↗
• MalfunctionMay 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A DISTAL BRANCH OF THE HEPATIC ARTERY USING RUBY COILS AND POD PACKING COILS (POD PCS). DURING THE PROCEDURE, TWO RUBY COILS AND A POD PC WERE UNABLE TO ADVANCE THROUGH A BEND IN THE PATIENT¿S VESSEL, DESPITE THE MICROCATHETER BEING SWITCHED OUT BETWEEN EACH COIL. THEREFORE, THE RUBY COILS AND POD PC WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW COILS. IT WAS REPORTED THAT THE PATIENT¿S VESSELS WERE EXCESSIVELY TORTUOUS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573552 ↗
• MalfunctionApr 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (POD PC). DURING THE PROCEDURE, AFTER ADVANCING A 30 CENTIMETERS POD PC INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN NOTICED THE COIL WAS TOO LARGE FOR THE VESSEL. THEREFORE, THE POD PC WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW 5 CENTIMETERS POD PC; HOWEVER, THE POD PC WAS UNABLE TO ADVANCE INTO THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE POD PC. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537783 ↗