POD RBYPODJ15-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00814548017648), received between Nov 10, 2017 and Jun 12, 2026 — classified as 5 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (41 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (PACKING COIL), AND A NON-PENUMBRA CATHETER. THE PHYSICIAN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS AT THE TARGET LOCATION. THE PHYSICIAN CONTINUED TO ADVANCE THE PACKING COIL DESPITE RESISTANCE, DURING WHICH THE MICROCATHETER REPEATEDLY KICKED BACK, FOLLOWED BY UNINTENTIONAL DETACHMENT OF THE PACKING COIL. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL RUBY COILS, 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 25487915 ↗
• MalfunctionFeb 3, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING A POD PACKING COIL (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE PACKING COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254280 ↗
• MalfunctionNov 7, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT TIBIAL ARTERY USING A POD PACKING COIL (PACKING COIL), A RUBY COIL DETACHMENT HANDLE (HANDLE), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO EMBOLIZATION COILS IN THE TARGET LOCATION. A NEW PACKING COIL WAS ADVANCED TO THE TARGET LOCATION, AND THE PHYSICIAN ATTEMPTED TO DETACH THE PACKING COIL USING THE HANDLE, BUT THE PACKING COIL WOULD NOT DETACH. IT WAS REPORTED THAT THE PACKING COIL PUSHER ASSEMBLY WAS STUCK WITHIN THE HANDLE. THE PHYSICIAN THEN REMOVED THE PACKING COIL PUSHER ASSEMBLY AND LANTERN FROM THE PATIENT. THE PACKING COIL HAD UNKNOWINGLY DETACHED WITHIN THE NON-PENUMBRA CATHETER. WHILE ADVANCING A NEW LANTERN THROUGH THE NON-PENUMBRA CATHETER, THE PHYSICIAN MET RESISTANCE AT THE DISTAL END. IMAGING REVEALED THE DETACHED COIL HAD DETACHED WITHIN THE NON-PENUMBRA CATHETER. THE CATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503554 ↗
• MalfunctionAug 20, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE INTERCOSTAL ARTERY USING A POD PACKING COIL (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE COILS (UNKNOWN) IN THE TARGET LOCATION. WHILE ADVANCING AND POSITIONING A PACKING COIL INTO THE TARGET LOCATION USING THE MICROCATHETER, THE PHYSICIAN NOTICED THE PACKING COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DETACHED PACKING COIL WAS PARTIALLY INSIDE THE MICROCATHETER AND PARTIALLY IN THE AORTA. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED PACKING COIL. THE PHYSICIAN WAS ADVANCING A NEW PACKING COIL INTO THE VESSEL, BUT THE SAME ISSUE OCCURRED, AND A SNARE DEVICE WAS USED TO REMOVE THE DETACHED PACKING COIL. THE PROCEDURE WAS COMPLETED USING NEW PACKING 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 22855543 ↗
• MalfunctionMay 19, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (PACKING COIL), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS IN THE TARGET LOCATION. WHILE ADVANCING A PACKING COIL THROUGH THE MICROCATHETER, THE PACKING COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045565 ↗
• MalfunctionNov 7, 2024Failure 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 LUMBAR ARTERY USING POD PACKING COILS (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE FIRST PACKING COIL INTO THE TARGET VESSEL. THE PHYSICIAN ADVANCED THE SECOND PACKING COIL INTO THE TARGET VESSEL; HOWEVER, THE COIL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE PHYSICIAN RETRACTED AND RE-ADVANCED THE PACKING COIL SEVERAL TIMES. WHILE RETRACTING THE PACKING COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE PACKING COIL WAS UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED, AND THE PACKING COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 20636482 ↗
• MalfunctionNov 5, 2024Material 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 A POD PACKING COIL (PACKING 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 THE PHYSICIAN WAS ADVANCING THE PACKING COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PACKING COIL BECAME STUCK, AND THE PHYSICIAN KINKED THE PUSHER ASSEMBLY. WHEN PULLING THE PUSHER ASSEMBLY BACK, THE PACKING COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PACKING COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THREE NON-PENUMBRA COILS, ALONG WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606038 ↗
• MalfunctionOct 8, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING POD PACKING COILS (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE PACKING COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. ANOTHER PACKING COIL WAS ADVANCED INTO THE TARGET VESSEL; HOWEVER, THE PACKING COIL WOULD NOT ANCHOR PROPERLY. WHILE ADVANCING AND RETRACTING THE PACKING COIL, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND TWO NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20403654 ↗
• MalfunctionSep 17, 2024Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD PACKING COIL (PACKING COIL), AND A RUBY COIL. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PACKING COIL STOPPED ADVANCING. THE PHYSICIAN REMOVED THE PACKING COIL. AFTER INSPECTING THE PACKING COIL, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PACKING COIL THROUGH THE LANTERN AGAIN; HOWEVER, RESISTANCE WAS STILL ENCOUNTERED. WHILE ADVANCING THE PACKING COIL AGAINST RESISTANCE, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE PACKING COIL WAS REMOVED. THE PHYSICIAN THEN DETERMINED THAT THE TARGET VESSEL WAS SUFFICIENTLY EMBOLIZED AND THE PROCEDURE ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242028 ↗
• MalfunctionDec 26, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PC), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS AND TWO POD PCS IN TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT THE GUIDEWIRE WAS EXTENDED PAST THE TARGET VESSEL FOR SUPPORT. WHEN THE PHYSICIAN BEGAN TO REMOVE THE GUIDEWIRE, ALL OF THE PREVIOUSLY PLACED COILS THAT WERE IMPLANTED MIGRATED TO THE MAIN SPLENIC ARTERY. AFTER PERFORMING AN ANGIOGRAM, THE PHYSICIAN DECIDED TO LEAVE THE COILS IN THE MAIN SPLENIC ARTERY. THE PROCEDURE HAD 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 18393381 ↗
• 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 (C00010017) 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 (F00000758); 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 (F00000869) 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,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151680 ↗
• 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 (C00010017) 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 (F00000758); 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 (F00000869) 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, A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18151636 ↗
• MalfunctionNov 14, 2023Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT AXILLARY ARTERY USING POD PACKING COILS (POD PC) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL AND ONE POD PC INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER POD PC INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT CONTINUED TO ADVANCE THE POD PC. AFTER ADVANCING THE POD PC AGAINST RESISTANCE THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. UPON REMOVAL THE PHYSICIAN FOUND THAT THE PUSHER ASSEMBLY OF THE POD PC HAD FRACTURED AND THAT THE POD PC UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE POD PC WAS REMOVED. ON THE BACK TABLE, THE POD PC WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW POD PC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136292 ↗
• MalfunctionAug 28, 2023Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD PACKING COILS (POD PC), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A 4F CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A NON-PENUMBRA COIL AND THREE POD PCS INTO THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN ADVANCED A NEW POD PC THROUGH THE LANTERN AND INTO THE TARGET VESSEL. HOWEVER, THE POD PC WOULD NOT FORM IN THE TARGET VESSEL. AFTER MULTIPLE ATTEMPTS TO FORM THE POD PC IN THE TARGET VESSEL, THE POD PC UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 17638179 ↗
• MalfunctionJun 30, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY USING A POD PACKING COIL (POD PC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD PC IN THE TARGET VESSEL USING A MICROCATHETER. HOWEVER, THE PHYSICIAN NOTICED THE POD PC MIGRATED INTO THE MAIN RENAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE POD PC. THE PROCEDURE WAS COMPLETED USING A NEW 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 17243295 ↗
• MalfunctionJun 24, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL BRANCHES USING POD PACKING COILS (POD PC) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD PC THROUGH THE MICROCATHETER, THE PHYSICIAN WAS EXPERIENCING RESISTANCE AND THE COIL WOULD NOT ADVANCE. THEREFORE, THE POD PC WAS REMOVED. NEXT, THE PHYSICIAN WAS ADVANCING A NEW POD PC THROUGH THE MICROCATHETER AND EXPERIENCED RESISTANCE. SUBSEQUENTLY, WHILE RETRACTING THE POD PC, THE PHYSICIAN NOTICED THAT THE POD PC HAD UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED POD PC INTO THE TARGET LOCATION AND THE COIL WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED USING NEW POD PCS 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 17195953 ↗
• MalfunctionMay 21, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTOPULMONARY COLLATERALS USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (POD PC), RUBY COIL LPS, RUBY COILS, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE LANTERN INTO THE DIAGNOSTIC CATHETER; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN WOULD NOT ADVANCE MORE THAN FEW MILLIMETERS INTO THE DIAGNOSTIC CATHETER. THEREFORE, THE LANTERN WAS REMOVED AND A NON-PENUMBRA MICROCATHETER WAS ADVANCED THROUGH THE DIAGNOSTIC CATHETER. THE PHYSICIAN THEN PLACED A FEW RUBY COILS IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED THE POD PC INTO THE TARGET LOCATION; HOWEVER, WHILE ATTEMPTING TO REPOSITION THE POD PC, THE POD PC UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED AND THE POD PC WAS FLUSHED OUT ON THE BACK TABLE. THE PHYSICIAN THEN USED THE SAME MICROCATHETER AND PLACED ANOTHER POD PC SUCCESSFULLY. THE PHYSICIAN THEN USED ANOTHER NON-PENUMBRA MICROCATHETER TO ADVANCE THE RUBY COIL LPS. WHILE ATTEMPTING TO ADVANCE THE RUBY COIL LP INTO THE MICROCATHETER, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16971072 ↗
• MalfunctionMay 12, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING POD PACKING COILS (POD PC), A RUBY COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD PC THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE POD PC UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PC AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925108 ↗
• MalfunctionMar 18, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERLOBAR ARTERIES USING A RUBY COIL, A POD PACKING COIL (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED, AND THE RUBY COIL WAS FLUSHED ON THE BACK TABLE. THE PHYSICIAN THEN PLACED AND DETACHED ANOTHER RUBY COIL IN THE TARGET VESSEL SUCCESSFULLY USING THE SAME LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE POD PC; HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE POD PC UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND FLUSHED THE POD PC OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PC AND THE SAME LANTERN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570164 ↗
• MalfunctionFeb 24, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING A POD PACKING COIL (POD PC), A RUBY COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RUBY COIL IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED THE POD PC INTO THE TARGET VESSEL BUT THE POD PC WAS NOT COILING AS EXPECTED. THEREFORE, THE PHYSICIAN PULLED THE MICROCATHETER BACK; HOWEVER, THE ISSUE DID NOT RESOLVE. THE PHYSICIAN THEN DECIDED TO REMOVE THE POD PC. WHILE RETRACTING THE POD PC, THE POD PC UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A GUIDE WIRE TO PUSH THE POD PC OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE POD PC DID NOT LAND TO THE INTENDED LOCATION, BUT IT HELPED IN EMBOLIZING THE ARTERY. THE PROCEDURE ENDED AT THIS POINT AND THE PATIENT HAD A SUCCESSFUL EMBOLIZATION OF THE TARGET VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440483 ↗
• MalfunctionDec 22, 2022Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD PACKING COILS (POD PCS), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE NON-PENUMBRA COIL AND FIVE POD PCS. AFTER ADVANCING THE NEXT POD PC INTO THE TARGET LOCATION, THE PHYSICIAN MADE APPROXIMATELY SIX ATTEMPTS TO GET THE POD PC TO TAKE THE DESIRED SHAPE AND WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE POD PC WAS UNINTENTIONALLY DETACHED INSIDE THE LANTERN DURING AN ATTEMPT TO MOVE THE COIL BY HAND WHILE VISUALIZING IT ON THE ANGIOGRAM. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED AND THE POD PC WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN TO IMPLANT ANOTHER POD PC OF THE SAME SIZE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038339 ↗
• MalfunctionDec 1, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT BRACHIAL ARTERY USING A POD PACKING COIL (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD PC THROUGH THE LANTERN, THE POD PC UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED FROM THE PATIENT. 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 15899988 ↗
• MalfunctionNov 17, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  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 15820104 ↗
• MalfunctionOct 4, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A POD PACKING COIL (POD PC), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A CATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, ONE NON-PENUMBRA COIL WAS SUCCESSFULLY IMPLANTED. AFTER ADVANCING A POD PC INTO THE TARGET LOCATION, THE PHYSICIAN MOVED THE COIL BACK AND FORTH AND REPORTED THAT IT DID NOT FIT. SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED AND WAS COMPLETELY CONTAINED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED AND THE POD PC WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A RUBY COIL, THE SAME 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 15536753 ↗
• MalfunctionAug 12, 2022Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY USING A POD PACKING COIL (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE PHYSICIAN BROKE THE PUSHER ASSEMBLY OF THE COIL. CONSEQUENTLY, THE POD PC UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN USED A WIRE TO PUSH THE DETACHED POD PC TO THE TARGET LOCATION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15217498 ↗