RUBY Coil RBY2C1260-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00814548019093), received between Feb 5, 2019 and Sep 23, 2026 — classified as 1 injury, 41 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (26 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876177 ↗
• InjurySep 4, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A SHEATH (6FR X 10CM). IT WAS NOTED THAT THE LEFT RENAL ARTERY WAS TORTUOUS WITH STEEP ANGLES. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE CATHETER AND LANTERN TO THE TARGET LOCATION AND PLACED RUBY COILS. THE PHYSICIAN STARTED PACKING ANOTHER RUBY COIL BUT FELT RESISTANCE. THE PHYSICIAN TRIED TO REPOSITION THE RUBY COIL, BUT THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE LANTERN AND THE TARGET LOCATION. THE CATHETER AND LANTERN WERE REMOVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO SNARE THE TAIL OF THE RUBY COIL, BUT THE RUBY COIL STARTED TO UNRAVEL. ANOTHER PHYSICIAN USED A NEW SNARE DEVICE BUT WAS ONLY ABLE TO PULL PART OF THE RUBY COIL. THE PHYSICIAN DECIDED TO LEAVE THE DETACHED RUBY COIL IN PLACE. IT WAS REPORTED THAT THE RUBY COIL WAS IN THE LEFT RENAL ARTERY WITH THE TAIL END IN THE AORTA. THE PROCEDURE WAS COMPLETED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22964262 ↗
• MalfunctionMar 17, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE LANTERN AND RUBY COIL WERE ADVANCED TO THE TARGET LOCATION. THE LANTERN WAS KINKED AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY 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 21626166 ↗
• MalfunctionDec 6, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE SUPERIOR MESENTERIC ARTERY (SMA) USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, A GUIDEWIRE, AND A PUSHER WIRE. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A PUSHER WIRE TO PUSH THE RUBY COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING RUBY COIL LPS 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 20865596 ↗
• MalfunctionJul 15, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A RUBY COIL, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DETACHED RUBY COIL. THEREFORE, THE PHYSICIAN USED ANOTHER RUBY COIL TO PUSH THE DETACHED RUBY COIL FROM THE MICROCATHETER INTO THE TARGET LOCATION AND THE RUBY COIL WAS SUCCESSFULLY IMPLANTED. 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 19744259 ↗
• MalfunctionMay 19, 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 RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE NEXT RUBY COIL INTO THE TARGET LOCATION USING THE MICROCATHETER; HOWEVER, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL TO REPOSITION IT. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED SALINE TO FLUSH THE DETACHED RUBY COIL OUT OF THE MICROCATHETER AND INTO THE TARGET LOCATION AND THE RUBY COIL WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE RUBY COIL MIGHT HAD BECOME CAUGHT ON A LOOP OF THE PREVIOUSLY IMPLANTED RUBY COIL, CAUSING RESISTANCE. 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 19348555 ↗
• MalfunctionAug 30, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDOANEURYSM IN THE LEFT TIBIOPERONEAL (TP) TRUNK USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE TARGET VESSEL, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 17657126 ↗
• MalfunctionJun 16, 2023Fracture; Physical Resistance/Sticking; Premature Separation; Fracture; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE PROXIMAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE PUSHER ASSEMBLY WAS FRACTURED AND THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND FIVE POD PACKING COILS (POD PC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144770 ↗
• MalfunctionApr 24, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD PACKING COILS (POD PC), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE POD PCS IN TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT AFTER PLACING THE THREE POD PCS, THE PHYSICIAN NOTICED THE DISTAL END AND MIDSHAFT OF THE LANTERN WAS KINKED BY THE COIL COMPACTION. THEREFORE, THE LANTERN WAS REMOVED. THE PHYSICIAN THEN INSERTED A NEW LANTERN IN THE TARGET LOCATION AND ADVANCED ADDITIONAL POD PCS AND RUBY COILS INTO THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN PULLED BACK ON THE LANTERN TO BE REMOVED AND NOTICED ALL OF THE PREVIOUSLY PLACED POD PCS AND RUBY COILS THAT WERE IMPLANTED HAD MIGRATED FROM THE SUBCLAVIAN ARTERY TO THE BRACHIAL ARTERY UNDER FLUOROSCOPY. THE LANTERN WAS REMOVED, AND THE PHYSICIAN PERFORMED A CUTDOWN SURGERY AND REMOVED THE MIGRATED POD PCS AND RUBY COILS. 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 16797242 ↗
• MalfunctionJun 17, 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 A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN BUT PROCEEDED WITH ADVANCEMENT. AFTER THE RUBY COIL WAS ADVANCED INTO THE TARGET LOCATION, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE MOVING THE COIL BACK AND FORTH TO ACHIEVE THE INTENDED POSITION. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AND WAS COMPLETELY CONTAINED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, A NEW RUBY COIL, AND THREE POD PACKING COILS (POD PCS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733885 ↗
• MalfunctionMar 8, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC ARTERY PSEUDOANEURYSM USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL IN THE TARGET LOCATION USING THE LANTERN AND USED THE HANDLE TO DETACH IT. HOWEVER, WHILE SLOWLY REMOVING THE PUSHER ASSEMBLY OF THE RUBY COIL UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD NOT DETACHED AND SUBSEQUENTLY, THE RUBY COIL WAS PULLED OUT OF THE PSEUDOANEURYSM. WHILE THE PHYSICIAN ATTEMPTED TO PUSH THE RUBY COIL BACK INTO POSITION, THE RUBY COIL UNINTENTIONALLY DETACHED WITH THE DISTAL END OF THE RUBY COIL IN THE HEPATIC ARTERY. THEREFORE, THE PHYSICIAN REMOVED THE DETACHED RUBY COIL USING A SNARE DEVICE. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT SINCE THE RUBY COIL THAT WAS PREVIOUSLY PLACED HAD CLOSED THE PSEUDOANEURYSM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697298 ↗
• MalfunctionDec 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GONADAL VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY FOR THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12934877 ↗
• MalfunctionNov 12, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LOWER BRANCHES OF THE RENAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE WITHIN THE TARGET VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUED OCCURRED WITH A SECOND RUBY COIL. THEREFORE, THE RUBY COIL WAS ALSO REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO TREAT DIFFERENT BRANCHES THAN THE INTENDED ORIGINAL VESSEL. THE PROCEDURE WAS COMPLETED USING RUBY COIL LPS AND A SMALLER SIZE NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807506 ↗
• MalfunctionOct 13, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, FOUR COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET VESSEL. NEXT, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, IT WOULD NOT MOVE IN THE LANTERN AND THE PHYSICIAN NOTICED IT HAD BECOME DETACHED. THEREFORE, THE RUBY COIL, LANTERN, AND CATHETER WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, A NEW LANTERN, AND A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627917 ↗
• MalfunctionSep 30, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A RUBY COIL THROUGH THE MIDDLE OF THE LANTERN. UPON RETRIEVAL, THE RUBY COIL DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL, 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 12558245 ↗
• MalfunctionSep 24, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL WITHIN ITS INTRODUCER SHEATH, THE SCRUB TECHNOLOGIST KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12524176 ↗
• MalfunctionSep 7, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, POD PACKING COILS (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 12435248 ↗
• MalfunctionAug 23, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SHORT GASTRIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA COILS, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL AND TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR POD PACKING COILS (POD PCS) 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 12356212 ↗
• MalfunctionAug 23, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SHORT GASTRIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA COILS, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL AND TWO NON-PENUMBRA COILS INTO THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR POD PACKING COILS (POD PCS) 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 12356187 ↗
• MalfunctionAug 20, 2021Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS CALCIFIED. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE FIRST RUBY COIL AND SUBSEQUENTLY, THE PUSHER WIRE BECAME KINKED WHEN THE COIL WAS ADVANCED APPROXIMATELY TWENTY CENTIMETERS INTO THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN NOTICED THE RUBY COIL HAD DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT AND THE RUBY COIL WAS REMOVED. THE SAME MICROCATHETER WAS RE-INSERTED AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12349227 ↗
• MalfunctionJul 23, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, AS THE TECH WAS ADVANCING A RUBY COIL IN INTRODUCER SHEATH, THEY KINKED THE PUSHER ASSEMBLY OF THE COIL, MAKING IT UNABLE TO ADVANCE FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 12218475 ↗
• MalfunctionJul 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER, AND AN ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A NON-PENUMBRA EMBOLIZATION DEVICE THROUGH THE PARENT CATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE MIDDLE OF THE LANTERN, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER RUBY COIL, NO RESISTANCE WAS ENCOUNTERED; HOWEVER, AFTER FOUR TO FIVE LOOPS OF THE COIL WERE INSIDE THE TARGET LESION, THE PHYSICIAN DECIDED TO RE-POSITION THE COIL. WHILE RETRACTING THE COIL, IT BECAME DETACHED PARTLY INSIDE THE PATIENT AND PARTLY INSIDE THE LANTERN. THE LANTERN AND PARENT CATHETER WERE REMOVED TOGETHER WITH THE DETACHED COIL AND THE RUBY COIL WAS FLUSHED OUT OF THE PARENT CATHETER ON THE BACK TABLE. ON THE BACK TABLE, THE PHYSICIAN DISCOVERED THE LANTERN WAS BROKEN AT THE DISTAL TIP; HOWEVER, THE TIP WAS STILL CONNECTED TO THE MAIN SHAFT BY A WIRE. IT WAS ALSO REPORTED THAT THE PHYSICIAN PREFERRED TO PROCEED USING A STENTING PROCEDURE; THEREFORE, THE EMBOLIZATION PROCEDURE WAS CONCLUDED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139813 ↗
• MalfunctionJul 8, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER, AND AN ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A NON-PENUMBRA EMBOLIZATION DEVICE THROUGH THE PARENT CATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE MIDDLE OF THE LANTERN, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE ADVANCING ANOTHER RUBY COIL, NO RESISTANCE WAS ENCOUNTERED; HOWEVER, AFTER FOUR TO FIVE LOOPS OF THE COIL WERE INSIDE THE TARGET LESION, THE PHYSICIAN DECIDED TO RE-POSITION THE COIL. WHILE RETRACTING THE COIL, IT BECAME DETACHED PARTLY INSIDE THE PATIENT AND PARTLY INSIDE THE LANTERN. THE LANTERN AND PARENT CATHETER WERE REMOVED TOGETHER WITH THE DETACHED COIL AND THE RUBY COIL WAS FLUSHED OUT OF THE PARENT CATHETER ON THE BACK TABLE. ON THE BACK TABLE, THE PHYSICIAN DISCOVERED THE LANTERN WAS BROKEN AT THE DISTAL TIP; HOWEVER, THE TIP WAS STILL CONNECTED TO THE MAIN SHAFT BY A WIRE. IT WAS ALSO REPORTED THAT THE PHYSICIAN PREFERRED TO PROCEED USING A STENTING PROCEDURE; THEREFORE, THE EMBOLIZATION PROCEDURE WAS CONCLUDED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139812 ↗
• MalfunctionJul 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL THROUGH THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE SAME LOCATION IN THE LANTERN, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN TO IMPLANT THE SAME RUBY COIL AND THREE POD PACKING COILS (POD PCS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139764 ↗
• MalfunctionJun 25, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE FROM THE INTRODUCER SHEATH TO THE PX SLIM. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071895 ↗