RUBY Coil RBY2C0530-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI M424RBY2C05300), received between Aug 14, 2015 and Aug 18, 2021 — classified as 3 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (19 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED THE NEXT RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12339718 ↗
• MalfunctionMar 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICOCELE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE RUBY COIL AND THEN REMOVED THE COIL. 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 11438998 ↗
• MalfunctionJan 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL PART WAY INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE RUBY COIL AND ATTEMPTED TO ADVANCE THE RUBY COIL INTO THE BOWL OF SALINE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 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; No Consequences Or Impact To Patient

  MAUDE report 11167212 ↗
• MalfunctionMar 12, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9826564 ↗
• MalfunctionNov 22, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUROUS. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN AND A NON-PENUMBRA CATHETER THOUGH A SHEATH IN THE TARGET VESSEL, THE LANTERN WOULD NOT TRACK, AND THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE LANTERN WAS REMOVED. SUBSEQUENTLY, ANOTHER MICROCATHETER WAS ADVANCED THROUGH THE SAME CATHETER AND SHEATH. NEXT, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN DECIDED TO WITHDRAW THE RUBY COIL, AND UPON WITHDRAWAL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND THE SAME MICROCATHETER, CATHETER, AND SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9366156 ↗
• MalfunctionJul 19, 2019Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICELLE ARTERY USING A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND RESISTANCE WAS ENCOUNTERED. WHILE EXTRACTING, A "POP" WAS FELT AND IT WAS OBSERVED THAT THE RUBY COIL HAD UNRAVELED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW 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 8808723 ↗
• MalfunctionFeb 6, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT ARTERIOVENOUS (AV) FISTULAS IN THE PATIENT¿S LEG USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE VESSELS WERE DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY POSITIONED A GUIDEWIRE, NON-PENUMBRA CATHETER, AND A LANTERN INTO THE TARGET VESSEL AND DEPLOYED FOUR RUBY COILS. THE TECHNICIAN THEN FELT RESISTANCE WHILE ADVANCING THE FIFTH RUBY COIL AND WAS ONLY ABLE TO ADVANCE 90% OF THE COIL INTO THE LANTERN BEFORE THE RUBY COIL BECAME KINKED. THE RUBY COIL WAS THEREFORE REMOVED. WHILE ADVANCING THE SIXTH RUBY COIL, THE TECHNICIAN AGAIN FELT RESISTANCE AND SAME ISSUE OCCURRED. THE SIXTH RUBY COIL WAS, THEREFORE, REMOVED. THE LANTERN WAS THEN REMOVED FROM THE PATIENT AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE LANTERN AND NO VISIBLE DAMAGE; HOWEVER, THE LANTERN WAS SET ASIDE AND A NEW LANTERN WAS USED TO CONTINUE THE PROCEDURE. THE SAME GUIDEWIRE AND THE SAME NON-PENUMBRA CATHETER WERE ALSO USED. THE PHYSICIAN THEN DECIDED TO RE-POSITION THE GUIDEWIRE, NON-PENUMBRA CATHETER, AND NEW LANTERN TOGETHER IN ORDER TO REGAIN ACCESS TO THE TARGET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313263 ↗
• MalfunctionJan 3, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING NEW 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 8215137 ↗
• MalfunctionOct 16, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL AT ALL WITHIN ITS INTRODUCER SHEATH, DESPITE MULTIPLE ATTEMPTS. THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970067 ↗
• MalfunctionSep 7, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER BUT CHANGED HIS MIND AND WANTED TO USE A POD6; THEREFORE, THE RUBY COIL WAS REMOVED AND THE POD6 WAS IMPLANTED. WHILE ATTEMPTING TO RE-USE THE RUBY COIL THAT WAS PREVIOUSLY REMOVED, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE ALL THE WAY THROUGH THE MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT RINSE THE RUBY COIL IN SALINE PRIOR TO RE-USING IT. THE PROCEDURE WAS COMPLETED USING ANOTHER POD6, TWO POD PACKING COILS (PODJS) 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 7855846 ↗
• MalfunctionSep 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS WITHIN A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846817 ↗
• MalfunctionJul 3, 2018Failure to Fold; Device Handling Problem; Failure to Fold; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY AND THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A POD6. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIAL TWO COILS IN THE ACCESSORY RENAL ARTERY USING A NON-PENUMBRA ARTERY. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND BENT THE RUBY COIL PUSHER ASSEMBLY TWICE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE IMA, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL PASSED THE FRICTION LOCK AND THE EMBOLIZATION COIL WAS COMING OUT OF THE PROXIMAL END OF THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE IMA; HOWEVER, THE RUBY COIL DID NOT TAKE ITS INTENDED SHAPE AND THEREFORE, WAS REMOVED. IT WAS REPORTED THE RUBY COIL PUSHER ASSEMBLY WAS KINKED. NEXT, THE PHYSICIAN ADVANCED TWO OTHER RUBY COILS IN THE IMA, BUT THE RUBY COILS DID NOT TAKE THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. WHILE ADVANCING A POD6 INTO THE IMA, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659451 ↗
• MalfunctionJul 3, 2018Bent; Physical Resistance; Bent; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY AND THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A POD6. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIAL TWO COILS IN THE ACCESSORY RENAL ARTERY USING A NON-PENUMBRA ARTERY. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND BENT THE RUBY COIL PUSHER ASSEMBLY TWICE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE IMA, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL PASSED THE FRICTION LOCK AND THE EMBOLIZATION COIL WAS COMING OUT OF THE PROXIMAL END OF THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE IMA; HOWEVER, THE RUBY COIL DID NOT TAKE ITS INTENDED SHAPE AND THEREFORE, WAS REMOVED. IT WAS REPORTED THE RUBY COIL PUSHER ASSEMBLY WAS KINKED. NEXT, THE PHYSICIAN ADVANCED TWO OTHER RUBY COILS IN THE IMA, BUT THE RUBY COILS DID NOT TAKE THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. WHILE ADVANCING A POD6 INTO THE IMA, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659199 ↗
• MalfunctionMay 22, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER RUBY COIL IN THE TARGET VESSEL USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. 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 Consequences Or Impact To Patient

  MAUDE report 7534655 ↗
• MalfunctionMay 18, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS 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 7526452 ↗
• MalfunctionMar 21, 2018Bent; Physical Resistance; Bent; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE FIRST RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT; THEREFORE, IT WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL; HOWEVER, THE COIL WAS UNDERSIZED AND WAS NOT FORMING. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH IT; HOWEVER, WHILE TRYING TO RE-SHEATH THE RUBY COIL, ITS PUSHER ASSEMBLY BECAME BENT. THE RUBY COIL WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING A POD6, ANOTHER 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 7358243 ↗
• MalfunctionMar 21, 2018Bent; Inadequacy of Device Shape and/or Size; Bent; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE FIRST RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT; THEREFORE, IT WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL; HOWEVER, THE COIL WAS UNDERSIZED AND WAS NOT FORMING. THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH IT; HOWEVER, WHILE TRYING TO RE-SHEATH THE RUBY COIL, ITS PUSHER ASSEMBLY BECAME BENT. THE RUBY COIL WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING A POD6, ANOTHER 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 7358233 ↗
• MalfunctionMar 15, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PUSHER ASSEMBLY OF THE RUBY COIL (RUBY COIL) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7342004 ↗
• MalfunctionMar 13, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL MAMMARY ARTERY (LIMA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER THE PHYSICIAN NOTICED THAT THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER CONTAINING THE DETACHED RUBY COIL AND THE PROCEDURE WAS COMPLETED USING OTHER COILS AND A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7334339 ↗
• MalfunctionOct 26, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRICTION; THEREFORE, THE PHYSICIAN DECIDED TO PULL THE RUBY COIL OUT. HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED OUTSIDE OF THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN PULLED THE REMAINDER OF THE RUBY COIL OUT AND 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 6979776 ↗
• MalfunctionOct 3, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL ABOUT HALF WAY OUT OF THE LANTERN AND THE COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE COIL WOULD NOT COMPLETELY ADVANCE OUT OF THE LANTERN. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN REMOVED THE LANTERN TO FLUSH IT; HOWEVER, THE LANTERN WAS ACCIDENTALLY DROPPED ON THE FLOOR. THEREFORE, THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6912524 ↗
• MalfunctionOct 3, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE COIL ABOUT HALF WAY OUT OF THE LANTERN AND THE COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE COIL WOULD NOT COMPLETELY ADVANCE OUT OF THE LANTERN. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN REMOVED THE LANTERN TO FLUSH IT; HOWEVER, THE LANTERN WAS ACCIDENTALLY DROPPED ON THE FLOOR. THEREFORE, THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6912500 ↗
• MalfunctionSep 7, 2017Detachment Of Device Component; Retraction Problem; Detachment Of Device Component; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED A RUBY COIL WITHIN A LANTERN DELIVERY MICROCATHETER (LANTERN) TO REPOSITION IT; HOWEVER, UPON RETRACTION THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN ATTEMPTED TO REMOVE THE RUBY COIL BY REMOVING THE LANTERN; HOWEVER, UPON REMOVAL OF THE LANTERN, THE RUBY COIL FELL OUT INTO THE NON-PENUMBRA CATHETER. THEREFORE, THE CATHETER WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING THE SAME CATHETER, THE SAME LANTERN, AND ADDITIONAL RUBY COILS. IT WAS REPORTED THAT THE PHYSICIAN USED AN RHV BUT DID NOT USE CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849538 ↗
• MalfunctionAug 29, 2017Failure to Advance; Physical Resistance; Difficult to Advance; Failure to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE FIRST RUBY COIL FULLY OUT OF THE TIP OF THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN FLUSHED THE MICROCATHETER AND THEN ATTEMPTED TO RE-ADVANCE THE SAME RUBY COIL; HOWEVER, THE SAME RESISTANCE WAS FELT. THE RUBY COIL WAS THEREFORE REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 6828249 ↗
• MalfunctionJun 23, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL OUT OF THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND INTO THE TARGET VESSEL BUT DECIDED TO RETRACT THE COIL FOR REPOSITIONING. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. UPON MANIPULATION, THE RUBY COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL, THEN FLUSHED THE COIL OUT AND REINSERTED THE LANTERN INTO THE PATIENT'S BODY. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING A NEW 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 6664612 ↗