RUBY Coil RBY4C2060-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI M424RBY4C20600), received between Aug 26, 2015 and Nov 2, 2021 — classified as 1 injury, 78 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (40 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 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 RUBY COILS, A NON-PENUMBRA MICROCATHETER AND SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE SEVENTH RUBY COIL APPROXIMATELY FIVE TO TEN CENTIMETERS INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL WAS RE-SHEATHED AND SAVED. NEXT, THE PHYSICIAN FLUSHED THE MICROCATHETER USING A SYRINGE AND CHECKED IF THERE WAS AN ISSUE WITH THE MICROCATHETER BY ADVANCING A GUIDEWIRE OVER THE MICROCATHETER. IT WAS REPORTED THAT THE GUIDEWIRE WAS EASILY ADVANCED OVER THE MICROCATHETER. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE PREVIOUSLY RE-SHEATHED RUBY COIL INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE HUB. THEREFORE, THE RUBY COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY PLACED FIVE RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE INTRODUCING THE TWELFTH RUBY COIL INTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741586 ↗
• MalfunctionSep 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL VEIN USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL AND HANDLE WERE REMOVED. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PHYSICIAN THEN INSERTED A NEW MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, NEW RUBY COILS 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 12447544 ↗
• MalfunctionJul 23, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12217414 ↗
• MalfunctionJul 2, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING RUBY COILS (RUBY COIL), A NON-PENUMBRA MICROCATHETER, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FOUR RUBY COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, THE COIL WOULD NOT ADVANCE OUT OF THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE BOTH THE RUBY COIL AND THE MICROCATHETER; WHILE REMOVING THE RUBY COIL OUT OF THE MICROCATHETER, THE RUBY COIL WAS KINKED. THE PHYSICIAN THEN DECIDED TO USE THE LANTERN INSTEAD OF THE MICROCATHETER AND TRIED ADVANCING ANOTHER RUBY COIL; HOWEVER, HE HAD DIFFICULTY ADVANCING THE RUBY COIL OUT OF THE TIP OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111340 ↗
• MalfunctionMay 26, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO A LANTERN, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882404 ↗
• MalfunctionMar 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A POD PACKING COIL (POD PC), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COILS AND A POD PC WERE RE-SHEATHED AND SAVED FOR LATER USE, AS INITIALLY THE TWO RUBY COILS AND THE POD PC WERE TOO LONG FOR THE BRANCH VESSEL. LATER, WHILE ATTEMPTING TO USE THE TWO PREVIOUSLY REMOVED RUBY COILS, THE PHYSICIAN NOTICED THAT THE TWO RUBY COILS WERE STUCK WITHIN ITS INTRODUCER SHEATHS AND WOULD NOT ADVANCE AT ALL. THEREFORE, THE TWO RUBY COILS WERE REMOVED. SUBSEQUENTLY, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE THE PREVIOUSLY REMOVED POD PC WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD PC. THEREFORE, THE POD PC WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11532280 ↗
• MalfunctionMar 16, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT PULMONARY ARTERY TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL 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 11499057 ↗
• MalfunctionMar 18, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL STAFF NOTICED THAT A RUBY COIL WAS DETACHED FROM ITS PUSHER ASSEMBLY AND THE EMBOLIZATION COIL FELL OUT OF THE PACKAGING. THE DAMAGED RUBY COIL WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE THEN CONTINUED WITH A NEW RUBY COIL. WHILE ADVANCING THE NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK; THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED TOGETHER AND THE RUBY COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING 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 9850074 ↗
• MalfunctionSep 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL OUT OF THE INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 9099267 ↗
• MalfunctionJul 26, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT TRANSFEMORAL ARTERY USING A RUBY COIL AND A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, AFTER ADVANCING APPROXIMATELY 20 CM INTO THE LANTERN, THE RUBY COIL REMAINED STUCK BEFORE REACHING THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A PODJ; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE PODJ UNINTENTIONALLY DETACHED WITHIN THE LANTERN WHILE BEING RETRACTED. THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW PODJ 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 8832320 ↗
• MalfunctionJul 25, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A EMBOLIZATION PROCEDURE IN THE POPLITEAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN MADE A DIRECT STICK INTO THE PATIENT'S ANATOMY, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, WHILE ADVANCING THE RUBY COIL, IT BECAME STUCK WITHIN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE NON-PENUMBRA MICROCATHETER WAS THEN RE-POSITIONED AND THE PHYSICIAN ATTEMPTED AGAIN TO ADVANCE THE SAME RUBY COIL; HOWEVER, THE COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS THEN REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL WITH THE SAME NON-PENUMBRA MICROCATHETER, BUT SAME ISSUE OCCURRED; THEREFORE, THE COIL WAS REMOVED. THE PHYSICIAN RE-POSITIONED THE NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO ADVANCE A THIRD RUBY COIL; HOWEVER, IT BECAME STUCK IN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE NON-PENUMBRA MICROCATHETER AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND SUCCESSFULLY PLACED 15 RUBY COILS WITHOUT AN ISS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826511 ↗
• MalfunctionJul 25, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A EMBOLIZATION PROCEDURE IN THE POPLITEAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN MADE A DIRECT STICK INTO THE PATIENT'S ANATOMY, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, WHILE ADVANCING THE RUBY COIL, IT BECAME STUCK WITHIN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE NON-PENUMBRA MICROCATHETER WAS THEN RE-POSITIONED AND THE PHYSICIAN ATTEMPTED AGAIN TO ADVANCE THE SAME RUBY COIL; HOWEVER, THE COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS THEN REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL WITH THE SAME NON-PENUMBRA MICROCATHETER, BUT SAME ISSUE OCCURRED; THEREFORE, THE COIL WAS REMOVED. THE PHYSICIAN RE-POSITIONED THE NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO ADVANCE A THIRD RUBY COIL; HOWEVER, IT BECAME STUCK IN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE NON-PENUMBRA MICROCATHETER AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND SUCCESSFULLY PLACED 15 RUBY COILS WITHOUT AN ISS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826507 ↗
• MalfunctionMay 3, 2019Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN A SIDE VESSEL OF THE PELVIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER RUBY COIL FULLY OUT OF THE LANTERN AND INTO THE ANEURYSM AND, THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL. WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEN FLUSHED THE DETACHED RUBY COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS THEN CONTINUED 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 8577589 ↗
• MalfunctionApr 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN THE PROXIMAL END OF A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537749 ↗
• MalfunctionApr 5, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, IT BECAME STUCK. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489632 ↗
• MalfunctionApr 5, 2019Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUBCLAVIAN ARTERY (SCA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS AND OTHER COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN 15 CENTIMETERS OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER AND SUCCESSFULLY ADVANCED A GUIDEWIRE THROUGH IT. HOWEVER, WHEN TRYING TO ADVANCE THE SAME RUBY COIL, THE PHYSICIAN AGAIN FELT RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED. LATER IN THE PROCEDURE, THE PHYSICIAN AGAIN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, DESPITE FLUSHING THE COIL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE COIL WAS TWISTED AND DEFORMED APPROXIMATELY 10-15 CENTIMETERS PROXIMAL TO THE TIP OF THE COIL. THE PHYSICIAN ATTEMPTED TO RE-SHEATH OR STRAIGHTEN THE RUBY COIL, HOWEVER, THE RUBY COIL THEN BROKE OFF OF ITS PUSHER ASSEMBLY OUTSIDE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489537 ↗
• MalfunctionApr 5, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUBCLAVIAN ARTERY (SCA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS AND OTHER COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN 15 CENTIMETERS OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER AND SUCCESSFULLY ADVANCED A GUIDEWIRE THROUGH IT. HOWEVER, WHEN TRYING TO ADVANCE THE SAME RUBY COIL, THE PHYSICIAN AGAIN FELT RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED. LATER IN THE PROCEDURE, THE PHYSICIAN AGAIN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, DESPITE FLUSHING THE COIL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE COIL WAS TWISTED AND DEFORMED APPROXIMATELY 10-15 CENTIMETERS PROXIMAL TO THE TIP OF THE COIL. THE PHYSICIAN ATTEMPTED TO RE-SHEATH OR STRAIGHTEN THE RUBY COIL, HOWEVER, THE RUBY COIL THEN BROKE OFF OF ITS PUSHER ASSEMBLY OUTSIDE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489530 ↗
• MalfunctionFeb 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING APPROXIMATELY 30 CENTIMETERS OF A RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK BEFORE REACHING THE DISTAL END OF THE LANTERN; 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 Consequences Or Impact To Patient

  MAUDE report 8338928 ↗
• MalfunctionJan 18, 2019Failure 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 THE RUBY COIL INTO THE NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COIL 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 8261183 ↗
• MalfunctionJan 18, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED EIGHT RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). ANOTHER RUBY COIL THEN BECAME KINKED WHILE ADVANCING WITHIN THE LANTERN, AND THE PHYSICIAN THEN FELT RESISTANCE. THEREFORE, THE LANTERN WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260903 ↗
• MalfunctionJan 11, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. THE PHYSICIAN THEN DECIDED TO WITHDRAW THE RUBY COIL. HOWEVER, WHILE ATTEMPTING TO WITHDRAW THE RUBY COIL, THE PHYSICIAN APPLIED FORCE AND THE RUBY COIL UNINTENTIONALLY DETACHED, WITH APPROXIMATELY HALF OF THE RUBY COIL IN THE PATIENT AND THE OTHER HALF INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING 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 8241608 ↗
• MalfunctionSep 7, 2018Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS; THEREFORE, THE LANTERN AND RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857461 ↗
• MalfunctionAug 27, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN FELT LIKE THE RUBY COIL WAS ¿HITTING A WALL¿ AFTER ADVANCING IT APPROXIMATELY HALF WAY INTO THE LANTERN; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE LANTERN WAS FLUSHED MULTIPLE TIMES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7820018 ↗
• MalfunctionAug 14, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE AORTA USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, PRIOR TO INSERTION INTO THE GUIDING CATHETER, THE PHYSICIAN NOTICED A THIN METAL FIBER AT THE TIP OF A LANTERN; THEREFORE, IT WAS NOT USED IN THE PROCEDURE AND A NEW LANTERN WAS OPENED. WHILE ADVANCING A RUBY COIL THROUGH THE NEW LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND 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 Consequences Or Impact To Patient

  MAUDE report 7781957 ↗
• MalfunctionJul 13, 2018Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), HOWEVER, THE PHYSICIAN WAS UNABLE TO RETRACT THE INTRODUCER SHEATH OFF THE PROXIMAL END OF THE RUBY COIL¿S PUSHER ASSEMBLY. 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 7686587 ↗