RUBY Coil RBY4C0835-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI M424RBY4C08350), received between Aug 14, 2015 and Jul 22, 2021 — classified as 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (11 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL BRANCH USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION, BUT THE RUBY COIL WOULD NOT FORM AND THEREFORE IT WAS REMOVED. NEXT, THE PHYSICIAN DECIDED TO USE ANOTHER RUBY COIL; HOWEVER, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED WHILE ADVANCING THROUGH THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED AS WELL. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214247 ↗
• MalfunctionMay 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD COIL, NON-PENUMBRA GUIDE CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MICROCATHETER INTO THE MID SPLENIC AND PLACED A POD COIL. THE MICROCATHETER WAS THEN FLUSHED AND WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST STARTED TO EXPERIENCE RESISTANCE. SUBSEQUENTLY, THE RUBY COIL WAS REMOVED AND INSPECTED, THE MICROCATHETER WAS ALSO RE-FLUSHED; HOWEVER, WHEN ATTEMPTING TO ADVANCE THE SAME RUBY COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11866817 ↗
• MalfunctionDec 8, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEIN USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND A PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10968903 ↗
• MalfunctionJul 24, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE COIL IN THE TARGET VESSEL USING THE LANTERN. THEN, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN FELT THE RUBY COIL LIKE A ¿SLINKY¿. THEREFORE, THE ENTIRE SYSTEM WAS REMOVED. UPON REMOVAL OF THE ENTIRE SYSTEM, THE PHYSICIAN NOTICED THAT THE RUBY COIL UNRAVELED, AND THE DISTAL END OF THE LANTERN WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 10322180 ↗
• MalfunctionJul 17, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LIENAL ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR PENUMBRA COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE LAST RUBY COIL, THE HANDLE FAILED TO DETACH THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE ENDED AFTER THE COIL WAS REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289641 ↗
• MalfunctionMar 4, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. HOWEVER, UPON RETRACTION, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787203 ↗
• MalfunctionFeb 14, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714591 ↗
• InjuryFeb 14, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY TO TREAT AN ANEURYSM USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE ANEURYSM SAC USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN AND A FEW CENTIMETERS INTO THE ANEURYSM SAC, THE PHYSICIAN EXPERIENCED RESISTANCE AND IMMEDIATELY STOPPED PUSHING THE RUBY COIL FORWARD. WHILE ATTEMPTING TO WITHDRAW THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL, BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO SECURE THE DETACHED RUBY COIL TO THE VESSEL WALL BY PLACING A SELF-EXPANDING STENT. 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 9712908 ↗
• MalfunctionDec 20, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, 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 ON THE BACK TABLE. IT WAS REPORTED THAT THE SCRUB NURSE EXPERIENCED RESISTANCE AT SOME POINT WHILE USING THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507955 ↗
• MalfunctionNov 22, 2019Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365129 ↗
• MalfunctionNov 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365112 ↗
• MalfunctionNov 11, 2019Material 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 RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN REPORTED THAT THE RUBY COIL WAS NOT ADVANCING SMOOTHLY. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT, AND WHILE PULLING BACK AND ADVANCING THE RUBY COIL, THE PHYSICIAN FELT THE RUBY COIL UNINTENTIONALLY DETACH IN THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO FLUSH IT USING A 3CC SYRINGE, BUT IT WOULD NOT ADVANCE FURTHER. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. AFTER REMOVAL, THE DISTAL END OF RUBY COIL WAS NOTICED TO BE DAMAGED. THE PHYSICIAN THEN CONTINUED THE PROCEDURE USING ADDITIONAL RUBY COILS. WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK IN THE AORTIC PORTION OF THE LANTERN. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT, AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN WHEN THE PHYSICIAN WAS PULLING BACK AND ADVANCING THE RUBY COIL. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307042 ↗
• MalfunctionNov 2, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GONADAL VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL AND NON-PENUMBRA MICROCATHETER THROUGH A MODIFIED NON-PENUMBRA CATHETER IN THE TARGET VESSEL, THE RUBY COIL STARTED TAKING SHAPE INSIDE THE CATHETER; THEREFORE, THE PHYSICIAN DECIDED TO PUSH AND PULL THE RUBY COIL. WHILE PUSHING AND PULLING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED; THEREFORE, THE CATHETER CONTAINING THE MICROCATHETER AND DETACHED RUBY COIL WERE REMOVED. IT WAS REPORTED THAT THE REMOVAL OF THE ENTIRE SYSTEM COMPROMISED FURTHER TREATMENT DUE TO A LOSS OF ACCESS TO THE TARGET VESSEL. THE PHYSICIAN THEN OPENED A LANTERN. WHILE REMOVING THE SHAPING MANDREL FROM THE DISTAL TIP OF THE LANTERN, THE INNER PORTION OF THE LANTERN WAS NOTICED TO BE HANGING FROM THE DISTAL TIP. THE DAMAGE TO THE LANTERN WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN OPENED A SECOND LANTERN, RESUMED THE PROCEDURE, AND WAS ABLE TO REGAIN ACCESS TO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING THE SEC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269838 ↗
• MalfunctionOct 1, 2019Failure 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. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE FIRST TWO RUBY COILS THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO OTHER RUBY COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, IT WAS REMOVED. 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 9141877 ↗
• MalfunctionJan 28, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY (SA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL HALFWAY THROUGH A NON-PENUMBRA MICROCATHETER AND DECIDED TO RETRACT THE COIL TO PLACE THE MICROCATHETER MORE DISTAL. HOWEVER, WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281934 ↗
• InjuryJan 18, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS IN THE TARGET VESSEL WITH THE LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL INTO THE ANEURYSM, IT UNINTENTIONALLY DETACHED WITHIN MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261954 ↗
• MalfunctionJan 16, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE WHILE ATTEMPTING TO ADVANCE THE LANTERN THROUGH A NON-PENUMBRA DIAGNOSTIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE LANTERN APPROXIMATELY 20 CENTIMETERS INTO THE DIAGNOSTIC CATHETER AND THE LANTERN WOULD NOT ADVANCE FURTHER. THEREFORE, THE LANTERN WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH THE DIAGNOSTIC CATHETER AND PLACED TWO COILS IN THE TARGET VESSEL. WHILE ADVANCING A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE RUBY COIL MADE A FRICTION NOISE AND THE PHYSICIAN TRIED TO SLOWLY RETRACT THE RUBY COIL. HOWEVER, THERE WAS NO ONE TO ONE MOVEMENT AND WHEN THE PHYSICIAN RETRACTED THE RUBY COIL PUSHER ASSEMBLY, THE EMBOLIZATION COIL DID NOT MOVE BACK IN THE INTRODUCER SHEATH. IT WAS REPORTED THAT ONLY THE TIP OF THE RUBY COIL WAS INSIDE THE MICROCATHETER AND THE PHYSICIAN JUST PULLED THE WHOLE COIL OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR POD PACKING COILS (PODJS), TWO RUBY COILS AND THE SAME MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253550 ↗
• MalfunctionDec 27, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, THE PUSHER ASSEMBLY WAS KINKED WHILE INSERTING THE RUBY COIL INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8201377 ↗
• MalfunctionDec 11, 2018Break; Material Frayed; Break; Material Frayed

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE RUBY COIL WAS OVERSIZED AND PULLED IT OUT OF THE PATIENT TO RE-SHEATH IT. HOWEVER, WHILE RE-SHEATHING THE RUBY COIL OUTSIDE OF THE PATIENT'S BODY, THE RUBY COIL DETACHED AND FRAYED. THEREFORE, THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8153037 ↗
• MalfunctionNov 1, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER TWO TIMES AND EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT DIFFICULTY WAS EXPERIENCED RE-SHEATHING THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8030350 ↗
• MalfunctionAug 29, 2018Break; Inadequacy of Device Shape and/or Size; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A RUBY COIL WITHIN THE PATIENT, HOWEVER, THE RUBY COIL WAS THE WRONG SIZE AND WAS THEREFORE REMOVED. AFTER BEING RETRACTED OUT OF THE MICROCATHETER, THE RUBY COIL BROKE OFF FROM ITS PUSHER ASSEMBLY WHILE IT WAS BEING RE-SHEATHED. 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 7827310 ↗
• MalfunctionJun 20, 2018Kinked; Device Operates Differently Than Expected; Kinked; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED AND REMOVED A RUBY COIL FROM THE NON-PENUMBRA MICROCATHETER BECAUSE IT WAS NOT FORMING AS EXPECTED IN THE TARGET LOCATION. THE EMBOLIZATION COIL THEN BECAME KINKED AS THE PHYSICIAN WAS RETRACTING THE RUBY COIL INTO ITS INTRODUCER SHEATH ON THE BACK TABLE AND, THEREFORE, THE RUBY COIL COULD NOT BE FULLY RE-SHEATHED. 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 7620774 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING RUBY COILS AND POD6. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL BETWEEN THE ARTERIAL AND VENOUS CONNECTION IN A FIGURE 8 FASHION USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN AGGRESSIVELY APPLIED FORWARD TENSION ON THE LANTERN AND MOVED THE COIL IN AND OUT THE TREATMENT SITE. CONSEQUENTLY, THE PUSHER ASSEMBLY PET LOCK BECAME DAMAGED AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN ATTACHED A SYRINGE TO THE BACK OF THE LANTERN AND PULLED NEGATIVE PRESSURE BACK. THUS, THE DETACHED COIL WAS ASPIRATED OUT. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL AND POD6. BOTH COILS WERE ALSO ASPIRATED OUT AFTER THE UNINTENTIONAL DETACHMENT AND THE LANTERN REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. IT SHOULD BE NOTED THAT THERE WAS NO NOTED DAMAGE OR ISSUE WITH THE INITIAL LANTERN. THE PHYSICIAN JUST WANTED TO START FRESH WITH A NEW LANTERN. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7288912 ↗
• MalfunctionNov 10, 2017Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component

  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 DETERMINED THAT A RUBY COIL WAS THE INCORRECT SIZE AND DECIDED TO REMOVE AND RE-SHEATH IT. HOWEVER, WHILE RE-SHEATHING THE RUBY COIL OUTSIDE THE PATIENT¿S BODY, THE RUBY COIL DETACHED. 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 Consequences Or Impact To Patient

  MAUDE report 7018760 ↗
• MalfunctionOct 23, 2017Positioning Failure; Failure to Fold; Device Operates Differently Than Expected; Positioning Failure; Failure to Fold; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT TWO RUBY COILS IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE COILS WERE NOT TAKING THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6969064 ↗