RUBY Coil RBY2C0435-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI M424RBY2C04350), received between Aug 21, 2015 and Feb 1, 2021 — classified as 3 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (32 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 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2021Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN LOST ACCESS WITH THE MICROCATHETER. SUBSEQUENTLY, THE HOSPITAL TECHNICIAN ATTEMPTED TO RE-SHEATH THE RUBY COIL; HOWEVER, THE RUBY COIL COULD NOT BE RETRACTED BACK INTO THE ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A POD PACKING COIL (POD PC), 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 11263190 ↗
• MalfunctionJan 21, 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, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE MICROCATHETER, THE RUBY COIL DETACHED FROM THE PUSHER ASSEMBLY WITHIN THE INTRODUCER SHEATH BEFORE ENTERING THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE INTRODUCER SHEATH CONTAINING THE DETACH RUBY COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS 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 11211105 ↗
• MalfunctionJan 15, 2021Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT PROFUNDA FEMORIS ARTERY USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA ANGLED CATHETER AND MICROGUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE DISTAL TIP OF THE RUBY COIL OUT OF THE MICROCATHETER AND IN THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN MANIPULATED THE MICROCATHETER AND CATHETER TO TROUBLESHOOT; HOWEVER, THE RUBY COIL STILL WOULD NOT TAKE ITS INTENDED SHAPE. DURING MANIPULATION, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL, AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL, AND THE RUBY COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA COIL, THE SAME MICROCATHETER AND THE SAME ANGLED CATHETER. 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 11181624 ↗
• MalfunctionDec 3, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY A THIRD OF A RUBY COIL INTO THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE INTRODUCER SHEATH SLIGHTLY AND THE RUBY COIL STARTED TO TAKE SHAPE IN THE ROTATING HEMOSTASIS VALVE (RHV). THE PHYSICIAN THEN DECIDED TO RE-SHEATH THE RUBY COIL; HOWEVER, THE COIL DETACHED FROM ITS PUSHER ASSEMBLY OUTSIDE 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; No Consequences Or Impact To Patient

  MAUDE report 10943070 ↗
• InjuryOct 9, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FISTULA IN THE COLLATERAL ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, THE PHYSICIAN LOST ACCESS WITH THE MICROCATHETER TO THE TARGET VESSEL AND, THEREFORE, DECIDED TO REMOVE THE RUBY COIL. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME UNRAVELED. THE PHYSICIAN, THEREFORE USED AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WITH ASPIRATION AND A SNARE DEVICE TO REMOVE THE RUBY 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; No Consequences Or Impact To Patient

  MAUDE report 10656736 ↗
• InjuryOct 8, 2020Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE, BUT, WAS ABLE TO ADVANCE THE COIL THROUGH THE MICROCATHETER UNDER CONTINUOUS FLUSH. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL TO REPOSITION MICROCATHETER; HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. NEXT, THE PHYSICIAN INSERTED THE SAME MICROCATHETER AND ADVANCED A NEW RUBY COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER OUT OF THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITH HALF OF THE COIL IN THE ILIAC ARTERY AND THE REMAINING HALF OF THE RUBY COIL WAS IN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER; HOWEVER

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

  MAUDE report 10652769 ↗
• MalfunctionOct 8, 2020Physical 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 NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE, BUT, WAS ABLE TO ADVANCE THE COIL THROUGH THE MICROCATHETER UNDER CONTINUOUS FLUSH. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL TO REPOSITION MICROCATHETER, HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE COIL WAS FLUSHED OUT. NEXT, THE PHYSICIAN INSERTED THE SAME MICROCATHETER, AND ADVANCED A NEW RUBY COIL, HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER OUT OF THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED WITH HALF OF THE COIL IN THE ILIAC ARTERY, AND THE REMAINING HALF OF THE RUBY COIL WAS IN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER, H

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

  MAUDE report 10652768 ↗
• MalfunctionAug 13, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WHILE BEING RETRACTED. IT WAS ALSO REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405278 ↗
• MalfunctionApr 1, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE MICROCATHETER AND INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE WITH 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 MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913271 ↗
• MalfunctionJul 25, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT TRANSFEMORAL ARTERY USING A RUBY COIL. DURING A PROCEDURE, THE RUBY COIL BECAME STUCK WHILE IT WAS BEING ADVANCED THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, THE RUBY COIL WAS REMOVED. A NEW RUBY COIL AND THE SAME LANTERN WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828108 ↗
• MalfunctionJun 13, 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 A RUBY COIL THROUGH THE DISTAL TIP OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE SAME ISSUE OCCURRED WHEN THE PHYSICIAN WAS UNABLE TO ADVANCE ANOTHER RUBY COIL THROUGH THE DISTAL TIP OF THE SAME MICROCATHETER AND, THEREFORE, THE SECOND RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS THEN 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 8696264 ↗
• MalfunctionApr 3, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE ANOTHER RUBY COIL OUT OF THE TIP OF THE MICROCATHETER AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN 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 8478100 ↗
• MalfunctionMar 20, 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, THE PHYSICIAN SUCCESSFULLY PLACED FOUR RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE LANTERN AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A POD PACKING 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 8437385 ↗
• MalfunctionMar 1, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED INITIAL RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA 4F GUIDE CATHETER. WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL WOULD NOT STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL HAD ¿KNOTTED¿ ON ITSELF. THE PHYSICIAN THEN CONTINUED THE PROCEDURE BY PLACING ADDITIONAL RUBY COILS USING THE SAME GUIDE CATHETER. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL WOULD NOT STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL HAD ALSO ¿KNOTTED¿ ON ITSELF. AFTER THAT, THE PROCEDURE CONTINUED USING ADDITIONAL RUBY COILS. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE GUIDE CATHETER; THER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382178 ↗
• InjuryFeb 7, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS THROUGH THE PATIENT¿S RIGHT FEMORAL ARTERY. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A RUBY COIL OUT OF THE TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE PHYSICIAN RETRACTED THE COIL. WHILE RETRACTING, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN ATTEMPTED TO PLACE THE RUBY COIL BY ADVANCING IT WITH THE PUSHER ASSEMBLY BUT WAS UNABLE TO. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE MICROCATHETER WITH THE RUBY COIL INSIDE, HOWEVER ONLY THE NITINOL WIRE CAME OUT WITH THE LANTERN. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE REST OF THE RUBY COIL. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT THE RUBY COIL MIGHT HAVE BEEN TOO LARGE FOR THE TARGET LOCATION, CAUSING RESISTANCE. THE PHYSICIAN THEN PUNCTURED THE LEFT FEMORAL ARTERY AND SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET LOCATION USING THE SAME LANTERN. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PODJ OUT OF THE TIP OF THE LANTERN AND, THEREFORE, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319128 ↗
• MalfunctionNov 2, 2018Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VERTEBRAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX POD COILS USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN THE PX SLIM AND THAT THE RUBY COIL BECAME STRETCHED. THEREFORE THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN 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 8035731 ↗
• MalfunctionSep 27, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND POD PACKING COILS (PODJ). DURING THE PROCEDURE, WHILE ADVANCING BOTH COILS THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE, THEREFORE THE COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 7914918 ↗
• MalfunctionSep 20, 2018Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER, THE EMBOLIZATION COIL WOULD NOT FORM WITHIN THE VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED, 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 7894744 ↗
• MalfunctionAug 13, 2018Failure 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, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, ADDITIONAL 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 7778579 ↗
• MalfunctionApr 23, 2018Bent; Kinked; Bent; Kinked

  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. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT AND KINKED AFTER AGGRESSIVE FORWARD AND BACKWARD MOTION. THEREFORE, THE RUBY COIL AND LANTERN WERE 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. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451497 ↗
• MalfunctionApr 4, 2018Detachment Of Device Component; Retraction Problem; Physical Resistance; Detachment Of Device Component; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-PENUMBRA MICROCATHETER TO INJECT A MIXTURE OF LIPIODOL, GEL FOAM, AND SOTRADECOL. THE PHYSICIAN THEN SUCCESSFULLY PLACED A RUBY COIL, AND THEN INJECTED MORE OF THE MIXTURE. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER THE RUBY COIL BECAME STUCK WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE ATTEMPTED TO RETRACT AND REMOVE THE RUBY COIL, HOWEVER THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER, AND THEREFORE THE MICROCATHETER WAS REMOVED WITH THE EMBOLIZATION COIL INSIDE. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396011 ↗
• MalfunctionMar 22, 2018Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN LOST ACCESS INTO THE GDA AND DECIDED TO WITHDRAW THE COIL. HOWEVER, WHILE RE-SHEATHING THE RUBY COIL OUTSIDE OF THE PATIENT¿S BODY, IT BECAME DETACHED. THEREFORE, 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 7361845 ↗
• MalfunctionMar 6, 2018Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  WHILE PREPARING A NEW RUBY COIL AND POD PACKING COIL (PODJ) FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT BOTH COILS WERE DETACHED UPON REMOVAL FROM THEIR DISPENSER HOOPS. THE DETACHED RUBY COIL AND PODJ WERE FOUND PRIOR TO USE. THEREFORE, THE COILS WERE NOT USED IN THE PROCEDURE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7317945 ↗
• MalfunctionFeb 23, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE MID-WAY THROUGH THE LANTERN AND THE RUBY COIL WOULDN'T 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 7293755 ↗
• MalfunctionFeb 13, 2018Separation Failure; Device Operates Differently Than Expected; Separation Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE, DESPITE THE PET LOCK ON THE PUSHER WIRE BEING SEPARATED. THE PHYSICIAN THEREFORE RETRACTED AND REMOVED THE RUBY COIL, AND COMPLETED THE PROCEDURE USING ADDITIONAL RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267956 ↗