RUBY Coil RBY2C2457-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI M424RBY2C24570), received between Aug 21, 2015 and Nov 30, 2021 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (30 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, IT WAS REPORTED THAT A RUBY COIL COULD NOT BE IMPLANTED. THEREFORE, THE RUBY COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12897604 ↗
• MalfunctionSep 30, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, POD PACKING COILS (PODJS), AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT. THE LANTERN WAS NOTED TO BE KINKED AND THEREFORE, WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND IMPLANTED ANOTHER RUBY COIL USING A NEW LANTERN. SUBSEQUENTLY, WHILE ADVANCING A PODJ THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PODJ UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED, AND THE PODJ WAS TAKEN OUT. IT WAS REPORTED THAT THE DETACHED PODJ WAS OBSERVED TO BE HANGING BY THE UNDERLYING NYLON UPON REMOVAL OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER PODJ AND THE SAME LANTERN. 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 10609933 ↗
• MalfunctionJul 31, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC CONGESTION USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. THE PHYSICIAN THEN ADVANCED, ANOTHER RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. NEXT, THE PHYSICIAN ADVANCED THE THIRD RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. 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 10352261 ↗
• MalfunctionJul 31, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC CONGESTION USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. THE PHYSICIAN THEN ADVANCED, ANOTHER RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. NEXT, THE PHYSICIAN ADVANCED THE THIRD RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. 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 10352236 ↗
• MalfunctionApr 4, 2020Physical 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 NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE PROXIMAL END OF THE MICROCATHETER, WHERE IT SUBSEQUENTLY BECAME STUCK AND DETACHED. THEREFORE, THE RUBY COIL WAS REMOVED FROM THE MICROCATHETER. 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 Consequences Or Impact To Patient

  MAUDE report 9926184 ↗
• MalfunctionMar 13, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FIBULAR ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE ANEURYSM SAC USING THE LANTERN. WHILE ADVANCING THE THIRD RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY HALF OF THE RUBY COIL AND IMMEDIATELY STOPPED ADVANCING THE RUBY COIL FORWARD. WHILE ATTEMPTING TO WITHDRAW THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ELEVEN 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 9831398 ↗
• MalfunctionDec 31, 2019Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE SECOND RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN; THEREFORE, IT WAS REMOVED AND RE-SHEATHED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, THE RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS NO LONGER USED. THE PHYSICIAN CONTINUED THE PROCEDURE USING TWO OTHER RUBY COILS AND THE SAME LANTERN. WHILE ADVANCING THE FIFTH RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. THE PHYSICIAN THEN RETRACTED THE RUBY COIL AND ATTEMPTED TO RE-SHEATH IT BACK INTO ITS INTRODUCER SHEATH; HOWEVER, TEN CENTIMETERS COULD NOT BE RE-SHEATHED. THEREFORE, THE RUBY COIL WAS NOT USED. 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 9537092 ↗
• MalfunctionSep 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL WITH A NON-PENUMBRA MICROCATHETER INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, IT WAS REMOVED. 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 Consequences Or Impact To Patient

  MAUDE report 9089395 ↗
• MalfunctionAug 28, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL INTO THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL, TOOK THE RUBY COIL OUT AND REINSERTED THE SAME MICROCATHETER INTO THE PATIENT'S BODY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THEN REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940790 ↗
• 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 8696268 ↗
• MalfunctionApr 23, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL BECAME KINKED APPROXIMATELY AN INCH IN FRONT OF THE DETACHMENT ZONE UPON REMOVING FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8541794 ↗
• MalfunctionMar 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL TO THE TIP OF THE LANTERN DELIVERY MICROCATHETER (LANTERN), IT WAS MET WITH A HARD STOP AND WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN THEREFORE REMOVED THE RUBY COIL AND THE PROCEDURE WAS COMPLETED USING OTHER COILS WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424309 ↗
• MalfunctionFeb 22, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE PAST THE ROTATING HEMOSTASIS VALVE (RHV); THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE BUT RESISTANCE WAS ENCOUNTERED. THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364633 ↗
• MalfunctionJan 25, 2019Failure to Advance; Failure to Advance

  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 EXPERIENCED FRICTION AND, THEREFORE, REMOVED THE RUBY COIL. THE PHYSICIAN THEN RE-ADJUSTED THE LANTERN AND ATTEMPTED TO RE-ADVANCE THE SAME RUBY COIL; HOWEVER, FRICTION WAS ENCOUNTERED AGAIN. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8277688 ↗
• MalfunctionJan 11, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN USED A 60CC SYRINGE TO ASPIRATE THE DETACHED RUBY COIL OUT OF THE LANTERN. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL, HOWEVER FELT RESISTANCE AFTER ADVANCING IT HALF WAY THROUGH THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND THE LANTERN; HOWEVER, THE LANTERN WAS NOTED TO BE KINKED MID SHAFT. THE PROCEDURE WAS THEREFORE COMPLETED USING NEW 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 8241520 ↗
• MalfunctionDec 28, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED THE RUBY COIL BECAUSE THE COIL WAS TOO LARGE FOR THE TARGET LOCATION. HOWEVER, WHILE RETRACTING WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN USED A SYRINGE TO CREATE NEGATIVE SUCTION AND REMOVED THE RUBY COIL. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COILS AND POD PACKING COILS WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204093 ↗
• MalfunctionDec 6, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY 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 WHILE ADVANCING ANOTHER RUBY COIL INTO THE LANTERN AND, THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. IT WAS REPORTED THAT THE PUSHER ASSEMBLY OF THE RUBY COIL WAS SLIGHTLY KINKED. THE PHYSICIAN THEN FLUSHED THE LANTERN AND WAS ABLE TO SUCCESSFULLY ADVANCE A GUIDEWIRE THROUGH THE LANTERN. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SAME RUBY COIL, HOWEVER, THE COIL WAS UNABLE TO ADVANCE AND THE RUBY COIL BECAME STUCK BETWEEN A NEURON 6F 070 DELIVERY CATHETER (NEURON 070) AND NEURON SELECT CATHETER 5F (5F SELECT). THEREFORE, THE LANTERN, 5F SELECT, AND NEURON 070 WERE REMOVED WITH THE RUBY COIL INSIDE. THE PUSHER ASSEMBLY OF THE RUBY COIL THEN BECAME KINKED IN SEVERAL MORE LOCATIONS. THE PHYSICIAN THEN REINSERTED THE SAME NEURON 070, 5F SELECT, AND LANTERN, AND THEN SUCCESSFULLY PLACED ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8137658 ↗
• MalfunctionSep 28, 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 SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING TWO RUBY COILS THROUGH THE LANTERN AND, THEREFORE, THE RUBY COILS WERE 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 7920323 ↗
• MalfunctionSep 11, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN INADVERTENTLY KINKED A RUBY COIL PUSHER ASSEMBLY WHILE ATTEMPTING TO ADVANCE IT THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE 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 7865923 ↗
• MalfunctionJul 5, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION TO TREAT AN ABDOMINAL AORTIC ANEURYSM ENDOLEAK (AAA ENDOLEAK) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED TWO RUBY COILS IN THE TARGET VESSEL AND USED A HANDLE TO DETACH THE COILS. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL IN THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH COMPLETELY. IT WAS REPORTED THAT THE HANDLE WAS NOT MAKING THE SAME CLICKING SOUND. THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE AND SUCCESSFULLY DETACHED THE RUBY COIL. NEXT, THE HOSPITAL TECHNOLOGIST, BENT AND BROKE A RUBY COIL PUSHER ASSEMBLY ON THE BACK TABLE WHILE REMOVING THE RUBY COIL OUT OF THE DISPENSER HOOP. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7665080 ↗
• MalfunctionJun 5, 2018Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Device Handling Problem; Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DETERMINED THAT THE RUBY COIL WAS THE WRONG SIZE AND REMOVED IT INTACT. WHILE RE-SHEATHING THE RUBY COIL, THE HOSPITAL TECHNOLOGIST PULLED TOO HARD AND THE RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY. 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 7571342 ↗
• MalfunctionApr 24, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER. 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 7454990 ↗
• MalfunctionApr 24, 2018Inadequacy of Device Shape and/or Size; Failure to Advance; Physical Resistance; Inadequacy of Device Shape and/or Size; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO FULLY ADVANCE A PODJ AND A RUBY COIL OUT OF THE DISTAL TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN) BECAUSE THE COILS WERE TOO LARGE. THE PHYSICIAN THEREFORE REMOVED THE PODJ AND THE RUBY COIL AND PLACED THEM ON THE BACK TABLE. LATER IN THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REUSE THE PODJ AND RUBY COIL, HOWEVER WAS UNABLE TO ADVANCE THE COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE LANTERN. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER PODJ, HOWEVER LOST ACCESS WITH THE LANTERN AND DIAGNOSTIC CATHETER, CAUSING THE PODJ TO BREAK IN HALF. THE PHYSICIAN ATTEMPTED TO REMOVE THE PODJ; HOWEVER, THE SR WIRE INSIDE THE PODJ THEN SNAPPED IN HALF, AND THE PODJ UNRAVELED. THE PHYSICIAN ATTEMPTED TO PULL OUT THE PODJ BY PULLING THE SR WIRE, HOWEVER, WAS UNABLE TO REMOVE THE EMBOLIZATION COIL. THE PHYSICIAN, THEREFORE, CUT THE SR WIRE OF THE PODJ AND PUSHED THE EMBOLIZATION COIL INTO THE TARGET LOCATION. THE EMBOLIZATION PART OF THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO ALLEGED DEFICIENCY AGAINST THE LANTERN AND THERE WAS NO RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454765 ↗
• MalfunctionApr 3, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A LANTERN THROUGH A NON-PENUMBRA SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN BECAME KINKED. SUBSEQUENTLY, A RUBY COIL WOULD NOT ADVANCE THROUGH THE LANTERN; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, NEW RUBY COILS AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393001 ↗
• MalfunctionMar 15, 2018Bent; Physical Resistance; Bent; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL ABOUT HALFWAY THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), AND CONSEQUENTLY THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT. IT WAS REPORTED THAT THE RUBY COIL¿S PUSHER ASSEMBLY WAS NOT ALIGNED WELL WITH THE ROTATING HEMOSTASIS VALVE (RHV). THE RUBY COIL WAS THEREFORE REMOVED AND 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 7341450 ↗