RUBY Coil RBY2C1460-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI M424RBY2C14600), received between Aug 13, 2015 and Sep 6, 2022 — classified as 4 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (44 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL APPROXIMATELY THROUGH THE PROXIMAL TO MID-SHAFT SECTION OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE OR RETRACT THE RUBY COIL. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS REPORTED THAT WHILE REMOVING THE DETACHED RUBY COIL FROM THE MICROCATHETER, THE RUBY COIL UNRAVELED. THE PROCEDURE WAS COMPLETED BY 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 15363023 ↗
• MalfunctionFeb 16, 2022Premature Separation; 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 RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHILE BEING ADVANCE IN THE TORTUOUS SEGMENT OF THE SPLENIC ARTERY. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541371 ↗
• 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 12741601 ↗
• MalfunctionFeb 16, 2021Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUNG 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 SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11335975 ↗
• MalfunctionJul 27, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA SHEATH, A NON-PENUMBRA SELECT CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO RUBY COILS IN THE ANEURYSM USING THE LANTERN. WHILE ADVANCING THE THIRD RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN IN THE EXTERNAL ILIAC ARTERY. THEREFORE, THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE DETACHED RUBY COIL OUT OF THE LANTERN AND INTO THE ANEURYSM. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE RUBY COIL PUSHER ASSEMBLY WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL 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 10329817 ↗
• MalfunctionFeb 28, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK AND SUBSEQUENTLY ITS PUSHER ASSEMBLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED AND THE RUBY COIL WAS THEREFORE 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 Consequences Or Impact To Patient

  MAUDE report 9767827 ↗
• InjuryDec 23, 2019Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT TESTICULAR VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A SECOND RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER THE MAJORITY OF THE RUBY COIL HAD EXITED THE MICROCATHETER. THE PHYSICIAN REPORTED THAT THERE WAS ¿DISRUPTION¿ WITH THE DISTAL MARKER ON THE PUSHER ASSEMBLY (BETWEEN THE END OF THE COIL AND THE DISTAL MARKER ON THE PUSHER ASSEMBLY). IT WAS ALSO REPORTED THAT IT WAS CREATING A ¿Z¿ SHAPE OR SLIDING OVER ITSELF. AFTER PULLING BACK ON THE PUSHER ASSEMBLY, HALF OF THE RUBY COIL REMAINED IN THE MICROCATHETER. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER, BUT THE RUBY COIL FAILED TO ADVANCE. WHILE WITHDRAWING THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS UNRAVELING AND FOLLOWING THE PATH OF THE MICROCATHETER. SINCE PART OF THE RUBY COIL REMAINED IN THE PATIENT, THE PHYSICIAN PERFORMED A COMPUTED TOMOGRAPHY (CT) AND NOTICED RADIOLUCENT FILAMENT EXTENDING INTO THE ATRIUM OF THE HEART. THE RUBY COIL WAS REMOVED USING A SNARE. IT WAS REPORTED THAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513301 ↗
• MalfunctionNov 22, 2019Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS) AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED FROM THE PATIENT AND THE DETACHED RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN CONTINUED THE PROCEDURE BY RE-ADVANCING THE SAME MICROCATHETER AND ANOTHER RUBY COIL INTO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE RUBY COIL USING THE HANDLE, THE PHYSICIAN REALIZED THAT THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS STUCK IN THE HANDLE. HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH AND IMPLANT THE RUBY COIL INTO THE TARGET VESSEL AFTER CLICKING THE HANDLE APPROXIMATELY 2-3 TIMES. IT WAS REPORTED THAT THE PUSHER ASSEMBLY REMAINED STUCK IN THE HANDLE; THEREFORE, THE HANDLE WAS REMOVED FROM THE PROCEDURE. UPON ADVANCING THE NEXT POD PC INTO THE MICROCATHETER, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ANOTHER RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365723 ↗
• MalfunctionAug 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 A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO EMBOLIZE THE INFLOW ARTERY, THE PHYSICIAN ADVANCED A RUBY COIL (LOT # C15823) INTO THE TARGET VESSEL USING A LANTERN AND, ATTEMPTED TO DEPLOY THE COIL. HOWEVER, THE RUBY COIL WAS PROLAPSING INTO THE ANEURYSM SACK DUE TO THE HIGH FLOW VESSEL AND, THEREFORE, THE RUBY COIL WAS REMOVED, RINSED IN SALINE BOWL AND, RE-SHEATHED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THREE LARGER SIZE RUBY COILS (LOT #¿S C15907, F90316 AND, C14897) BUT THE SAME ISSUE OCCURRED AND, ALL THREE RUBY COILS WERE PROLAPSING INTO THE ANEURYSM SACK. THEREFORE, ALL THREE RUBY COILS WERE REMOVED, RINSED IN SALINE BOWL AND, RE-SHEATHED FOR LATER USE. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA BALLOON CATHETER INTO THE VESSEL, INFLATED THE BALLOON TO STOP THE FLOW AND ATTEMPTED TO ADVANCE THE PREVIOUS RUBY COILS (LOT #¿S C15907, F90316 AND, C14897, C15823); HOWEVER, ALL FOUR COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. IT WAS REPORTED THAT THE RUBY COILS WERE COAGULATED WITH BLOOD INSIDE THEIR IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923535 ↗
• MalfunctionAug 22, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING PREPARATION FOR THE PROCEDURE, THE PUSHER WIRE OF A RUBY COIL BECAME KINKED WHILE ADVANCING INTO A PX SLIM DELIVERY MICROCATHETER. TWO ADDITIONAL RUBY COILS ALSO BECAME KINKED WHILE ADVANCING INTO THE PX SLIM. THE PROCEDURE SUCCESSFULLY CONTINUED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8923285 ↗
• MalfunctionFeb 22, 2019Retraction Problem; Failure to Advance; Physical Resistance/Sticking; Retraction Problem; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN 2/3 OF THE WAY THROUGH THE LANTERN. THE RUBY COIL WAS THEN RETRACTED AND RE-ADVANCED, HOWEVER IT BECAME STUCK AT THE SAME PLACE WITHIN THE LANTERN. THE RUBY COIL WAS THEN REMOVED AND THE LANTERN WAS FLUSHED. UPON ADVANCEMENT OF ANOTHER RUBY COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THIS RUBY COIL WAS ALSO REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A THIRD RUBY COIL THROUGH THE LANTERN, AND THE SAME ISSUE AGAIN OCCURRED. THE THIRD RUBY COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME LANTERN. AFTER THE PROCEDURE, THE RUBY COILS WERE INSPECTED AND WERE FOUND TO HAVE VISIBLE DISINTEGRATION OF THE COIL BRAID NEAR THE DETACHMENT ZONE. IT WAS ALSO REPORTED THAT NO PIECES OF THE DAMAGED COILS WERE LEFT IN THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362725 ↗
• MalfunctionJan 22, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING PREPARATION FOR THE PROCEDURE, A LANTERN WAS ACCIDENTALLY DROPPED ON THE GROUND. THE LANTERN WAS DROPPED PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW LANTERN. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A COIL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY BECAME KINKED; THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PROCEDURE WAS CONTINUED 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 8268373 ↗
• InjuryJan 4, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER WHEN IT UNINTENTIONALLY DETACHED. THE RUBY COIL WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE, AND 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 8219014 ↗
• MalfunctionDec 11, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ADVANCED A RUBY COIL INTO THE TARGET VESSEL BUT FELT RESISTANCE WHILE ADVANCING. THE RUBY COIL WOULD NOT ADVANCE MORE THAN HALFWAY THROUGH THE LANTERN. THE RUBY COIL WAS THEN RETRACTED AND RE-SHEATHED. A SECOND ATTEMPT WAS MADE TO ADVANCE THE RUBY COIL, BUT THE SAME ISSUE OCCURRED. THE RUBY COIL WAS THEN 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 8151583 ↗
• MalfunctionNov 12, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE RETRACTING TWO RUBY COILS FOR RE-POSITIONING, THE PHYSICIAN EXPERIENCED FRICTION AND SUBSEQUENTLY, THE RUBY COILS UNINTENTIONALLY DETACHED INSIDE THE LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COILS AND FLUSHED THE COILS OUT. 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 8062800 ↗
• MalfunctionNov 2, 2018Break; Device Damaged Prior to Use; Material Deformation; Break; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL, THE NURSING STAFF ACCIDENTALLY KINKED THE PUSHER WIRE AND THE RUBY COIL DETACHED. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8034014 ↗
• InjuryOct 29, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER BUT DECIDED TO RETRACT THE RUBY COIL FOR REPOSITIONING. WHILE REPOSITIONING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS 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 8017574 ↗
• MalfunctionOct 18, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT ENDOLEAK IN THE ILLIO-LUMBAR ASCENDING VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS EXTREMELY TINY. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT TRACK THROUGH THE LANTERN; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN OPENED A NEW RUBY COIL AND ATTEMPTED TO ADVANCE IT THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE RUBY COIL WOULD NOT TRACK THROUGH THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL AND FLUSH IT OUT. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7982465 ↗
• MalfunctionJul 5, 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. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; 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 7664087 ↗
• MalfunctionJun 29, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE TO TREAT VARICES PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETETER (LANTERN), THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL FOR REPOSITIONING. THE RUBY COIL WAS RINSED IN SALINE AFTER BEING REMOVED BUT WHEN THE PHYSICIAN ATTEMPTED TO REUSE IT, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651051 ↗
• MalfunctionJun 28, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE HUB OF A NON-PENUMBRA MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE. SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY 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 7646261 ↗
• MalfunctionJun 25, 2018Stretched; Failure to Advance; Stretched; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN, THE RUBY COIL WOULD EXIT THE END OF THE LANTERN; THEREFORE, IT WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL WAS "STRETCHED" AND THE PHYSICIAN DID NOT WANT TO RE-USE IT. THE PHYSICIAN ALSO REMOVED THE LANTERN AND FOUND THAT THE TIP OF THE LANTERN WAS SLIGHTLY KINKED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND SIX ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7634674 ↗
• MalfunctionMay 16, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN FOUND THAT THE PUSHER ASSEMBLY OF THE RUBY COIL WAS BROKEN UPON REMOVAL FROM THE PACKAGING. IN ADDITION, THERE WAS A WIRE HANGING BETWEEN THE TWO PARTS OF THE BROKEN PUSHER ASSEMBLY. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7520184 ↗
• MalfunctionMay 1, 2018Detachment Of Device Component; Failure to Advance; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL FULLY OUT OF THE TIP OF THE LANTERN; THE RUBY COIL WAS ABLE TO ADVANCE ABOUT 1/4TH OF THE WAY OUT OF THE LANTERN BEFORE IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE DETACHED RUBY COIL INSIDE. THE PHYSICIAN THEN INSERTED A NEW LANTERN, HOWEVER THIS SAME ISSUE OCCURRED WITH A SECOND RUBY COIL, AND THEREFORE THE LANTERN WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND THE SECOND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476943 ↗
• MalfunctionMay 1, 2018Detachment Of Device Component; Failure to Advance; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL FULLY OUT OF THE TIP OF THE LANTERN; THE RUBY COIL WAS ABLE TO ADVANCE ABOUT 1/4TH OF THE WAY OUT OF THE LANTERN BEFORE IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE DETACHED RUBY COIL INSIDE. THE PHYSICIAN THEN INSERTED A NEW LANTERN, HOWEVER THIS SAME ISSUE OCCURRED WITH A SECOND RUBY COIL, AND THEREFORE THE LANTERN WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND THE SECOND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476942 ↗