RUBY Coil RBY2C2060-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI M424RBY2C20600), received between Aug 17, 2015 and Feb 3, 2023 — classified as 2 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (28 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16298196 ↗
• MalfunctionJul 14, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER (PROGREAT), AND A NON-PENUMBRA SHEATH (DESTINATION). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH THE MICROCATHETER. WHILE ADVANCING THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE RUBY COIL WAS FORMING IN THE VESSEL; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITH PART OF THE COIL INSIDE THE MICROCATHETER AND PART IN THE VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL WITH A SYRINGE AND ASPIRATION. NEXT, THE PHYSICIAN PLACED MULTIPLE COILS SUCCESSFULLY. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL INTO THE MICROCATHETER, HOWEVER, RESISTANCE WAS MET AND THE RUBY COIL BECAME STUCK NEAR THE HUB OF THE CATHETER. WHILE RETRACTING THE COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023579 ↗
• MalfunctionJan 31, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, POD PACKING COIL (PODJ) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR RUBY COILS AND ONE PODJ IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING APPROXIMATELY HALF OF THE LENGTH OF A RUBY COIL THROUGH THE LANTERN AND INTO THE ANEURYSM SAC, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITH HALF OF THE RUBY COIL WITHIN THE LANTERN AND THE OTHER HALF WITHIN THE ANEURYSM SAC. THEREFORE, THE PHYSICIAN SLOWLY REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING RUBY COILS, POD COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13400357 ↗
• MalfunctionDec 13, 2021Physical 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, RESISTANCE WAS ENCOUNTERED WHEN A RUBY COIL WAS ADVANCED HALFWAY INTO THE MICROCATHETER. UPON RETRACTION, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN FLUSHED THE DETACHED RUBY COIL INTO THE TARGET VESSEL. SUBSEQUENTLY, THE MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12985631 ↗
• MalfunctionNov 30, 2021Entrapment of Device; Failure to Advance; Physical Resistance/Sticking; Entrapment of Device; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL WITHIN ITS INTRODUCER SHEATH AND INTO THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. AFTER PULLING APPROXIMATELY FIVE TO TEN CENTIMETERS OF THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH, THE RUBY COIL BECAME STUCK. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE PULLING THE PUSHER ASSEMBLY OF THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO PULL OUT THE ENTIRE PUSHER ASSEMBLY OUT OF THE LANTERN AND SUBSEQUENTLY, THE DISTAL END OF THE COIL BECAME STUCK INSIDE THE ROTATING HEMOSTASIS VALVE (RHV) OF THE LANTERN. THE PHYSICIAN THEN DISCONNECTED THE RHV FROM THE LANTERN AND CONFIRMED THAT THE DISTAL END OF THE RUBY COIL WAS INSIDE. THE PHYSICIAN ATTEMPTED TO FLUSH OVER THE SIDE PORT AND FROM THE TIP OF THE RHV TO HELP LOOSEN THE RUBY COIL AND BE ABLE TO REMOVE THE RUBY COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE RHV WITH THE RUBY COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A NEW RHV AND THE SAME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901513 ↗
• MalfunctionSep 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL VEIN USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL AND HANDLE WERE REMOVED. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PHYSICIAN THEN INSERTED A NEW MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, NEW RUBY COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447543 ↗
• MalfunctionSep 9, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL VEIN USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL AND HANDLE WERE REMOVED. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PHYSICIAN THEN INSERTED A NEW MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, NEW RUBY COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447540 ↗
• MalfunctionAug 30, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL HALFWAY THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE RUBY COIL TO CHECK IF THE MICROCATHETER WAS STILL PLACED IN ITS CORRECT POSITION. AFTER CONFIRMING THAT THE MICROCATHETER WAS STILL PLACED IN ITS CORRECT POSITION AND THAT THE MICROCATHETER COULD BE FLUSHED WITHOUT ANY PROBLEM, THE PHYSICIAN RE-INSERTED THE RUBY COIL INTO THE MICROCATHETER. HOWEVER, WHILE ADVANCING THE RUBY COIL HALFWAY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND DECIDED TO RETRACT IT. WHILE RETRACTING THE RUBY COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY WITH PART OF THE RUBY COIL OUTSIDE THE PATIENT AND THE OTHER PART INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN WAS ABLE TO PULL THE DETACHED RUBY COIL OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS, TWO POD PACKING COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12384717 ↗
• MalfunctionMay 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN THE LEFT VENTRICLE USING A RUBY COIL AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL COULD NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852746 ↗
• MalfunctionMar 5, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. WHILE THE PHYSICIAN ATTEMPTED TO GENTLY RETRACT THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED AND BROKE INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11422323 ↗
• MalfunctionNov 25, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT TYPE II ENDOLEAK USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE ADVANCING A NEW RUBY COIL THROUGH THE DISTAL END OF THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE RUBY COIL BACK INTO THE DISTAL TIP OF THE LANTERN AND THEN REMOVED THE LANTERN WITH THE RUBY COIL TOGETHER FROM THE PATIENT. AFTERWARDS, THE RUBY COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL RUBY COILS, THE SAME LANTERN, AND THE SAME 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 10903851 ↗
• 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 10352241 ↗
• MalfunctionJul 10, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE IB ENDOLEAK IN THE IN LUMBAR ARTERY USING LANTERN DELIVERY MICROCATHETERS (LANTERNS), RUBY COILS, A NON-PENUMBRA SHEATH AND A NON-PENUMBRA SELECTIVE CATHETER. IT WAS NOTED THAT THE PATIENT¿S VESSEL ANATOMY WAS ELONGATED AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED LANTERN TO THE TARGET VESSEL USING THE SHEATH AND SELECTIVE CATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK AT THE MARKER BAND ON THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED TOGETHER FROM THE PATIENT. THE PHYSICIAN THEN ADVANCED A NEW LANTERN INTO THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK AT THE MARKER BAND ON THE DISTAL END OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT AFTER REMOVING THE RUBY COIL FROM THE LANTERN, IT WAS NOTICED THAT THE RUBY COIL WAS DAMAGED AND WAS UNABLE TO BE RETRACTED BACK INTO ITS INTRODUCER SHEATH. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL THROUGH THE LANTERN, BUT THE RUBY COIL ALSO BECAME STUCK LIKE THE FIRST TWO RUBY COILS. THEREFORE, THE RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256338 ↗
• MalfunctionJun 19, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL JUGULAR VEIN USING RUBY COILS, POD PACKING COILS (PODJ) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL (C16974) INTO THE TARGET VESSEL USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCING THE LAST THREE CENTIMETERS OF THE COIL AND, THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE COIL BECAME UNRAVELED. THEREFORE, THE PX SLIM WAS REMOVED CONTAINING THE UNRAVELED RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO REMOVE IT. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL (F91740) THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN WHILE ADVANCING THE LAST THREE CENTIMETERS OF THE RUBY COIL. THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL, THE SAME ISSUE OCCURRED, AND THE RUBY COIL BECAME UNRAVELED. IT WAS ALSO REPORTED THAT THE RUBY COIL WAS CUT FROM THE END AS IT WAS STUCK INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM CONTAINING THE REMAINING RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176886 ↗
• MalfunctionJan 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DIAGNOSTIC CATHETER AND THE LANTERN IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO ADDITIONAL RUBY COILS THROUGH THE LANTERN, HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN THEN REMOVED THE DIAGNOSTIC CATHETER AND LANTERN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 9628920 ↗
• MalfunctionDec 11, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, THE SAME HANDLE AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454455 ↗
• 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 8923530 ↗
• MalfunctionMay 8, 2019Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO INSERT A NEW RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PUSHER ASSEMBLY BECAME KINKED WITH HALF OF THE RUBY COIL INSIDE OF THE HUB OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL HAD DETACHED UPON INSPECTION OUTSIDE OF THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY 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 8591877 ↗
• MalfunctionApr 26, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PUSHER ASSEMBLY BECAME KINKED WHILE ATTEMPTING TO ADVANCE THE RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN). 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 8557461 ↗
• MalfunctionApr 17, 2019Physical 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. DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), APPROXIMATELY 8 CENTIMETERS FROM THE DISTAL TIP, IT WAS MET WITH A HARD STOP AND THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE RUBY COIL WAS RETRACTED BACK INTO THE INTRODUCER SHEATH. WHILE ATTEMPTING TO ADVANCE THE SAME RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF THE INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. NEXT, WHILE ADVANCING A NEW RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE COIL BACK INTO THE INTRODUCER SHEATH. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITH HALF OF THE COIL INSIDE THE INTRODUCER SHEATH AND HALF OF THE COIL OUT OF THE INTRODUCER SHEATH. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED RUBY COIL BY REMOVING THE INTRODUCER SHEATH FROM THE MICROCATHETER. 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 8523079 ↗
• MalfunctionApr 17, 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 INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), APPROXIMATELY 8 CENTIMETERS FROM THE DISTAL TIP, IT WAS MET WITH A HARD STOP AND THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE RUBY COIL WAS RETRACTED BACK INTO THE INTRODUCER SHEATH. WHILE ATTEMPTING TO ADVANCE THE SAME RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF THE INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. NEXT, WHILE ADVANCING A NEW RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE COIL BACK INTO THE INTRODUCER SHEATH. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITH HALF OF THE COIL INSIDE THE INTRODUCER SHEATH AND HALF OF THE COIL OUT OF THE INTRODUCER SHEATH. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED RUBY COIL BY REMOVING THE INTRODUCER SHEATH FROM THE MICROCATHETER. 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 8523075 ↗
• MalfunctionMar 22, 2019Device Handling Problem; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING RUBY COILS. DURING THE PROCEDURE, AN UNSPECIFIED ISSUE OCCURRED WITH THE RUBY COIL, PRIOR TO ENTERING THE PATIENT. HOWEVER, IT WAS REPORTED THAT PERHAPS THE ORANGE INTRODUCER SHEATH WAS ACCIDENTALLY PULLED OFF. IT WAS ALSO REPORTED THAT THERE WAS NO DAMAGE TO THE RUBY COIL. THE RUBY COIL WAS THEN SET ASIDE AND WAS NO LONGER USED IN THE PROCEDURE. 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 8444459 ↗
• 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 8424308 ↗
• MalfunctionMar 1, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PUSHER ASSEMBLY OF A RUBY COIL WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE RUBY COIL WAS THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8382842 ↗
• MalfunctionFeb 1, 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. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER AND, WHILE RETRACTING AND RE-ADVANCING, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER AND RUBY COIL WERE THEREFORE REMOVED TOGETHER FROM THE PATIENT AND THE RUBY COIL WAS RETRIEVED FROM THE MICROCATHETER. THE MICROCATHETER WAS THEN RE-ADVANCED INTO THE PATIENT'S VESSEL AND THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296984 ↗