RUBY Coil RBY2C1660-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI M424RBY2C16600), received between Aug 13, 2015 and Nov 9, 2021 — classified as 2 injuries, 65 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.

• InjuryNov 9, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL OUT FROM THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PLACED TWO RUBY COILS IN THE VESSEL USING THE PX SLIM. SUBSEQUENTLY, WHILE ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783771 ↗
• MalfunctionJun 29, 2021Failure 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, A RUBY COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE 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

  MAUDE report 12084273 ↗
• MalfunctionNov 13, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATHS, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. 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 10840745 ↗
• MalfunctionAug 26, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC PAIN DISEASE IN THE OVARIAN VARICOSE VEIN USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL APPROXIMATELY FOUR TO FIVE CENTIMETERS AND THE PHYSICIAN WAS NOT SATISFIED; THEREFORE, THE RUBY COIL WAS RETRACTED BACK INTO THE PX SLIM. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL A FEW CENTIMETERS AND WAS UNSATISFIED WITH THE RUBY COIL DEPLOYMENT AND RETRACTED THE RUBY COIL BACK WITHIN THE PX SLIM. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE RUBY COIL AND PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457264 ↗
• MalfunctionMar 5, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND, SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN PULLED THE DETACHED RUBY COIL OUT FROM THE MICROCATHETER AND SUCCESSFULLY REMOVED THE 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 Consequences Or Impact To Patient

  MAUDE report 9795587 ↗
• MalfunctionFeb 28, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PHYSICIAN THEN, ADVANCED A NEW RUBY COIL THROUGH A NEW LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770240 ↗
• MalfunctionFeb 3, 2020Failure to Advance; Failure to Advance

  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 SUCCESSFULLY PLACED THE FIRST RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. HOWEVER, THE NEXT RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 9660821 ↗
• MalfunctionOct 14, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK IN THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE LANTERN TO REMOVE THE RUBY COIL, BUT IT WAS AGAIN STUCK; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED AS ONE UNIT. WHILE FLUSHING THE LANTERN, A BUNCH OF CLOT CAME OUT. IT WAS REPORTED THAT THIS MAY HAVE BEEN THE CONTRIBUTING CAUSE TO THE RUBY COIL BECOMING STUCK IN THE LANTERN. THE PHYSICIAN RESUMED THE PROCEDURE USING TWO OTHER RUBY COILS AND THE SAME LANTERN. UPON PERFORMING THE FINAL ANGIOGRAM, IT WAS NOTICED THAT THE IMA WAS FULL OF CLOT. SUBSEQUENTLY, A CAT6 WAS OPENED TO ASPIRATE THE CLOT. HOWEVER, THE CAT6 WAS INADVERTENTLY DROPPED OUTSIDE OF THE STERILE FIELD. THE CAT6 WAS CONTAMINATED PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188363 ↗
• MalfunctionOct 1, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE FIRST TWO RUBY COILS THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO OTHER RUBY COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9141878 ↗
• 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 8923279 ↗
• MalfunctionJul 25, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A EMBOLIZATION PROCEDURE IN THE POPLITEAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN MADE A DIRECT STICK INTO THE PATIENT'S ANATOMY, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, WHILE ADVANCING THE RUBY COIL, IT BECAME STUCK WITHIN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE NON-PENUMBRA MICROCATHETER WAS THEN RE-POSITIONED AND THE PHYSICIAN ATTEMPTED AGAIN TO ADVANCE THE SAME RUBY COIL; HOWEVER, THE COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS THEN REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL WITH THE SAME NON-PENUMBRA MICROCATHETER, BUT SAME ISSUE OCCURRED; THEREFORE, THE COIL WAS REMOVED. THE PHYSICIAN RE-POSITIONED THE NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO ADVANCE A THIRD RUBY COIL; HOWEVER, IT BECAME STUCK IN THE NON-PENUMBRA MICROCATHETER; THEREFORE, THE NON-PENUMBRA MICROCATHETER AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND SUCCESSFULLY PLACED 15 RUBY COILS WITHOUT AN ISS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826512 ↗
• MalfunctionJul 3, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A NEW RUBY COIL INTO THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, POD PACKING 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 8758404 ↗
• MalfunctionJun 26, 2019Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL NEAR THE DISTAL TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THE RUBY COIL BECAME STUCK. THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT IT. HOWEVER, WHILE RETRACTING THE RUBY COIL, IT BROKE AND BEGAN TO UNWIND. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND THE RUBY COIL TOGETHER. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS. THE PROCEDURE WAS THEN COMPLETED USING 13 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 8734994 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY AND THE AORTA USING POD5S AND RUBY COILS. DURING THE PROCEDURE, THE FELLOW ACCIDENTALLY DROPPED A POD5 ON THE FLOOR WHILE REMOVING IT FROM THE PACKAGING HOOP. THE POD5 WAS DROPPED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS THEN CONTINUED USING A NEW POD5. THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE FELLOW THEN ACCIDENTALLY KINKED A RUBY COIL (F83494) WHILE REMOVING IT FROM THE PACKAGING HOOP. THE PHYSICIAN STILL ATTEMPTED TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, HOWEVER, WAS UNABLE TO. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED. THROUGHOUT THE REMAINDER OF THE PROCEDURE, THREE MORE RUBY COILS WERE INADVERTENTLY KINKED UPON REMOVAL FROM THEIR PACKAGING HOOPS AND, THEREFORE, NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8575043 ↗
• MalfunctionMay 2, 2019Failure to Advance; Material Split, Cut or Torn; Physical Resistance/Sticking; Failure to Advance; Material Split, Cut or Torn; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC 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 ADVANCE ANOTHER RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT A SLIT WAS FOUND AT THE TIP OF THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, POD, POD PACKING COILS (POD PC), 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 8574834 ↗
• MalfunctionApr 19, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS AND OTHER COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK AFTER ADVANCING A FEW CENTIMETERS PAST THE HUB OF THE MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN MADE SEVERAL ATTEMPTS TO ADVANCE THE RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532567 ↗
• MalfunctionMar 1, 2019Failure 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. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE OR RETRACT ANOTHER RUBY COIL WITHIN THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PULL THE RUBY COIL OUT OF THE MICROCATHETER, AND THEN ANOTHER RUBY COIL WAS SUCCESSFULLY PLACED. THE PHYSICIAN THEN AGAIN FELT RESISTANCE AND WAS UNABLE TO ADVANCE OR RETRACT ANOTHER RUBY COIL. THIS RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER AS WELL, AND WAS REMOVED BY PULLING THE COIL OUT FROM THE PROXIMAL END OF THE MICROCATHETER. THE PROCEDURE WAS THEN 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; No Known Impact Or Consequence To Patient

  MAUDE report 8381044 ↗
• MalfunctionJan 4, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING POD4S AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO POD PACKING COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ATTEMPTED TO PLACE A POD4 INTO THE TARGET VESSEL USING THE LANTERN, HOWEVER, THE POD4 WAS NOT TAKING ITS INTENDED SHAPE. THE POD4 WAS THEREFORE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A RUBY COIL USING THE SAME LANTERN, HOWEVER, THE RUBY COIL WAS NOT TAKING ITS INTENDED SHAPE. THE RUBY COIL WAS, THEREFORE, ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING 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 8219313 ↗
• MalfunctionSep 18, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING TWO RUBY COILS THROUGH THE LANTERN; THEREFORE, THE RUBY COILS WERE REMOVED. UPON REMOVAL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN WHILE RE-SHEATHING THE RUBY COILS. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ADDITIONAL RUBY COILS IN THE TARGET VESSEL USING THE SAME LANTERN. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING A NEW RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO THE LANTERN. THE PHYSICIAN CONTINUED ADVANCING THE RUBY COIL THROUGH THE LANTERN; HOWEVER, AS THE FIRST EMBOLIZATION COIL LOOP EXITED THE LANTERN, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN USED A 60CC SYRINGE TO APPLY ASPIRATION WITHIN THE LANTERN AND REMOVED THE LANTERN AND DETACHED RUBY COIL FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT DUE TO REACHING A SAFE CONTRAST LIMIT FOR THE PATIENT. THERE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887701 ↗
• MalfunctionSep 7, 2018Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS; THEREFORE, THE LANTERN AND RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857465 ↗
• MalfunctionAug 3, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILLIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) THE PHYSICIAN EXPERIENCED RESISTANCE AND, CONSEQUENTLY, THE RUBY COIL PUSHER WIRE BECAME KINKED; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COIL. 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 7747717 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT ADVANCING INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT SAME ISSUE OCCURRED WITH FOUR OTHER RUBY COILS. UPON TURNING ON THE LIGHTS IN THE OPERATING ROOM, IT WAS NOTICED THAT THE EMBOLIZATION COILS WERE ON THE GROUND. IT WAS CONCLUDED THAT THE FIVE RUBY COILS, UNKNOWINGLY AT THE TIME, HAD DETACHED UPON REMOVAL FROM THE PACKAGING HOOPS PRIOR TO THE ATTEMPTS MADE TO ADVANCE THEM INTO THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL IN THE TARGET VESSEL AND USED A HANDLE TO SUCCESSFULLY DETACH IT; HOWEVER, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, 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 7580727 ↗
• MalfunctionMay 31, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A FALSE LUMEN BEHIND A THORACIC GRAFT IN THE AORTA USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED AS THE PHYSICIAN WAS REPOSITIONING IT. THE PHYSICIAN, THEREFORE, REMOVED THE LANTERN DELIVERY MICROCATHETER (LANTERN) WITH THE DETACHED RUBY COIL INSIDE AND FLUSHED IT OUT ON THE BACK TABLE. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN 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 7557814 ↗
• MalfunctionMay 2, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, PRIOR TO USE, A RUBY COIL WAS DROPPED ON THE FLOOR WHILE BEING HANDED TO THE SCRUB TECHNOLOGIST BY THE NURSE. THEREFORE, THE RUBY COIL WAS SET ASIDE AND A NEW RUBY COIL WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. WHILE REMOVING ANOTHER RUBY COIL FROM THE DISPENSER HOOP, THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY. 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 Patient Involvement

  MAUDE report 7480663 ↗
• MalfunctionApr 23, 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 HOSPITAL TECHNICIAN ACCIDENTALLY DETACHED THE RUBY COIL (RUBY COIL) UPON REMOVAL FROM THE PACKAGING. THE RUBY COIL DETACHED PRIOR TO USE. 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 7452543 ↗