RUBY Coil RBY2C0630-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI M424RBY2C06300), received between Aug 14, 2015 and May 8, 2021 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (16 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2021Failure 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 AND A MICROCATHETER. DURING THE PROCEDURE, WHILE THE PHYSICIAN ADVANCED A RUBY COIL HALFWAY THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL WAS REMOVED. AFTERWARDS, WHILE THE PHYSICIAN ADVANCED A NEW RUBY COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE RUBY COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED TOGETHER. 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 11795223 ↗
• MalfunctionMay 8, 2021Failure 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 AND A MICROCATHETER. DURING THE PROCEDURE, WHILE THE PHYSICIAN ADVANCED A RUBY COIL HALFWAY THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL WAS REMOVED. AFTERWARDS, WHILE THE PHYSICIAN ADVANCED A NEW RUBY COIL THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE RUBY COIL BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED TOGETHER. 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 11795222 ↗
• MalfunctionJan 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WOULD ONLY ADVANCE APPROXIMATELY HALFWAY THROUGH THE LANTERN AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, BOTH THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS 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; No Consequences Or Impact To Patient

  MAUDE report 11125336 ↗
• MalfunctionJul 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; 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 10256294 ↗
• MalfunctionMar 12, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD, RUBY COILS, A POD PACKING COIL (POD PC) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A POD COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN THEN IMPLANTED A NEW RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE INSERTING A POD PC INTO THE HUB OF THE MICROCATHETER, THE POD PC UNINTENTIONALLY DETACHED IN THE HUB OF THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED AND THE POD PC WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA 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 9825900 ↗
• MalfunctionNov 5, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE RUBY COIL APPROXIMATELY FIVE CENTIMETERS WITHIN THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD AND POD PACKING COILS (POD PC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282434 ↗
• MalfunctionOct 11, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL DETACHED PARTIALLY IN THE INTRODUCER SHEATH AND PARTIALLY INTO THE LANTERN; THEREFORE, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL OUT FROM THE LANTERN. THE HOSPITAL TECHNOLOGIST THEN ATTEMPTED TO ADVANCE ANOTHER TWO RUBY COILS; HOWEVER, THEY DETACHED PARTIALLY IN THE INTRODUCER SHEATH AND PARTIALLY INTO THE LANTERN. THEREFORE, THE HOSPITAL TECHNOLOGIST PULLED THE TWO RUBY COILS OUT FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING OTHER 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 9182855 ↗
• InjuryAug 29, 2019Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FISTULA OFF THE LEFT MAIN CORONARY ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD5 AND TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). HOWEVER, AFTER DETACHING THE SECOND RUBY COIL AS THE THIRD COIL, THE PHYSICIAN NOTICED A FEW PROXIMAL COIL LOOPS MOVED BACK. IT WAS REPORTED THAT THE PHYSICIAN DID NOT WANT THE COIL TO LAND TOO PROXIMAL; THEREFORE, A NON-PENUMBRA SNARE DEVICE WAS ADVANCED THROUGH A NON-PENUMBRA DIAGNOSTIC CATHETER TO SNARE THE RUBY COIL. DURING REMOVAL, THE RUBY COIL BROKE THE DIAGNOSTIC CATHETER; THEREFORE, THE PHYSICIAN DOCKED THE SNARE DEVICE TO THE COIL FILAMENT AS A WIRE EXTENDER. NEXT, THE PHYSICIAN RE-ADVANCED THE SAME LANTERN THROUGH THE DIAGNOSTIC CATHETER AND OVER THE BROKEN RUBY COIL AND CAREFULLY PULLED THE FILAMENT BACK WHILE ADVANCING THE LANTERN FORWARD. THE REMAINDER OF THE RUBY COIL WAS RECAPTURED INTO THE LANTERN AND THE ENTIRE SYSTEM WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS ENDED AT THIS POINT AND THE FINAL ANGIOGRAM SHOWED OCCLUSION OF THE FISTULA AS WELL AS A NORMAL AND UNOBSTRUCTED FLOW IN THE CORONARY ARTERIES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8946929 ↗
• MalfunctionJul 1, 2019Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL RUBY COILS IN THE TARGET VESSEL USING THE LANTERN AND A 5F GUIDE CATHETER. WHILE ADVANCING THE LAST RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE ATTEMPTING TO RETRACT THE RUBY COIL FOR REPOSITIONING, RESISTANCE WAS ALSO EXPERIENCED AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. IT WAS REPORTED THAT PART OF THE RUBY COIL UNRAVELED IN THE PATIENT¿S BODY. THEREFORE, THE PHYSICIAN REMOVED THE GUIDE CATHETER, THE LANTERN AND THE DETACHED RUBY COIL TOGETHER. THE PROCEDURE WAS ENDED AT THIS POINT AND NO ADDITIONAL COIL WAS NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750810 ↗
• 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 GASTRODUODENAL ARTERY (GDA) USING POD6S AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD5 IN THE TARGET VESSEL BUT IT WAS DEEMED TO BE SMALL; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A POD6 THROUGH A NON-PENUMBRA MICROCATHETER BUT RESISTANCE WAS FELT AND THE POD6 WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED THE PREVIOUSLY REMOVED POD5 IN THE MICROCATHETER TO CHECK FOR KINKS IN THE MICROCATHETER. AFTER REMOVING THE POD5, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE POD6 AGAIN THROUGH THE MICROCATHETER; HOWEVER, THE POD6 FAILED TO ADVANCE AND, THEREFORE, WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER POD6 THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED FRICTION AND, THE POD6 WOULD NOT ADVANCE AND WAS KINKED. THEREFORE, IT WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL, BUT IT WAS DEEMED TO BE LARGE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL ADVANCED PARTLY THROUGH THE MICROCATHETER, THEN RESISTANCE WAS ENCOUNTERED. SUBSEQUENTLY, THE R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384172 ↗
• MalfunctionFeb 6, 2019Failure 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 ARTERIOVENOUS (AV) FISTULAS IN THE PATIENT¿S LEG USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE VESSELS WERE DIFFICULT TO ACCESS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY POSITIONED A GUIDEWIRE, NON-PENUMBRA CATHETER, AND A LANTERN INTO THE TARGET VESSEL AND DEPLOYED FOUR RUBY COILS. THE TECHNICIAN THEN FELT RESISTANCE WHILE ADVANCING THE FIFTH RUBY COIL AND WAS ONLY ABLE TO ADVANCE 90% OF THE COIL INTO THE LANTERN BEFORE THE RUBY COIL BECAME KINKED. THE RUBY COIL WAS THEREFORE REMOVED. WHILE ADVANCING THE SIXTH RUBY COIL, THE TECHNICIAN AGAIN FELT RESISTANCE AND SAME ISSUE OCCURRED. THE SIXTH RUBY COIL WAS, THEREFORE, REMOVED. THE LANTERN WAS THEN REMOVED FROM THE PATIENT AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE LANTERN AND NO VISIBLE DAMAGE; HOWEVER, THE LANTERN WAS SET ASIDE AND A NEW LANTERN WAS USED TO CONTINUE THE PROCEDURE. THE SAME GUIDEWIRE AND THE SAME NON-PENUMBRA CATHETER WERE ALSO USED. THE PHYSICIAN THEN DECIDED TO RE-POSITION THE GUIDEWIRE, NON-PENUMBRA CATHETER, AND NEW LANTERN TOGETHER IN ORDER TO REGAIN ACCESS TO THE TARGET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8313260 ↗
• MalfunctionOct 10, 2018Failure 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 TWO RUBY COILS THROUGH THE TIP OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 7954298 ↗
• MalfunctionSep 14, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE, DESPITE ATTEMPTING MULTIPLE TIMES. THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PHYSICIAN COMPLETED THE PROCEDURE USING A NEW RUBY COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877439 ↗
• 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 7747718 ↗
• MalfunctionApr 18, 2018Kinked; Device Damaged Prior to Use; Device Handling Problem; Kinked; Device Damaged Prior to Use; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY KINKED THE PUSHER ASSEMBLY OF A RUBY COIL WHILE REMOVING IT FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE, AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE TECHNICIAN THEN ACCIDENTLY CAUSED ANOTHER RUBY COIL TO FALL OFF OF THE BACK TABLE AND ON TO THE FLOOR LATER IN THE PROCEDURE. THE RUBY COIL BECAME CONTAMINATED PRIOR TO USE, AND THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7441960 ↗
• MalfunctionApr 4, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN A FEW CENTIMETERS INTO THE LANTERN, AND THEREFORE THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND 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 7395895 ↗
• MalfunctionDec 27, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER. UPON ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN WITH THE DETACHED RUBY COIL FROM THE PATIENT AND FLUSHED OUT THE RUBY COIL, BEFORE REINSERTING THE LANTERN. HOWEVER, THIS SAME INCIDENT OCCURRED WITH THREE ADDITIONAL RUBY COILS. WHEN THE PHYSICIAN REMOVED THE LANTERN WITH THE FOURTH DETACHED RUBY COIL, A KINK WAS FOUND ON THE LANTERN. THE PROCEDURE WAS THEREFORE COMPLETED USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND 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 7148204 ↗
• MalfunctionDec 19, 2017Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DID NOT MENTION FEELING ANY RESISTANCE; HOWEVER, THE COILS BECAME STUCK AND WERE UNABLE TO ADVANCE OUT OF THE MICROCATHETER. THEREFORE, THE RUBY COILS WERE REMOVED AND THE PROCEDURE WAS THEN COMPLETED USING NEW 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 7131212 ↗
• MalfunctionDec 6, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 7088008 ↗
• MalfunctionSep 7, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. PRIOR TO THE PROCEDURE, THE VESSEL SIZE WAS MEASURED ON THE CT SCAN AND AN 8X40 CENTIMETER (CM) RUBY COIL WAS SELECTED FOR THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE 8X40 CM RUBY COIL (LOT #F75936) INTO THE TARGET VESSEL BUT REALIZED THAT THE COIL WAS TOO LARGE. UPON REMOVING THE RUBY COIL, THE TECHNOLOGIST INADVERTENTLY BENT/KINKED THE RUBY COIL PUSHER ASSEMBLY. THE PHYSICIAN CONTINUED THE PROCEDURE BY SUCCESSFULLY DEPLOYING AND DETACHING FOUR NEW RUBY COILS. WHILE PREPARING TWO ADDITIONAL RUBY COILS (LOT #F72625 AND LOT #F75368) FOR THE PROCEDURE, THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED BOTH PUSHER ASSEMBLIES. THEREFORE, THE RUBY COILS WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TWO NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6850316 ↗
• MalfunctionJul 28, 2017Detachment Of Device Component; Premature Activation; Detachment Of Device Component; Premature Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). AS THE PHYSICIAN ADVANCED ANOTHER RUBY COIL, THE LANTERN BACKED INTO THE DIAGNOSTIC CATHETER; CONSEQUENTLY, THE RUBY COIL DETACHED. THE RUBY COIL DETACHED IN THE TARGET LOCATION AND, THEREFORE, IT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS 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 6752696 ↗
• MalfunctionJul 26, 2017Retraction Problem; Out-Of-Box Failure; Material Protrusion/Extrusion; Retraction Problem; Out-Of-Box Failure; Material Protrusion/Extrusion

  WHILE ATTEMPTING TO REMOVE A RUBY COIL FROM ITS DISPENSER HOOP FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE RUBY COIL INTRODUCER SHEATH WAS PROTRUDING OUT OF THE DISPENSER HOOP. THE RUBY COIL WAS UNSHEATHED AND COULD NOT BE RE-SHEATHED. THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING ANOTHER COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6744024 ↗
• MalfunctionMay 2, 2017Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO RETRACT THE COIL. HOWEVER, WHILE THE COIL WAS BEING RETRACTED WITH SLIGHT RESISTANCE, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. SINCE THE COIL WAS PARTIALLY STICKING OUT OF THE LANTERN'S HUB, THE PHYSICIAN WAS ABLE TO PULL THE COIL OUT OF THE LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE SAME LANTERN BUT ENCOUNTERED RESISTANCE. THE RUBY COIL WAS THEN RESHEATHED AND ANOTHER ATTEMPT WAS MADE TO ADVANCE THE COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THEREFORE, THE RUBY COIL WAS REMOVED AND 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 6539058 ↗
• MalfunctionApr 26, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, AFTER SUCCESSFULLY DEPLOYING AND DETACHING TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN ATTEMPTED TO PLACE A THIRD RUBY COIL. HOWEVER; WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN FELT A GRITTINESS AND THEN THE RUBY COIL UNINTENTIONALLY DETACHED WHILE PARTIALLY ADVANCED OUTSIDE OF THE LANTERN. THEREFORE, THE PHYSICIAN USED A SYRINGE TO FLUSH THE DETACHED RUBY COIL INTO THE TARGET LOCATION. 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 6522395 ↗
• MalfunctionApr 18, 2017Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEEDING FROM THE SUPERIOR MESENTERIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING THROUGH A LANTERN DELIVERY MICROCATHETER, A RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE THE PHYSICIAN REMOVED THE LANTERN WITH THE DETACHED RUBY COIL INSIDE AND COMPLETED THE PROCEDURE USING A NEW MICROCATHETER AND NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6501644 ↗