RUBY Coil RBY2C1240-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI M424RBY2C12400), received between Sep 3, 2015 and Jul 14, 2022 — classified as 1 death, 1 injury, 33 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (9 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. 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 15023575 ↗
• MalfunctionApr 5, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE IN THE RENAL ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE THE PHYSICIAN ADVANCED A RUBY COIL INTO THE SMALL ANEURYSM BETWEEN THE FEEDING RENAL POLAR ARTERY AND THE BIG ANEURYSM, THE PHYSICIAN NOTICED THAT THE ANEURYSM WAS OPEN ON THE DISTAL SIDE; THEREFORE, THE RUBY COIL WOULD NOT STAY IN PLACE. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE LANTERN TO ATTEMPT TO POSITION THE RUBY COIL PROXIMAL TO THE ANEURYSM INTO THE FEEDING RENAL POLAR ARTERY. HOWEVER, DUE TO EXTREMELY HIGH FLOW IN THE ARTERY, THE RUBY COIL WOULD NOT ANCHOR, AND THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL INTO ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE LAST FIVE CENTIMETERS OF THE RUBY COIL INTO ITS INTRODUCER SHEATH. THE PHYSICIAN THEN ATTEMPTED TO GENTLY PULL THE RUBY COIL A LITTLE MORE AND HEARD A SOUND. IT WAS NOTICED THAT THE RUBY COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY, WITH APPROXIMATELY FIVE CENTIMETERS OF THE RUBY COIL HANGING OUT OF ITS INTRODUCER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615229 ↗
• MalfunctionJan 13, 2021Material Separation

  WE OPENED A RUBY COIL. THE SCRUB NURSE ATTEMPTED TO PREP THIS FOR THE SURGEON AND A PIECE OF IT BROKE. WE WERE UNABLE TO FIX THIS TO BE UTILIZED. WE ENDED UP HAVING TO WASTE IT. THE ACTUAL COIL WAS TAKEN OFF OF THE STERILE FIELD. PER RN SCRUB, IT SEPARATED WHEN I WAS TRYING TO GET IT OUT OF THE COIL IT COMES IN. NOT SURE IF IT WAS USER ERROR (AS IN I PUSHED IT TOO MUCH TRYING TO GET IT OUT QUICKLY) OR IF IT WAS DEFECTIVE. BY THAT POINT IN THE CASE IT WAS VERY LIKELY USER ERROR BUT SINCE WE WEREN'T 100% SURE WE FIGURED IT WAS BETTER SAFE THAN SORRY AND REPORTED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162996 ↗
• MalfunctionSep 25, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PANCREATICODUODENAL ARTERY ANEURYSM (PDA) USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL IN THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, THE SAME HANDLE AND 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 10587292 ↗
• InjuryAug 13, 2020Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED AND BECAME UNRAVELED WITH THE INNER WIRE EXPOSED. AFTER REMOVAL OF THE RUBY COIL, THE PHYSICIAN PERFORMED AN ANGIOGRAM AND NOTICED PIECES OF THE RUBY COIL HAD BROKEN OFF AND MIGRATED INTO THE HEPATIC ARTERY. IT WAS REPORTED THAT PART OF THE RUBY COIL INNER WIRE WAS INSIDE OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO RETRIEVE THE BROKEN PIECES OF THE RUBY COIL WITH A SNARE DEVICE; HOWEVER, THE PHYSICIAN WAS ONLY ABLE TO REMOVE A PORTION OF THE RUBY COIL. IT WAS ALSO REPORTED THAT DURING THE SNARING PROCESS, PIECES OF THE RUBY COIL WERE LEFT IN THE FEMORAL AND AORTA. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10403375 ↗
• MalfunctionMay 5, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN REMOVED THE RUBY COIL FROM ITS INTRODUCER SHEATH ON THE BACK TABLE AND NOTICED THAT THE RUBY COIL WAS KINKED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10026512 ↗
• MalfunctionJan 8, 2020Failure to Advance; Physical Resistance/Sticking; 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 IMPLANTED THE INITIAL RUBY COILS INTO THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9566321 ↗
• MalfunctionAug 28, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL, TOOK THE RUBY COIL OUT AND REINSERTED THE SAME MICROCATHETER INTO THE PATIENT'S BODY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THEN REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS 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 8940760 ↗
• MalfunctionNov 9, 2018Failure 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 WAS ONLY ABLE TO ADVANCE A RUBY COIL PART WAY INTO THE NON-PENUMBRA MICROCATHETER. IT WAS ALSO REPORTED THAT THE PHYSICIAN FELT RESISTANCE AS THE RUBY COIL WAS GOING INTO THE MICROCATHETER. THE RUBY COIL WAS THEN REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS 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 8055738 ↗
• MalfunctionMay 30, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE PHYSICIAN AGAIN FELT RESISTANCE. WHILE ATTEMPTED TO RETRACT, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE. THE PHYSICIAN COMPLETED THE PROCEDURE BY ADVANCING ADDITIONAL COILS THROUGH THE DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553593 ↗
• MalfunctionApr 20, 2018Detachment Of Device Component; Unraveled Material; Detachment Of Device Component; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO DEPLOY A RUBY COIL IN THE TARGET VESSEL, THE LANTERN BACKED UP IN THE NON-PENUMBRA SHEATH AND CONSEQUENTLY, THE RUBY COIL BECAME TANGLED BETWEEN THE LANTERN AND THE SHEATH. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED, WITH THE LEFT PART OF THE RUBY COIL RUNNING DOWN THE LEFT SIDE OF THE GONADAL VEIN. THEREFORE, THE PHYSICIAN TRIED BRINGING A LONG SHEATH TO THE COIL MASS AND PUSH THE REST OF THE RUBY COIL WITH A COIL PUSHER AND TWO BALLOONS. HOWEVER, THE RUBY COIL BECAME UNRAVELED AND REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS ENDED AT THAT POINT AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7448810 ↗
• MalfunctionApr 17, 2018Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER AND THE RUBY COIL BECAME STUCK. THE PHYSICIAN THEN REPOSITION THE MICROCATHETER, AND ATTEMPTED TO ADVANCE THE RUBY COIL; HOWEVER, WAS STILL UNABLE TO ADVANCE THE RUBY COIL, THEREFORE IT WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL, HOWEVER THE SAME RESISTANCE WAS EXPERIENCED AND THE RUBY COIL BECAME STUCK. WHILE RETRACTING TO REMOVE THE RUBY COIL, IT UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE DETACHED RUBY COIL INSIDE. THE PHYSICIAN THEN PLACED A NEW NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER RESISTANCE WAS EXPERIENCED AGAIN DESPITE ATTEMPTS TO REPOSITION THE MICROCATHETER. THE RUBY COIL AND MICROCATHETER WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (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 7437113 ↗
• MalfunctionMar 9, 2018Kinked; Inadequacy of Device Shape and/or Size; Kinked; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT AND LEFT SUBCLAVIAN ARTERIES USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL, THE PHYSICIAN RETRACTED IT FROM THE RIGHT SUBCLAVIAN ARTERY BECAUSE THE RUBY COIL WAS THE WRONG SIZE. HOWEVER, UPON REMOVAL FROM THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL BECAME KINKED. THIS SAME ISSUE THEN OCCURRED WITH A SECOND RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO PLACE A RUBY COIL IN THE LEFT SUBCLAVIAN ARTERY, HOWEVER THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED UPON INSERTION INTO A LANTERN; THEREFORE, IT WAS REMOVED. THIS SAME ISSUE THEN OCCURRED WITH ANOTHER RUBY COIL, AND THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329085 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ATTEMPTED TO DEPLOY FOUR OTHER RUBY COILS, HOWEVER WAS UNABLE TO DUE TO THE EXTREME ANGLE OF ACCESS INTO THE ANEURYSM, DESPITE MAKING MULTIPLE ADJUSTMENTS TO THE PLACEMENT OF THE LANTERN. CONSEQUENTLY, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COILS UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE LANTERN TO PULL OUT EACH OF THE FOUR DETACHED RUBY COILS, AND REINSERTED THE SAME LANTERN. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN AND ADDITIONAL RUBY COILS AFTER THE ACCESS SHEATH WAS ADJUSTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7321478 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component; Migration or Expulsion of Device; Detachment Of Device Component; Migration or Expulsion of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROXIMAL SEGMENT OF THE SPLENIC ARTERY USING A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA DIAGNOSTIC CATHETER, THEN ADVANCED A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO GET THE RUBY COIL TO SEAT IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT THE COIL WASN'T COMING BACK WITH THE PUSHER ASSEMBLY. AT THIS POINT, APPROXIMATELY 10 CM OF THE RUBY COIL WAS OUTSIDE OF THE DISTAL TIP OF THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE COIL'S PUSHER ASSEMBLY, ATTACHED A SYRINGE TO THE BACK OF THE LANTERN AND PULLED NEGATIVE PRESSURE BACK IN AN ATTEMPT TO TRY TO KEEP THE RUBY COIL IN THE LANTERN WHEN REMOVING IT. THE LANTERN WAS THEN REMOVED WITH THE RUBY COIL NOW RESIDING INSIDE OF THE DIAGNOSTIC CATHETER. THERE WAS APPROXIMATELY 12 CM OF COIL OUTSIDE OF THE TIP THE DIAGNOSTIC CATHETER AND IT WAS DETERMINED THAT THE SAFEST OPTION WAS TO PUSH THE DETACHED COIL OUT OF THE DIAGNOSTIC CATHETER WHERE IT MIGRATED INTO THE DISTAL SPLENIC ARTERY. THE RUBY COIL WAS LEFT IN THE VESSEL AFTER THOUGHTFUL CONSIDERATION TO SNARE IT. THE PROCEDURE WAS COMPLETED USING OTHER COI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7290377 ↗
• MalfunctionJan 3, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, AND THEREFORE THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162264 ↗
• MalfunctionNov 21, 2017Failure 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, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL THROUGH THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE RUBY COIL AND CHANGED THE ROTATING HEMOSTASIS VALVE (RHV) TO A NEW ONE. NEXT, THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE RUBY COIL THROUGH THE LANTERN BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING FOUR NEW RUBY COILS, THE SAME LANTERN AND THE SECOND RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049053 ↗
• MalfunctionNov 17, 2017Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY BENT A RUBY COIL PUSHER ASSEMBLY WHILE REMOVING THE RUBY COIL FROM ITS DISPENSER HOOP. THE RUBY COIL PUSHER ASSEMBLY BECAME BENT PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7040934 ↗
• MalfunctionJul 13, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN DECIDED TO RETRACT THE COIL FOR REPOSITIONING. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED INSIDE THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY 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 6711320 ↗
• MalfunctionJun 15, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA DIAGNOSTIC CATHETER IN THE TARGET VESSEL, THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH THE DIAGNOSTIC CATHETER. WHILE DEPLOYING A RUBY COIL, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE COIL WAS FORMING INSIDE THE TARGET VESSEL AND DECIDED TO REMOVE IT FOR RE-POSITIONING. IT WAS REPORTED THAT THE PHYSICIAN DID NOT MENTION RESISTANCE WHILE ATTEMPTING TO RETRACT THE RUBY COIL; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL FROM THE PATIENT AND USED A WIRE TO REMOVE THE COIL FROM THE LANTERN. THE PHYSICIAN THEN REINSERTED THE LANTERN INTO THE PATIENT¿S BODY. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL FROM THE PATIENT. THE PROCEDURE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6643322 ↗
• DeathMay 31, 2017Break; Retraction Problem; Break; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A BENCHMARK DELIVERY CATHETER (BENCHMARK DC) AND RUBY COILS. DURING THE PROCEDURE, THE BENCHMARK DC BECAME KINKED UPON INSERTION INTO THE NON-PENUMBRA SHEATH; THEREFORE THE BENCHMARK DC WAS REMOVED, AND A NEW 5F NON-PENUMBRA CATHETER WAS PLACED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). TWO RUBY COILS WHERE ADVANCED TO THE TARGET VESSEL USING THE LANTERN AND WERE BOTH RETRACTED IN ORDER TO REPOSITION THE LANTERN. HOWEVER, THE TECHNICIAN EXPERIENCED DIFFICULTY RE-SHEATHING BOTH OF THESE RUBY COILS ANS SUBSEQUENTLY, THEY BECAME BROKEN WITHIN THEIR INTRODUCER SHEATHS. THEREFORE THESE RUBY COILS WERE NOT RE-USED AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6603496 ↗
• MalfunctionMar 22, 2017Bent; Failure to Fold; Device Handling Problem; Bent; Failure to Fold; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE EXTERNAL AND INTERNAL ILIAC ARTERY USING RUBY COILS AND POD PACKING COILS (PODJ COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, DUE TO A VERY HIGH FLOW IN THE INTERNAL ILIAC ARTERY, BOTH RUBY COILS WOULD NOT TAKE THEIR INTENDED SHAPE AND ANCHOR IN THE ANEURYSM. AFTER SEVERAL FAILED ATTEMPTS, THE RUBY COILS WERE REMOVED AND A POD8 COIL WAS SUCCESSFULLY DEPLOYED AND DETACHED IN THE ANEURYSM. THE SCRUB TECHNOLOGIST THEN INADVERTENTLY BENT BOTH RUBY COILS PUSHER ASSEMBLIES WHILE ATTEMPTING TO RE-SHEATH THEM. NEXT, THE SCRUB TECHNOLOGIST INADVERTENTLY PULLED OFF THE INTRODUCER SHEATH OF PODJ COIL AFTER REMOVING IT FROM THE PACKAGING HOOP. WHILE ATTEMPTING TO RE-SHEATH IT, THE PODJ COIL PUSHER ASSEMBLY WAS ACCIDENTALLY BROKEN; THEREFORE, THE PODJ COIL WAS SET ASIDE. THE PHYSICIAN THEN OPENED A NEW PODJ COIL AND ATTEMPTED TO ADVANCE IT THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS EXPERIENCED PRIOR TO THE COIL EXITING THE LANTERN AND THE PHYSICIAN DECIDED TO RETRACT IT. UPON RETRACTION, THE PODJ COIL UNINTENTIONALLY DETACHED FROM THE PUSH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424673 ↗
• MalfunctionMar 7, 2017Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, TWO RUBY COILS ACCIDENTALLY FELL ON THE GROUND; THEREFORE, THE TWO RUBY COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6384303 ↗
• MalfunctionFeb 3, 2017Failure to Advance; Failure to Advance

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF WAS UNABLE TO ADVANCE FOUR RUBY COILS PASS THEIR FRICTION LOCKS AND OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE FOUR RUBY COILS WERE NOT USED FOR THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6301750 ↗
• MalfunctionNov 8, 2016Physical Resistance; Device Handling Problem; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN ANEURYSM AND A DISSECTION IN THE LEFT COMMON ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH A DIAGNOSTIC CATHETER INTO THE SITE OF TREATMENT AND MEASURED THE ANEURYSM TO BE 11 CENTIMETERS. THE PHYSICIAN THEN PROCEEDED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, WHILE ADVANCING THE RUBY COIL AND PRIOR TO DETACHMENT, THE LANTERN KICKED OUT THE HYPOGASTRIC ARTERY WITH ABOUT 10 CENTIMETERS OF THE RUBY COIL ADVANCED .THEREFORE, THE PHYSICIAN REMOVED THE LANTERN IN ORDER TO REGAIN ACCESS TO THE TARGET VESSEL. THE RUBY COIL WAS RE-SHEATHED; HOWEVER, THE TECHNOLOGIST FAILED TO FLUSH IT BEFORE RESHEATHING IT. AFTER GAINING ACCESS TO THE TARGET VESSEL AGAIN, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PREVIOUS RUBY COIL THROUGH THE SAME LANTERN; HOWEVER, RESISTANCE WAS EXPERIENCED AND THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COILS AND THE SAME LANTERN WITH NO ISSUES. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE(RHV) AND THE PATIENT ANATOMY WAS DESCRIBED TO BE SLIGHTLY TOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6086039 ↗