RUBY Coil RBY4C0620-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI M424RBY4C06200), received between Aug 20, 2015 and May 13, 2021 — classified as 5 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE THE BRACHIAL BRANCH USING A POD COIL, RUBY COILS, AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. NEXT, THE POD COIL BECAME STUCK WHILE ADVANCING THROUGH THE LANTERN; THEREFORE, THE POD COIL AND LANTERN WERE REMOVED. THE PHYSICIAN INSERTED A NEW LANTERN INTO THE TARGET LOCATION, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE AND THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821875 ↗
• MalfunctionDec 16, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MID SPLENIC ARTERY USING A RUBY COIL, POD COIL, POD PACKING COIL (POD PC), NON-PENUMBRA 5FR SHEATH, GUIDE CATHETER (C2), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE RIGHT GROIN USING THE 5FR SHEATH AND A GUIDE CATHETER WAS ADVANCED THROUGH THE SHEATH. THE PHYSICIAN THEN ADVANCED THE MICROCATHETER THROUGH THE GUIDE CATHETER AND PLACED A POD COIL AND POD PC IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO PLACE A RUBY COIL IN THE VESSEL, THE PHYSICIAN ADVANCED APPROXIMATELY 20 PERCENT OF THE RUBY COIL OUT THE DISTAL TIP OF THE MICROCATHETER; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED WITH 80 PERCENT OF THE RUBY COIL STILL INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND GUIDE CATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING OTHER COILS WITH THE SAME MICROCATHETER, GUIDE CATHETER, AND SHEATH. 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 11023195 ↗
• MalfunctionAug 13, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WHILE BEING RETRACTED. IT WAS ALSO REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405274 ↗
• MalfunctionMar 19, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INFERIOR PANCREATICODUODENAL ARTERY (IPDA) ANEURYSM USING A RUBY COIL, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED 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 9857820 ↗
• MalfunctionMar 8, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY BLEED USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE AND THEREFORE THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. HOWEVER, UPON REMOVAL, THE RUBY COIL DETACHED OUTSIDE OF THE PATIENT¿S BODY. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL INTO THE TARGET VESSEL; HOWEVER, THE RUBY COIL WAS OVERSIZED, AND THE PHYSICIAN DECIDED TO RETRACT IT. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED AND BECAME STUCK INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS 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 Consequences Or Impact To Patient

  MAUDE report 8405178 ↗
• MalfunctionJan 18, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN PULLED THE RUBY COIL FROM THE MICROCATHETER BY HAND. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261596 ↗
• MalfunctionSep 6, 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 A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE BY READJUSTING THE MICROCATHETER AND THEN SUCCESSFULLY PLACING MULTIPLE RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852880 ↗
• MalfunctionJun 14, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE LANTERN WAS IN A TIGHT ANGLE INTO THE GUTTER OF A STENT GRAFT AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL AND REMOVED THE COIL. 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 7602133 ↗
• MalfunctionMay 22, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7534274 ↗
• MalfunctionMar 8, 2018Detachment Of Device Component; Retraction Problem; Mechanical Jam; Detachment Of Device Component; Retraction Problem; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A COLLATERAL VESSEL OFF A DIALYSIS FISTULA USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL BECAME STUCK IN THE LANTERN WITH APPROXIMATELY 10 CENTIMETERS OF COIL OUTSIDE OF THE LANTERN; THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL BACK INTO THE LANTERN. HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED, WITH APPROXIMATELY 10 CENTIMETERS OF THE COIL IN TARGET VESSEL AND 10 CENTIMETERS OF THE COIL IN LANTERN. THE PHYSICIAN CONSIDERED INJECTING THE COIL BUT WAS CONCERNED DUE TO THE HIGH FLOW OF THE FISTULA THAT THE COIL WOULD MIGRATE CENTRALLY. THEREFORE, THE PHYSICIAN SLOWLY PULLED BACK THE LANTERN INTO THE GLIDE CATHETER AND REMOVED THE ENTIRE SYSTEM FROM THE PATIENT. 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 7325933 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC USING RUBY COILS AND A POD PACKING COIL (PODJ). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO PLACE 11 RUBY COILS AND ONE PODJ. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED MICROCATHETERS THREE TIMES. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN AVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242785 ↗
• InjuryJan 19, 2018Detachment Of Device Component; Retraction Problem; Unraveled Material; Detachment Of Device Component; Retraction Problem; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. A RUBY COIL THEN BECAME STUCK WITHIN THE MICROCATHETER AND THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO RETRACT THE RUBY COIL. CONSEQUENTLY, THE RUBY COIL BROKE INTO TWO PIECES UPON ATTEMPTING TO RETRACT AGAINST RESISTANCE, LEAVING ONE PIECE ATTACHED TO THE PUSHER WIRE, AND THE OTHER PIECE WITHIN THE PATIENT. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE PIECE RUBY COIL WITHIN THE PATIENT, HOWEVER THE RUBY COIL THEN BEGAN TO UNWIND. THE PHYSICIAN THEREFORE USED A SECOND ACCESS POINT IN THE GROIN OF THE PATIENT TO REMOVE THE RUBY COIL USING A SNARE DEVICE. THE PROCEDURE THEN ENDED AT THIS POINT BECAUSE THE EMBOLIZATION IN THE TARGET LOCATION WAS SUFFICIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7207291 ↗
• MalfunctionOct 31, 2017Retraction Problem; Failure to Advance; Physical Resistance; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO ATTEMPTS TO ADVANCE A RUBY COIL OUT OF A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE. WHILE ATTEMPTING TO REPOSITION THE RUBY COIL INSIDE THE LANTERN, THE RUBY COIL BECAME STUCK AND WOULD NOT RETRACT; THEREFORE, THE PHYSICIAN PULLED IT OUT INTACT. 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 6990596 ↗
• 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 6850416 ↗
• MalfunctionJul 26, 2017Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE NURSE INADVERTENTLY KNOCKED THE BACK TABLE OVER AND CONSEQUENTLY, THREE RUBY COILS BECAME CONTAMINATED. THE RUBY COILS BECAME CONTAMINATED PRIOR TO USE AND THEREFORE, WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6744763 ↗
• MalfunctionMay 19, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE COIL INSIDE AND SUCCESSFULLY COMPLETED THE PROCEDURE USING ADDITIONAL COILS AND A NEW LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6578633 ↗
• MalfunctionApr 25, 2017Detachment Of Device Component; Kinked; Physical Resistance; Detachment Of Device Component; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE END OF THE NON-PENUMBRA MICROCATHETER AND INTO THE EXISTING COIL MASS WITHIN THE PATIENT; CONSEQUENTLY THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE DETACHED COIL INSIDE, AND THEN COMPLETED THE PROCEDURE USING THE SAME MICROCATHETER 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 6521037 ↗
• MalfunctionJan 6, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY, THE TECHNOLOGIST INADVERTENTLY KINKED THE END OF THE RUBY COIL PUSHER ASSEMBLY UPON REMOVAL FROM THE PACKAGING. THE PUSHER ASSEMBLY BECAME KINKED PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6231359 ↗
• MalfunctionNov 17, 2016Detachment Of Device Component; Device Operates Differently Than Expected; Detachment Of Device Component; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, UPON ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE RUBY COIL WAS PACKING; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED IN THE MICROCATHETER AS THE PHYSICIAN WAS ATTEMPTING TO RESHEATH IT. PART OF THE RUBY COIL WAS HANGING OUT OF THE HUB OF THE MICROCATHETER; THEREFORE THE PHYSICIAN REMOVED THE RUBY COIL BY PULLING IT OUT. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL THROUGH THE SAME MICROCATHETER; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THIS NEW RUBY COIL WAS PACKING; THEREFORE THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, UPON ATTEMPTING TO RESHEATH THIS RUBY COIL, IT UNINTENTIONALLY DETACHED WITH PART OF THE COIL OUTSIDE OF THE HUB OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PULL THE RUBY COIL OUT OF THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND NON-PENUMBRA COILS. THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE AND DID NOT MAINTAIN CONTINUOUS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6109473 ↗
• MalfunctionOct 28, 2016Detachment 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 ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND A NEW RUBY COIL. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6064388 ↗
• MalfunctionOct 12, 2016Device Slipped; Failure to Advance; Material Deformation; Device Slipped; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED ANOTHER MANUFACTURER'S SHEATH AND THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH IT. THE PHYSICIAN ALSO HAD A BALLOON IN PLACE TO DO A BALLOON-ASSISTED COILING BECAUSE OF THE WIDE NECK OF THE ANEURYSM. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS OPENED TO CONTINUE THE PROCEDURE. WHILE ATTEMPTING TO ADVANCE THIS SECOND RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT. THEREFORE, THE RUBY COIL WAS REMOVED AND A THIRD RUBY COIL WAS OPENED. AFTER THE PHYSICIAN DEPLOYED ABOUT HALF OF THE COIL INTO THE ANEURYSM, SOME OF THE LOOPS OF THE COIL BEGAN TO PROLAPSE INTO THE PARENT ARTERY. THE PHYSICIAN THEN RETRACTED THE RUBY COIL COMPLETELY BACK INTO THE LANTERN IN ORDER TO REPOSITION THE COIL. WHILE ATTEMPTING TO RE-ADVANCE THE COIL INTO THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6024881 ↗
• MalfunctionOct 12, 2016Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED ANOTHER MANUFACTURER'S SHEATH AND THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH IT. THE PHYSICIAN ALSO HAD A BALLOON IN PLACE TO DO A BALLOON-ASSISTED COILING BECAUSE OF THE WIDE NECK OF THE ANEURYSM. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS OPENED TO CONTINUE THE PROCEDURE. WHILE ATTEMPTING TO ADVANCE THIS SECOND RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT. THEREFORE, THE RUBY COIL WAS REMOVED AND A THIRD RUBY COIL WAS OPENED. AFTER THE PHYSICIAN DEPLOYED ABOUT HALF OF THE COIL INTO THE ANEURYSM, SOME OF THE LOOPS OF THE COIL BEGAN TO PROLAPSE INTO THE PARENT ARTERY. THE PHYSICIAN THEN RETRACTED THE RUBY COIL COMPLETELY BACK INTO THE LANTERN IN ORDER TO REPOSITION THE COIL. WHILE ATTEMPTING TO RE-ADVANCE THE COIL INTO THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6024877 ↗
• MalfunctionSep 28, 2016Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY TO TREAT AN ANEURYSM IN THE LEFT KIDNEY, USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING THE FIFTH RUBY COIL IN THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN REALIZED THAT THE RUBY COIL WAS OVER-SIZED AND DECIDED TO RETRACT IT. HOWEVER, WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO RE-SHEATH IT. THE RUBY COIL WAS THEN PULLED OUT OF THE PX SLIM AND UPON RETRACTION, IT APPEARED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME PX SLIM. IT SHOULD BE NOTED THAT THE PHYSICIAN MAINTAINED CONTINUOUS FLUSH THROUGH THE ROTATING HEMOSTASIS VALVE (RHV). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5983820 ↗
• InjuryAug 31, 2016Detachment Of Device Component; Retraction Problem; Physical Resistance; Detachment Of Device Component; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE DEPLOYING A RUBY COIL INTO THE ANEURYSM USING ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE COIL WAS TAKING SHAPE INSIDE THE ANEURYSM AND DECIDED TO RETRACT IT FOR REPOSITIONING. HOWEVER, WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE PATIENT'S BODY. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DETACHED COIL USING A SNARE DEVICE AND THE PROCEDURE ENDED AT THAT POINT. IT SHOULD BE NOTED THAT THE PHYSICIAN FLUSHED THE MICROCATHETER PRIOR TO ADVANCING THE RUBY COIL AND USED A ROTATING HEMOSTASIS VALVE (RHV) DURING THE PROCEDURE. TWO DAYS AFTER THE PROCEDURE, THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT'S BODY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5919655 ↗
• MalfunctionAug 31, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING THE FIRST RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE HOSPITAL TECHNICIAN ENCOUNTERED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE, BUT DID NOT MAINTAIN CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5917321 ↗