RUBY Coil RBY2C0420-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI M424RBY2C04200), received between Oct 14, 2015 and Jul 27, 2021 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO USE A RUBY COIL; THEREFORE, IT WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE SPECIFIC ISSUE WITH THE RUBY COIL WAS PROVIDED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233117 ↗
• MalfunctionMar 16, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. NEXT, THE PHYSICIAN KEPT CLICKING THE HANDLE AND THE RUBY COIL EVENTUALLY DETACHED. THE PHYSICIAN THEN REMOVED THE HANDLE AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, AND BY MANUALLY DETACHING ADDITIONAL RUBY COILS AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499459 ↗
• MalfunctionMar 9, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING PACKING COIL LPS, RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN MOVED THE PACKING COIL LP BACK AND FORTH IN AN ATTEMPT TO ADVANCE THE COIL WITHOUT SUCCESS. THEREFORE, THE PACKING COIL LP WAS REMOVED, AND ANOTHER PACKING COIL LP WAS SUCCESSFULLY IMPLANTED. LATER IN THE CASE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL TO THE TARGET LOCATION AND SUBSEQUENTLY, IT DETACHED INSIDE THE LANTERN. THE RUBY COIL WAS THEN PULLED BACK AND REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449133 ↗
• MalfunctionSep 10, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE RUBY COIL UNINTENTIONALLY DETACHED FROM ITS WIRE. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8980985 ↗
• MalfunctionNov 23, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL FROM ITS INITIAL POSITION IN THE INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100115 ↗
• MalfunctionApr 5, 2018Failure to Fold; Device Operates Differently Than Expected; Failure to Fold; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER 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 7399699 ↗
• MalfunctionJan 4, 2018Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, WHICH MADE IT DIFFICULT TO REACH THE TARGET VESSEL. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED. AFTER TWO ATTEMPTS, THE PHYSICIAN WAS UNABLE TO REGAIN ACCESS TO THE TARGET VESSEL AND THE PATIENT BECAME NON-COMPLIANT. THEREFORE, THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND RETREAT THE PATIENT ANOTHER TIME. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7164838 ↗
• MalfunctionOct 24, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Device Handling Problem; Device Damaged Prior to Use; Out-Of-Box Failure; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RADIOLOGY TECHNICIAN INADVERTENTLY PULLED A RUBY COIL OUT OF ITS INTRODUCER SHEATH PRIOR TO INSERTION INTO THE MICROCATHETER. THE RUBY COIL WAS UNSHEATHED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6973340 ↗
• InjurySep 5, 2017Detachment Of Device Component; Entrapment of Device; Premature Activation; Detachment Of Device Component; Entrapment of Device; Premature Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTRODUODENAL ARTERY BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE INITIAL RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. AFTER THAT, THE PHYSICIAN ADVANCED A RUBY COIL OUT OF THE NON-PENUMBRA MICROCATHETER AND INTO THE TARGET VESSEL BUT DECIDED TO RETRACT THE COIL FOR REPOSITIONING. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED LEAVING ITS DISTAL END IN THE COMMON HEPATIC ARTERY. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL; HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE RUBY COIL AND THE RUBY COIL DISTAL END WAS LEFT IN THE COMMON HEPATIC ARTERY. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. IT WAS REPORTED THAT THE DISTAL END OF THE RUBY COIL IN THE HEPATIC ARTERY WAS CONSIDERED INSIGNIFICANT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6843635 ↗
• MalfunctionAug 8, 2017Failure 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, THE PHYSICIAN DEPLOYED AND DETACHED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE HUB OF THE LANTERN. THE PHYSICIAN THEN MADE MULTIPLE ATTEMPTS TO ADJUST THE LANTERN AND RUBY COIL BUT WAS STILL UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH. THEREFORE, BOTH THE RUBY COIL AND LANTERN WERE REMOVED. IT WAS REPORTED THAT THE RUBY COIL WAS ABLE TO BE ADVANCED OUT OF ITS INTRODUCER SHEATH WHEN NOT INSERTED INTO THE HUB OF THE LANTERN. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6775360 ↗
• 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 6744818 ↗
• MalfunctionJun 28, 2017Material Too Rigid or Stiff; Failure to Advance; Physical Resistance; Material Too Rigid or Stiff; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING NEURON 6F 070 DELIVERY CATHETERS (NEURON 070¿S) AND RUBY COILS. IT WAS NOTED THAT THE PATIENT HAD A VERY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO GAIN ACCESS USING A NON-PENUMBRA 6F SHEATH AND A NEURON 070, WITH A NON-PENUMBRA SELECT CATHETER LOADED IN THE NEURON 070. WHILE ATTEMPTING TO ADVANCE THE NEURON 070 THROUGH THE SHEATH, THE PHYSICIAN INADVERTENTLY KINKED THE NEURON 070. THEREFORE, THE NEURON 070 WAS REMOVED AND A NEW NEURON 070 WAS OPENED; HOWEVER, THE PHYSICIAN WAS UNABLE TO ACCESS THE CELIAC TRUNK WITH THIS SYSTEM BECAUSE OF THE TORTUOSITY OF THE PATIENT. THE NEURON 070 SYSTEM WAS REMOVED AND A NON-PENUMBRA SELECT CATHETER WAS USED TO SELECT THE CELIAC AND ACCESS THE DISTAL PART OF THE VESSEL WITH A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER THAT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL INTO THE TARGET VESSEL. WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE TWO NEW RUBY COILS OUT OF THE LANTERN AND INTO THE TARGET VESSEL, BOTH COILS WERE VERY STIFF TO ADVANCE AND RESISTANCE WAS MET. THEREFORE, THE PHYSICIAN SUCCESSFULLY REMOVED BOTH COILS AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675726 ↗
• MalfunctionJun 28, 2017Material Too Rigid or Stiff; Failure to Advance; Physical Resistance; Material Too Rigid or Stiff; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING NEURON 6F 070 DELIVERY CATHETERS (NEURON 070¿S) AND RUBY COILS. IT WAS NOTED THAT THE PATIENT HAD A VERY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO GAIN ACCESS USING A NON-PENUMBRA 6F SHEATH AND A NEURON 070, WITH A NON-PENUMBRA SELECT CATHETER LOADED IN THE NEURON 070. WHILE ATTEMPTING TO ADVANCE THE NEURON 070 THROUGH THE SHEATH, THE PHYSICIAN INADVERTENTLY KINKED THE NEURON 070. THEREFORE, THE NEURON 070 WAS REMOVED AND A NEW NEURON 070 WAS OPENED; HOWEVER, THE PHYSICIAN WAS UNABLE TO ACCESS THE CELIAC TRUNK WITH THIS SYSTEM BECAUSE OF THE TORTUOSITY OF THE PATIENT. THE NEURON 070 SYSTEM WAS REMOVED AND A NON-PENUMBRA SELECT CATHETER WAS USED TO SELECT THE CELIAC AND ACCESS THE DISTAL PART OF THE VESSEL WITH A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER THAT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL INTO THE TARGET VESSEL. WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE TWO NEW RUBY COILS OUT OF THE LANTERN AND INTO THE TARGET VESSEL, BOTH COILS WERE VERY STIFF TO ADVANCE AND RESISTANCE WAS MET. THEREFORE, THE PHYSICIAN SUCCESSFULLY REMOVED BOTH COILS AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675711 ↗
• MalfunctionJun 13, 2017Bent; Physical Resistance; Bent; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND INADVERTENTLY BENT THE RUBY COIL PUSHER WIRE WHILE ADVANCING INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE THE RUBY COIL WAS THEREFORE 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 6637168 ↗
• MalfunctionJun 7, 2017Inadequacy of Device Shape and/or Size; Malposition of Device; Device Operates Differently Than Expected; Inadequacy of Device Shape and/or Size; Malposition of Device; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL DUODENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER THE DISTAL END OF A RUBY COIL EXITED THE TIP OF THE HIGH FLOW MICROCATHETER, THE PHYSICIAN NOTICED THAT THE COIL WAS UNABLE TO TAKE ITS INTENDED SHAPE AND PROCEEDED TO ¿RUN¿ DOWN THE VESSEL. THE PHYSICIAN DETERMINED THAT THE RUBY COIL WAS OVERSIZED FOR THE VESSEL AND THEREFORE, RE-SHEATHED AND SAVED THE RUBY COIL ON THE TABLE FOR LATER USE. THE PHYSICIAN THEN PLACED A MICRO VASCULAR PLUG IN THE TARGET VESSEL AND RE-ATTEMPTED TO USE THE SAME RUBY COIL; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THE PHYSICIAN TRIED RINSING IT OFF IN A BOWL OF SALINE BUT THE RUBY COIL WOULD STILL NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THE MICROCATHETER WAS THEN FLUSHED AND AN ATTEMPT WAS MADE TO UNSHEATH THE RUBY COIL ON THE BACK TABLE; HOWEVER, THE RUBY COIL WOULD STILL NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMALLER SIZED RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6620484 ↗
• MalfunctionJun 7, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN THE COIL REACHED THE END OF THE INTRODUCER SHEATH. SUBSEQUENTLY, THE COIL WAS UNABLE TO ADVANCE OUT OF THE TIP OF THE INTRODUCER SHEATH. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619999 ↗
• MalfunctionMay 17, 2017Failure to Advance; Physical Resistance; Device Handling Problem; Failure to Advance; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME MICROCATHETER. THERE WAS NO KNOWN NOTICEABLE DAMAGE TO THE RUBY COIL. AFTER THE PROCEDURE, IT WAS DISCOVERED THAT THE NON-PENUMBRA MICROCATHETER THAT THE PHYSICIAN WAS USING WAS INCOMPATIBLE WITH THE RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574160 ↗
• MalfunctionApr 5, 2017Detachment Of Device Component; Entrapment of Device; Physical Resistance; Detachment Of Device Component; Entrapment of Device; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER AND THE RUBY COIL BECAME TANGLED IN THE HUB OF THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AND FELL ON THE GROUND AS THE PHYSICIAN ATTEMPTED TO RETRACT IT BACK INTO THE INTRODUCER SHEATH. WHILE ATTEMPTING TO ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ACCIDENTALLY BENT THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, THE RUBY COIL WAS REMOVED. 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

  MAUDE report 6460931 ↗
• MalfunctionApr 5, 2017Bent; Device Handling Problem; Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER AND THE RUBY COIL BECAME TANGLED IN THE HUB OF THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AND FELL ON THE GROUND AS THE PHYSICIAN ATTEMPTED TO RETRACT IT BACK INTO THE INTRODUCER SHEATH. WHILE ATTEMPTING TO ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ACCIDENTALLY BENT THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, THE RUBY COIL WAS REMOVED. 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

  MAUDE report 6460920 ↗
• MalfunctionMar 17, 2017Failure to Advance; Physical Resistance; Device Handling Problem; Failure to Advance; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER AND INTO THE TARGET VESSEL, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE. HOWEVER, DUE TO TORTUOUS ANATOMY, THE MICROCATHETER BACKED OUT OF THE VESSEL. THE PHYSICIAN THEN RETRACTED AND RESHEATHED THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH IN ORDER TO REPOSITION THE MICROCATHETER. THE PHYSICIAN MENTIONED THAT THERE WAS RESISTANCE WHILE THE COIL WAS BEING RETRACTED. WHEN ATTEMPTING TO RE-DEPLOY THE RUBY COIL, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RUBY COIL OUT OF ITS INTRODUCER SHEATH. CONSEQUENTLY, UPON APPLYING FORCE, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE RUBY COIL WAS NOT RE-DEPLOYED AND A NEW RUBY COIL WAS OPENED. HOWEVER, THE SAME ISSUE OCCURRED AND RUBY COIL WAS RESHEATHED IN ORDER TO REPOSITION THE MICROCATHETER. WHILE ATTEMPTING TO RESHEATH THE RUBY COIL, THE PHYSICIAN MENTIONED THAT THERE WAS RESISTANCE AND SUBSEQUENTLY, THE COIL UNINTENTIONALLY DETACHED BEFORE THE COIL COULD BE FULLY RESHEATHED. THE RUBY COIL WAS ALREADY OUT OF THE PATIENT'S BODY AND OUT OF THE MI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6414590 ↗
• MalfunctionMar 1, 2017Separation Failure; Device Operates Differently Than Expected; Separation Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (PODJ) AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A 135CM LANTERN (B)(4) THROUGH A NON-PENUMBRA SHEATH, AND ADVANCED A RUBY COIL (B)(4) THROUGH IT. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE RUBY COIL USING A RUBY COIL DETACHMENT HANDLE (HANDLE); HOWEVER, THE RUBY COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW HANDLE TO DETACH THIS RUBY COIL AND THE NEW HANDLE FAILED TO DETACH THE RUBY COIL AS WELL; THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. BOTH HANDLES WERE ABLE TO SUCCESSFULLY DETACH OTHER RUBY COILS LATER IN THE PROCEDURE. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL (B)(4) THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL BECAME STUCK AND UNABLE TO ADVANCE OUT OF THE TIP OF THE LANTERN. THE PHYSICIAN THEN REMOVED THE RUBY COIL; HOWEVER, UPON REMOVAL, THE PHYSICIAN INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY. UPON ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE SAME LANTERN, THE PHYSICIAN NOTICED THAT RUBY COIL BECAME ST

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6368381 ↗
• MalfunctionFeb 6, 2017Detachment Of Device Component; Unraveled Material; Physical Resistance; Detachment Of Device Component; Unraveled Material; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE ADVANCING THE RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER AND, THEREFORE, ATTEMPTED TO RETRACT THE COIL. THE RUBY COIL UNINTENTIONALLY DETACHED AND THEN BEGAN UNRAVELING WITHIN THE MICROCATHETER; THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE UNRAVELING AND DETACHED COIL INSIDE. THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6303714 ↗
• MalfunctionDec 1, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEINS USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SOME RUBY COILS, POD COILS, OTHER MANUFACTURERS'' COILS AND VASCULAR PLUGS INTO THE PORTAL VEINS. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE OTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE RUBY COIL AND ITS INTRODUCER SHEATH WERE REMOVED FROM THE HUB OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL ONTO THE TABLE AND NOTICED THAT THE COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREAFTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NEW RUBY COILS, POD COILS, OTHER MANUFACTURERS' COILS AND VASCULAR PLUGS. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT MAINTAIN A CONTINUOUS FLUSH THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) BUT DID FLUSH THE MICROCATHETER IN BETWEEN EACH COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6140425 ↗
• MalfunctionAug 4, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  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 INSERTED THE LANTERN THROUGH ANOTHER MANUFACTURER'S SHEATH AND INTO THE PATIENT. WHILE ADVANCING THREE RUBY COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, ALL THREE RUBY COILS BECAME STUCK AT THE SAME LOCATION AND WERE UNABLE TO ADVANCE OUT OF THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED ALL THREE RUBY COILS AND CONTINUED THE PROCEDURE BY DELIVERING ANOTHER MANUFACTURER'S COILS INTO THE TARGET VESSEL USING THE SAME LANTERN. WHILE THE PHYSICIAN WAS ADVANCING THE LAST NON-PENUMBRA COIL THROUGH THE SAME LANTERN, THE COIL BECAME STUCK IN THE LANTERN. THEREFORE, THE LANTERN AND COIL WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURERS'' MICROCATHETER AND COILS. THERE WERE NO OBSERVED DAMAGES TO THE LANTERN AFTER REMOVAL FROM THE PATIENT'S BODY. IN ADDITION, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5846973 ↗
• MalfunctionJun 16, 2016Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THE RUBY COIL WAS REMOVED AND THE PHYSICIAN THEN ATTEMPTED TO USE TWO OTHER MICROCATHETERS FROM THE SAME MANUFACTURER BUT WAS UNSUCCESSFUL. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND ANOTHER MANUFACTURER'S MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5730979 ↗