RUBY Coil RBY4C0204-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00814548018270), received between Aug 16, 2018 and Oct 15, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (20 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER SUCCESSFULLY DETACHING THE RUBY COIL IN THE TARGET LOCATION, THE RUBY COIL MIGRATED DISTALLY IN THE GDA. THE PHYSICIAN USED A SNARE DEVICE AND SUCCESSFULLY REMOVED THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23299398 ↗
• MalfunctionMay 8, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED OTHER COILS IN THE VESSEL USING THE LANTERN. NEXT, WHILE ADVANCING A RUBY COIL INTO THE TARGET LOCATION, THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19274124 ↗
• MalfunctionFeb 23, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE NURSE KINKED THE RUBY COIL PUSHER WIRE AND THEN ATTEMPTED TO STRAIGHTEN IT. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL INTO THE MICROCATHETER AND SUBSEQUENTLY NOTICED THAT THE PUSHER WIRE WAS FRACTURED. WHILE REMOVING THE DISTAL END OF THE RUBY COIL PUSHER WIRE, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN THEN MANUALLY ASPIRATED THE RUBY COIL OUT OF THE MICROCATHETER USING A SYRINGE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18765254 ↗
• MalfunctionNov 10, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GLIDE CATHETER, A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED EIGHT RUBY COILS. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE RUBY COIL. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT AND REMOVE THE RUBY COIL. UPON RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE RETRACTING THE RUBY COIL THROUGH THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116473 ↗
• MalfunctionNov 21, 2022Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR EPIGASTRIC ARTERY (SEA) USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL. NEXT, THE PHYSICIAN ADVANCED A SECOND RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL COULD NOT BE DETACHED. THEN, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL FROM THE PATIENT. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE HAD ENDED AT THIS POINT AS THE PHYSICIAN DETERMINED NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835084 ↗
• MalfunctionNov 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FISTULA USING RUBY COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP THROUGH THE MICROCATHETER AND ATTEMPTED TO DETACH THE RUBY COIL LP. THE RUBY COIL LP WOULD NOT DETACH WITH THE HANDLE. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. A RUBY COIL WAS THEN ADVANCED THROUGH THE MICROCATHETER, BUT THE RUBY COIL BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), 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

  MAUDE report 12783054 ↗
• MalfunctionAug 27, 2021Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE PAST THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12377705 ↗
• MalfunctionAug 2, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL MIDWAY IN THE LANTERN, THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, BENT THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE LANTERN WAS SUBSEQUENTLY REPOSITIONED TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259646 ↗
• MalfunctionJun 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT EPIGASTRIC BLEED USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE DELIVERING THE NEXT RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11972572 ↗
• MalfunctionMay 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, A DIAGNOSTIC CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL (F101571) IN THE TARGET VESSEL. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F94874) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL (F101967) THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE RUBY COIL IN THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL (F100571) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT TWO RUBY COILS (F101967 AND F98624), THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO RUBY COILS IN THE TARGET VESSEL. IT WAS REPORTED THAT ALL THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COILS AROUND A CURVE. THEN, THE PHYSICIAN ADVANCED A RUBY COIL (F99601) TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845876 ↗
• MalfunctionMay 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER , A DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL (F101571) IN THE TARGET VESSEL. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F94874) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL (F101967) THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE RUBY COIL IN THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL (F100571) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT TWO RUBY COILS (F101967 AND F98624), THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO RUBY COILS IN THE TARGET VESSEL. IT WAS REPORTED THAT ALL THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COILS AROUND A CURVE. THEN, THE PHYSICIAN ADVANCED A RUBY COIL (F99601)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845859 ↗
• MalfunctionMay 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER , A DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL (F101571) IN THE TARGET VESSEL. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F94874) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL (F101967) THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE RUBY COIL IN THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL (F100571) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT TWO RUBY COILS (F101967 AND F98624), THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO RUBY COILS IN THE TARGET VESSEL. IT WAS REPORTED THAT ALL THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COILS AROUND A CURVE. THEN, THE PHYSICIAN ADVANCED A RUBY COIL (F99601)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845852 ↗
• MalfunctionMay 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, A DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL (F101571) IN THE TARGET VESSEL. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F94874) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL (F101967) THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE RUBY COIL IN THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL (F100571) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT TWO RUBY COILS (F101967 AND F98624), THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO RUBY COILS IN THE TARGET VESSEL. IT WAS REPORTED THAT ALL THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COILS AROUND A CURVE. THEN, THE PHYSICIAN ADVANCED A RUBY COIL (F99601) T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845843 ↗
• MalfunctionMay 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL INTO THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING GELFOAM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838665 ↗
• MalfunctionMar 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL VEINS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL PAST THE HUB OF THE LANTERN. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556287 ↗
• MalfunctionMar 18, 2021Premature Separation; 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, WHILE ATTEMPTING TO PLACE A RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN WAS ADVANCING A RUBY COIL THROUGH THE MICROCATHETER WHEN THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL IN THE TARGET LOCATION; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN THEREFORE, REMOVED THE RUBY COIL. SUBSEQUENTLY, THE PHYSICIAN INSERTED A THIRD RUBY COIL IN THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL SEGMENT OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS, ANOTHER COIL, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520445 ↗
• MalfunctionFeb 10, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS AND A NON-PENUMBRA. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET LOCATION AND WAS NOT SATISFIED WITH THE SIZE OF A RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN, PLACED A SMALLER RUBY COIL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER RUBY COIL HALFWAY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11311259 ↗
• MalfunctionDec 17, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PHYSICIAN WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE BEYOND APPROXIMATELY THE LAST TWO CENTIMETERS OF THE MICROCATHETER. CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME 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 11031493 ↗
• MalfunctionSep 24, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS, RUBY COIL DETACHMENT HANDLE (HANDLE) AND, NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED RUBY COILS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL INTO THE VESSEL 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10584258 ↗
• MalfunctionAug 4, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, ONE RUBY COIL WAS IMPLANTED IN THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL, IT BECAME STUCK INSIDE THE LANTERN MID-SHAFT. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS 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 10362474 ↗
• MalfunctionJun 19, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE ANEURYSM USING THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE AND BEGAN TO MIGRATE DOWN THE BRANCH COMING OFF THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO PLACE THE RUBY COIL; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. 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 10176300 ↗
• MalfunctionJun 16, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. UPON REMOVAL, THE PHYSICIAN LOST ACCESS TO THE SMA. THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS AGAIN; THEREFORE, THE COIL EMBOLIZATION PROCEDURE WAS ABORTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10160272 ↗
• MalfunctionMar 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING RUBY COILS, NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE TARGET VESSEL WAS A HIGH FLOW AREA. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE THE FIRST 2 MM X 4 MM RUBY COIL WAS ADVANCED INTO THE MICROCATHETER. THE 2 MM X 4 MM RUBY COIL WAS UNABLE TO ADVANCE FURTHER THROUGH THE MICROCATHETER; THEREFORE, IT WAS REMOVED AND INSPECTED FOR DAMAGE. THE PHYSICIAN WAS UNABLE TO FIND ANY DAMAGE AND PROCEEDED TO MAKE TWO ADDITIONAL ATTEMPTS TO RE-ADVANCE THE COIL WITHOUT SUCCESS. THE 2 MM X 4 MM RUBY COIL WAS AGAIN REMOVED AND INSPECTED FOR DAMAGE. NO DAMAGE WAS FOUND. THE PHYSICIAN DISCONTINUED USE OF THE COIL AND USED ANOTHER 2 MM X 4 MM RUBY COIL WITH CONTINUOUS FLUSH TO PROCEED. HOWEVER, THE SAME ISSUE OCCURRED; THE COIL WAS WITHDRAWN AND RE-ADVANCED TWO ADDITIONAL TIMES WITHOUT SUCCESS. THEREFORE, THE 2 MM X 4 MM RUBY COIL WAS REMOVED AND A NON-PENUMBRA COIL WAS IMPLANTED. NEXT, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE WHILE ADVANCING A 4 MM X 35 MM RUBY COIL OUT OF THE MICROCATHETER. AS THE 4 MM X 35 MM RUBY COIL WAS ADVANCED INTO THE VESSEL, IT BEGAN TO FORM B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849425 ↗
• MalfunctionMar 18, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING RUBY COILS, NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE TARGET VESSEL WAS A HIGH FLOW AREA. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE THE FIRST 2 MM X 4 MM RUBY COIL WAS ADVANCED INTO THE MICROCATHETER. THE 2 MM X 4 MM RUBY COIL WAS UNABLE TO ADVANCE FURTHER THROUGH THE MICROCATHETER; THEREFORE, IT WAS REMOVED AND INSPECTED FOR DAMAGE. THE PHYSICIAN WAS UNABLE TO FIND ANY DAMAGE AND PROCEEDED TO MAKE TWO ADDITIONAL ATTEMPTS TO RE-ADVANCE THE COIL WITHOUT SUCCESS. THE 2 MM X 4 MM RUBY COIL WAS AGAIN REMOVED AND INSPECTED FOR DAMAGE. NO DAMAGE WAS FOUND. THE PHYSICIAN DISCONTINUED USE OF THE COIL AND USED ANOTHER 2 MM X 4 MM RUBY COIL WITH CONTINUOUS FLUSH TO PROCEED. HOWEVER, THE SAME ISSUE OCCURRED; THE COIL WAS WITHDRAWN AND RE-ADVANCED TWO ADDITIONAL TIMES WITHOUT SUCCESS. THEREFORE, THE 2 MM X 4 MM RUBY COIL WAS REMOVED AND A NON-PENUMBRA COIL WAS IMPLANTED. NEXT, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE WHILE ADVANCING A 4 MM X 35 MM RUBY COIL OUT OF THE MICROCATHETER. AS THE 4 MM X 35 MM RUBY COIL WAS ADVANCED INTO THE VESSEL, IT BEGAN TO FORM B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849414 ↗
• MalfunctionMar 3, 2020Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DETACHED AND PLACED A RUBY COIL IN THE TARGET VESSEL USING THE HANDLE; HOWEVER, PART OF THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK INSIDE OF THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9783250 ↗