RUBY Coil RBY4C0860-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00814548018393), received between Sep 20, 2018 and Sep 29, 2026 — classified as 3 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (25 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937684 ↗
• MalfunctionSep 29, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936955 ↗
• MalfunctionSep 15, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776846 ↗
• MalfunctionNov 5, 2024Stretched; Premature Separation; Stretched; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL STRETCHED AND UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED. 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 20606765 ↗
• MalfunctionMay 17, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), A ROTATING HEMOSTASIS VALVE (RHV), AND A BASE CATHETER (6F). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE RETRACTING THE RUBY COIL TO REPOSITION, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE BASE CATHETER. THE BASE CATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, THE SAME LANTERN, THE SAME RHV, AND THE SAME BASE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347805 ↗
• MalfunctionMar 8, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ILIAC ARTERY ANEURYSM USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER DURING ADVANCEMENT. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE COMPLETION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18863031 ↗
• MalfunctionDec 20, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN DECIDED TO RETRACT THE COIL BACK INTO INTRODUCER SHEATH TO REPOSITION THE MICROCATHETER. WHILE RETRACTING THE RUBY COIL BACK INTO MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE APPROXIMATELY MORE THAN HALF OF DETACHED RUBY COIL WAS CONTAINED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED AN OCCLUSION BALLOON TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 18361589 ↗
• MalfunctionSep 29, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, A POD PACKING COIL (POD PC), A NON-PENUMBRA CATHETER AND A GUIDEWIRE ((B)(4)). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE CATHETER INTO THE TARGET LOCATION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE THROUGH THE LANTERN. THE PHYSICIAN PULLED THE LANTERN BACK BUT THE ISSUE REMAINED THE SAME. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN PULLED THE COIL BACK; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN AND THE RUBY COIL WERE REMOVED. UPON REMOVAL, THE DISTAL END OF THE LANTERN WAS NOTICED TO BE KINKED. NEXT, THE PHYSICIAN PLACED NON-PENUMBRA COILS DISTAL TO THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED A NEW LANTERN TO THE TARGET LOCATION AND SUCCESSFULLY PLACED TWO RUBY COILS. AFTER PLACING TWO RUBY COILS, THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE POD PC THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD PC WOULD NOT EXIT THE DISTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844670 ↗
• MalfunctionJan 12, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE FIRST RUBY COIL INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED THE SECOND RUBY COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL, BUT THE RUBY COIL WOULD STILL NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE RUBY COIL TO PUSH THE DETACHED RUBY COIL SUCCESSFULLY INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A THIRD RUBY COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THE PHYSICIAN THEN USED A NEW HANDLE TO SUCCESSFULLY DETACH THE RUBY COIL INTO THE TARGET VESSEL. AFTER THAT, THE PHYSICIAN ADVANCED A POD PC I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153814 ↗
• MalfunctionOct 11, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD COIL IN THE TARGET VESSEL USING THE LANTERN. NEXT, WHILE ADVANCING THE RUBY COIL INTO THE VESSEL USING THE LANTERN, THE PHYSICIAN NOTICED THE LANTERN WOULD KICKBACK OUT OF THE GUIDE CATHETER. SUBSEQUENTLY, THE PHYSICIAN WAS ADVANCING THE LANTERN OVER THE RUBY COIL AND BACK THROUGH THE GUIDE CATHETER WHEN THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE GUIDE CATHETER. THEREFORE, THE GUIDE CATHETER AND LANTERN WAS REMOVED CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, THE SAME LANTERN, AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584054 ↗
• MalfunctionJul 26, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. NEXT, WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS ADVANCING THE RUBY COIL AGGRESSIVELY WHEN THE COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT HALF OF THE DETACHED RUBY COIL WAS INSIDE THE ANEURYSM. THEREFORE, THE PHYSICIAN INJECTED SALINE INTO THE LANTERN TO PUSH THE OTHER HALF OF THE DETACHED RUBY COIL INTO THE ANEURYSM AND THE COIL WAS SUCCESSFULLY IMPLANTED. 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 15108700 ↗
• MalfunctionDec 7, 2021Entrapment of Device; Failure to Advance; Physical Resistance/Sticking; Entrapment of Device; Failure to Advance; Physical Resistance/Sticking

  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, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK WITHIN THE LANTERN. THEREFORE, THE LANTERN AND THE RUBY COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NEW LANTERN. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE DEFICIENCY OR DAMAGE TO THE FIRST LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957892 ↗
• MalfunctionNov 30, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL. SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12897965 ↗
• InjuryNov 11, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS, POD COILS, A NON-PENUMBRA MICROCATHETER, AND A DIAGNOSTIC CATHETER. IT WAS REPORTED THAT ACCESS TO THE TARGET VESSEL WAS CHALLENGING AND LONG. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND DIAGNOSTIC CATHETER, THE MICROCATHETER AND DIAGNOSTIC CATHETER KEPT KICKING OUT DUE TO THE CHALLENGING ACCESS. THEREFORE, THE POD COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH A SECOND POD COIL. THEREFORE, THE POD COIL WAS ALSO REMOVED. NEXT, WHILE ADVANCING A RUBY COIL TO THE TARGET VESSEL, THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE TARGET VESSEL. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PUSH THE DETACHED RUBY COIL INTO THE TARGET LOCATION USING THE PUSHER ASSEMBLY; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE ENDED AT THIS POINT DUE TO RADIATION EXPOSURE BECAUSE ACCESS WAS CHALLENGING AND LONG, AND THE PHYSICIAN PLANNED TO BRING THE PATIENT BACK IN ON A LATER DATE. THERE WAS NO REPORT OF AN ADVERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12792067 ↗
• MalfunctionNov 7, 2021Stretched; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ILIAC VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL TO THE TARGET VESSEL USING THE LANTERN AND REMOVED THE INTRODUCER SHEATH. SUBSEQUENTLY, THE RUBY COIL WAS NOTICED TO BE STRETCHED AND EXITING THE LANTERN. THEREFORE, THE RUBY COIL WAS RETRACTED AND REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12760087 ↗
• MalfunctionOct 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL WAS STUCK AND WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627753 ↗
• MalfunctionSep 23, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PCS), RUBY COILS, NON-PENUMBRA SHEATH, NON-PENUMBRA CATHETER, A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED APPROXIMATELY TWENTY FIVE PENUMBRA COILS IN THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT TWO POD PCS AND ONE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COILS WOULD NOT ADVANCE FULLY AND ONLY HALF OF THE COILS WOULD ENTER THE MICROCATHETER. THEREFORE, THE THREE COILS WERE REMOVED. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED BEFORE THE COILS WERE INTRODUCED. THE PHYSICIAN THEN USED A GUIDEWIRE IN ORDER TO CLEAR THE MICROCATHETER AND WAS SUBSEQUENTLY ABLE TO DELIVER MULTIPLE COILS USING THE SAME MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA 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 12521956 ↗
• MalfunctionAug 20, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL SPERMATIC VEIN USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 12349070 ↗
• MalfunctionAug 4, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT TRACK THROUGH THE LANTERN, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THEY WERE REMOVED, AND THE LANTERN WAS FLUSHED. THE PROCEDURE WAS COMPLETED USING TWO 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 12274584 ↗
• MalfunctionJun 3, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT OVARIAN VEIN USING RUBY COILS (RUBY COIL) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH, AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. 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 11932857 ↗
• MalfunctionMay 25, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO A LANTERN, THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN BENT THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL 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 11882250 ↗
• MalfunctionMay 19, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL DETACHED IN THE INTRODUCER SHEATH. IT WAS REPORTED THE PHYSICIAN HAD FELT RESISTANCE AND WHEN ATTEMPTING TO RETRACT THE RUBY COIL, THE RUBY COIL DETACHED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852762 ↗
• MalfunctionMay 18, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL WHILE ADVANCING THE RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL 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 11843826 ↗
• MalfunctionMar 27, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE RIGHT RENAL ARTERY USING A RUBY COIL, A POD COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING A RUBY COIL APPROXIMATELY HALFWAY INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A POD COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. 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 11578743 ↗
• MalfunctionMar 8, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS, POD PACKING COILS (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE LANTERN INTO THE TARGET VESSEL; HOWEVER, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THE LANTERN CONTAINING THE DETACHED POD PC WAS, THEREFORE, REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD PC¿S, POD 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 11440959 ↗