RUBY Coil RBY2C0312-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI M424RBY2C03120), received between Sep 30, 2015 and Jun 16, 2022 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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.

• MalfunctionJun 16, 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 ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN BUT DECIDED TO REPOSITION THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEN AFTER SEVERAL ATTEMPTS, THE PHYSICIAN FLUSHED THE DETACHED RUBY COIL OUT OF THE LANTERN AND INTO THE TARGET VESSEL USING A SYRINGE. 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 14721149 ↗
• MalfunctionFeb 18, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, AND USED THE HANDLE TO DETACH THE RUBY COIL. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE (PET LOCK) ON THE RUBY COIL PUSHER ASSEMBLY WAS SEPARATED, INDICATING A SUCCESSFUL DETACHMENT. HOWEVER, AFTER DETACHMENT, THE RUBY COIL WAS NOT VISIBLE IN THE TARGET VESSEL UNDER FLUOROSCOPY, DESPITE NOT HAVING PULLED BACK THE RUBY COIL PUSHER ASSEMBLY YET, BUT POSSIBLY ONLY BY APPROXIMATELY ONE CENTIMETER. THEREFORE, THE PHYSICIAN REMOVED AND FLUSHED THE MICROCATHETER TO SEE IF THE DETACHED RUBY COIL WAS IN THE MICROCATHETER, BUT THE RUBY COIL WAS NOT IN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED AND FLUSHED THE DIAGNOSTIC CATHETER. IT WAS NOTICED AT THAT POINT THAT THE DETACHED RUBY COIL WAS INSIDE THE DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, THE SAME HANDLE, MICROCATHETER, AND DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIEN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722906 ↗
• MalfunctionFeb 13, 2020Failure 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, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER IN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL BECAME STUCK; THEREFORE, IT WAS RESHEATHED BUT NOT RINSED IN SALINE. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL BECAME STUCK AGAIN; THEREFORE, IT WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707920 ↗
• MalfunctionJan 16, 2020Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LATERAL THORACIC ARTERY USING A POD3, RUBY COILS, NON-PENUMBRA DIAGNOSTIC CATHETER AND, LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD3 INTO THE TARGET VESSEL USING A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD3 PUSHER ASSEMBLY BECAME BENT; THEREFORE, IT WAS REMOVED. NEXT, WHILE ADVANCING A RUBY COIL, THE PHYSICIAN WAS NOT SATISFIED OF THE LOCATION WHERE THE COIL HAD LANDED; THEREFORE, IT WAS REMOVED. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE DIAGNOSTIC CATHETER AND BECAME STUCK. THEREFORE, THE LANTERN AND DIAGNOSTIC CATHETER WERE REMOVED CONTAINING THE DETACHED RUBY COIL. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL USING THE SAME LANTERN AND DIAGNOSTIC CATHETER. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN WAS MORE AGGRESSIVE WITH THE RUBY COIL AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, THE SAME LANTERN AND DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596906 ↗
• MalfunctionDec 3, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INFERIOR PHRENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE THIRD RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN DECIDED TO RETRACT THE RUBY COIL TO FLUSH THE MICROCATHETER. HOWEVER, UPON REMOVAL OF THE RUBY COIL PUSHER ASSEMBLY, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PHYSICIAN THEN TRIED TO FLUSH THE DETACHED RUBY COIL OUT OF THE MICROCATHETER BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PATIENT THEN EXPIRED THREE DAYS POST-PROCEDURE FROM OTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403203 ↗
• MalfunctionApr 17, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING RUBY COILS. DURING THE PROCEDURE, THE DISTAL END OF THE RUBY COIL BECAME KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE PHYSICIAN CONTINUED TO ADVANCE THE SAME RUBY COIL INTO THE TARGET VESSEL USING A VELOCITY DELIVERY MICROCATHETER (VELOCITY); HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITIONING OF THE RUBY COIL IN THE VESSEL AND DECIDED TO RE-SHEATH THE COIL FOR REPOSITIONING. WHILE ADVANCING THE RUBY COIL BACK THROUGH THE VELOCITY, THE PHYSICIAN EXPERIENCED RESISTANCE; HOWEVER, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THE SAME 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 8522720 ↗
• MalfunctionFeb 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET AROUND THE CORNER TO ADVANCE A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE GDA USING A 0.018 GUIDEWIRE. WITHOUT HAVING AN ALTERNATIVE GUIDEWIRE TO IMPROVE THE ADVANCEMENT OF THE LANTERN, THE PHYSICIAN REMOVED IT, THEN ADVANCED A NON-PENUMBRA MICROCATHETER CONTAINING ITS OWN PREPACKED 0.021 GUIDEWIRE INTO THE TARGET VESSEL. THE PHYSICIAN THEN INSERTED A RUBY COIL INTRODUCER SHEATH INTO THE ROTATING HEMOSTASIS VALVE (RHV), CLOSED THE RHV AND WATCHED THE RETROGRADE FLUSH. WHEN THE FLUSH WAS COMPLETED, THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COIL INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE RUBY COIL WOULD NOT ADVANCE. THE PHYSICIAN THEN REMOVED THE RUBY COIL AND WAS ABLE TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE. THE PHYSICIAN THEN RE-INSERTED THE RUBY COIL INTO THE RHV; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE RUBY COIL WOULD NOT ADVANCE INTO THE MICROCATHETER. AFTER SEVERAL FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN REMOVED THE MIC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8345347 ↗
• MalfunctionDec 21, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ASCENDING LEFT LUMBAR VEIN USING RUBY COILS AND POD PACKING COILS (PODJ). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTALLY BENT THE PUSHER ASSEMBLY WHILE INSERTING THE RUBY COIL AND THE PODJ INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), THEREFORE; THE RUBY COIL AND PODJ WERE REMOVED. THE PROCEDURE WAS ABORTED AT THIS POINT DUE TO LOSING ACCESS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189971 ↗
• MalfunctionJul 27, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL. HOWEVER, WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER WITH THE DETACHED RUBY COIL INSIDE FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7729059 ↗
• MalfunctionMay 30, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER RUBY COIL IN THE TARGET VESSEL USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE THE LAST RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL WOULD NOT ADVANCE. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552869 ↗
• MalfunctionMay 16, 2018Device Damaged Prior to Use; Device Operates Differently Than Expected; Device Damaged Prior to Use; Device Operates Differently Than Expected

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE INTRODUCER SHEATH OF THE RUBY COIL (RUBY COIL) WAS NOT INTACT UPON REMOVAL FROM THE PACKAGING HOOP AND THE PUSHER ASSEMBLY OF THE RUBY COIL CAME OUT OF THE HOOP WITHOUT THE INTRODUCER SHEATH. THE REPORTED ISSUE WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A LANTERN DELIVERY MICROCATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7519162 ↗
• MalfunctionMay 10, 2018Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance; Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED TO REMOVE A RUBY COIL FROM A LANTERN DELIVERY MICROCATHETER BECAUSE THE RUBY COIL WAS THE WRONG SIZE. HOWEVER, UPON RETRACTION, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. THE LANTERN WAS THEREFORE REMOVED WITH THE RUBY COIL INSIDE. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN; HOWEVER, THE SAME ISSUE OCCURRED WITH ANOTHER 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 Consequences Or Impact To Patient

  MAUDE report 7504672 ↗
• MalfunctionApr 24, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL, BUT WAS UNABLE TO DETACH IT USING THE HANDLE. THEREFORE, THE RUBY COIL WAS REMOVED AND 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 7455225 ↗
• MalfunctionApr 16, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BRANCH OF THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE MICROCATHETER, AND THEREFORE THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434513 ↗
• MalfunctionApr 3, 2018Failure to Advance; Physical Resistance; Failure to Advance; 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 WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND THEREFORE THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392263 ↗
• MalfunctionMar 13, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DUODENAL ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE BEING ADVANCED THROUGH A NON-PENUMBRA MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL FROM THE PATIENT'S BODY AND FLUSHED OUT THE RUBY COIL. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER IN THE TARGET VESSEL AND 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 7336214 ↗
• MalfunctionDec 11, 2017Bent; Device Handling Problem; Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTLY BENT THE PUSHER WIRE OF A RUBY COIL WHILE ATTEMPTING TO ADVANCE IT INTO A LANTERN DELIVERY MICROCATHETER (LANTERN). THE RUBY COIL WAS THEREFORE REMOVED, AND 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 7106425 ↗
• MalfunctionNov 29, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRACT A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER FOR REPOSITIONING, THE RUBY COIL UNINTENTIONALLY DETACHED OUTSIDE OF THE MICROCATHETER AND IN THE ANEURYSM. THE PROCEDURE WAS COMPLETED BY PACKING THE DETACHED RUBY COIL INTO THE ANEURYSM WITH ANOTHER RUBY COIL USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7069137 ↗
• MalfunctionNov 29, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068451 ↗
• MalfunctionSep 1, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A PSEUDO-ANEURYSM IN BUTTOCKS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE FIVE RUBY COILS THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS THROUGH THE LANTERN; THEREFORE THE RUBY COILS AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS AND AN ADDITIONAL RUBY COIL. IN ADDITION, THERE WAS NO NOTED DAMAGE ON THE LANTERN AFTER REMOVAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6838255 ↗
• MalfunctionJul 6, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SMALL BRANCH IN A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6691232 ↗
• MalfunctionJun 23, 2017Bent; Failure to Advance; Bent; Failure to Advance

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED INITIAL RUBY COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE; HOWEVER, THE COIL UNINTENTIONALLY DETACHED WHILE PARTIALLY INSIDE THE VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. NEXT, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE; HOWEVER, THE COIL WAS UNABLE TO COMPLETELY ADVANCE OUT OF THE TIP OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND IT WAS NOTED THAT THE PUSHER ASSEMBLY APPEARED TO BE BENT. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ADDITIONAL COILS AND A 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 6663401 ↗
• MalfunctionJun 1, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL INTO THE TARGET VESSEL AND THEN ATTEMPTED TO DETACH THE COIL USING THE HANDLE BUT WAS UNABLE TO DO SO. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS AN ADVERSE EFFECT TO THE PATIENT. IT SHOULD BE NOTED THAT THE MANUFACTURER MADE THREE ATTEMPTS TO REACH OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6607007 ↗
• MalfunctionMar 29, 2017Out-Of-Box Failure; Material Protrusion/Extrusion; Out-Of-Box Failure; Material Protrusion/Extrusion

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT HALF OF THE RUBY COIL WAS HANGING OUT ITS INTRODUCER SHEATH UPON REMOVAL FROM THE DISPENSER HOOP. THE RUBY COIL WAS NOTICED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6444826 ↗
• MalfunctionMar 17, 2017Detachment Of Device Component; Retraction Problem; Physical Resistance; Detachment Of Device Component; Retraction Problem; Physical Resistance

  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 6414597 ↗