RUBY Coil RBY2C1035-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI M424RBY2C10350), received between Aug 13, 2015 and Aug 5, 2021 — classified as 2 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (36 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 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERY PSEUDOANEURYSM (PAP) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL TO REPOSITION THE MICROCATHETER. HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE RETRACTING THE RUBY COIL AND IT UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285008 ↗
• MalfunctionJul 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL BRANCH USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION, BUT THE RUBY COIL WOULD NOT FORM AND THEREFORE IT WAS REMOVED. NEXT, THE PHYSICIAN DECIDED TO USE ANOTHER RUBY COIL; HOWEVER, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED WHILE ADVANCING THROUGH THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED AS WELL. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214249 ↗
• MalfunctionJan 15, 2021Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DIGESTIVE ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL WOULD BECAME STUCK AND WOULD NOT ADVANCE OUT OF THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA 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 11177091 ↗
• MalfunctionDec 17, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE PELVIC VEIN USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE THROUGH THE LANTERN. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT THE LANTERN WAS KINKED. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. AFTER THE REMOVAL, NO KINK ON THE LANTERN WAS NOTED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY 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 11025374 ↗
• MalfunctionNov 20, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, 5FR NON-PENUMBRA SHEATH, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL OUT FROM THE INTRODUCER SHEATH AND INTO THE DISTAL END OF THE MICROCATHETER, THE PHYSICIAN NOTICED THE PUSHER ASSEMBLY OF THE RUBY COIL TO BE KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 10880167 ↗
• MalfunctionSep 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD PACKING COILS (PODJS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THREE RUBY COILS AND A PODJ SEPARATELY THROUGH THE PROXIMAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS AND PODJ BECAME STUCK. THEREFORE, THE RUBY COILS AND PODJ WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 10543985 ↗
• MalfunctionSep 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD PACKING COILS (PODJS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THREE RUBY COILS AND A PODJ SEPARATELY THROUGH THE PROXIMAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS AND PODJ BECAME STUCK. THEREFORE, THE RUBY COILS AND PODJ WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 10543980 ↗
• MalfunctionMar 11, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL. DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819320 ↗
• MalfunctionJan 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DIAGNOSTIC CATHETER AND THE LANTERN IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO ADDITIONAL RUBY COILS THROUGH THE LANTERN, HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN THEN REMOVED THE DIAGNOSTIC CATHETER AND LANTERN. THE PROCEDURE WAS COMPLETED USING 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 9628932 ↗
• MalfunctionDec 13, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TESTICULAR VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER (PROGREAT). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COILS GOT STUCK INSIDE THE MICROCATHETER AND SUBSEQUENTLY UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. IT WAS REPORTED THAT THE UNINTENTIONAL DETACHMENTS MAY HAVE OCCURRED DURING RETRACTION OF THE RUBY COILS AFTER THEY BECAME STUCK. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS 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 9470258 ↗
• MalfunctionDec 13, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TESTICULAR VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER (PROGREAT). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COILS GOT STUCK INSIDE THE MICROCATHETER AND SUBSEQUENTLY UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. IT WAS REPORTED THAT THE UNINTENTIONAL DETACHMENTS MAY HAVE OCCURRED DURING RETRACTION OF THE RUBY COILS AFTER THEY BECAME STUCK. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS 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 9470223 ↗
• MalfunctionNov 14, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD10 IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE WITHIN THE INTRODUCER SHEATH. THE PHYSICIAN THEN RETRACTED AND ATTEMPTED TO ADVANCE THE SAME RUBY COIL, BUT THE SAME RESISTANCE 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 Consequences Or Impact To Patient

  MAUDE report 9323210 ↗
• MalfunctionNov 1, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK AT THE DISTAL END OF THE LANTERN. THE PHYSICIAN ATTEMPTED TO PUSH THE RUBY COIL THROUGH THE LANTERN BUT WAS UNABLE TO GET THE RUBY COIL TO MOVE. THE PHYSICIAN THEN ATTEMPTED FLUSH THE RUBY COIL OUT OF THE LANTERN AND INTO THE ANEURYSM; HOWEVER, THE RUBY COIL REMAINED STUCK IN THE SAME LOCATION. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW 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 9268365 ↗
• MalfunctionSep 5, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  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 PLACED THE LANTERN THROUGH A NON-PENUMBRA DIAGNOSTIC CATHETER WITHOUT ISSUE. WHILE ADVANCING A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE LANTERN AND UNINTENTIONALLY DETACHED WHEN THE PHYSICIAN ATTEMPTED TO PULL IT BACK; THEREFORE, THE RUBY COIL WAS REMOVED BY PULLING THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL OUT OF ITS INTRODUCER SHEATH AND THROUGH THE LANTERN. HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE TIP OF THE LANTERN AND WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL, IT UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED/OVALIZED THREE CENTIMETERS FROM THE TIP. THE PROCEDURE WAS THEN COMPLETED USING FIVE OTHER RUBY COILS, A NEW LANTERN, AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8967458 ↗
• MalfunctionSep 5, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  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 PLACED THE LANTERN THROUGH A NON-PENUMBRA DIAGNOSTIC CATHETER WITHOUT ISSUE. WHILE ADVANCING A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE LANTERN AND UNINTENTIONALLY DETACHED WHEN THE PHYSICIAN ATTEMPTED TO PULL IT BACK; THEREFORE, THE RUBY COIL WAS REMOVED BY PULLING THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL OUT OF ITS INTRODUCER SHEATH AND THROUGH THE LANTERN. HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE TIP OF THE LANTERN AND WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL, IT UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED/OVALIZED THREE CENTIMETERS FROM THE TIP. THE PROCEDURE WAS THEN COMPLETED USING FIVE OTHER RUBY COILS, A NEW LANTERN, AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8967457 ↗
• MalfunctionJul 18, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY CATHETER (LANTERN), RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY KNOCKED THE LANTERN AND THE HANDLE TO THE FLOOR WHILE THEY WERE ON THE STERILE FIELD. THE LANTERN AND HANDLE DROPPED ON THE FLOOR PRIOR TO USE AND THEREFORE, WERE NOT USED IN THE PROCEDURE. A SECOND LANTERN AND HANDLE WERE THEN OPENED. ONCE GAINING ACCESS TO THE IIA, THE PHYSICIAN ADVANCED THE SECOND LANTERN OVER A GUIDE-WIRE AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN INSPECTED, THEN RE-INSERTED THE SAME LANTERN INTO THE PATIENT'S BODY AND PLACED A NEW RUBY COIL WITH NO ISSUES. AFTER THIS, ANOTHER RUBY COIL WAS INADVERTENTLY KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THIS RUBY COIL WAS FOUND PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802850 ↗
• MalfunctionJul 12, 2019Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC 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 A 115 CM LANTERN IN THE TARGET VESSEL USING A NON-PENUMBRA ANGIOGRAPHIC CATHETER AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO RETRACT THE RUBY COIL SEVERAL TIMES AND REPOSITIONED THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE OF THE MICROCATHETER. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 135 CM LANTERN THROUGH THE ANGIOGRAPHIC CATHETER; HOWEVER, IT WOULD ONLY ADVANCE APPROXIMATELY 40 CENTIMETERS AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE LANTERN WAS REMOVED AND ONE OF THE TRANSITION ZONES WAS FOUND TO BE ENLARGED AND ELEVATED. NEXT, THE PHYSICIAN PLACED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE PAST THE DISTAL TIP OF THE MICROCATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787316 ↗
• MalfunctionJul 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC 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 A 115 CM LANTERN IN THE TARGET VESSEL USING A NON-PENUMBRA ANGIOGRAPHIC CATHETER AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO RETRACT THE RUBY COIL SEVERAL TIMES AND REPOSITIONED THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE OF THE MICROCATHETER. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 135 CM LANTERN THROUGH THE ANGIOGRAPHIC CATHETER; HOWEVER, IT WOULD ONLY ADVANCE APPROXIMATELY 40 CENTIMETERS AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE LANTERN WAS REMOVED AND ONE OF THE TRANSITION ZONES WAS FOUND TO BE ENLARGED AND ELEVATED. NEXT, THE PHYSICIAN PLACED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE PAST THE DISTAL TIP OF THE MICROCATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787313 ↗
• MalfunctionJul 12, 2019Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC 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 A 115 CM LANTERN IN THE TARGET VESSEL USING A NON-PENUMBRA ANGIOGRAPHIC CATHETER AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO RETRACT THE RUBY COIL SEVERAL TIMES AND REPOSITIONED THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE OF THE MICROCATHETER. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A 135 CM LANTERN THROUGH THE ANGIOGRAPHIC CATHETER; HOWEVER, IT WOULD ONLY ADVANCE APPROXIMATELY 40 CENTIMETERS AND WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE LANTERN WAS REMOVED AND ONE OF THE TRANSITION ZONES WAS FOUND TO BE ENLARGED AND ELEVATED. NEXT, THE PHYSICIAN PLACED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE PAST THE DISTAL TIP OF THE MICROCATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787312 ↗
• MalfunctionMay 10, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS INADVERTENTLY KINKED UPON REMOVAL FROM ITS PACKAGING. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8601488 ↗
• MalfunctionApr 26, 2019Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT COMMON ILIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, DESPITE REPOSITIONING THE MICROCATHETER. THEREFORE, THE PHYSICIAN RETRACTED THE COIL. HOWEVER, WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE AND FLUSHED THE COIL OUT. 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 8556634 ↗
• MalfunctionApr 5, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A 10X35 RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. UPON ADVANCEMENT OF THE NEXT 12X60 RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT IT WAS NOT ABLE TO ADVANCE THROUGH THE LANTERN. THE 12X60 RUBY COIL AND LANTERN WERE THEREFORE REMOVED FROM THE PROCEDURE. WHILE EXAMINING THE LANTERN, THE PHYSICIAN FOUND THAT THERE WAS NO FLOW THROUGH IT AND DECIDED TO CUT IT AT THE PROXIMAL END NEAR THE HUB. IT WAS THEN REPORTED THAT HALF OF THE 10X35 RUBY COIL PUSHER WIRE WAS FOUND BROKEN OFF WITHIN THE LANTERN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, NON-PENUMBRA 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 8489647 ↗
• MalfunctionOct 28, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THREE RUBY COILS THROUGH THE HUB OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE MICROCATHETER AND RUBY COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING AN AMPLATZER PLUG WITH THE GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8012315 ↗
• MalfunctionOct 19, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS OUT OF THE TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, THE RUBY COILS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND ADDITIONAL COILS. IT WAS NOTED THAT THE RUBY COILS BECAME DAMAGED AS THEY WERE BEING RE-SHEATHED INTO THEIR INTRODUCER SHEATHS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7986865 ↗
• MalfunctionOct 19, 2018Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS OUT OF THE TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, THE RUBY COILS WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND ADDITIONAL COILS. IT WAS NOTED THAT THE RUBY COILS BECAME DAMAGED AS THEY WERE BEING RE-SHEATHED INTO THEIR INTRODUCER SHEATHS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7986861 ↗