RUBY Coil RBY2C1260-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI M424RBY2C12600), received between Aug 13, 2015 and Dec 8, 2022 — classified as 6 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (49 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 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING A RUBY COIL AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE PX SLIM INTO THE PATIENT. NEXT, WHILE ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. UPON RETRACTION OF THE RUBY COIL PUSHER ASSEMBLY, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15943596 ↗
• MalfunctionAug 12, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE MICROCATHETER AND THE RUBY COIL WOULD ONLY ADVANCE A FEW MILLIMETERS OUT OF THE TIP OF THE MICROCATHETER. NEXT, THE PHYSICIAN RETRACTED AND ADVANCED THE RUBY COIL A FEW MILLIMETERS IN AND OUT OF THE TIP OF THE MICROCATHETER APPROXIMATELY TWO OR THREE TIMES, BUT RESISTANCE WAS STILL ENCOUNTERED AND THE RUBY COIL WOULD NOT ADVANCE BEYOND THE TIP OF THE MICROCATHETER. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED 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 15221195 ↗
• MalfunctionNov 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL OUT FROM THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PLACED TWO RUBY COILS IN THE VESSEL USING THE PX SLIM. SUBSEQUENTLY, WHILE ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783767 ↗
• MalfunctionJul 14, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VISCERAL VESSEL USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. 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 12170282 ↗
• MalfunctionFeb 1, 2021Failure 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 SPLENIC ARTERY USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO RUBY COILS IN THE SPLENIC ANEURYSM. AFTER ADVANCING THE THIRD RUBY COIL APPROXIMATELY 20CM, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK AT THE ROTATING HEMOSTASIS VALVE (RHV). THE PHYSICIAN HAD EXPERIENCED RESISTANCE, AND THE RUBY COIL WAS UNABLE TO ADVANCE FURTHER IN THE PX SLIM. SUBSEQUENTLY, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED THE RUBY COIL INTO A BOWL OF SALINE TO RINSE OFF AND NOTICED THE RUBY COIL HAD DETACHED ON THE BACK TABLE. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COILS AND THE SAME PX SLIM. 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 11263424 ↗
• InjuryNov 5, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE RUBY COIL. WHILE RETRACTING THE RUBY COIL TO REPOSITION IT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED ALL DEVICES FROM THE PATIENT AND THEN REMOVED THE RUBY COIL FROM THE LANTERN. THE PHYSICIAN THEN PLACED TWO RUBY COILS INTO THE ANEURYSM USING THE LANTERN. WHILE IMPLANTING THE LAST RUBY COIL (F93620) INSIDE THE ANEURYSM, THE RUBY COIL UNINTENTIONALLY DETACHED AND SUBSEQUENTLY, PART OF THE RUBY COIL WAS IN THE RENAL ARTERY. THEREFORE, THE PHYSICIAN PLACED A STENT TO HOLD PART OF THE RUBY COIL WITHIN THE VESSEL WALL. THE PROCEDURE ENDED AT THIS POINT. 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 10792316 ↗
• MalfunctionOct 14, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. 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 10678008 ↗
• MalfunctionSep 21, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, A POD PACKING COIL (POD PC), A NON-PENUMBRA CATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE SPLENIC ARTERY HAD LITTLE TO NO TORTUOSITY. DURING THE PROCEDURE, AFTER SUCCESSFULLY EMBOLIZING A THREE TO FIVE MILLIMETERS EFFERENT ARTERY COMING OUT OF THE SPLENIC ARTERY ANEURYSM, THE PHYSICIAN RETRACTED THE LANTERN INTO THE SPLENIC ARTERY ANEURYSM AND EFFORTLESSLY PLACED A RUBY COIL INTO THE ANEURYSM. AFTER INTRODUCING A SECOND RUBY COIL APPROXIMATELY TWENTY CENTIMETERS INTO THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE PHYSICIAN RETRACTED THE RUBY COIL COMPLETELY INTO THE LANTERN. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL, THE PHYSICIAN EXPERIENCED DIFFICULTY PUSHING THE RUBY COIL OUT OF THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE RUBY COIL WAS STRETCHED WITH VERY SMALL CURLS OF ONE MILLIMETER OR LESS. THE PHYSICIAN THEN PLACED A RUBY COIL SUCCESSFULLY. NEXT, AFTER INTRODUCING APPROXIMATELY HALF OF ANOTHER RUBY COIL (F92489) INTO THE ANEURYSM, T

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

  MAUDE report 10560407 ↗
• MalfunctionAug 26, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC PAIN DISEASE IN THE OVARIAN VARICOSE VEIN USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL APPROXIMATELY FOUR TO FIVE CENTIMETERS AND THE PHYSICIAN WAS NOT SATISFIED; THEREFORE, THE RUBY COIL WAS RETRACTED BACK INTO THE PX SLIM. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL A FEW CENTIMETERS AND WAS UNSATISFIED WITH THE RUBY COIL DEPLOYMENT AND RETRACTED THE RUBY COIL BACK WITHIN THE PX SLIM. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK WITHIN THE PX SLIM. THEREFORE, THE RUBY COIL AND PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10457265 ↗
• MalfunctionJun 19, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL JUGULAR VEIN USING RUBY COILS, POD PACKING COILS (PODJ) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL (C16974) INTO THE TARGET VESSEL USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCING THE LAST THREE CENTIMETERS OF THE COIL AND, THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE COIL BECAME UNRAVELED. THEREFORE, THE PX SLIM WAS REMOVED CONTAINING THE UNRAVELED RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO REMOVE IT. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL (F91740) THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN WHILE ADVANCING THE LAST THREE CENTIMETERS OF THE RUBY COIL. THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL, THE SAME ISSUE OCCURRED, AND THE RUBY COIL BECAME UNRAVELED. IT WAS ALSO REPORTED THAT THE RUBY COIL WAS CUT FROM THE END AS IT WAS STUCK INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM CONTAINING THE REMAINING RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176880 ↗
• MalfunctionJun 3, 2020Failure 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 LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS, A POD PACKING 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 10115053 ↗
• MalfunctionFeb 28, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK AND SUBSEQUENTLY ITS PUSHER ASSEMBLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED AND THE RUBY COIL WAS THEREFORE 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 Consequences Or Impact To Patient

  MAUDE report 9767808 ↗
• MalfunctionNov 22, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS) AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED FROM THE PATIENT AND THE DETACHED RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN CONTINUED THE PROCEDURE BY RE-ADVANCING THE SAME MICROCATHETER AND ANOTHER RUBY COIL INTO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE RUBY COIL USING THE HANDLE, THE PHYSICIAN REALIZED THAT THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS STUCK IN THE HANDLE. HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH AND IMPLANT THE RUBY COIL INTO THE TARGET VESSEL AFTER CLICKING THE HANDLE APPROXIMATELY 2-3 TIMES. IT WAS REPORTED THAT THE PUSHER ASSEMBLY REMAINED STUCK IN THE HANDLE; THEREFORE, THE HANDLE WAS REMOVED FROM THE PROCEDURE. UPON ADVANCING THE NEXT POD PC INTO THE MICROCATHETER, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ANOTHER RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365650 ↗
• MalfunctionSep 10, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH AND, 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 8981283 ↗
• MalfunctionAug 28, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL INTO THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL, TOOK THE RUBY COIL OUT AND REINSERTED THE SAME MICROCATHETER INTO THE PATIENT'S BODY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THEN REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940792 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, THROMBUS MIGRATED INTO THE CAROTID TERMINUS AND THERE WAS OCCLUSION OF THE LEFT A2 SEGMENT. THE RELATIONSHIP BETWEEN THIS ADVERSE EVENT (CEREBRAL THROMBOEMBOLIS) AND THE 3MAX IS UNCERTAIN, HOWEVER IT IS UNRELATED TO THE ANGIOGRAPHIC PROCEDURE AND THE INDEX STROKE. THE PATIENT WAS DISCHARGED WITH SOME RESIDUAL DEFICITS AND SHOWED IMPROVEMENT AT FOLLOW-UP.

  Patient problems: Occlusion

  MAUDE report 8903730 ↗
• MalfunctionJul 16, 2019Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE PX SLIM, THE RUBY COIL BECAME STUCK INSIDE OF THE PX SLIM; THEREFORE, PHYSICIAN ATTEMPTED TO RETRACT IT. WHILE RETRACTING THE RUBY COIL NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE PX SLIM CONTAINING THE DETACHED RUBY COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN WAS UNABLE TO REMOVE THE PX SLIM. THEREFORE, THE PHYSICIAN REMOVED THE GUIDE CATHETER, THE PX SLIM AND RUBY COIL TOGETHER. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MICROCATHETER AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795655 ↗
• MalfunctionJul 1, 2019Device Fell; Device Fell

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF OPENED THE STERILE PACKAGING AND THE RUBY COIL WAS INADVERTENTLY DROPPED ON THE FLOOR. THE RUBY COIL WAS CONTAMINATED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8750252 ↗
• InjuryMay 28, 2019Break; Premature Separation; Break; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) AND THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND POD5S. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST RUBY COIL WAS ADVANCED INTO THE IMA USING A LANTERN DELIVERY MICROCATHETER (LANTERN), BUT WOULD NOT TAKE SHAPE IN THE VESSEL. THE RUBY COIL WAS THEREFORE REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A POD5; HOWEVER, THE POD5 WAS UNABLE TO ADVANCE OUT OF THE ROTATING HEMOSTASIS VALVE (RHV)AND INTO THE LANTERN AND WAS THEREFORE REMOVED. ANOTHER POD5 WAS THEN IMPLANTED SUCCESSFULLY IN THE IMA USING THE SAME LANTERN. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL INTO THE IIA AND MADE SEVERAL ATTEMPTS TO REPOSITION IT WITHIN THE VESSEL. WHILE RETRACTING THE RUBY COIL INTO THE LANTERN DURING AN ATTEMPT TO REPOSITION, THE RUBY COIL UNINTENTIONALLY DETACHED AND BROKE INTO TWO PIECES. IT WAS NOTED THAT ONE PIECE OF THE RUBY COIL BROKE OFF IN THE PATIENT'S VESSEL AND ANOTHER PIECE BROKE OFF INSIDE THE LANTERN. THE LANTERN AND PIECE OF THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT AND A SNARE WAS USED TO RETRIEVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646304 ↗
• MalfunctionApr 18, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER BUT WAS UNABLE TO ADVANCE IT OUT. IT WAS REPORTED THAT THE RUBY COIL WAS ONLY ABLE TO ADVANCE TO THE MIDDLE PART OF THE MICROCATHETER. THE RUBY COIL AND MICROCATHETER WERE THEN REMOVED AND WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER 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 8527058 ↗
• MalfunctionApr 5, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER. CONSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE OF THE MICROCATHETER AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8489195 ↗
• MalfunctionNov 12, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE RETRACTING TWO RUBY COILS FOR RE-POSITIONING, THE PHYSICIAN EXPERIENCED FRICTION AND SUBSEQUENTLY, THE RUBY COILS UNINTENTIONALLY DETACHED INSIDE THE LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED RUBY COILS AND FLUSHED THE COILS OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8062783 ↗
• MalfunctionOct 3, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN, THE PHYSICIAN INADVERTENTLY KINKED THE LANTERN. SUBSEQUENTLY, RESISTANCE WAS ENCOUNTERED AND THE RUBY COIL WOULD NOT ADVANCE. AFTER MULTIPLE FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7932512 ↗
• MalfunctionSep 6, 2018Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking; Failure to Advance; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING A RUBY COIL. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL APPROXIMATELY HALF WAY INTO THE ANEURYSM USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO POD PACKING COILS AND THE SAME LANTERN. IT WAS REPORTED THAT THE TIP OF THE LANTERN MIGHT HAVE BEEN TOO CLOSE TO THE WALL OF THE ANEURYSM. ADDITIONALLY, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY WAS KINKED ABOUT 20- 30 DEGREES PRIOR TO ADVANCING THE RUBY COIL THROUGH ITS INTRODUCER SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853237 ↗
• MalfunctionAug 3, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) THE PHYSICIAN EXPERIENCED RESISTANCE AND, CONSEQUENTLY, THE RUBY COIL PUSHER WIRE BECAME KINKED; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER 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 Consequences Or Impact To Patient

  MAUDE report 7747587 ↗