RUBY Coil RBY4C0860-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 276 adverse event reports that list this exact device (DI M424RBY4C08600), received between Aug 13, 2015 and Mar 25, 2024 — classified as 16 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (116 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 276 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY USING RUBY COILS AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET LOCATION AND REPORTED THAT THE COIL WAS NOT TAKING ITS INTENDED SHAPE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO GET THE RUBY COIL TO TAKE ITS INTENDED SHAPE WITHOUT SUCCESS. THE PHYSICIAN THEN OBSERVED UNDER FLUOROSCOPY THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE PATIENT''S VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED USING FORCEPS AND A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING AND ANOTHER RUBY COIL, A NON-PENUMBRA COIL, A VASCULAR PLUG, AND THE SAME MICROCATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 18968925 ↗
• MalfunctionMar 24, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE RETRACTING THE RUBY COIL TO REPOSITION IT, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN SUCCESSFULLY FLUSHED THE DETACHED RUBY COIL INTO THE TARGET VESSEL USING A SYRINGE. 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

  MAUDE report 13894814 ↗
• MalfunctionJan 12, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND NON-PENUMBRA GUIDE CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUROUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE THIRD RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED "SLIGHT" RESISTANCE AND STOPPED ADVANCING THE RUBY COIL. UPON RETRACTION, THE RUBY COIL BROKE WITH PART OF THE EMBOLIZATION COIL IN THE ANEURYSM AND THE OTHER PART IN THE FEEDING VESSEL. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY OF THE RUBY COIL WITH PART OF THE RUBY COIL STILL ATTACHED TO IT. THE REMAINING RUBY COIL WAS LEFT IN PLACE AND THE PROCEDURE WAS ENDED AT THIS POINT. SUBSEQUENT COMPUTED TOMOGRAPHY (CT) SCANS SHOWED MIGRATION OF THE BROKEN RUBY COIL INTO THE SMA. THE PATIENT WAS THEN SENT TO ANOTHER FACILITY WHERE THEY REMOVED APPROXIMATELY FIVE CENTIMETERS OF THE RUBY COIL. NEXT, THE EMBOLIZATION OF THE ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK FOLLOWED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239989 ↗
• InjuryNov 2, 2021Stretched; Unraveled Material; Premature Separation; Stretched; Unraveled Material; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS, A NON-PENUMBRA MICROCATHETER AND SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SIX RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE SEVENTH RUBY COIL APPROXIMATELY FIVE TO TEN CENTIMETERS INTO THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL WAS RE-SHEATHED AND SAVED. NEXT, THE PHYSICIAN FLUSHED THE MICROCATHETER USING A SYRINGE AND CHECKED IF THERE WAS AN ISSUE WITH THE MICROCATHETER BY ADVANCING A GUIDEWIRE OVER THE MICROCATHETER. IT WAS REPORTED THAT THE GUIDEWIRE WAS EASILY ADVANCED OVER THE MICROCATHETER. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE PREVIOUSLY RE-SHEATHED RUBY COIL INTO THE HUB OF THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE HUB. THEREFORE, THE RUBY COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY PLACED FIVE RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE INTRODUCING THE TWELFTH RUBY COIL INTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741656 ↗
• MalfunctionJun 18, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A RUBY COIL AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING A PX SLIM AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK WITHIN THE HANDLE. THEREFORE, THE RUBY COIL AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A NEW HANDLE 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 12025791 ↗
• MalfunctionJun 17, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12018989 ↗
• MalfunctionJun 14, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE RETRACTING A RUBY COIL TO REPOSITION IT, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. 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 11995004 ↗
• MalfunctionMar 30, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK IN 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

  MAUDE report 11589948 ↗
• MalfunctionFeb 6, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WAS STUCK AND WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT 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; No Consequences Or Impact To Patient

  MAUDE report 11290239 ↗
• MalfunctionDec 30, 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 LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL APPROXIMATELY TEN CENTIMETERS THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK. THEREFORE, THE PHYSICIAN RETRACTED THE RUBY COIL INTO ITS INTRODUCER SHEATH AND PUT THE RUBY COIL IN WATER. LATER, THE PHYSICIAN ATTEMPTED TO RE-USE THE RUBY COIL AND WHILE ATTEMPTING TO ADVANCE THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, IT WAS NOTICED THAT THE RUBY COIL HAD DETACHED FROM ITS PUSHER ASSEMBLY OUTSIDE THE PATIENT. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND IT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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; No Consequences Or Impact To Patient

  MAUDE report 11099220 ↗
• MalfunctionDec 30, 2020Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPERMATIC VEIN USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DIAGNOSTIC CATHETER AND MICROCATHETER IN THE TARGET VESSEL. THEN, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER AND INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE MICROCATHETER INADVERTENTLY PULLED BACK INTO THE DIAGNOSTIC CATHETER AND THEN IT WAS NOTICED THAT THE RUBY COIL WAS TAKING SHAPE IN THE DIAGNOSTIC CATHETER. AFTERWARDS, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT WAS ABLE TO REMOVE THE DIAGNOSTIC CATHETER, WITH THE RUBY COIL INSIDE, OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL NON-PENUMBRA COILS, THE SAME MICROCATHETER, AND THE SAME DIAGNOSTIC CATHETER. 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 11094844 ↗
• MalfunctionDec 7, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND 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 10963172 ↗
• MalfunctionSep 21, 2020Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  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 10560419 ↗
• MalfunctionAug 12, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ENDOLEAK OFF THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS INADVERTENTLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH 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 10397102 ↗
• 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 10176881 ↗
• MalfunctionMay 11, 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 A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL APPROXIMATELY 30 PERCENT THROUGH THE DISTAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE FURTHER; 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 10044654 ↗
• MalfunctionApr 9, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946524 ↗
• MalfunctionFeb 28, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PHYSICIAN THEN, ADVANCED A NEW RUBY COIL THROUGH A NEW LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9770243 ↗
• MalfunctionFeb 18, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 9722504 ↗
• MalfunctionFeb 14, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POPLITEAL ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN, THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE THROUGH THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS RE-SHEATHED, THE LANTERN WAS REMOVED AND NO LONGER USED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED THE PREVIOUSLY RE-SHEATHED RUBY COIL AND EIGHT ADDITIONAL RUBY COILS IN THE TARGET VESSEL USING A NEW LANTERN. WHILE ATTEMPTING TO ADVANCE THE TENTH RUBY COIL INTO THE LANTERN, THE RUBY COIL WOULD NOT FULLY ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN. IT WAS REPORTED THAT THE RUBY COIL FELT STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714898 ↗
• MalfunctionJan 15, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND POD PACKING COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS AND POD PACKING COILS IN THE TARGET VESSEL. HOWEVER, THE NEXT RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9592151 ↗
• MalfunctionDec 6, 2019Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS. DURING ADVANCEMENT TO THE IMA VIA THE SUPERIOR MESENTERIC ARTERY (SMA), A RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY AND UNRAVELED. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9432292 ↗
• InjuryNov 22, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365178 ↗
• MalfunctionNov 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365174 ↗
• MalfunctionNov 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PX SLIM 045 INTO A NON-PENUMBRA DIAGNOSTIC CATHETER FOLLOWED BY AN 8X60 RUBY COIL. HOWEVER, THE 8X60 RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE PX SLIM 045 AND RESISTANCE WAS EXPERIENCED DURING BOTH ADVANCEMENT AND RETRACTION. THE 8X60 RUBY COIL WAS SUBSEQUENTLY REMOVED. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED THROUGH THE PX SLIM 045 AND THE SAME ISSUE OCCURRED. THEREFORE, THIS 8X60 RUBY COIL WAS ALSO REMOVED. THE SAME ISSUE WAS THEN ENCOUNTERED WITH A THIRD 8X60 RUBY COIL, AND THIS COIL WAS ALSO REMOVED. FOLLOWING THESE EVENTS, THE PHYSICIAN DECIDED TO REMOVE THE PX SLIM 045 FROM THE PROCEDURE. THE PHYSICIAN CONTINUED THE PROCEDURE USING A PX SLIM STRAIGHT TIP AND REGAINED ACCESS TO THE TARGET VESSEL ON THE IPSILATERAL SIDE. ANOTHER 8X60 RUBY COIL WAS THEN ADVANCED INTO THE PX SLIM STRAIGHT TIP. WHILE ADVANCING THE 8X60 RUBY COIL OUT OF THE PX SLIM STRAIGHT TIP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE 8X60 RUBY COIL BECAME PARTIALLY DETACHED. THE PX SLIM STRAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365161 ↗