RUBY Coil RBY4C0305-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00814548018317), received between Aug 14, 2018 and Apr 10, 2026 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Failure to Fold; Premature Separation

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE INVOLVING MULTIPLE VESSELS OF THE RIGHT INTERNAL ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). ONE TARGET VESSEL WAS SUCCESSFULLY TREATED, AFTER WHICH THE LANTERN WAS REPOSITIONED. DURING ADVANCEMENT OF A RUBY COIL INTO THE SUBSEQUENT TARGET VESSEL, THE COIL DID NOT FORM AS INTENDED. THE PHYSICIAN ELECTED TO WITHDRAW THE COIL. DURING RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN MICROCATHETER. THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED FROM THE PATIENT, AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW LANTERN MICROCATHETER. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845311 ↗
• MalfunctionSep 5, 2025Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT THE PATENT DUCTUS ARTERIOSUS USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE RUBY COIL IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING A SECOND RUBY COIL INTO THE TARGET LOCATION, THE BACK END OF THE RUBY COIL PUSHER ASSEMBLY HAD KINKED, AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983376 ↗
• MalfunctionMay 30, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN WAS ADVANCING THE NEXT RUBY COIL THROUGH THE MICROCATHETER BUT EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. WHILE RETRACTING, THE PHYSICIAN WAS STILL EXPERIENCING RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE PROXIMAL END OF THE MICROCATHETER. IT WAS REPORTED THE DETACHED RUBY COIL WAS CONFIRMED TO BE WITHIN THE MICROCATHETER UNDER FLUOROSCOPY. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115393 ↗
• MalfunctionAug 4, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. HOWEVER, WHILE RETRACTING, THE PHYSICIAN STILL EXPERIENCED RESISTANCE AND THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. THE MICROCATHETER WAS THEN REINSERTED BACK INTO THE VESSEL. SUBSEQUENTLY, IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH THE NEXT TWO RUBY COILS. BOTH DETACHED RUBY COILS WERE CONTAINED INSIDE OF THE MICROCATHETER AND THE MICROCATHETER WAS REMOVED. BOTH RUBY COILS WERE THEN FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466776 ↗
• MalfunctionJan 11, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH, AND THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN TRIED DETACHING THE COIL MANUALLY, BUT THE RUBY COIL LP STILL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER WITH THE RUBY COIL LP INSIDE. WHILE RETRACTING THE MICROCATHETER, THE RUBY COIL LP UNINTENTIONALLY DETACHED IN THE HEPATIC ARTERY. A SNARE DEVICE WAS USED TO RETRIEVE THE COIL; HOWEVER, THE COIL COULD NOT BE RETRIEVED. THE RUBY COIL LP WAS LEFT IN THE HEPATIC ARTERY. 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 13219471 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL LP AND RUBY COIL BECAME KINKED WHILE ADVANCING THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL LP AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775261 ↗
• MalfunctionOct 28, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN KINKED THE RUBY COIL UPON INSERTING IT INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THE RUBY COIL STARTED TO TAKE SHAPE WITHIN THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712145 ↗
• MalfunctionOct 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT GASTRIC BRANCH USING RUBY COIL LPS, PACKING COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE LEFT GASTRIC BRANCH USING THE FIRST MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP USING A NEEDLE DRIVER BUT, THE COIL STILL FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH FIVE RUBY COIL LPS AND FOUR PACKING COIL LPS IN THE TARGET LOCATION USING THE HANDLE. THEREFORE, THE PHYSICIAN USED THE NEEDLE DRIVER TO MANUALLY DETACH THE PACKING COIL LPS AND RUBY COIL LPS. NEXT, WHILE ATTEMPTING TO PLACE A RUBY COIL IN THE RIGHT GASTRIC BRANCH, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE TIP OF THE SECOND MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619534 ↗
• MalfunctionAug 17, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS, POD PACKING COILS (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN PLACED THE NEXT RUBY COIL INTO THE ANEURYSM; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE PHYSICIAN DECIDED TO PULL THE RUBY COIL BACK. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE FIRST RUBY COIL WAS ALSO PULLED BACK INTO THE LANTERN. THEREFORE, BOTH THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331052 ↗
• MalfunctionAug 17, 2021Positioning Problem; Positioning Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS, POD PACKING COILS (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN PLACED THE NEXT RUBY COIL INTO THE ANEURYSM; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, THE PHYSICIAN DECIDED TO PULL THE RUBY COIL BACK. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE FIRST RUBY COIL WAS ALSO PULLED BACK INTO THE LANTERN. THEREFORE, BOTH THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331050 ↗
• MalfunctionJul 15, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE BACK END OF A RUBY COIL BENT DURING COIL INSERTION INTO MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174213 ↗
• MalfunctionMay 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER , A DIAGNOSTIC CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL (F101571) IN THE TARGET VESSEL. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F94874) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL (F101967) THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE RUBY COIL IN THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL (F100571) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT TWO RUBY COILS (F101967 AND F98624), THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO RUBY COILS IN THE TARGET VESSEL. IT WAS REPORTED THAT ALL THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COILS AROUND A CURVE. THEN, THE PHYSICIAN ADVANCED A RUBY COIL (F99601)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845881 ↗
• MalfunctionMay 9, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT GASTRIC ARTERY AND CELIAC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS), A LANTERN DELIVERY MICROCATHETERS (LANTERN), AND 0.018 WIRE. IT WAS REPORTED THE PATIENT HAD A BLEEDING PSEUDO-ANEURYSM ARISING FROM THE LEFT GASTRIC ARTERY. DURING THE PROCEDURE, THE WIRE WOULD NOT ADVANCE THROUGH THE LANTERN SMOOTHLY. THE LANTERN WAS REMOVED, AND THE PHYSICIAN OPENED THE SECOND LANTERN. HOWEVER RIGHT AFTER, THE PHYSICIAN WAS ABLE TO GET THE WIRE TO ADVANCE SMOOTHLY BY FLUSHING THE FIRST LANTERN AND WETTING THE WIRE AND USED THIS LANTERN IN THE PROCEDURE. THE PHYSICIAN STARTED WITH THE RUBY COIL (F103831) WHICH WAS FOUND TOO LARGE IN DIAMETER AND KICKED THE LANTERN FROM THE VESSEL. SUBSEQUENTLY, AS THE PHYSICIAN PULLED THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. IT WAS REPORTED THAT THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING AND RETRACTING THE COIL. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO COIL THE ORIGIN OF THE VESSEL AT THE CELIAC ARTERY, WHICH THEY WERE ABLE TO ACCESS WITH EASE AND IMPLANTED THE FIRST RUBY COIL. NEXT, THE PHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795433 ↗
• MalfunctionMar 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN WAS ADVANCING A RUBY COIL THROUGH THE MICROCATHETER WHEN THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL IN THE TARGET LOCATION; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN THEREFORE, REMOVED THE RUBY COIL. SUBSEQUENTLY, THE PHYSICIAN INSERTED A THIRD RUBY COIL IN THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL SEGMENT OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS, 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

  MAUDE report 11520490 ↗
• MalfunctionNov 9, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) OFF OF THE SUPERFICIAL FEMORAL ARTERY (SFA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN APPROXIMATELY SEVENTY-FIVE PERCENT OF THE RUBY COIL WAS ADVANCED OUT OF THE LANTERN. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE RUBY COIL, IT DETACHED INTO THE PATIENT'S VESSEL. SUBSEQUENTLY, A SNARE DEVICE WAS USED AND THE RUBY COIL WAS SUCCESSFULLY REMOVED. NEXT, THE PHYSICIAN FELT RESISTANCE WHEN APPROXIMATELY SEVENTY-FIVE PERCENT OF THE NEXT RUBY COIL WAS ADVANCED OUT OF THE LANTERN. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE RUBY COIL, IT DETACHED INTO THE PATIENT'S VESSEL. HOWEVER, THE PHYSICIAN WAS ABLE TO REMOVE THE LANTERN AND FLUSH THE RUBY COIL OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED BY RE-INSERTING THE SAME LANTERN AND USING ANOTHER RUBY COIL. IT WAS ALSO REPORTED THAT, WHILE ANALYZING THE ANGIOGRAM IMAGES, THE TARGET LOCATION WAS REVEALED TO BE NO MORE THAN 2 MM IN SIZE. 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 10814348 ↗
• MalfunctionNov 6, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A PULMONARY COLLATERAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED RUBY COILS INTO THE TARGET LOCATION. WHILE INTRODUCING THE NEXT RUBY COIL TO THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE RUBY COIL ADVANCED JUST BEYOND THE HUB OF THE LANTERN BEFORE IT GOT STUCK AND COULD NOT ADVANCE FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 10805414 ↗
• MalfunctionJul 28, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON CAROTID ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS COILING A RUBY COIL INTO ONE OF THE FEEDER VESSELS OF THE ANEURYSM, THE PROXIMAL END OF THE RUBY COIL WAS INADVERTENTLY KINKED. 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 Consequences Or Impact To Patient

  MAUDE report 10335634 ↗
• MalfunctionJun 5, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN GASTRODUODENAL ARTERY (GDA) 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 BECAME BENT. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL LP AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123425 ↗
• MalfunctionApr 16, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR RECTUM ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACE FOUR RUBY COILS IN THE TARGET VESSEL USING THE PROGREAT. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968973 ↗
• InjuryNov 12, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING ANOTHER RUBY COIL INTO THE TARGET VESSEL, THE RUBY COIL WAS KICKING THE LANTERN KICKED OUT OF THE ANEURYSM AND INTO THE PROPER HEPATIC ARTERY; THEREFORE, THE RUBY COIL WAS RETRACTED. HOWEVER, WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED, WITH PART OF THE COIL IN THE ANEURYSM AND THE OTHER PART IN THE LANTERN. THE PHYSICIAN ATTEMPTED TO REMOVE THE LANTERN WITH ASPIRATION TO SECURE THE DETACHED RUBY COIL; HOWEVER, THE RUBY COIL ENDED UP IN THE COMMON HEPATIC ARTERY AND CELIAC TRUNK. A SNARE DEVICE WAS THEN USED TO REMOVE THE DETACHED RUBY COIL; HOWEVER, THE COIL WAS PUSHED BY THE FLOW OF THE VESSEL FROM THE ANEURYSM INTO THE PROPER HEPATIC ARTERY AND GASTRODUODENAL ARTERY (GDA). THE PHYSICIAN DECIDED TO END THE PROCEDURE AND LEAVE THE DETACHED COIL AS A NON-TARGETED EMBODIMENT IN ORDER TO AVOID FURTHER COMPLICATIONS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9310733 ↗
• MalfunctionMay 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE AT THE MIDDLE OF THE MICROCATHETER AND THE RUBY COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT 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 8612066 ↗
• MalfunctionMay 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROEPIPLOIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A 4X6 RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER AND REPORTED THAT THE COIL PUSHER WIRE SUBSEQUENTLY BECAME KINKED. THE 4X6 RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. IT WAS ALSO REPORTED THAT RESISTANCE WAS EXPERIENCED WHILE ADVANCING THE NEXT COIL, A 3X5 RUBY COIL, THROUGH THE PROXIMAL PART OF THE SAME MICROCATHETER. THE PHYSICIAN THEN DECIDED NOT TO ADVANCE THE 3X5 RUBY COIL ANY FURTHER THROUGH THE MICROCATHETER AND, THEREFORE, THE 3X5 RUBY COIL WAS REMOVED AND WAS NOT USED IN THE PROCEDURE. 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 8577492 ↗
• MalfunctionFeb 27, 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 FELT RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL THROUGH ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE RUBY COIL WOULD ADVANCE A SHORT DISTANCE THROUGH ITS INTRODUCER SHEATH BEFORE ABRUPTLY STOPPING. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL AND THE SAME ISSUE OCCURRED. THE SECOND RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A POD4 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 8376402 ↗
• MalfunctionSep 25, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE LANTERN AND, THEREFORE THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THERE MIGHT BE AN ISSUE WITH THE DETACHMENT ZONE BETWEEN THE EMBOLIZATION COIL AND THE PUSHER ASSEMBLY OF THE RUBY COIL AND, THEREFORE, IT WAS NOT REUSED. 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 7908324 ↗
• MalfunctionAug 15, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; 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 7786779 ↗