RUBY Coil RBY4C0415-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00814548018348), received between Jan 15, 2019 and Jun 25, 2025 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (22 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE (IIA) USING A POD PACKING COIL (PACKING COIL), RUBY COILS, AND A NON-MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED TWO ADDITIONAL PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE COIL BECAME STUCK. THE PHYSICIAN RETRACTED THE RUBY COIL AND WHILE ATTEMPTING TO RE-ADVANCE IT THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT, AND THE RUBY COIL WAS THEN FLUSHED OUT OF THE MICROCATHETER. 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 22331124 ↗
• MalfunctionDec 29, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) 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 RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422685 ↗
• MalfunctionAug 25, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION AND FOUND THAT IT WAS NOT THE CORRECT SIZE. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL TO THE TARGET LOCATION, THE RUBY COIL BECAME STUCK INSIDE THE PX SLIM AND THE PHYSICIAN NOTICED THAT THE COIL WAS UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE RUBY COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE PX SLIM USING SALINE SOLUTION. THE PROCEDURE WAS COMPLETED USING A SMALLER SIZE RUBY COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. WHILE PERFORMING THE FINAL RADIOLOGICAL CONTROL TO OBSERVE THE PATENCY OF THE RIGHT RENAL ARTERY, THE PHYSICIAN REPORTED THAT PART OF THE RUBY COIL WENT THROUGH THE ANEURYSMAL NECK, INVADING THE LUMEN OF THE RIGHT RENAL ARTERY. HOWEVER, NO FURTHER ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627955 ↗
• MalfunctionMay 19, 2023Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL. HOWEVER, THE RUBY COIL WOULD NOT FORM INTO THE TARGET VESSEL. THE PHYSICIAN THEN MADE A SECOND ATTEMPT TO PLACE THE RUBY COIL INTO THE TARGET VESSEL; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE ANGIOGRAPHIC CATHETER CONTAINING THE LANTERN AND RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, THE SAME LANTERN, AND THE SAME ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16964348 ↗
• MalfunctionAug 1, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL INTO THE TARGET LOCATION. WHILE INTRODUCING THE NEXT RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN WHEN THE DISTAL END OF THE COIL WAS APPROXIMATELY IN THE MIDDLE TO DISTAL END OF THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL OF THE SAME SIZE, THE SAME HANDLE, THE SAME LANTERN, THE SAME CATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138259 ↗
• MalfunctionMay 31, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER AND IT BECAME STUCK INSIDE. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO RETRACT THE RUBY COIL WITHOUT SUCCESS AND, SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHEN THE DISTAL END OF THE COIL WAS IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE COIL WAS PUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL OF THE SAME SIZE, ADDITIONAL COILS, THE SAME MICROCATHETER, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547999 ↗
• MalfunctionMay 24, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT UTERINE FIBROID USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS INTO THE TARGET LOCATION. NEXT, WHILE ATTEMPTING TO ADVANCE THE THIRD RUBY COIL, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE COIL. THE PHYSICIAN THEN TRIED TO STRAIGHTEN THE RUBY COIL AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL 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 14489066 ↗
• MalfunctionApr 29, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE RUBY COILS. WHILE ADVANCING THE NEXT RUBY COIL NEAR THE DISTAL END OF THE LANTERN, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL SLOWLY AND ENCOUNTERED RESISTANCE AGAIN. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE RUBY COIL WAS FLUSHED OUT ON THE BACK TABLE. IT WAS ALSO REPORTED THAT THE PHYSICIAN DAMAGED THE RUBY COIL PUSHER WIRE. THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE SAME LANTERN INTO THE TARGET LOCATION AND REPORTED THAT IT WAS UNABLE TO ADVANCE. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND SIX NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253717 ↗
• MalfunctionApr 7, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL AROUND A CURVE IN THE VASCULATURE BUT WAS ABLE TO CONTINUE ADVANCING THE COIL SMOOTHLY. WHEN THE RUBY COIL REACHED THE TARGET LOCATION, THE PHYSICIAN PULLED BACK ON THE PUSHER WIRE TO PACK THE COIL MORE TIGHTLY. HOWEVER, THE RUBY COIL WAS NOT RETRACTING AS EXPECTED AND THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD BECOME UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE RUBY COIL WAS PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE PATIENT'S VESSEL WHEN IT DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED, AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. IT WAS ALSO REPORTED THAT THE RUBY COIL PUSHER WIRE WAS KINKED; HOWEVER, IT IS UNKNOWN WHEN IT BECAME KINKED. 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 14046544 ↗
• MalfunctionMar 15, 2022Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL THROUGH THE LANTERN SHAFT AND, SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN. IT WAS ALSO REPORTED THAT THE PHYSICIAN INADVERTENTLY KINKED THE RUBY COIL PUSHER WIRE. WHILE REMOVING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE RUBY COIL WAS COMPLETELY CONTAINED INSIDE THE LANTERN; THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A POD COIL, THE SAME LANTERN, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13764891 ↗
• MalfunctionNov 11, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE COILS IN THE TARGET LOCATION USING THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE MICROCATHETER WAS FLUSHED BEFORE AND AFTER PLACING EACH COIL. NEXT, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL STARTED TO TAKE SHAPE WITHIN THE MICROCATHETER AND, CONSEQUENTLY, THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW COILS 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 12800620 ↗
• MalfunctionJul 8, 2021Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE INTRODUCER SHEATH OF A RUBY COIL INTO THE HUB OF THE MICROCATHETER, THE PUSHER ASSEMBLY BECAME BENT. THEREFORE, THE RUBY COIL WAS REMOVED. 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 12139773 ↗
• MalfunctionJul 6, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTROINTESTINAL (GI) BLEEDING 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 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER . THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125950 ↗
• MalfunctionJun 28, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VENOUS SINUS USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL APPROXIMATELY TWENTY TO THIRTY CENTIMETERS THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080996 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING RUBY COILS, NON-PENUMBRA MICROCATHETER, NON-PENUMBRA CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN ADVANCING A RUBY COIL THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED TOGETHER. SUBSEQUENTLY, THE RUBY COIL REMOVED OUT FROM THE MICROCATHETER AND THE MICROCATHETER WAS FLUSHED. HOWEVER, THE PHYSICIAN WAS STILL EXPERIENCING RESISTANCE WHEN ADVANCING THE SAME RUBY COIL THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. 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 12080683 ↗
• MalfunctionJun 15, 2021Failure 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 AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL TO THE DISTAL TIP OF THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN INSERTED A NEW RUBY COIL AND ATTEMPTED TO ADVANCE IT THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL TO THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005527 ↗
• MalfunctionMay 9, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  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 11795434 ↗
• MalfunctionApr 30, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE INFERIOR MESENTERIC ARTERY (IMA) TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE MICROCATHETER, THE TECHNICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE TECHNICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL 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

  MAUDE report 11757961 ↗
• MalfunctionApr 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH THE INTRODUCER SHEATH AND THEN THE RUBY COIL STOPPED. THE PHYSICIAN PULLED THE RUBY COIL BACK AND TRIED TO ADVANCE THE RUBY COIL AGAIN, BUT THE RUBY COIL WOULD NOT ADVANCE PAST A CERTAIN POINT IN THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11660800 ↗
• MalfunctionApr 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A GASTRORENAL SHUNT USING RUBY COILS, A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS AND ONE POD PACKING COIL (POD PC) INTO THE TARGET LOCATION. AFTER ALIGNING THE NEXT RUBY COIL INTRODUCER SHEATH TO THE MICROCATHETER HUB, THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL INTO THE MICROCATHETER AND REPORTED THAT THE COIL WAS STUCK IN THE HUB. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE RUBY COIL WITHOUT SUCCESS; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD PC 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 11606715 ↗
• MalfunctionJan 13, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE PULMONARY ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE LANTERN IN THE TARGET LOCATION AND ADVANCED THE RUBY COIL INTO THE VESSEL FOR DEPLOYMENT. HOWEVER, THE PHYSICIAN WAS ONLY ABLE TO ADVANCE HALF OF THE RUBY COIL OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. IT WAS ALSO REPORTED THAT DUE TO TORTUOSITY OF THE VESSEL, THE PHYSICIAN WAS EXPERIENCING RESISTANCE ADVANCING THE REST OF THE COIL OUT OF THE MICROCATHETER. THE PHYSICIAN APPLIED MORE FORCE TO ADVANCE THE RUBY COIL AGAINST RESISTANCE AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, A 60CC SYRINGE WAS USED TO FLUSH THE REST OF THE RUBY COIL OUT OF THE LANTERN. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO REMOVE AND REPLACE THE LANTERN WITH A ANOTHER MICROCATHETER FOR ADDITIONAL SUPPORT, THERE WAS NO ALLEGED MALFUNCTION AND OR DEFICIENCY AGAINST THE LANTERN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW NON-PENUMBRA 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 11167578 ↗
• MalfunctionJan 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT ANOTHER RUBY COIL INTO THE LANTERN, THE PHYSICIAN NOTICED THE RUBY COIL BECAME DETACHED WITHIN THE INTRODUCER SHEATH; PRIOR TO ENTERING THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. 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 11128851 ↗
• MalfunctionDec 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL INFERIOR MESENTERIC ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED EIGHT RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ADVANCING TWO MORE RUBY COILS THROUGH THE MICROCATHETER, BOTH RUBY COILS WERE STUCK IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, BOTH RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11085707 ↗
• MalfunctionOct 15, 2020Failure 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 AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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; No Consequences Or Impact To Patient

  MAUDE report 10687668 ↗
• MalfunctionSep 11, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED THE RUBY COIL THROUGH THE LANTERN SEVERAL TIMES ON THE BACK TABLE AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BROKE, AND THE RUBY COIL DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN FLUSHED THE RUBY COIL OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, TWO POD PACKING COILS (POD PCS), 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 10521411 ↗