RUBY Coil RBY4C0630-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00814548018362), received between Aug 16, 2018 and Nov 13, 2024 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (16 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR NON-PENUMBRA COILS AND A RUBY COIL INTO THE TARGET VESSEL. WHILE ADVANCING ANOTHER RUBY COIL, IT GOT STUCK IN THE MID-SHAFT OF THE MICROCATHETER. WHEN ATTEMPTING TO RETRACT THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED. AT THIS POINT, THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675523 ↗
• MalfunctionOct 22, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED INCREASING RESISTANCE AND THE RUBY COIL WAS STUCK AT THE MID-SHAFT OF THE MICROCATHETER. THE PHYSICIAN THEN PULLED THE PUSHER ASSEMBLY OF THE RUBY COIL BACK AND NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS 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 20510868 ↗
• MalfunctionApr 24, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS, POD PACKING COILS (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THE PHYSICIAN EXPERIENCED RESISTANCE WHILE REPOSITIONING THE LANTERN. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN. NEXT, THE LANTERN WAS RE-POSITIONED AGAIN. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL TO THE TARGET LOCATION; HOWEVER, THE RUBY COIL DID NOT FORM CORRECTLY AND THE LANTERN WOULD KICK BACK. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE NEXT POD PC. THEREFORE, THE POD PC 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 16801990 ↗
• MalfunctionJan 17, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC 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 ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL IN THE MIDDLE OF THE LANTERN. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT AND THE RUBY COIL WAS FLUSHED OUT FROM THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL OF THE SAME SIZE, FIVE 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

  MAUDE report 16189775 ↗
• MalfunctionNov 7, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A RUBY COIL THROUGH THE DISTAL END OF THE MICROCATHETER. THE RUBY COIL BECAME STUCK AFTER THE PHYSICIAN MADE FOUR TO FIVE ATTEMPTS TO GET THE COIL TO TAKE THE DESIRED SHAPE IN THE TARGET VESSEL. DURING THE ADVANCEMENT ATTEMPTS, RESISTANCE WAS ENCOUNTERED AND IT WAS REPORTED THAT THE RUBY COIL DID NOT FOLLOW THE PUSHER WIRE. SUBSEQUENTLY THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744035 ↗
• MalfunctionAug 24, 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, 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 FIRST RUBY COIL WAS ADVANCED INTO THE TARGET LOCATION AND WAS NOT TAKING THE DESIRED SHAPE. WHILE RETRACTING THE RUBY COIL, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED EXCESSIVE FORCE AND SUBSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING SIX NON-PENUMBRA COILS, THE SAME MICROCATHETER, AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283358 ↗
• MalfunctionMar 25, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A GLUTEAL VESSEL OFF OF THE HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, A DIAGNOSTIC CATHETER, AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE LANTERN WAS ADVANCED APPROXIMATELY TWO-THIRDS OF THE WAY THROUGH THE DIAGNOSTIC CATHETER. WHEN THE LANTERN WAS APPROXIMATELY THREE-FOURTHS OF THE WAY THROUGH THE DIAGNOSTIC CATHETER, IT WOULD NOT ADVANCE FURTHER. UPON REMOVAL, THE DISTAL END OF THE LANTERN WAS OVALIZED. THE PHYSICIAN OPENED A NEW LANTERN AND SUCCESSFULLY ADVANCED IT THROUGH THE SAME DIAGNOSTIC CATHETER DURING TESTING ON THE BACK TABLE. HOWEVER, WHILE ATTEMPTING TO INTRODUCE THE LANTERN TO THE PATIENT, RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT THROUGH THE DISTAL END OF THE DIAGNOSTIC CATHETER. UPON REMOVAL, THE DISTAL END OF THE LANTERN WAS OVALIZED. THEREFORE, THE DIAGNOSTIC CATHETER WAS ALSO REMOVED FROM USE. NEXT, THE PHYSICIAN ADDED A LONG SHEATH AND USED A NEW DIAGNOSTIC CATHETER WITH A NEW LANTERN. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A RUBY COIL THROUGH THE DISTAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905022 ↗
• InjuryNov 16, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER PARTIALLY DEPLOYING THE RUBY COIL IN THE TARGET LOCATION USING THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE REST OF THE RUBY COIL IN THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE RUBY COIL; HOWEVER, WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12824672 ↗
• MalfunctionOct 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, POD COILS, POD PACKING COILS (POD PC), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE POD COIL AND TWO POD PCS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A RUBY COIL, THE RUBY COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS CONTINUED USING SEVEN ADDITIONAL RUBY COILS, TWO POD COILS, SEVEN POD PCS AND THE SAME MICROCATHETER. SUBSEQUENTLY, THE PROCEDURE WAS THEN COMPLETED USING EIGHT NON-PENUMBRA COILS AND ANOTHER NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619246 ↗
• MalfunctionOct 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL BROKE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12583492 ↗
• MalfunctionAug 4, 2021Failure 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 A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT TRACK THROUGH THE LANTERN, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THEY WERE REMOVED, AND THE LANTERN WAS FLUSHED. THE PROCEDURE WAS COMPLETED USING TWO NEW 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

  MAUDE report 12274601 ↗
• MalfunctionJul 31, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL IN THE SUPERIOR GLUTEAL ARTERY. WHILE ADVANCING THE NEXT RUBY COIL OVER THE HUB OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. HOWEVER, THE DISTAL TIP OF THE RUBY COIL WAS ABLE TO ADVANCE PAST THE HUB. THE RUBY COIL WAS RETRACTED AND RE-ADVANCED; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL OVER THE SAME LOCATION. SUBSEQUENTLY, THE PHYSICIAN INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, A RUBY COIL BECAME STUCK DURING ADVANCEMENT THROUGH THE LANTERN; THEREFORE THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED FROM THE PATIENT. SUBSEQUENTLY, A NON-PENUMBRA MICROCATHETER WAS USED TO SUCCESSFULLY IMPLANT THE SAME RUBY COIL. THE PROCEDURE WAS COMPLETED USING TWO RUBY COILS AND TWO POD PACKING COILS (POD PCS) TO EMBOLIZE THE SUPERIOR GLUTEAL ARTERY AND THREE RUBY COILS AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257238 ↗
• MalfunctionJul 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, VELOCITY DELIVERY MICROCATHETER (VELOCITY), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE ACCESS TO THE PATIENT'S TARGET ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. NEXT, THE PHYSICIAN INSERTED THE VELOCITY INTO THE PATIENT. WHILE ADVANCING THE PREVIOUSLY REMOVED RUBY COIL THROUGH THE VELOCITY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD ONLY ADVANCE APPROXIMATELY FIVE CENTIMETERS OUT OF THE TIP OF THE VELOCITY BEFORE BECOMING STUCK. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME VELOCITY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186064 ↗
• MalfunctionJun 28, 2021Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING RUBY COILS, POD PACKING COILS (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED POD PCS IN THE TARGET VESSEL USING THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE ANEURYSM USING THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE AND, CONSEQUENTLY, KICKED THE LANTERN OUT OF THE TARGET VESSEL. 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 12079345 ↗
• MalfunctionJun 18, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHILE THE RUBY COIL WAS BEING ADVANCED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NEW POD COILS AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028389 ↗
• MalfunctionMay 27, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN RETRACTED AND READVANCED THE RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED TWO MORE TIMES. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN RETRACTED AND READVANCED THE RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS ALSO 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 11895153 ↗
• MalfunctionApr 1, 2021Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN RUBY COILS IN THE TARGET LOCATION. WHILE ATTEMPTING TO IMPLANT THE NEXT RUBY COIL, IT WOULD NOT TAKE ITS INTENDED SHAPE. SEVERAL ATTEMPTS WERE MADE TO GET THE RUBY COIL TO TAKE SHAPE IN THE TARGET LOCATION WITHOUT SUCCESS AND THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. AFTER THE RUBY COIL WAS WITHDRAWN INTO THE LANTERN, IT DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT AND THE RUBY COIL WAS THEN REMOVED FROM THE LANTERN. 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

  MAUDE report 11606691 ↗
• MalfunctionFeb 7, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE LAST RUBY COIL, THE PHYSICIAN ADVANCED APPROXIMATELY TEN PERCENT OF THE RUBY COIL OUT OF THE MICROCATHETER AND THE RUBY COIL UNINTENTIONALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE REMAINING RUBY COIL INTO THE VESSEL. 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 11290497 ↗
• MalfunctionJan 19, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND AN ANGIOGRAPHIC CATHETER (5F). DURING THE PROCEDURE, TWO COILS WERE IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING A RUBY COIL, IT DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT TOGETHER. AFTER REMOVING THE RUBY COIL, THE LANTERN WAS RE-ADVANCED AND THREE OTHER COILS WERE IMPLANTED IN THE TARGET VESSEL. NEXT, WHILE ADVANCING A POD PC, ALMOST THE ENTIRE POD PC COIL WAS INSIDE THE TARGET VESSEL WHEN IT PREMATURELY DETACHED. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE POD PC USING A GOOSE-NECK SNARE. IT WAS ALSO REPORTED THAT THE POD PC UNRAVELED AND BROKE OFF TWICE. THE PHYSICIAN WAS ABLE TO RETRIEVE A PART OF THE COIL WITH THE SNARE AND THE PROCEDURE WAS THEN ENDED. ON (B)(6) 2020, A POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THE REMAINING UNRAVELED COIL MOVED FROM THE SPLENIC ARTERY TOWARDS THE AORTA AND THE PATIENT WAS IN STABLE CONDITION. THEREFORE, NO FURTHER ACTION WAS TAKEN TO REMOVE THE REMAINING POD PC.

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

  MAUDE report 11197656 ↗
• MalfunctionDec 23, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THREE BRANCH VESSELS OF THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, TWO POD COILS AND ONE RUBY COIL WERE IMPLANTED IN A BRANCH VESSEL USING THE HANDLE. WHILE ATTEMPTING TO ADVANCE A POD COIL INTO THE SECOND BRANCH VESSEL, THE COIL DETACHED INSIDE THE MICROCATHETER AND PARTIALLY IN THE VESSEL. HOWEVER, THE PHYSICIAN WAS ABLE TO PUSH IT INTO THE TARGET SITE. NEXT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL AND SUBSEQUENTLY, THE RUBY COIL DETACHED WHILE ADVANCING THROUGH THE PROXIMAL SHAFT OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER AND RUBY COIL WERE REMOVED FROM THE PATIENT TOGETHER AND THE RUBY COIL WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL RUBY COILS, THE SAME HANDLE, 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 11067855 ↗
• MalfunctionSep 17, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE MOVING A RUBY COIL TO MAKE IT FORM, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. SUBSEQUENTLY, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER RUBY COIL AND THE SAME MICROCATHETER. WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AGAIN. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551370 ↗
• MalfunctionJul 22, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED FIVE RUBY COILS INTO THE TARGET VESSEL USING THE HANDLE. HOWEVER, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR RUBY COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10309457 ↗
• MalfunctionMar 18, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING RUBY COILS, NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE TARGET VESSEL WAS A HIGH FLOW AREA. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE THE FIRST 2 MM X 4 MM RUBY COIL WAS ADVANCED INTO THE MICROCATHETER. THE 2 MM X 4 MM RUBY COIL WAS UNABLE TO ADVANCE FURTHER THROUGH THE MICROCATHETER; THEREFORE, IT WAS REMOVED AND INSPECTED FOR DAMAGE. THE PHYSICIAN WAS UNABLE TO FIND ANY DAMAGE AND PROCEEDED TO MAKE TWO ADDITIONAL ATTEMPTS TO RE-ADVANCE THE COIL WITHOUT SUCCESS. THE 2 MM X 4 MM RUBY COIL WAS AGAIN REMOVED AND INSPECTED FOR DAMAGE. NO DAMAGE WAS FOUND. THE PHYSICIAN DISCONTINUED USE OF THE COIL AND USED ANOTHER 2 MM X 4 MM RUBY COIL WITH CONTINUOUS FLUSH TO PROCEED. HOWEVER, THE SAME ISSUE OCCURRED; THE COIL WAS WITHDRAWN AND RE-ADVANCED TWO ADDITIONAL TIMES WITHOUT SUCCESS. THEREFORE, THE 2 MM X 4 MM RUBY COIL WAS REMOVED AND A NON-PENUMBRA COIL WAS IMPLANTED. NEXT, THE PHYSICIAN ENCOUNTERED SOME RESISTANCE WHILE ADVANCING A 4 MM X 35 MM RUBY COIL OUT OF THE MICROCATHETER. AS THE 4 MM X 35 MM RUBY COIL WAS ADVANCED INTO THE VESSEL, IT BEGAN TO FORM B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9849480 ↗
• MalfunctionDec 18, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE INTRODUCER SHEATH, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD6 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 9491902 ↗
• MalfunctionDec 6, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT OVARIAN VEIN USING A POD DETACHMENT HANDLE (HANDLE) AND A RUBY COIL. DURING THE PROCEDURE, THE TIP OF THE HANDLE WAS FOUND TO BE BROKEN UPON OPENING THE PACKAGING; THEREFORE, THE HANDLE WAS NOT USED IN THE PROCEDURE. NEXT, WHILE PLACING A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DECIDED TO RE-SHEATH AND REPOSITION THE RUBY COIL. HOWEVER, WHILE RETRACTING, THE COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THE PHYSICIAN THEREFORE FLUSHED THE LANTERN AND PLACED THE DETACHED RUBY COIL IN THE VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL WITH THE SAME LANTERN, ANSEL SHEATH AND GLIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9426910 ↗