RUBY Coil RBY4C0315-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00814548018324), received between Sep 7, 2018 and Jul 3, 2025 — classified as 1 injury, 48 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (23 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT ACCESSORY RENAL ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE LOWER BRANCH OF THE RIGHT SMALL ACCESSORY RENAL ARTERY. IT WAS REPORTED THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE WRONG BIFURCATION OF THE RIGHT ACCESSORY RENAL ARTERY. WHILE RETRACTING THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LOWER BRANCH OF THE RIGHT ACCESSORY RENAL ARTERY. THE PHYSICIAN DECIDED TO LEAVE THE DETACHED RUBY COIL IN THE LOWER BRANCH OF THE RIGHT ACCESSORY RENAL ARTERY AS IT WAS DETERMINED TO BE SAFE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME MICROCATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 22398444 ↗
• MalfunctionMay 21, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE RUBY COIL TO PUSH THE DETACHED RUBY COIL INTO THE TARGET LOCATION WITH RESISTANCE AND NOTICED THAT THE PROXIMAL END OF THE RUBY COIL WAS HANGING OUT OF THE TARGET LOCATION. THE PHYSICIAN DECIDED TO USE A SNARE DEVICE TO RETRIEVE THE COIL AND THE RUBY COIL FRACTURED IN THE INTERNAL CAROTID PSEUDOANEURYSM DURING THE RETRIEVAL ATTEMPT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE FRACTURED RUBY COIL FROM THE PATIENT AND NO FRAGMENT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066564 ↗
• MalfunctionMar 27, 2025Physical 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 THE RUBY COIL INTO THE TARGET LOCATION USING THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH. WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT ON THE BACK TABLE. THE MICROCATHETER WAS THEN REINSERTED BACK INTO THE TARGET LOCATION. 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 21709631 ↗
• MalfunctionMay 17, 2024Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CORONARY FISTULA COMING OFF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING A RUBY COIL INTO THE TARGET LOCATION. IT WAS REPORTED THAT THE RUBY COIL WOULD FORM THE FIRST LOOP IN THE VESSEL BUT, THE RUBY COIL LP WOULD NOT FORM THE SECOND LOOP AND WOULD RUN DOWN THE VESSEL. THE PHYSICIAN THEN DECIDED TO RETRACT THE RUBY COIL; HOWEVER, AFTER RETRACTING HALF OF THE RUBY COIL BACK INTO THE MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347103 ↗
• MalfunctionOct 25, 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 (PROGREAT). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE RUBY COIL FURTHER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE RUBY COIL THEN CAME OUT OF THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE 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 18008226 ↗
• MalfunctionAug 25, 2023Migration; Migration

  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 17627954 ↗
• MalfunctionAug 7, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATIONS (AVM) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE INSIDE OF THE MICROCATHETER AND STOPPED ADVANCING THE RUBY COIL. THE PHYSICIAN PERFORMED A FLUOROSCOPY AND NOTICED THAT THE RUBY COIL WAS NOT VISIBLE ON THE SCREEN. THE RUBY COIL PUSHER ASSEMBLY WAS RETRACTED INTO THE MICROCATHETER AND THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE COIL; HOWEVER, THE RUBY COIL WAS STUCK AND WOULD NOT ADVANCE. THE RUBY COIL WAS THEN REMOVED AND RETRACTED BACK INTO ITS INTRODUCER SHEATH AND THE MICROCATHETER WAS DOUBLE FLUSHED. THE PHYSICIAN MADE ANOTHER ATTEMPT TO ADVANCE THE SAME RUBY COIL THROUGH THE MICROCATHETER, BUT THE SAME ISSUE HAD OCCURRED. THE RUBY COIL PUSHER ASSEMBLY WAS REMOVED AND THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT ATTACHED TO THE PUSHER ASSEMBLY. THE MICROCATHETER WAS REMOVED AND FLUSHED AGAIN. WHEN THE PHYSICIAN PLACED THE MICROCATHETER UNDER FLUOROSCOPY, THE RUBY COIL WAS FOUND TO BE DETACHED AND STUCK IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470266 ↗
• MalfunctionMar 18, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERLOBAR ARTERIES USING A RUBY COIL, A POD PACKING COIL (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED, AND THE RUBY COIL WAS FLUSHED ON THE BACK TABLE. THE PHYSICIAN THEN PLACED AND DETACHED ANOTHER RUBY COIL IN THE TARGET VESSEL SUCCESSFULLY USING THE SAME LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE POD PC; HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE POD PC UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND FLUSHED THE POD PC OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER POD PC AND THE SAME LANTERN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569516 ↗
• MalfunctionJan 26, 2023Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL INTO THE LANTERN AND THE PUSHER ASSEMBLY OF THE RUBY COIL BROKE. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE LANTERN AND PARTIALLY IN THE PATIENT'S VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE 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 16246943 ↗
• MalfunctionOct 7, 2022Break; Premature Separation; Break; Premature Separation

  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, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED APPROXIMATELY MIDWAY IN THE LANTERN. THE PHYSICIAN THEN REMOVED THE PUSHER ASSEMBLY; HOWEVER, THE RUBY COIL REMAINED IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. UPON INSPECTION, IT WAS NOTICED THAT THE PROXIMAL END NEAR THE DETACHMENT ZONE HAD BECOME SLIGHTLY SEPARATED. THE PROCEDURE WAS COMPLETED USING 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 15565978 ↗
• MalfunctionApr 29, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LLIOLUMBER ARTERY USING RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE COILS INTO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT FIT. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN NON-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 14256719 ↗
• MalfunctionApr 14, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERCOSTAL ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE OUT OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A SECOND RUBY COIL USING THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RE-ADVANCE THE FIRST RUBY COIL THROUGH THE MICROCATHETER AGAIN; HOWEVER, THE RUBY COIL BECAME STUCK IN THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE RUBY COIL; HOWEVER, WHILE RETRACTING IT, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE TO PIN THE RUBY COIL WITHIN THE MICROCATHETER AND THEN REMOVE THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE RUBY COIL WAS THEN REMOVED FROM THE MICROCATHETER AND THE MICROCATHETER WAS REINSERTED INTO THE PATIENT. 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 14114923 ↗
• MalfunctionMar 14, 2022Premature Separation; 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. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION. AFTER SEVERAL ATTEMPTS WERE MADE TO FORM THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A RUBY COIL, A POD PACKING COIL (POD PC), 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 13764258 ↗
• MalfunctionFeb 17, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A PENUMBRA COIL DETACHMENT HANDLE (HANDLE), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS AND USED THE HANDLE TO IMPLANT TWO PENUMBRA SMART COILS (SMART COILS) AND TWO POD COILS. AFTER ADVANCING A RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN ATTEMPTED TO DETACH IT WITH THE HANDLE; HOWEVER, THE RUBY COIL DID NOT DETACH. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. WHILE USING THE GUIDEWIRE TO PUSH THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE; HOWEVER, THE RUBY COIL WAS SUCCESSFULLY IMPLANTED. SUBSEQUENTLY, IMAGING REVEALED THAT THE GUIDEWIRE HAD PERFORATED THE LANTERN. THEREFORE, THE LANTERN AND THE GUIDEWIRE WERE REMOVED. AN ANGIOGRAPHY SHOWED THAT THE TARGET VESSEL WAS SUFFICIENTLY EMBOLIZED; THEREFORE, 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 13551016 ↗
• MalfunctionJan 10, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL VESSEL (GI) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE NEXT RUBY COIL, THE PHYSICIAN NOTICED IT WOULD NOT FIT IN THE TARGET LOCATION; THEREFORE, THE RUBY COIL WAS RETRACTED. WHILE RETRACTING, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL FRACTURED INSIDE THE MICROCATHETER. THE RUBY COIL WAS THEN REMOVED FROM THE PATIENT BY PULLING THE MICROCATHETER OUT. THE PROCEDURE ENDED AT THIS POINT AND NO EXTRA COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214201 ↗
• MalfunctionDec 17, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN NOTICED THE LANTERN WOULD KICKBACK OUT OF THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO RESHEATHED THE RUBY COIL, READVANCED THE LANTERN INTO THE VESSEL AND ATTEMPTED TO ADVANCE THE RUBY COIL AGAIN; HOWEVER, THE LANTERN KEPT KICKING OUT OF THE VESSEL. WHILE RETRACTING THE RUBY COIL TO BE RESHEATHED ON THE FOURTH ATTEMPT, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. 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 13029083 ↗
• MalfunctionNov 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 AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL INTO THE TARGET LOCATION; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. 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 12832985 ↗
• MalfunctionNov 9, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL TO THE TARGET VESSEL AND SUCCESSFULLY DETACHED IT USING THE HANDLE. HOWEVER, AFTER THE DETACHMENT, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK IN THE HANDLE. THEREFORE, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS REPORTED THAT THE HANDLE WAS UNABLE TO FULLY COVER THE PUSHER ASSEMBLIES OF THE RUBY COILS AND THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PUSHER ASSEMBLIES OF THE RUBY COILS INTO THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778947 ↗
• MalfunctionJun 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN A RENAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL THROUGH THE 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 11983427 ↗
• MalfunctionMay 18, 2021Unraveled Material; Unraveled Material

  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 11845918 ↗
• 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) T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845848 ↗
• MalfunctionMay 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  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, WHILE ADVANCING A RUBY COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN RE-SHEATHED AND INSPECTED THE RUBY COIL AND NO ISSUE WAS FOUND. THE PHYSICIAN THEN TRIED TO READVANCE THE RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. 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 11777250 ↗
• MalfunctionApr 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY STENOSED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A POD PC INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A RUBY COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REPORTED THAT THE COIL WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE POD PCS AND EIGHT NON-PENUMBRA COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606686 ↗
• MalfunctionMar 15, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DEEP FEMORAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A RUBY COIL BECAME STUCK INSIDE THE PROXIMAL TO MIDDLE END OF THE FLUSHED MICROCATHETER, AFTER THE ENTIRE LENGTH OF THE COIL WAS INSIDE THE MICROCATHETER. THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND INADVERTENTLY BROKE THE PUSHER WIRE AND DETACHED THE COIL INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE RUBY COIL DETACHED IN THE SAME LOCATION IT HAD BEEN STUCK. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11487903 ↗
• MalfunctionJan 17, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS MILDLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE FIRST RUBY COIL APPROXIMATELY FIVE CENTIMETERS INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE RUBY COIL UNINTENTIONALLY DETACHED AT THE HUB OF THE LANTERN. THEREFORE, THE LANTERN AND DETACHED RUBY COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A POD COIL, A POD PACKING 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 11183249 ↗