RUBY Coil RBY4C0630-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI M424RBY4C06300), received between Aug 20, 2015 and Oct 26, 2020 — classified as 1 death, 7 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (26 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 79 reports, in the reporter's own words as published by the FDA.

• DeathOct 26, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERIPANCREATIC ARCADE ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, A SHEATH AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SHEATH AND DIAGNOSTIC CATHETER IN THE SUPERIOR MESENTERIC ARTERY (SMA). THE PHYSICIAN THEN FRAMED THE ANEURYSM USING A RUBY COIL AND ATTEMPTED TO FILL THE ANEURYSM BY ADVANCING ANOTHER RUBY COIL THROUGH THE MICROCATHETER. WHILE ADVANCING THE RUBY COIL INTO THE ANEURYSM, NO RESISTANCE WAS REPORTED; HOWEVER, THE MICROCATHETER KICKED BACK SLIGHTLY WHEN THE PHYSICIAN WAS PUSHING THE LAST THREE TO FIVE CENTIMETERS OF THE RUBY COIL INTO THE ANEURYSM. THE PHYSICIAN THEN RE-ADVANCED THE MICROCATHETER BACK INTO THE ANEURYSM AND SUCCESSFULLY PLACED THE REMAINING RUBY COIL. NEXT, THE PHYSICIAN ADVANCED AN ADDITIONAL RUBY COIL (F85376) INTO THE ANEURYSM AND THE MICROCATHETER KICKED BACK ONCE MORE WHEN PUSHING THE LAST THREE TO FIVE CENTIMETERS OF THE RUBY COIL INTO THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO REINSERT THE MICROCATHETER BACK INTO THE ANEURYSM BUT WAS UNSUCCESSFUL AFTER A FEW ATTEMPTS. THE PHYSICIAN THEN RETRACTED THE RUBY COIL A BIT AND ATTEMPTED TO PUSH IT FO

  Patient problems: Death; Foreign Body In Patient

  MAUDE report 10735479 ↗
• MalfunctionJul 16, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE FIRST RUBY COIL WAS NOT ABLE TO ADVANCE MORE THAN 1 MM INTO THE HUB OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS, ONE POD 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 10286684 ↗
• MalfunctionJul 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE IB ENDOLEAK IN THE IN LUMBAR ARTERY USING LANTERN DELIVERY MICROCATHETERS (LANTERNS), RUBY COILS, A NON-PENUMBRA SHEATH AND A NON-PENUMBRA SELECTIVE CATHETER. IT WAS NOTED THAT THE PATIENT¿S VESSEL ANATOMY WAS ELONGATED AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED LANTERN TO THE TARGET VESSEL USING THE SHEATH AND SELECTIVE CATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK AT THE MARKER BAND ON THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED TOGETHER FROM THE PATIENT. THE PHYSICIAN THEN ADVANCED A NEW LANTERN INTO THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK AT THE MARKER BAND ON THE DISTAL END OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT AFTER REMOVING THE RUBY COIL FROM THE LANTERN, IT WAS NOTICED THAT THE RUBY COIL WAS DAMAGED AND WAS UNABLE TO BE RETRACTED BACK INTO ITS INTRODUCER SHEATH. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL THROUGH THE LANTERN, BUT THE RUBY COIL ALSO BECAME STUCK LIKE THE FIRST TWO RUBY COILS. THEREFORE, THE RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256305 ↗
• MalfunctionJul 10, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE IB ENDOLEAK IN THE IN LUMBAR ARTERY USING LANTERN DELIVERY MICROCATHETERS (LANTERNS), RUBY COILS, A NON-PENUMBRA SHEATH AND A NON-PENUMBRA SELECTIVE CATHETER. IT WAS NOTED THAT THE PATIENT¿S VESSEL ANATOMY WAS ELONGATED AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED LANTERN TO THE TARGET VESSEL USING THE SHEATH AND SELECTIVE CATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK AT THE MARKER BAND ON THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED TOGETHER FROM THE PATIENT. THE PHYSICIAN THEN ADVANCED A NEW LANTERN INTO THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK AT THE MARKER BAND ON THE DISTAL END OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT AFTER REMOVING THE RUBY COIL FROM THE LANTERN, IT WAS NOTICED THAT THE RUBY COIL WAS DAMAGED AND WAS UNABLE TO BE RETRACTED BACK INTO ITS INTRODUCER SHEATH. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL THROUGH THE LANTERN, BUT THE RUBY COIL ALSO BECAME STUCK LIKE THE FIRST TWO RUBY COILS. THEREFORE, THE RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256304 ↗
• MalfunctionFeb 14, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714717 ↗
• MalfunctionJan 29, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING TWO RUBY COILS AND A POD PC THROUGH THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COILS AND POD PC WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 9643795 ↗
• InjuryDec 20, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SINUS SAGITTALIS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PENUMBRA COILS IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN ADVANCED A RUBY COIL TO THE VESSEL BUT THEN DECIDED TO REPOSITION THE RUBY COIL. WHILE RETRACTING THE RUBY COIL TO REPOSITION IT, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE VESSEL; SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE IT USING A SNARE DEVICE, BUT THE RUBY COIL STRETCHED AND REMAINED IN THE VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, ANOTHER LANTERN, AND GLUE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9507689 ↗
• MalfunctionDec 19, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRACHIAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493028 ↗
• MalfunctionDec 3, 2019Failure 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, A RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN TRIED TO ADVANCE THE RUBY COIL ON THE BACK TABLE, BUT IT REMAINED WITHIN ITS INTRODUCER SHEATH. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405828 ↗
• MalfunctionNov 13, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING A LANTERN. HOWEVER, IT WOULD NOT FORM IN THE VESSEL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER TWO RUBY COILS ONE BY ONE IN THE TARGET VESSEL, HOWEVER, THEY WOULD NOT FORM; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY RESHEATHING THE RUBY COILS. THE PROCEDURE WAS COMPLETED USING A PLUG AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317250 ↗
• MalfunctionSep 4, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROFUNDA FEMORIS ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; SUBSEQUENTLY, THE RUBY COIL COULD NOT BE ADVANCED AND UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DISTAL TIP OF THE LANTERN HAD KINKED WHILE BEING ADVANCED THROUGH A TIGHT VESSEL. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8961764 ↗
• InjuryJul 3, 2019Use of Device Problem; Use of Device Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INTER-COSTAL ANEURYSM USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A STENT DEVICE IN THE THORACIC PART OF THE DESCENDING AORTA TO OVERCOME A STENOSIS OF THE AORTA. NEXT, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE MESHES OF THE STENT DEVICE AND INTO THE ANEURYSM. THE PHYSICIAN THEN WENT FURTHER INTO THE VESSEL AND SACRIFICED IT USING THREE RUBY COILS. AFTER THAT, THE PHYSICIAN WENT BACKWARDS INTO THE INTERCOSTAL ANEURYSM AND FILLED WITH TWO RUBY COILS. THE PHYSICIAN THEN PLACED ANOTHER RUBY COIL IN THE VESSEL AND DETACHED IT USING A RUBY COIL DETACHMENT HANDLE (HANDLE). IT WAS REPORTED THAT THE RUBY COIL WAS NOT COMPLETELY ADVANCED OUT OF THE LANTERN AND INTO THE ANEURYSM WHEN THE DETACHMENT OCCURRED AND APPROXIMATELY SEVEN CENTIMETERS OF THE RUBY COIL WAS STILL IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND TRIED TO FLUSH THE REMAINING RUBY COIL OUT OF THE DIAGNOSTIC CATHETER AND INTO THE ANEURYSM BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE DIAGNOSTIC CATHETER AND CAUGHT THE PART OF THE RUBY COIL THAT WAS HANGING OU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8761209 ↗
• MalfunctionJun 26, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL AND A PODJ INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. UPON ADVANCEMENT OF ANOTHER RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK APPROXIMATELY 10 CM INTO THE MICROCATHETER. THE PHYSICIAN THEN RETRACTED THE RUBY COIL, FLUSHED THE MICROCATHETER, AND MADE ANOTHER ATTEMPT TO ADVANCE. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RE-ADVANCING THE RUBY COIL AND REPORTED THAT THE RUBY COIL BECAME STUCK IN THE SAME LOCATION. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734692 ↗
• MalfunctionOct 10, 2018Positioning Failure; Positioning Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A RUBY COIL DID NOT DEPLOY WHEN IT WAS TRIGGERED WITH A HANDLE. THE ACTUAL EVENT DATE IS UNKNOWN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952730 ↗
• MalfunctionSep 6, 2018Activation Problem

  COIL DID NOT DEPLOY WHEN IT WAS TRIGGERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7850480 ↗
• MalfunctionSep 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS WITHIN A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846829 ↗
• MalfunctionJul 25, 2018Break; Break

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF REMOVED THE RUBY COIL FROM THE PACKAGING HOOP AND FLUSHED IT. HOWEVER, WHEN THEY WERE TRYING TO RE-SHEATH THE RUBY COIL INTO THE INTRODUCER SHEATH, THE EMBOLIZATION COIL DETACHED FROM THE PUSHER ASSEMBLY. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7720655 ↗
• MalfunctionJul 3, 2018Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY AND THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A POD6. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIAL TWO COILS IN THE ACCESSORY RENAL ARTERY USING A NON-PENUMBRA ARTERY. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND BENT THE RUBY COIL PUSHER ASSEMBLY TWICE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE IMA, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL PASSED THE FRICTION LOCK AND THE EMBOLIZATION COIL WAS COMING OUT OF THE PROXIMAL END OF THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE IMA; HOWEVER, THE RUBY COIL DID NOT TAKE ITS INTENDED SHAPE AND THEREFORE, WAS REMOVED. IT WAS REPORTED THE RUBY COIL PUSHER ASSEMBLY WAS KINKED. NEXT, THE PHYSICIAN ADVANCED TWO OTHER RUBY COILS IN THE IMA, BUT THE RUBY COILS DID NOT TAKE THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. WHILE ADVANCING A POD6 INTO THE IMA, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659244 ↗
• MalfunctionMay 22, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED ANOTHER RUBY COIL IN THE TARGET VESSEL USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT 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 7534573 ↗
• MalfunctionApr 25, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA SHEATH IN THAT PATIENT'S BODY, THEN ADVANCED A LANTERN THROUGH THE SHEATH. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE OUT OF THE END OF THE LANTERN; THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE LANTERN WAS BENT. THEREFORE, THE PHYSICIAN OPENED AND PLACED A NEW LANTERN IN THE TARGET VESSEL. WHILE ATTEMPTING TO DEPLOY A NEW RUBY COIL IN THE TARGET VESSEL, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO LARGE AND THEREFORE, THE RUBY COIL WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, THE SECOND LANTERN AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7458916 ↗
• MalfunctionApr 20, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE LOBE SEGMENT OF THE PULMONARY ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER, AND THEREFORE THE MICROCATHETER WAS REMOVED WITH THE RUBY COIL INSIDE. THE PHYSICIAN THEN INSERTED A NEW NON-PENUMBRA MICROCATHETER, AND ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER THE RUBY COIL WAS UNABLE TO DEPLOY. THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL RUBY COILS. ALTHOUGH THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT, MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FOR THE SECOND RUBY COIL. AS OF (B)(6) 2018, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7446113 ↗
• MalfunctionMar 27, 2018Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING AN INITIAL RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COIL BECAME STUCK. THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL, HOWEVER THE EMBOLIZATION COIL THEN UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE, AND THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373199 ↗
• InjuryMar 2, 2018Detachment Of Device Component; Unraveled Material; Detachment Of Device Component; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC VEIN USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY HAD SOME TORTUOSITY. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED WITH PART OF THE COIL IN THE LANTERN AND THE OTHER PART IN THE COIL MASS. THE PHYSICIAN THEN REMOVED THE LANTERN AND THE DETACHED COIL REMAINED IN THE PATIENT¿S BODY. NEXT, THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED COIL BY REMOVING THE ACCESS SHEATH BUT THE COIL BROKE FURTHER AND BEGAN TO UNRAVEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE RUBY COIL IN PIECES. THE PROCEDURE THEN ENDED AFTER REMOVAL OF THE COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7311635 ↗
• MalfunctionMar 1, 2018Detachment Of Device Component; Physical Resistance; Device Operates Differently Than Expected; Detachment Of Device Component; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE MICROCATHETER, AND THIS RUBY COIL DID NOT TAKE ITS INTENDED SHAPE WHEN IT WAS ADVANCED INTO THE TARGET LOCATION. THE RUBY COIL WAS THEREFORE RETRACTED TO BE REMOVED, AND THE PHYSICIAN REPORTED FEELING RESISTANCE WHILE RETRACTING. THE EMBOLIZATION COIL WAS REPORTED TO HAVE UNINTENTIONALLY DETACHED, AND THEREFORE THE MICROCATHETER WAS REMOVED WITH THE EMBOLIZATION COIL INSIDE. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ADDITIONAL COILS, 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 7306400 ↗
• MalfunctionFeb 27, 2018Detachment Of Device Component; Retraction Problem; Device Operates Differently Than Expected; Detachment Of Device Component; Retraction Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE RUBY COILS IN THE TARGET LOCATION USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A FOURTH RUBY COIL (F66607) INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED AND NOT USED. THE PHYSICIAN THEN SUCCESSFULLY PLACED MULTIPLE RUBY COILS IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL (F72714) THROUGH THE LANTERN BUT SUBSEQUENTLY REMOVED THE RUBY COIL, IN ORDER TO REPOSITION THE LANTERN. THIS RUBY COIL WAS RINSED IN SALINE AFTER BEING REMOVED BUT DETACHED OUTSIDE OF THE PATIENT AS THE PHYSICIAN ATTEMPTED TO RETRACT IT INTO ITS INTRODUCER SHEATH. THE PHYSICIAN, THEREFORE, CONTINUED THE PROCEDURE AND SUCCESSFULLY PLACED MULTIPLE RUBY COILS IN THE TARGET LOCATION. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ONE LAST RUBY COIL (F68921), HOWEVER, THE RUBY COIL KEPT KICKING OUT OF THE ANEURYSM AS IT WAS BEING ADVANCED. IT WAS REPORTED THAT THE ANEURYSM WAS DENSELY PACKED AT THIS POINT. UPON ATTEMPTING TO RETRACT THE RUBY COIL FROM THE LANTERN, IT UNINTENTIONAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300045 ↗