RUBY Coil RBY4C0305-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI M424RBY4C03050), received between Aug 26, 2015 and Nov 2, 2021 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (8 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.

• InjuryNov 2, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND OTHER COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A RUBY COIL INTO THE TARGET LOCATION, THE RUBY COIL KEPT KICKING BACK ON THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL BACK INTO THE MICROCATHETER. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE TARGET LOCATION. THE PHYSICIAN THEN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO LEAVE THE RUBY COIL IN THE TARGET LOCATION WITH THE TAIL OF THE COIL PROTRUDING. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED BETWEEN COILS. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12736292 ↗
• MalfunctionMay 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A DISTAL BRANCH OF THE HEPATIC ARTERY USING RUBY COILS AND POD PACKING COILS (POD PCS). DURING THE PROCEDURE, TWO RUBY COILS AND A POD PC WERE UNABLE TO ADVANCE THROUGH A BEND IN THE PATIENT¿S VESSEL, DESPITE THE MICROCATHETER BEING SWITCHED OUT BETWEEN EACH COIL. THEREFORE, THE RUBY COILS AND POD PC WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW COILS. IT WAS REPORTED THAT THE PATIENT¿S VESSELS WERE EXCESSIVELY TORTUOUS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573558 ↗
• MalfunctionSep 21, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THE RUBY COIL WAS NOT USABLE UPON REMOVAL FROM THE PACKAGING HOOP. THE RUBY COIL, THEREFORE, WAS NOT USED IN PROCEDURE, AND THE PROCEDURE WAS COMPLETED USING A RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7899766 ↗
• MalfunctionSep 19, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WHILE BEING RE-SHEATHED OUTSIDE OF THE PATIENT. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE PATIENT USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND ATTEMPTED TO RETRACT IT IN ORDER TO REPOSITION THE PX SLIM. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED AND OCCLUDED THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN DID NOT MAKE AN ATTEMPT TO RETRIEVE THE DETACHED RUBY COIL AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME PX SLIM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891005 ↗
• MalfunctionAug 22, 2018Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN FOUND THAT THE DISTAL END OF THE RUBY COIL'S PUSHER ASSEMBLY WAS BENT UPON REMOVAL FROM THE PACKAGING. 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 7806266 ↗
• MalfunctionAug 7, 2018Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND POD4S. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND IMMEDIATELY REMOVED THE COIL. IT WAS REPORT THAT THE SAME ISSUE OCCURRED WITH A POD4. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7758814 ↗
• MalfunctionJun 19, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL APPROXIMATELY 80% OUT OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DECIDED TO RETRACT THE COIL FOR REPOSITIONING; HOWEVER, WHEN THE PHYSICIAN PULLED BACK THE RUBY COIL PUSHER ASSEMBLY, IT WAS NOTICED THAT THE RUBY COIL HAD ALREADY UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PHYSICIAN FELT VERY MINIMAL RESISTANCE BEFORE PULLING THE RUBY COIL BACK. THE DETACHED COIL WAS CLOSE TO THE OSTIUM OF THE HEPATIC ARTERY AND GASTRIC ARTERY; THEREFORE, THE PHYSICIAN USED THE RUBY COIL PUSHER ASSEMBLY TO ADVANCE THE REST OF THE COIL INTO THE GASTRIC ARTERY. THE PROCEDURE WAS ENDED AFTER PUSHING THE COIL INTO THE GASTRIC ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7615982 ↗
• MalfunctionJun 7, 2018Bent; Material Too Rigid or Stiff; Physical Resistance; Bent; Material Too Rigid or Stiff; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD4S, AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A POD4 WITHIN THE PROXIMAL END OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE POD4 WAS REMOVED. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A RUBY COIL AND, CONSEQUENTLY, THE PUSHER ASSEMBLY BECAME BENT. THE RUBY COIL WAS THEREFORE REMOVED. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PODJ OUT OF THE DISTAL TIP OF THE MICROCATHETER AND, THEREFORE THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579495 ↗
• MalfunctionMay 11, 2018Device Handling Problem; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL. DURING THE PROCEDURE, WHILE REMOVING THE RUBY COIL OUT OF THE PATIENT TO RESHEATH IT, THE DOCTOR INADVERTENTLY HIT THE MONITOR. AS A RESULT, THE RUBY COIL WAS CONTAMINATED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507362 ↗
• MalfunctionMar 14, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL BECAME KINKED AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN). THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338649 ↗
• MalfunctionFeb 28, 2018Detachment Of Device Component; Retraction Problem; Physical Resistance; Device Operates Differently Than Expected; Detachment Of Device Component; Retraction Problem; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL RUBY COIL INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER WITHOUT AN ISSUE. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A NEW RUBY COIL BUT IT WOULD NOT FORM CORRECTLY IN THE VESSEL SO HE DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN MENTIONED FEELING RESISTANCE. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AS IT WAS EXITING THE HUB OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PULL OUT THE DETACHED RUBY COIL AND DECIDED TO SWITCH TO A NEW NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ADVANCED THE COIL ABOUT THREE QUARTERS OF THE WAY THROUGH THE MICROCATHETER AND THEN ENCOUNTERED RESISTANCE. CONSEQUENTLY, THE RUBY COIL BECAME STUCK AND WAS UNABLE TO ADVANCE FURTHER. THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTION, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PHYSICIAN THEN MANUALLY INJECTED C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303428 ↗
• MalfunctionFeb 22, 2018Kinked; Device Handling Problem; Kinked; Device Handling Problem

  WHILE PREPARING A NEW RUBY COIL ON THE BACK TABLE FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY KINKED THE RUBY COIL PUSHER ASSEMBLY. THE DAMAGE TO THE PUSHER ASSEMBLY OCCURRED PRIOR TO USE IN THE PATIENT. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7290913 ↗
• MalfunctionFeb 8, 2018Detachment Of Device Component; Retraction Problem; Physical Resistance; Detachment Of Device Component; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN ILEAL LYMPHOMA USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE ATTEMPTED TO RETRACT THE RUBY COIL. HOWEVER, UPON RETRACTION, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED FROM ITS PUSHER WIRE, AND THEREFORE THE PHYSICIAN REMOVED THE LANTERN WITH THE DETACHED RUBY COIL INSIDE. UPON REMOVAL, IT WAS FOUND THAT THE LANTERN WAS KINKED. THE PROCEDURE WAS THEN COMPLETED USING A NEW 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 7252060 ↗
• MalfunctionOct 6, 2017Bent; Device Damaged Prior to Use; Device Handling Problem; Bent; Device Damaged Prior to Use; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE THE HOSPITAL TECHNICIAN WAS REMOVING A RUBY COIL FROM THE PACKAGING HOOP, THE COIL ACCIDENTALLY BECAME UNSHEATHED. UPON ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE PUSHER WIRE BECAME BENT. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925410 ↗
• MalfunctionSep 26, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT GASTRIC ARTERY PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL FULLY OUT OF THE NON-PENUMBRA MICROCATHETER AND INTO THE VESSEL, DESPITE MULTIPLE ATTEMPTS TO RE-POSITION THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SECOND RUBY COIL OUT OF THE MICROCATHETER AT ALL, DESPITE MULTIPLE ATTEMPTS; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS, THE SAME MICROCATHETER, AND GEL FOAM WAS DELIVERED TO EMBOLIZE THE VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895477 ↗
• MalfunctionAug 31, 2017Retraction Problem; Failure to Advance; Mechanical Jam; Retraction Problem; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE TWO ENDOLEAK USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE INITIAL COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A 5F NON-PENUMBRA CATHETER. WHILE ATTEMPTING TO DEPLOY THE LAST RUBY COIL INTO THE TARGET VESSEL, THE LANTERN WAS INADVERTENTLY PULLED BACK INTO THE 5F CATHETER. CONSEQUENTLY, WHEN THE RUBY COIL WAS ADVANCED OUT OF THE LANTERN, IT BECAME LODGED INTO THE 5F CATHETER AND WOULD NOT MOVE FORWARD OR BACKWARD. THEREFORE, THE PHYSICIAN REMOVED THE SYSTEM ALL TOGETHER AS ONE UNIT AND THE PROCEDURE WAS ENDED. IT WAS REPORTED THAT THERE WAS NO NOTED DAMAGE TO THE RUBY COIL AND LANTERN AFTER REMOVAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836788 ↗
• MalfunctionAug 16, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A RUBY COIL PUSHER ASSEMBLY WAS BENT UPON REMOVAL FROM ITS DISPENSER HOOP. THE DAMAGED RUBY COIL WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6798346 ↗
• MalfunctionAug 8, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL DETACHMENT HANDLE (HANDLE). PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTICE THAT THE NOSE CONE OF THE HANDLE HAD COME OFF WITHIN THE PACKAGING; HOWEVER THE NOSE CONE WAS PUSHED BACK ON AND THE PHYSICIAN ATTEMPTED TO REUSE THE HANDLE DURING THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE; THEREFORE THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, THE SAME RUBY COIL, 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 6775770 ↗
• MalfunctionJun 21, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (RH1). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED SEVERAL RUBY COILS INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THE RH1. THE PHYSICIAN THEN DEPLOYED THE LAST RUBY COIL AND ATTEMPTED TO DETACH IT USING THE SAME RH1. HOWEVER, AFTER TWO ATTEMPTS, THE RUBY COIL DID NOT DETACH. THE PHYSICIAN ALSO TRIED TO MANUALLY DETACH THE COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL WAS REMOVED AND 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 6659065 ↗
• MalfunctionMay 3, 2017Separation Failure; Physical Resistance; Separation Failure; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRONCHIAL ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING TWO RUBY COILS IN THE TARGET VESSEL THROUGH TORTUOUS ANATOMY USING A NON-PENUMBRA MICROCATHETER. UPON ATTEMPTING TO DETACH THE RUBY COILS USING THE HANDLE, THE PHYSICIAN NOTICED THAT THE RUBY COILS WERE UNABLE TO BE DETACHED USING THE HANDLE ; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6540589 ↗
• MalfunctionApr 4, 2017Physical Resistance; Mechanical Jam; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456714 ↗
• MalfunctionJan 26, 2017Bent; Device Handling Problem; Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY. THERE WAS NO RESISTANCE REPORTED WHILE ADVANCING THE COIL. THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6280861 ↗
• MalfunctionNov 16, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE BEING ADVANCED THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, A RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN REMOVED THE MICROCATHETER FROM THE PATIENT AND FLUSHED THE DETACHED RUBY COIL OUT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND TWO NEW RUBY COILS. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE CONTINUOUS FLUSH AND DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV); HOWEVER, A MANUAL FLUSH WAS PERFORMED BEFORE EVERY COIL INSERTION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106754 ↗
• MalfunctionSep 9, 2016Kinked; Physical Resistance; Device Handling Problem; Kinked; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING TWO RUBY COILS THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), TWO ASSISTING RESIDENTS ENCOUNTERED RESISTANCE AND DECIDED TO APPLY EXTRA FORCE TO PUSH THE COILS FORWARD RATHER THAN RETRACTING AND REPOSITIONING THE LANTERN. CONSEQUENTLY, BOTH RUBY COIL PUSHER ASSEMBLIES WERE INADVERTENTLY KINKED BY THE TWO ASSISTING RESIDENTS. THEREFORE, BOTH RUBY COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE LANTERN WAS FLUSHED BEFORE EACH COIL INSERTION AND THAT A ROTATING HEMOSTASIS VALVE (RHV) WAS USED THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5940975 ↗
• MalfunctionAug 12, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL ANY FURTHER. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY 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 5872565 ↗