RUBY Coil RBY2C0825-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI M424RBY2C08250), received between Aug 13, 2015 and May 8, 2023 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC-DEPENDENT PELVIC VARICEA USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO COILS INTO THE TARGET LOCATION. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN VISUALIZED VIA FLUOROSCOPY THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WHILE THE RUBY COIL WAS PARTIALLY INSIDE THE LANTERN AND PARTIALLY IN THE TARGET LOCATION. NEXT, THE PHYSICIAN FLUSHED THE LANTERN WITH SALINE SOLUTION USING A 3ML SYRINGE AND SUCCESSFULLY IMPLANTED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING TWO 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 16892057 ↗
• MalfunctionJul 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY THREE CENTIMETERS OF THE RUBY COIL THROUGH THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE HOSPITAL TECHNICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER; THE SAME ISSUE OCCURRED. THE RUBY COIL WAS THEREFORE REMOVED. IT WAS ALSO REPORTED THAT THE HOSPITAL TECHNICIAN RE-ATTEMPTED TO ADVANCE BOTH RUBY COILS ON THE BACK TABLE; HOWEVER, IT WAS UNSUCCESSFUL. 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 Consequences Or Impact To Patient

  MAUDE report 10347747 ↗
• MalfunctionMar 2, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, AFTER INSERTING THE RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN) THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL OUT OF THE LANTERN. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8384300 ↗
• MalfunctionFeb 12, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, THE RUBY COIL WAS COILING INSIDE THE CATHETER AND WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS; THEREFORE, THE RUBY COILS AND THE CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND FOUR ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331134 ↗
• MalfunctionNov 2, 2018Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE USING A RUBY COIL AND, CONSEQUENTLY, THE RUBY COIL UNRAVELED. THE RUBY COIL WAS REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032634 ↗
• MalfunctionOct 18, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN THE LANTERN AND, THEREFORE, THE PHYSICIAN RETRACTED THE RUBY COIL. HOWEVER, WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN ADVANCED A GUIDEWIRE THROUGH THE LANTERN AND CONFIRMED THE DETACHED RUBY COIL WAS STILL WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN WITH THE DETACHED RUBY COIL INSIDE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN 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 7980598 ↗
• MalfunctionJun 21, 2018Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE DISTAL END OF A RUBY COIL PUSHER ASSEMBLY BECAME KINKED AS THE HOSPITAL STAFF WAS ADVANCING IT OUT OF THE INTRODUCER SHEATH AND 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 7626320 ↗
• MalfunctionMar 7, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY AN INITIAL RUBY COIL INTO THE DESIRED LOCATION IN THE ANEURYSM; HOWEVER, THE RUBY COIL WAS UNABLE TO STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED FROM THE PATIENT WITHOUT ANY NOTICEABLE DAMAGE. NO OTHER COILS WERE ATTEMPTED TO BE PLACED PRIOR TO THE RUBY COIL. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING A NEW POD8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322531 ↗
• MalfunctionDec 12, 2017Positioning Failure; Physical Resistance; Device Operates Differently Than Expected; Positioning Failure; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL; HOWEVER, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE. AFTER THE RUBY COIL WAS ADVANCED AND RETRACTED SEVERAL TIMES, IT UNINTENTIONALLY DETACHED. THE PHYSICIAN MENTIONED EXPERIENCING RESISTANCE WHILE RETRACTING THE RUBY COIL WITHIN THE LANTERN. A SYRINGE WAS THEN PLACED ON THE BACK OF THE LANTERN FOR NEGATIVE SUCTION AND BOTH THE LANTERN AND DETACHED RUBY COIL WERE PULLED OUT OF THE PATIENT. THEREAFTER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL 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 7110105 ↗
• MalfunctionSep 22, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PELVIC CONGESTION USING RUBY COILS AND POD6''S. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY GETTING SUPPORT AND ACCESS TO THE TARGET VESSEL AND WAS UNABLE TO PLACE THE SHEATH AT THE DESIRED LOCATION. CONSEQUENTLY, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS AND ONE POD6, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS THROUGH THE NON-PENUMBRA MICROCATHETER. THE RUBY COILS, POD6 AND MICROCATHETER WERE THEN REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE MICROCATHETER WAS KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887724 ↗
• MalfunctionAug 21, 2017Detachment Of Device Component; Detachment of Device or Device Component; Difficult to Advance; Detachment Of Device Component; Detachment of Device or Device Component; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, AND SUBSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER NON-PENUMBRA MICROCATHETER 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 6808898 ↗
• MalfunctionJul 18, 2017Unraveled Material; Out-Of-Box Failure; Unraveled Material; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL UNRAVELED ON THE TRAY PRIOR TO USE. THE DAMAGE TO THE RUBY COIL WAS NOTICED PRIOR TO USE.

  Patient problems: No Patient Involvement

  MAUDE report 6723348 ↗
• MalfunctionJul 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD8''S AND RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD8 AND TWO RUBY COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE POD8 AND RUBY COILS WERE REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 6704496 ↗
• MalfunctionJul 3, 2017Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC ARTERIO-ENTERIC FISTULA USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA 5F SHEATH IN THE ARTERIOTOMY AND USED A NON-PENUMBRA 5F SELECT CATHETER TO ACCESS THE CELIAC ARTERY. WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH A PX SLIM DELIVERY MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN THE RUBY COILS REACHED THE END OF THE PX SLIM AND SUBSEQUENTLY, BOTH RUBY COILS WOULD NOT ADVANCE THROUGH THE PX SLIM; THEREFORE, BOTH RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL RUBY COILS AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684953 ↗
• MalfunctionMay 1, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE AND THE RUBY COIL KEPT GETTING STUCK IN THE MICROCATHETER. THE SCRUB TECHNOLOGIST BELIEVES THAT THE VERY TORTUOUS NATURE OF THE VESSEL WAS CAUSING THE MICROCATHETER TO CINCH DOWN ON THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COILS THROUGH THE MICROCATHETER, RESISTANCE WAS FELT AND SUBSEQUENTLY, THE RUBY COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED BOTH RUBY COILS AFTER REMOVING THEM FROM THE PACKAGING HOOP. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER AND TWO ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6535681 ↗
• MalfunctionApr 12, 2017Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DID NOT MENTION FEELING ANY RESISTANCE; HOWEVER, THE COIL BECAME STUCK HALF WAY THROUGH THE MICROCATHETER AND WAS UNABLE TO ADVANCE ANY FURTHER. THE RUBY COIL WAS THEN REMOVED AND A NEW RUBY COIL WAS OPENED. HOWEVER, THE SAME ISSUE OCCURRED AND THE RUBY COIL WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND COMPLETED THE PROCEDURE USING ADDITIONAL 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 6487990 ↗
• MalfunctionMar 22, 2017Bent; Failure to Fold; Device Handling Problem; Bent; Failure to Fold; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE EXTERNAL AND INTERNAL ILIAC ARTERY USING RUBY COILS AND POD PACKING COILS (PODJ COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, DUE TO A VERY HIGH FLOW IN THE INTERNAL ILIAC ARTERY, BOTH RUBY COILS WOULD NOT TAKE THEIR INTENDED SHAPE AND ANCHOR IN THE ANEURYSM. AFTER SEVERAL FAILED ATTEMPTS, THE RUBY COILS WERE REMOVED AND A POD8 COIL WAS SUCCESSFULLY DEPLOYED AND DETACHED IN THE ANEURYSM. THE SCRUB TECHNOLOGIST THEN INADVERTENTLY BENT BOTH RUBY COILS PUSHER ASSEMBLIES WHILE ATTEMPTING TO RE-SHEATH THEM. NEXT, THE SCRUB TECHNOLOGIST INADVERTENTLY PULLED OFF THE INTRODUCER SHEATH OF PODJ COIL AFTER REMOVING IT FROM THE PACKAGING HOOP. WHILE ATTEMPTING TO RE-SHEATH IT, THE PODJ COIL PUSHER ASSEMBLY WAS ACCIDENTALLY BROKEN; THEREFORE, THE PODJ COIL WAS SET ASIDE. THE PHYSICIAN THEN OPENED A NEW PODJ COIL AND ATTEMPTED TO ADVANCE IT THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS EXPERIENCED PRIOR TO THE COIL EXITING THE LANTERN AND THE PHYSICIAN DECIDED TO RETRACT IT. UPON RETRACTION, THE PODJ COIL UNINTENTIONALLY DETACHED FROM THE PUSH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424659 ↗
• MalfunctionMar 15, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). IT WAS NOTED THAT THE PATIENT HAD AN ABNORMAL HYPOGASTRIC ARTERY AND IT WAS DIFFICULT TO GAIN ACCESS VIA THE CONTRALATERAL APPROACH DUE TO AN ACUTE TURN AT THE ARCH OF THE ILIACS. DURING THE PROCEDURE, WHILE RETRACTING A RUBY COIL (LOT #F72627) BACK INTO A LANTERN (LOT #F70657) FOR REPOSITIONING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY INSIDE THE LANTERN AROUND THE ACUTE ANGLE AREA. THEREFORE, THE LANTERN WAS REMOVED WITH THE DETACHED COIL INSIDE. THE PHYSICIAN THEN ATTEMPTED TO ACCESS FROM THE CONTRALATERAL SIDE USING A NEW LANTERN (LOT #F72064). WHILE A NEW RUBY COIL (LOT #F60720) WAS BEING PREPARED ON THE BACK TABLE FOR USE, THE RUBY COIL PUSHER ASSEMBLY WAS BENT AND HAD UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. WITHOUT KNOWING THAT, THE PHYSICIAN ADVANCED THE RUBY COIL THROUGH THE NEW LANTERN AND INTO THE PATIENT BUT DECIDED TO RETRACT THE COIL FOR REPOSITIONING. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6405073 ↗
• MalfunctionMar 15, 2017Bent; Detachment Of Device Component; Device Handling Problem; Bent; Detachment Of Device Component; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). IT WAS NOTED THAT THE PATIENT HAD AN ABNORMAL HYPOGASTRIC ARTERY AND IT WAS DIFFICULT TO GAIN ACCESS VIA THE CONTRALATERAL APPROACH DUE TO AN ACUTE TURN AT THE ARCH OF THE ILIACS. DURING THE PROCEDURE, WHILE RETRACTING A RUBY COIL (LOT #F72627) BACK INTO A LANTERN (LOT #F70657) FOR REPOSITIONING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY INSIDE THE LANTERN AROUND THE ACUTE ANGLE AREA. THEREFORE, THE LANTERN WAS REMOVED WITH THE DETACHED COIL INSIDE. THE PHYSICIAN THEN ATTEMPTED TO ACCESS FROM THE CONTRALATERAL SIDE USING A NEW LANTERN (LOT #F72064). WHILE A NEW RUBY COIL (LOT #F60720) WAS BEING PREPARED ON THE BACK TABLE FOR USE, THE RUBY COIL PUSHER ASSEMBLY WAS BENT AND HAD UNINTENTIONALLY DETACHED FROM ITS PUSHER ASSEMBLY. WITHOUT KNOWING THAT, THE PHYSICIAN ADVANCED THE RUBY COIL THROUGH THE NEW LANTERN AND INTO THE PATIENT BUT DECIDED TO RETRACT THE COIL FOR REPOSITIONING. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6405053 ↗
• MalfunctionDec 13, 2016Retraction Problem; Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected; Retraction Problem; Inadequacy of Device Shape and/or Size; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER AND INTO THE TARGET VESSEL WITHOUT AN ISSUE, THE PHYSICIAN NOTICED THAT THE COIL WAS UNABLE TO TAKE ITS INTENDED SHAPE AND REALIZED THAT THE COIL WAS THE INCORRECT SIZE FOR THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. WHILE RETRACTING THE COIL, THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE; HOWEVER, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. NEXT, THE MICROCATHETER WAS INSPECTED AND NO VISIBLE ISSUES WERE OBSERVED. THE PHYSICIAN THEN RE-INSERTED THE MICROCATHETER INTO THE PATIENT¿S BODY AND COMPLETED THE PROCEDURE USING A NEW POD6 COIL AND A NEW RUBY COIL. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH; HOWEVER, THE MICROCATHETER WAS FLUSHED BEFORE AND AFTER EACH COIL USED DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6172228 ↗
• MalfunctionSep 30, 2016Bent; Physical Resistance; Bent; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), AND THE RUBY COIL PUSHER ASSEMBLY BECAME BENT; THEREFORE IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL TO THE TARGET VESSEL USING THE SAME LANTERN; HOWEVER, THE PHYSICIAN WANTED TO REPOSITION THE RUBY COIL AND THEREFORE RETRACTED THE RUBY COIL QUICKLY WITH RESISTANCE, CAUSING IT TO SHRED APART. THE RUBY COIL UNINTENTIONALLY DETACHED IN THE PATIENT BODY, THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE ALL THE PARTS OF THE DETACHED RUBY COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND ADDITIONAL NON-PENUMBRA COILS, AND THE SAME LANTERN. THE PHYSICIAN FLUSHED BETWEEN EACH COIL AND DID NOT USE A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5990643 ↗
• MalfunctionSep 28, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, BOTH RUBY COIL PUSHER ASSEMBLIES BECAME KINKED. THE PHYSICIAN MENTIONED EXPERIENCING RESISTANCE WHILE ADVANCING RUBY COIL WITH LOT #F68732. SUBSEQUENTLY, BOTH RUBY COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COILS. IT IS UNKNOWN IF THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) OR IF A CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5984353 ↗
• MalfunctionJun 16, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD8 COILS AND RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A POD8 COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE POD8 COIL BECAME STUCK AND WOULD NOT ADVANCE OUT OF THE MICROCATHETER. THEREFORE, BOTH THE POD8 COIL AND MICROCATHETER WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A NEW MICROCATHETER FROM THE SAME MANUFACTURER BUT ALSO ENCOUNTERED RESISTANCE. THEREAFTER, BOTH THE RUBY COIL AND MICROCATHETER WERE REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A POD8 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 5730720 ↗
• MalfunctionMay 3, 2016Bent; Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE A RUBY COIL WAS BEING ADVANCED THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT. 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 5626010 ↗
• MalfunctionMar 18, 2016Retraction Problem; Inadequacy of Device Shape and/or Size; Retraction Problem; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL INTO THE PATIENT BUT NOTICED THAT THE RUBY COIL WAS TOO LARGE FOR THE TARGET VESSEL AND DECIDED TO REMOVE THE COIL TO USE IN ANOTHER AREA. HOWEVER, WHILE THE PHYSICIAN WAS ATTEMPTING TO RESHEATH THE RUBY COIL, IT WOULD NOT RETRACT BACK INTO ITS ORANGE SHEATH AND COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY 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 5510510 ↗