RUBY Coil RBY4C0415-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI M424RBY4C04150), received between Aug 14, 2015 and Jun 30, 2023 — classified as 5 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN USING SALINE. 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 17241247 ↗
• MalfunctionJul 14, 2022Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, A NEW RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A THIRD RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INTO ANOTHER VESSEL. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED USING A SNARE DEVICE. 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 15021470 ↗
• MalfunctionNov 6, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD PACKING COILS (POD PCS), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE LANTERN WAS INTRODUCED TO THE TARGET VESSEL AND PENUMBRA COILS WERE IMPLANTED. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE RUBY COIL PUSHER ASSEMBLY WAS BENT AND DID NOT ALLOW FOR SMOOTH ADVANCEMENT. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH A POD PC. THEREFORE, THE POD PC WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. 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 10802853 ↗
• MalfunctionFeb 18, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY (RA) USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER ADVANCING A FEW CENTIMETERS OF THE RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND IMMEDIATELY STOPPED ADVANCING THE RUBY COIL FORWARD. WHILE ATTEMPTING TO WITHDRAW THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED AND WAS NOT RETRACTABLE THROUGH THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE GUIDEWIRE TO PUSH THE DETACHED RUBY COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 9722761 ↗
• MalfunctionNov 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS) AND A RUBY COIL. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD6 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A PODJ (F84471); HOWEVER, THE COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO NEW PODJS (F84743 AND F91605) AND A RUBY COIL (F80309); HOWEVER, THE SAME ISSUE OCCURRED, AND THE COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE PODJS AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NON-PENUMBRA EMBOLIC AGENT IN ORDER TO NOT LOSE ACCESS TO THE TORTUOUS VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328607 ↗
• MalfunctionAug 23, 2019Premature Separation; Premature Separation

  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 RUBY COIL UNINTENTIONALLY DETACHED PRIOR TO REACHING THE TARGET VESSEL. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. 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 8925814 ↗
• MalfunctionMay 28, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) AND THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND POD5S. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST RUBY COIL WAS ADVANCED INTO THE IMA USING A LANTERN DELIVERY MICROCATHETER (LANTERN), BUT WOULD NOT TAKE SHAPE IN THE VESSEL. THE RUBY COIL WAS THEREFORE REMOVED AND NOT USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED TO ADVANCE A POD5; HOWEVER, THE POD5 WAS UNABLE TO ADVANCE OUT OF THE ROTATING HEMOSTASIS VALVE (RHV)AND INTO THE LANTERN AND WAS THEREFORE REMOVED. ANOTHER POD5 WAS THEN IMPLANTED SUCCESSFULLY IN THE IMA USING THE SAME LANTERN. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL INTO THE IIA AND MADE SEVERAL ATTEMPTS TO REPOSITION IT WITHIN THE VESSEL. WHILE RETRACTING THE RUBY COIL INTO THE LANTERN DURING AN ATTEMPT TO REPOSITION, THE RUBY COIL UNINTENTIONALLY DETACHED AND BROKE INTO TWO PIECES. IT WAS NOTED THAT ONE PIECE OF THE RUBY COIL BROKE OFF IN THE PATIENT'S VESSEL AND ANOTHER PIECE BROKE OFF INSIDE THE LANTERN. THE LANTERN AND PIECE OF THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT AND A SNARE WAS USED TO RETRIEVE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646289 ↗
• MalfunctionNov 28, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY ON THE IPSILATERAL SIDE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED A POD5 USING THE LANTERN. THE PHYSICIAN THEN ADVANCED A RUBY COIL THROUGH THE LANTERN BUT EXPERIENCED RESISTANCE WHILE ADVANCING. THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER THROUGH THE LANTERN AND THEREFORE, BOTH THE LANTERN AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN RETRACTED THE RUBY COIL FROM THE LANTERN AND NOTICED THAT IT HAD DETACHED. NO OTHER COILS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113498 ↗
• MalfunctionNov 5, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL 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 PROCEDURE WAS COMPLETED USING ANOTHER 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 8040462 ↗
• MalfunctionOct 4, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING THE HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7934552 ↗
• InjuryAug 15, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AS THE COIL STARTED TO FORM IN THE VESSEL, SUBSEQUENTLY; THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVED THE ENTIRE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING VASCULAR PLUG. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785272 ↗
• MalfunctionJun 11, 2018Inadequacy of Device Shape and/or Size; Failure to Advance; Inadequacy of Device Shape and/or Size; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE RUBY COIL WOULD NOT FIT THE TARGET VESSEL AND DECIDED TO REMOVE IT. WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL AFTER REMOVAL, THE RUBY COIL INTRODUCER SHEATH WOULD NOT GO FORWARD OR BACKWARD AND COULD NOT BE PUSHED ANY FURTHER. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 7588924 ↗
• InjuryMay 30, 2018Detachment Of Device Component; Positioning Problem; Detachment Of Device Component; Positioning Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING THE LAST RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO PUSH THE RUBY COIL IN THE GDA USING A COIL PUSHER WIRE; HOWEVER, THE RUBY COIL DID NOT SEAT PROPERLY IN THE GDA AND WAS SNARED OUT. THE PROCEDURE WAS COMPLETED AFTER REMOVAL OF THE RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553459 ↗
• MalfunctionMay 23, 2018Kinked; 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 FOUND THAT THE HYPOTUBE OF THE RUBY COIL WAS KINKED 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 7538353 ↗
• MalfunctionMay 7, 2018Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GASTROINTESTINAL BLEED USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE, AND THEREFORE THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT A SECOND RUBY COIL BROKE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492441 ↗
• MalfunctionMay 7, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GASTROINTESTINAL BLEED USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE, AND THEREFORE THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT A SECOND RUBY COIL BROKE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7492438 ↗
• InjuryFeb 7, 2018Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Detachment Of Device Component; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WAS ADVANCED INTO THE TARGET VESSEL, HOWEVER, THE COIL WAS NOT FORMING TO THE PHYSICIAN'S SATISFACTION; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PROCEEDED TO PLACE A NEW RUBY COIL WITH NO ISSUE. WHEN ADVANCING ANOTHER RUBY COIL IN THE ANEURYSM, THE PHYSICIAN WAS NOT ABLE TO GET A GOOD PACK BECAUSE THE COIL WAS TOO LONG. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL; HOWEVER, THE POSITION OF THE BASE CATHETER WAS VERY UNSTABLE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN FELT THAT THE LANTERN WAS RELATIVELY STABLE, AND INJECTED APPROXIMATELY HALF OF THE COIL IN THE SFA. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE REMAINDER OF THE RUBY COIL IN THREE PASSES. THE PHYSICIAN THEN SWITCHED TO A NEW BASE CATHETER AND A NEW LANTERN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247997 ↗
• MalfunctionNov 16, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) NEAR THE SUPERFICIAL FEMORAL ARTERY (SFA) USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WHILE PARTIALLY ADVANCED WITHIN THE NON-PENUMBRA MICROCATHETER AND PARTIALLY WITHIN THE VESSEL. THE PHYSICIAN THEN REMOVED THE MICROCATHETER; HOWEVER, THE DETACHED RUBY COIL REMAINED IN THE GUIDE CATHETER AND BEGAN TO FORM. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER WITH THE RUBY COIL INSIDE AND COMPLETED THE PROCEDURE USING A NEW CATHETER, NEW 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 7038197 ↗
• MalfunctionSep 21, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED AND REMOVED A RUBY COIL THAT WAS TOO SMALL; HOWEVER, UPON REMOVAL, THE RUBY COIL WAS DROPPED ON THE FLOOR. THIS RUBY COIL THEREFORE WAS NOT REUSED IN THE PROCEDURE. LATER IN THE PROCEDURE, IT WAS REPORTED THAT A RUBY COIL WAS UNABLE TO TAKE ITS INTENDED SHAPE; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, THE HOSPITAL TECHNICIAN INADVERTENTLY KINKED THE PUSHER WIRE OF A THIRD RUBY COIL WHILE ATTEMPTED TO INSERT THE RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW LANTERN. IN ADDITION, THERE WAS NO ALLEGED DEFICIENCY WITH THE FIRST LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6883225 ↗
• InjurySep 14, 2017Detachment Of Device Component; Premature Activation; Detachment of Device or Device Component; Physical Resistance/Sticking; Premature Separation; Detachment Of Device Component; Premature Activation; Detachment of Device or Device Component; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR PANCREATICODUODENAL ARTERY (IPDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RETRACT A RUBY COIL BACK INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) TO REPOSITION IT. HOWEVER, THE PHYSICIAN FELT RESISTANCE RETRACTING AND THE RUBY COIL UNINTENTIONALLY DETACHED NEAR THE HUB OF THE LANTERN. THE PHYSICIAN REMOVED THE PUSHER WIRE AND INJECTED CONTRAST INTO THE LANTERN, THINKING THAT THE COIL IMPLANT HAD BEEN REMOVED WITH THE PUSHER WIRE. CONSEQUENTLY, THE RUBY COIL WAS FLUSHED INTO THE PATIENT, AND THE PHYSICIAN THEREFORE MADE A SECOND PUNCTURE BELOW THE SHEATH AND USED A SNARE DEVICE TO RETRIEVE THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS 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 6865705 ↗
• MalfunctionSep 11, 2017Break; Detachment Of Device Component; Premature Activation; Break; Detachment Of Device Component; Premature Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). A RUBY COIL THEN UNINTENTIONALLY DETACHED WITHIN THE LANTERN AS THE LANTERN BACKED IN TO THE NON-PENUMBRA SHEATH. THE PHYSICIAN ATTEMPTED TO REMOVE THE LANTERN WITH THE RUBY COIL INSIDE, HOWEVER THE RUBY COIL REMAINED IN THE SHEATH; THEREFORE, THE PHYSICIAN PULLED OUT THE RUBY COIL USING HIS FINGERS. AS THE RUBY COIL WAS BEING PULLED OUT, THE COIL BROKE INTO TWO PIECES. THE PHYSICIAN REMOVED ONE PIECE, AND THE SECOND PIECE FLOWED INTO THE TARGET LOCATION; THEREFORE, IT WAS LEFT IN PLACE. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6855587 ↗
• MalfunctionSep 6, 2017Failure 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 MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE LANTERN. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ALLEGED DEFICIENCY AGAINST THE LANTERN. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846185 ↗
• MalfunctionAug 22, 2017Kinked; Sticking; Device Handling Problem; Kinked; Sticking; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE ADVANCING A RUBY COIL THROUGH THE TIP OF A NON-PENUMBRA MICROCATHETER; CONSEQUENTLY, THE RUBY COIL BECAME KINKED. THE RUBY COIL AND MICROCATHETER WAS THEREFORE REMOVED AND, UPON REMOVAL, IT WAS FOUND THAT THE MICROCATHETER WAS KINKED. A NEW MICROCATHETER WAS PLACED, AND THE TECHNICIAN ACCIDENTALLY KINKED A SECOND RUBY COIL WHILE ADVANCING IT INTO THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE RUBY COIL BECAME STICKY WITHIN THE INTRODUCER SHEATH BECAUSE IT HAD NOT BEEN CLEANED UPON REMOVAL; THEREFORE, IT COULD NOT BE ADVANCED OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. 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 6810314 ↗
• MalfunctionJul 11, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THREE RUBY COILS THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE RUBY COILS PUSHER ASSEMBLIES BECAME KINKED. THEREFORE, THE RUBY COILS WERE REMOVED. WHILE ADVANCING A NEW RUBY COIL THROUGH THE SAME MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO WITHDRAW THE COIL. HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY IN THE HEPATIC ARTERY. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6703625 ↗
• InjuryJun 30, 2017Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A DIAGNOSTIC CATHETER IN THE TARGET VESSEL THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH THE CATHETER. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED IMMEDIATE RESISTANCE AFTER THE FIRST CENTIMETER OF THE COIL WAS OUT OF THE TIP THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN REMOVED THE LANTERN AND ADVANCED THE SHEATH AND BASE CATHETER MORE DISTAL TO HELP ALLEVIATE SOME OF THE TORTUOSITY. THE PHYSICIAN THEN PLACED A NEW LANTERN IN THE TARGET VESSEL AND SUCCESSFULLY DEPLOYED AND DETACHED THREE RUBY COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN, THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE. IT WAS ALSO REPORTED THAT RESISTANCE WAS ENCOUNTERED IMMEDIATELY AFTER ADVANCING THE RUBY COIL INTO THE HUB OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. AFTER THAT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN. THEREFORE, THE P

  Patient problems: Thrombus

  MAUDE report 6682398 ↗