RUBY Coil RBY2C2457-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00814548019291), received between Oct 23, 2018 and Aug 27, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL AND WHILE ADVANCING THE RUBY COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE RUBY COIL STOPPED ADVANCING. THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL AND THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING SEVENTEEN COILS (RUBY COILS AND POD PACKING COILS), 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 20081524 ↗
• MalfunctionAug 26, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT ANEURYSMS IN THE KIDNEY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET LOCATION USING THE LANTERN. NEXT, WHILE ADVANCING ANOTHER RUBY COIL INTO THE ANEURYSM, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE NON-PENUMBRA CATHETER AND LANTERN. THEREFORE, THE NON-PENUMBRA CATHETER AND LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED OUT FROM THE GUIDE SHEATH. IT WAS REPORTED THAT WHILE REMOVING THE NON-PENUMBRA CATHETER AND LANTERN, THE DETACHED RUBY COIL WAS THEN CAUGHT AT HEMOSTASIS VALVE ADAPTER (HVA). THE PHYSICIAN THEN USED TWEEZERS TO REMOVE THE DETACHED RUBY COIL OUT FROM THE VALVE. THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS BACK INTO THE ANEURYSM AND THE PROCEDURE WAS 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 20065150 ↗
• MalfunctionDec 7, 2022Difficult to Advance; Material Deformation; Physical Resistance/Sticking; Difficult to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL AND EXPERIENCED RESISTANCE IN THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RUBY COIL. THEREFORE, THE RUBY COIL AND THE LANTERN WERE REMOVED. UPON REMOVAL, THE PUSHER ASSEMBLY WAS PULLED FROM THE LANTERN AND THE RUBY COIL WAS FOUND TO BE DETACHED. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER WITH SALINE AND REMOVED THE DETACHED COIL FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL OF THE SAME SIZE 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 15936261 ↗
• MalfunctionFeb 26, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA STENTS, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO STENTS IN THE VESSEL AND THEN ADVANCED A LANTERN THROUGH THE STENTS AND INTO THE ANEURYSM. NEXT, WHILE ADVANCING A RUBY COIL INTO THE ANEURYSM, THE PHYSICIAN NOTICED THE COIL WAS NOT TAKING ITS INTENDED SHAPE. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL TO REPOSITION IT. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN INADVERTENTLY RETRACTED THE LANTERN OUT OF THE ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE LANTERN OVER THE RUBY COIL AND BACK INTO THE ANEURYSM; HOWEVER, THE RUBY COIL DID NOT PROVIDE ADEQUATE STABILITY AND THE PHYSICIAN DECIDED TO RETRACT THE COIL TO START OVER. WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE RUBY COIL MAY HAVE GOTTEN CAUGHT ON THE EDGE OF THE STENT STRUTS AND BEGAN TAKING SHAPE. IT WAS ALSO REPORTED THAT APPROXIMATELY A FEW CENTIMETERS OF THE DETACHED RUBY COIL WAS IN THE ANEURYSM AND THE REST OF THE COIL WAS HANGING WITHIN THE SHEATH. THE PHYSICIAN ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13609409 ↗
• MalfunctionNov 30, 2021Material Deformation; Material Deformation

  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 A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894794 ↗
• MalfunctionOct 4, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, SIX RUBY COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE COIL DETACHED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS, FIVE POD PACKING COILS (POD PCS), A POD COIL, TEN NON-PENUMBRA COILS, 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 12573705 ↗
• MalfunctionSep 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, FOUR RUBY COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION USING THE LANTERN. WHILE INSERTING THE FIFTH RUBY COIL INTO THE LANTERN, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL AGAINST RESISTANCE UNTIL THE COIL REACHED THE MIDDLE OF THE LANTERN. SUBSEQUENTLY, THE RUBY COIL WAS REMOVED, AND THE LANTERN WAS FLUSHED INTERMITTENTLY. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL OF THE SAME SIZE AND NINE ADDITIONAL RUBY COILS WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441685 ↗
• MalfunctionJul 19, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA STENT, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT IN THE TARGET VESSEL. THE PHYSICIAN THEN PLACED THE MICROCATHETER THROUGH THE STENT AND WHEN ADVANCING A RUBY COIL AS THE FIRST COIL, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE DISTAL END OF THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND LANTERN. HOWEVER, WHILE RETRACTING, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. SUBSEQUENTLY, UPON REMOVAL, IT WAS NOTED THAT THE LANTERN WAS OVALIZED APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING SIX NEW RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188779 ↗
• MalfunctionJun 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COILS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION. NEXT, A RUBY COIL WAS ADVANCED THROUGH THE LANTERN AND RESISTANCE WAS ENCOUNTERED JUST BEFORE THE DISTAL TIP OF THE COIL WAS ADVANCED OUT OF THE LANTERN TIP. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL RUBY COILS, FOUR POD PACKING COILS (POD PCS), 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 12044585 ↗
• MalfunctionJun 2, 2021Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A 5F NON-PENUMBRA BASE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE FIRST RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND BASE CATHETER AS A TRI-AXIAL SETUP. THEN, WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL; HOWEVER, WHILE RETRACTING THE RUBY COIL, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL; HOWEVER, WHILE REMOVING THE MICROCATHETER, THE RUBY COIL UNRAVELED INTO THE BASE CATHETER. THEREFORE, THE PHYSICIAN CUT AND CLAMPED THE BASE CATHETER CONTAINING THE RUBY COIL AND REMOVED IT ALTOGETHER FROM THE PATIENT. THE PHYSICIAN THEN REGAINED ACCESS AND COMPLETED THE PROCEDURE USING ANOTHER RUBY COIL AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921084 ↗
• MalfunctionApr 21, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL HALFWAY THROUGH ITS INTRODUCER SHEATH, THE HOSPITAL TECHNOLOGIST KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL AND HAD DIFFICULTY ADVANCING THE RUBY COIL. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11704111 ↗
• MalfunctionFeb 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A SHEATH. DURING THE PROCEDURE, THE FIRST RUBY COIL WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, TWO RUBY COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. NEXT, TWO RUBY COILS WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THESE RUBY COILS WERE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND, UPON REMOVAL, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED PROXIMAL TO THE HUB. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN USED A NEW LANTERN TO SUCCESSFULLY IMPLANT ONE RUBY COIL. HOWEVER, THE NEXT RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER RUBY COIL, AND THE SAME SHEATH. 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 11376234 ↗
• MalfunctionFeb 17, 2021Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL TO THE DISTAL TIP OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE PAST THE TIP OF THE LANTERN. THE PHYSICIAN MADE TWO ATTEMPTS AND CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NEW 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 11338158 ↗
• MalfunctionNov 25, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT TYPE II ENDOLEAK USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, WHILE ADVANCING A NEW RUBY COIL THROUGH THE DISTAL END OF THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE PHYSICIAN RETRACTED THE RUBY COIL BACK INTO THE DISTAL TIP OF THE LANTERN AND THEN REMOVED THE LANTERN WITH THE RUBY COIL TOGETHER FROM THE PATIENT. AFTERWARDS, THE RUBY COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL RUBY COILS, 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; No Consequences Or Impact To Patient

  MAUDE report 10903755 ↗
• MalfunctionOct 30, 2020Failure to Fold; Failure to Advance; Physical Resistance/Sticking; Failure to Fold; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A PSEUDOANEURYSM OFF OF THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL WAS INSERTED INTO THE PSEUDOANEURYSM BUT WAS UNABLE TO STAY IN PLACE. THEREFORE, THE RUBY COIL WAS RE-SHEATHED AND PLACED IN A BOWL OF SALINE. WHEN THE RUBY COIL WAS USED AGAIN, IT BECAME STUCK INSIDE THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS RE-SHEATHED AND CLEANED IN A BOWL OF SALINE. WHEN THE RUBY COIL WAS INTRODUCED A THIRD TIME, IT BECAME STUCK INSIDE THE MICROCATHETER AGAIN. THEREFORE, THE RUBY COIL WAS REMOVED AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. 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 10766278 ↗
• MalfunctionSep 3, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL VEIN USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE RUBY COIL; HOWEVER, WERE ALL UNSUCCESSFUL. 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 Consequences Or Impact To Patient

  MAUDE report 10490609 ↗
• MalfunctionAug 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE MIDDLE DISTAL-END OF THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. 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 10424927 ↗
• MalfunctionAug 6, 2020Failure to Advance; Failure to Advance

  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 PLACED MULTIPLE RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL 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 10371995 ↗
• MalfunctionApr 1, 2020Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE RUBY COIL BECAME STUCK. THE PHYSICIAN THEN DECIDED TO REMOVE IT. WHILE REMOVING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO OTHER RUBY COILS, ELEVEN NON-PENUMBRA 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 9913666 ↗
• MalfunctionJul 15, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, THE RUBY COIL WAS REMOVED AND NOT USED IN THE PROCEDURE. ANOTHER RUBY COIL WAS THEN ADVANCED INTO THE LANTERN; HOWEVER, IT WAS DEEMED TOO BIG; THEREFORE, IT WAS REMOVED WITH NO ISSUE OR DAMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL 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 8789214 ↗
• MalfunctionNov 1, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD12, POD PACKING COILS (PODJS) AND RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A POD12 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DETERMINED THAT THE POD12 WAS OVERSIZED AND THEREFORE, IT WAS REMOVED. THE POD12 PUSHER ASSEMBLY THEN BECAME KINKED WHEN THE HOSPITAL TECHNOLOGIST SUBMERGED IT INTO SALINE TO FLUSH IT. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN. NEXT, THE PHYSICIAN IMPLANTED A POD10 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A PODJ THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PUSHER ASSEMBLY OF THE PODJ BECAME KINKED ON THE BACK END OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN IMPLANTED ANOTHER PODJ IN THE TARGET VESSEL WITH NO ISSUES. WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED, WITH SOME OF THE RUBY COIL IN THE PATIENT'S BODY. THEREFORE, THE PHYSICIAN USED MANUAL ASPIRATION TO PULL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028958 ↗
• MalfunctionOct 29, 2018Device Damaged Prior to Use; Device Handling Problem; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A HOSPITAL STAFF NOTICED THAT TWO RUBY COILS WERE ACCIDENTALLY UNSHEATHED UPON REMOVAL FROM THE DISPENSER HOOPS. THE REPORTED ISSUE WAS FOUND PRIOR TO USE AND PRIOR TO PATIENT INVOLVEMENT. THEREFORE, THE RUBY COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8017605 ↗
• MalfunctionOct 23, 2018Device Damaged Prior to Use; Deformation Due to Compressive Stress; Device Damaged Prior to Use; Deformation Due to Compressive Stress

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A RUBY COIL BECAME KINKED UPON REMOVAL FROM THE PACKAGING HOOP ON THE BACK TABLE. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7997429 ↗