RUBY Coil RBY2C2860-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI M424RBY2C28600), received between Aug 12, 2015 and Jul 17, 2020 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (20 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2020Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE AORTA USING RUBY COILS, POD PACKING COILS (PODJS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT THE NEXT COIL, A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PLACED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT A PODJ INTO THE LANTERN, THE SAME ISSUE OCCURRED. THE PUSHER ASSEMBLY OF THE PODJ KINKED AND SUBSEQUENTLY, THE PODJ DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN PLACED ONE PODJ INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, THE PHYSICIAN ATTEMPTED TO INSERT A PODJ INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED; THEREFORE, THE PODJ WAS REMOVED. THE PROCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290786 ↗
• MalfunctionDec 31, 2019Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE SECOND RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN; THEREFORE, IT WAS REMOVED AND RE-SHEATHED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, THE RUBY COIL DETACHED FROM ITS PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS NO LONGER USED. THE PHYSICIAN CONTINUED THE PROCEDURE USING TWO OTHER RUBY COILS AND THE SAME LANTERN. WHILE ADVANCING THE FIFTH RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. THE PHYSICIAN THEN RETRACTED THE RUBY COIL AND ATTEMPTED TO RE-SHEATH IT BACK INTO ITS INTRODUCER SHEATH; HOWEVER, TEN CENTIMETERS COULD NOT BE RE-SHEATHED. THEREFORE, THE RUBY COIL WAS NOT USED. 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 9537091 ↗
• MalfunctionAug 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO EMBOLIZE THE INFLOW ARTERY, THE PHYSICIAN ADVANCED A RUBY COIL (LOT # C15823) INTO THE TARGET VESSEL USING A LANTERN AND, ATTEMPTED TO DEPLOY THE COIL. HOWEVER, THE RUBY COIL WAS PROLAPSING INTO THE ANEURYSM SACK DUE TO THE HIGH FLOW VESSEL AND, THEREFORE, THE RUBY COIL WAS REMOVED, RINSED IN SALINE BOWL AND, RE-SHEATHED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THREE LARGER SIZE RUBY COILS (LOT #¿S C15907, F90316 AND, C14897) BUT THE SAME ISSUE OCCURRED AND, ALL THREE RUBY COILS WERE PROLAPSING INTO THE ANEURYSM SACK. THEREFORE, ALL THREE RUBY COILS WERE REMOVED, RINSED IN SALINE BOWL AND, RE-SHEATHED FOR LATER USE. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA BALLOON CATHETER INTO THE VESSEL, INFLATED THE BALLOON TO STOP THE FLOW AND ATTEMPTED TO ADVANCE THE PREVIOUS RUBY COILS (LOT #¿S C15907, F90316 AND, C14897, C15823); HOWEVER, ALL FOUR COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. IT WAS REPORTED THAT THE RUBY COILS WERE COAGULATED WITH BLOOD INSIDE THEIR IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923529 ↗
• MalfunctionJul 25, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DECIDED TO REMOVE THE COIL AND USE A SLIGHTLY LARGER SIZE COIL. HOWEVER, WHILE RE-SHEATHING THE RUBY COIL ON THE BACK TABLE, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BROKE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 8826278 ↗
• MalfunctionJan 11, 2019Physical 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). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN USED A 60CC SYRINGE TO ASPIRATE THE DETACHED RUBY COIL OUT OF THE LANTERN. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL, HOWEVER FELT RESISTANCE AFTER ADVANCING IT HALF WAY THROUGH THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND THE LANTERN; HOWEVER, THE LANTERN WAS NOTED TO BE KINKED MID SHAFT. THE PROCEDURE WAS THEREFORE COMPLETED USING NEW RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241518 ↗
• MalfunctionJul 31, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY KINKED THE RUBY COIL ON THE BACK TABLE. 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 7735330 ↗
• MalfunctionJul 25, 2018Deformation Due to Compressive Stress; Inadequate User Interface; Deformation Due to Compressive Stress; Inadequate User Interface

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED TWO RUBY COILS PUSHER ASSEMBLIES WHILE ATTEMPTING TO ADVANCE THE COILS INTO A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ADDITIONAL RUBY COILS, AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720364 ↗
• MalfunctionJul 5, 2018Bent; Break; Device Damaged Prior to Use; Bent; Break; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION TO TREAT AN ABDOMINAL AORTIC ANEURYSM ENDOLEAK (AAA ENDOLEAK) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED TWO RUBY COILS IN THE TARGET VESSEL AND USED A HANDLE TO DETACH THE COILS. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL IN THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL FAILED TO DETACH COMPLETELY. IT WAS REPORTED THAT THE HANDLE WAS NOT MAKING THE SAME CLICKING SOUND. THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE AND SUCCESSFULLY DETACHED THE RUBY COIL. NEXT, THE HOSPITAL TECHNOLOGIST, BENT AND BROKE A RUBY COIL PUSHER ASSEMBLY ON THE BACK TABLE WHILE REMOVING THE RUBY COIL OUT OF THE DISPENSER HOOP. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SECOND HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 7665112 ↗
• MalfunctionJun 11, 2018Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE HOSPITAL TECHNICAL THEN ACCIDENTLY KINKED THE PUSHER ASSEMBLIES OF A RUBY COIL AND A PODJ WHILE ATTEMPTING TO ADVANCE THE COILS THROUGH THE LANTERN AND, THEREFORE, THE COILS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD 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 7587070 ↗
• MalfunctionJun 6, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER TWO FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING SIX OTHER 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 7574135 ↗
• MalfunctionApr 5, 2018Bent; Failure to Advance; Physical Resistance; Bent; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM ENDOLEAK (AAA ENDOLEAK) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA SHEATH AND SUPPORT CATHETER, THEN ADVANCED A LANTERN THROUGH THE CATHETER. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE COIL WOULD NOT ADVANCE. THEREFORE, THE RUBY COIL WAS RE-SHEATHED AND IT WAS NOTED THAT THE COIL¿S PUSHER ASSEMBLY WAS BENT. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN AND UPON REMOVAL, IT WAS NOTICED THAT THE LANTERN WAS KINKED. A NEW LANTERN WAS THEN OPENED AND THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, TENSION AND FRICTION WAS ENCOUNTERED AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE LANTERN CONTAINING THE DETACHED COIL; HOWEVER, WHILE RETRACTING THE LANTERN, THE COIL CAME OUT OF THE LANTERN AND BECAME STUCK INSIDE THE SUPPORT CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE SUPPORT CATHETER WITH THE COIL AND DECIDED TO END THE PROCEDU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399780 ↗
• MalfunctionApr 4, 2018Difficult to Advance; Physical Property Issue; Difficult to Advance; Physical Property Issue

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS, POD PACKING COILS (PODJ¿S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST RUBY COIL IN THE TARGET VESSEL USING A LANTERN, THE PHYSICIAN DETERMINED THAT THE COIL WAS OVERSIZED AND DECIDED TO REMOVE IT; HOWEVER, THE RUBY COIL PUSHER ASSEMBLY WAS ACCIDENTALLY KINKED WHILE RE-SHEATHING THE RUBY COIL. THE PHYSICIAN THEN HAD DIFFICULTY ADVANCING THE SECOND RUBY COIL THROUGH THE LANTERN, AND MENTIONED THAT THE RUBY COIL FELT GRITTY AND THEREFORE IT WAS REMOVED. IT WAS ALSO REPORTED THAT THERE WAS A LOT OF BLOOD IN THE COIL¿S INTRODUCER SHEATH. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED THE THIRD RUBY COIL. WHILE ATTEMPTING TO ADVANCE THE FOURTH RUBY COIL THROUGH THE LANTERN, THE RUBY COIL FELT GRITTY AND A LOT OF BLOOD WAS ALSO NOTICED IN THE COIL'S INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THEREAFTER, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THE FIFTH, SIXTH AND SEVENTH COIL IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE EIGHTH AND NINTH COILS (PODJ¿S) THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396514 ↗
• MalfunctionMar 9, 2018Kinked; Device Damaged Prior to Use; Device Handling Problem; Kinked; Device Damaged Prior to Use; Device Handling Problem

  WHILE PREPARING A RUBY COIL FOR A COIL EMBOLIZATION PROCEDURE, A HOSPITAL STAFF INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY WHILE LOADING THE COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) ON THE BACK TABLE. THE KINKING OF THE RUBY COIL OCCURRED PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN.

  Patient problems: No Patient Involvement

  MAUDE report 7328525 ↗
• MalfunctionFeb 27, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH A MICROCATHETER, THE PHYSICIAN EXPERIENCED STIFFNESS AND DECIDED TO REMOVE THE COILS. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300135 ↗
• MalfunctionFeb 6, 2018Device Handling Problem; Device Handling Problem

  WHILE PREPARING A NEW RUBY COIL FOR A COIL EMBOLIZATION PROCEDURE, THE TECHNICIAN ACCIDENTALLY DROPPED THE RUBY COIL ONTO THE FLOOR WHILE IT WAS STILL INSIDE ITS PACKAGING HOOP. THE RUBY COIL WAS DROPPED PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7246368 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC USING RUBY COILS AND A POD PACKING COIL (PODJ). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO PLACE 11 RUBY COILS AND ONE PODJ. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED MICROCATHETERS THREE TIMES. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN AVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242768 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC USING RUBY COILS AND A POD PACKING COIL (PODJ). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO PLACE 11 RUBY COILS AND ONE PODJ. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED MICROCATHETERS THREE TIMES. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN AVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242766 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC USING RUBY COILS AND A POD PACKING COIL (PODJ). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO PLACE 11 RUBY COILS AND ONE PODJ. IT WAS REPORTED THAT THE PHYSICIAN SWITCHED MICROCATHETERS THREE TIMES. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN AVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7242763 ↗
• MalfunctionFeb 5, 2018Failure to Advance; Physical Resistance; Device Handling Problem; Failure to Advance; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COILS. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT A RUBY COIL INTO THE PAVM USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE RUBY COIL APPROXIMATELY 75% INTO THE PAVM AND THE COIL WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE LANTERN AND COIL WERE REMOVED AND THE PHYSICIAN FLUSHED CLOT OUT OF THE LANTERN. IT WAS REPORTED THAT THE RUBY COIL WAS THEN ACCIDENTALLY DROPPED ON THE FLOOR AFTER REMOVAL FROM THE LANTERN. THE PHYSICIAN WANTED TO START FRESH AND DECIDED TO USE A SECOND LANTERN. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN WAS ABLE TO GET THE LANTERN BACK ENGAGED INTO THE PAVM AND ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE RUBY COIL WOULD NOT ADVANCE. THE PHYSICIAN THEN DECIDED TO END THE PROCEDURE AT THIS POINT AND THE PATIENT WILL BE SCHEDULED FOR ANOTHER PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7240799 ↗
• MalfunctionDec 21, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE TO TREAT A LARGE VARICES USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL RUBY COILS USING A FORTY-FIVE DEGREE TIP LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL AND TWO NEW PODJ''S THROUGH THE SAME LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, ALL THREE COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A TOTAL OF ABOUT TWENTY RUBY COILS AND PODJ''S, THE INITIAL LANTERN AND A NEW LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN ONLY SWITCHED OUT THE LANTERN DURING THE PROCEDURE BECAUSE HE NEEDED A DIFFERENT TIP SHAPE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139244 ↗
• MalfunctionSep 25, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) IN THE RIGHT ANTERIOR TIBIAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT HAVE THE DISTAL END OF THE RUBY COIL INTRODUCER SHEATH WEDGED INTO THE END OF THE HUB OF THE LANTERN. IT WAS ALSO REPORTED THAT THE SCRUB TECHNOLOGIST ATTEMPTED TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE BUT THE COIL WOULD NOT ADVANCE. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING THREE OTHER RUBY COILS AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT USE A CONTINUOUS FLUSH THROUGHOUT THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6892281 ↗
• MalfunctionSep 21, 2017Positioning Failure; Failure to Advance; Device Handling Problem; Positioning Failure; Failure to Advance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER INTRODUCING THE INTRODUCER SHEATH OF A RUBY COIL THROUGH THE HUB OF A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN ASKED HIS FELLOW PHYSICIAN TO HOLD THE INTRODUCER SHEATH AND THE LANTERN TOGETHER. AFTER ADVANCING ABOUT FIVE CENTIMETER OF THE RUBY COIL INTO THE LANTERN, THE FELLOW PHYSICIAN INADVERTENTLY PULLED THE RUBY COIL INTRODUCER SHEATH BACK AND THE RUBY COIL BEGAN TO FORM OUTSIDE THE LANTERN; THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH THE RUBY COIL. WHILE RE-SHEATHING THE RUBY COIL, THE PHYSICIAN PULLED THE RUBY COIL PUSHER ASSEMBLY PASS THE FRICTION LOCK OF THE INTRODUCER SHEATH AND THE RUBY COIL BEGAN TO COME OUT THE PROXIMAL END OF THE INTRODUCER SHEATH; THEREFORE, THE PHYSICIAN REMOVED THE ENTIRE INTRODUCER SHEATH AND SUCCESSFULLY RE-SHEATHED THE RUBY COIL FROM THE PUSHER ASSEMBLY. AFTER THAT, THE PHYSICIAN LOADED THE RUBY COIL INTRODUCER SHEATH INTO THE HUB OF THE LANTERN AND ATTEMPTED TO RE-ADVANCE THE RUBY COIL INTO THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN. THEREFORE,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6883659 ↗
• MalfunctionAug 2, 2017Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  WHILE PREPARING TWO RUBY COILS ON THE BACK TABLE FOR A COIL EMBOLIZATION PROCEDURE, THE SCRUB TECHNOLOGISTS INADVERTENTLY KINKED BOTH RUBY COILS PUSHER ASSEMBLIES. THE KINKING OF THE RUBY COILS OCCURRED PRIOR TO USE AND THEREFORE, THE RUBY COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6761973 ↗
• MalfunctionJul 27, 2017Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL OUT OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED AND RE-SHEATHED. THE PHYSICIAN THEN ADJUSTED THE CATHETER AND ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THIS RUBY COIL WAS ALSO UNABLE TO ADVANCE. THE PHYSICIAN THEN REMOVED THE RUBY COIL AND THE LANTERN, AND INSERTED A NEW LANTERN. THE PHYSICIAN RE-ATTEMPTED BUT WAS STILL UNABLE TO ADVANCE THE FIRST RUBY COIL; THEREFORE IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED THE SECOND RUBY COIL AND ADDITIONAL RUBY COILS. THE PHYSICIAN THEN AGAIN FELT RESISTANCE ADVANCING ANOTHER RUBY COIL AND, UPON MANIPULATION, THE RUBY COIL BROKE WITHIN THE LANTERN. THE LANTERN WAS REMOVED WITH THE BROKEN RUBY COIL INSIDE, AND THE PROCEDURE WAS ENDED AT THAT POINT. ADDITIONALLY, THERE WAS NO ALLEGED DEFICIENCY WITH THE SECOND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747164 ↗
• MalfunctionJul 6, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN'S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND INTO THE LANTERN, THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND REMOVED THE COILS. THE PHYSICIAN THEN LOOSENED THE RHV ON THE NEURON 070 CATHETER (NEURON 070) AND RAN A GUIDEWIRE DOWN THE LANTERN WITHOUT ANY RESISTANCE. A NEW RUBY COIL WAS THEN OPENED AND RESISTANCE WAS ENCOUNTERED AT THE RHV CONNECTION ON THE NEURON 070. SUBSEQUENTLY, THE LANTERN WAS REMOVED AND A NEW LANTERN WAS OPENED FOR THE PROCEDURE. IT WAS REPORTED THAT A KINK WAS OBSERVED NEAR THE HUB OF THE FIRST LANTERN. NEXT, THE PHYSICIAN DEPLOYED A NEW RUBY COIL INTO THE ANEURYSM BUT DETERMINED THAT THE COIL WAS THE INCORRECT SIZE. THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS OPENED. WHILE ATTEMPTING TO ADVANCE THIS COIL INTO THE LANTERN, THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND REMOVED THE COIL. A NEW RUBY COIL WAS OPENED AND RESISTANCE WAS ENCOUNTERED AGAIN WHILE THE TECHNOLOGIST WAS ATTEMPTING TO LOAD THE COIL INTO THE LANTERN. THE COIL STOPPED ADVANCING AT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6689764 ↗