RUBY Coil RBY2C0320-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI M424RBY2C03200), received between Aug 19, 2015 and Aug 3, 2021 — classified as 3 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (33 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT PULMONARY ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271677 ↗
• MalfunctionJun 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED. NO ADDITIONAL INFORMATION REGARDING HOW THE DETACHED RUBY COIL WAS REMOVED WAS PROVIDED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035704 ↗
• MalfunctionJun 26, 2020Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION; IT WAS REPORTED THAT THE RUBY COIL WAS TOO LONG; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE RETRACTING THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH, THE RUBY COIL GOT STUCK AT THE TIP OF ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE RUBY COIL BACK INTO ITS THE INTRODUCER SHEATH. THEREFORE, THE PHYSICIAN PULLED THE INTRODUCER SHEATH OF THE LANTERN SHAFT SO THAT A SMALL PART OF THE RUBY COIL LOOKED OUT THE INTRODUCER SHEATH SLEEVE. 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 10201683 ↗
• MalfunctionJan 9, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER (RENEGADE). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, IT BECAME STUCK; THEREFORE, THE RUBY COIL WAS RETRACTED FOR REMOVAL. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND HEARD A ¿POP¿. SUBSEQUENTLY, THE RUBY COIL BROKE AND THE FILAMENT WIRE STARTED TO UNWIND WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS 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 9572439 ↗
• MalfunctionOct 1, 2019Failure 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 PROCESS, WHILE ADVANCING THE RUBY COIL ABOUT 3-5 CM USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS NOT ABLE TO ADVANCE FURTHER; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE RUBY COIL INTO A BOWL OF SALINE ON THE BACK TABLE AND EXPERIENCED RESISTANCE. THE RUBY COIL WAS RE-SHEATHED AND NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING 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 9142750 ↗
• MalfunctionMar 12, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8413084 ↗
• MalfunctionFeb 27, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SEVERAL PENUMBRA COILS IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING ANOTHER RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH INTO THE MICROCATHETER. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THIS RUBY COIL WAS ALSO REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING 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 8376367 ↗
• MalfunctionFeb 27, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SEVERAL PENUMBRA COILS IN THE TARGET VESSEL USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE ADVANCING ANOTHER RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL OUT OF ITS INTRODUCER SHEATH INTO THE MICROCATHETER. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THIS RUBY COIL WAS ALSO REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING 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 8376366 ↗
• MalfunctionFeb 1, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIALS RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE TWO OTHER RUBY COILS MORE THAN HALF-WAY THROUGH THE MICROCATHETER AND; THEREFORE, THE RUBY COILS WERE REMOVED. 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 8297149 ↗
• MalfunctionFeb 1, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIALS RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE TWO OTHER RUBY COILS MORE THAN HALF-WAY THROUGH THE MICROCATHETER AND; THEREFORE, THE RUBY COILS WERE REMOVED. 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 8297143 ↗
• MalfunctionJan 31, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS. IT WAS NOTED THAT THE PATIENT HAD A VERY ACUTE BEND TOWARDS THE SMA. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE. SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY KINKED AND THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 8294406 ↗
• MalfunctionDec 21, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PLACE THE DETACHED COIL IN THE TARGET LOCATION BY PUSHING IT WITH THE PUSHER ASSEMBLY. THE PROCEDURE WAS THEN 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 8190499 ↗
• MalfunctionDec 21, 2018Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN) THE PHYSICIAN DECIDED TO REMOVE AND RE-SHEATH THE RUBY COIL TO REPOSITION THE LANTERN. WHILE ADVANCING THE RUBY COIL BACK THROUGH THE LANTERN, RESISTANCE WAS EXPERIENCED. THE PHYSICIAN THEN NOTICED COAGULATED BLOOD AROUND THE DISTAL END OF THE COIL. IN ADDITION, THE HYPOTUBE BENT WHILE ATTEMPTING TO ADVANCE THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND POD PACKING COILS (PODJ) WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190154 ↗
• MalfunctionOct 28, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THE INITIAL COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK AT THE DISTAL END OF THE LANTERN; 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 8012301 ↗
• MalfunctionOct 4, 2018Device Damaged Prior to Use; Failure to Advance; Device Damaged Prior to Use; Failure to Advance

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL WAS ACCIDENTALLY UNSHEATHED ON THE BACK TABLE AND THE HOSPITAL STAFF WAS UNABLE TO RESHEATH IT. THE RUBY COIL WAS THEREFORE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS CONTINUED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7934332 ↗
• MalfunctionMay 30, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER RUBY COIL IN THE TARGET VESSEL USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE THE LAST RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL WOULD NOT ADVANCE. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552865 ↗
• MalfunctionMay 2, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, PRIOR TO USE, A RUBY COIL WAS DROPPED ON THE FLOOR WHILE BEING HANDED TO THE SCRUB TECHNOLOGIST BY THE NURSE. THEREFORE, THE RUBY COIL WAS SET ASIDE AND A NEW RUBY COIL WAS OPENED. WHILE ATTEMPTING TO ADVANCE THE NEW RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. WHILE REMOVING ANOTHER RUBY COIL FROM THE DISPENSER HOOP, THE SCRUB TECHNOLOGIST INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY. 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 Patient Involvement

  MAUDE report 7480670 ↗
• MalfunctionApr 6, 2018Bent; Device Handling Problem; Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC VARICOCELE USING RUBY COILS, DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN WAS AGGRESSIVE AND INADVERTENTLY BENT THE COIL¿S PUSHER ASSEMBLY; THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT ANOTHER RUBY COIL PUSHER ASSEMBLY BECAME BENT IN THE SAME MANNER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS 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 7402929 ↗
• MalfunctionFeb 16, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A VARIOCELE USING RUBY COILS. IT WAS NOTED THAT PATIENT'S ANATOMY WAS TORTUOUS BUT NOT EXTREME. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD ONLY ADVANCE HALF WAY IN A LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND 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 7277533 ↗
• MalfunctionFeb 7, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  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 7247993 ↗
• MalfunctionDec 6, 2017Kinked; Device Damaged Prior to Use; Device Handling Problem; Kinked; Device Damaged Prior to Use; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING PREPARATION FOR THE PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTALLY KINKED TWO RUBY COILS WHILE ADVANCING THEM INTO THE LANTERN ON THE BACK TABLE. A THIRD RUBY COIL ALSO BECAME KINKED DURING PREPARATION ON THE BACK TABLE. THE DAMAGE TO THESE RUBY COILS OCCURRED PRIOR TO USE, AND THEREFORE THEY WERE NOT USED IN THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS USING THE SAME LANTERN. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY PLACING A PODJ WITHIN THE TARGET LOCATION AND, CONSEQUENTLY, THE PODJ UNINTENTIONALLY DETACHED AS THE PHYSICIAN WAS MANIPULATING IT. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PODJ INSIDE, AND THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7089407 ↗
• MalfunctionNov 8, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT DEPLOY. THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION FROM THE HOSPITAL; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7010092 ↗
• MalfunctionSep 1, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS RETRACTED. UPON RETRACTION, THE PHYSICIAN STILL FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE, AND THEN FLUSHED TO REMOVE THE RUBY COIL. THE SAME MICROCATHETER WAS REINSERTED, AND THEN THIS OCCURRED AGAIN WITH A SECOND RUBY COIL, BEFORE A THIRD RUBY COIL WAS SUCCESSFULLY PLACED. A POD5 WAS SUCCESSFULLY PLACED, AND THEN THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A POD PACKING COIL (PODJ) THROUGH THE MICROCATHETER. THE PODJ WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A SHORTER PODJ 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 6839027 ↗
• MalfunctionSep 1, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL WAS RETRACTED. UPON RETRACTION, THE PHYSICIAN STILL FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE, AND THEN FLUSHED TO REMOVE THE RUBY COIL. THE SAME MICROCATHETER WAS REINSERTED, AND THEN THIS OCCURRED AGAIN WITH A SECOND RUBY COIL, BEFORE A THIRD RUBY COIL WAS SUCCESSFULLY PLACED. A POD5 WAS SUCCESSFULLY PLACED, AND THEN THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A POD PACKING COIL (PODJ) THROUGH THE MICROCATHETER. THE PODJ WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A SHORTER PODJ 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 6839024 ↗
• MalfunctionSep 1, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A PSEUDO-ANEURYSM IN BUTTOCKS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE FIVE RUBY COILS THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS THROUGH THE LANTERN; THEREFORE THE RUBY COILS AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS AND AN ADDITIONAL RUBY COIL. IN ADDITION, THERE WAS NO NOTED DAMAGE ON THE LANTERN AFTER REMOVAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6838289 ↗