RUBY Coil RBY2C0930-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI M424RBY2C09300), received between Sep 23, 2015 and Oct 22, 2020 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA DIAGNOSTIC CATHETER AND A NON-PENUMBRA VASCULAR PLUG. DURING THE PROCEDURE, THE PHYSICIAN PLACED A VASCULAR PLUG IN THE TARGET VESSEL BUT THERE WAS STILL A LOT OF FLOW COMING INTO THE SUBCLAVIAN ARTERY. THEREFORE, THE PHYSICIAN DECIDED TO PLACE A RUBY COIL. WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL, THE RUBY COIL WOULD NOT SEAT IN THE VESSEL AS THERE WAS A LOT OF FLOW COMING THROUGH THE VESSEL. IT WAS REPORTED THAT AFTER PULLING THE RUBY COIL IN AND OUT OF THE VESSEL NUMEROUS TIMES, THE RUBY COIL APPEARED TO BE BUCKLING INSIDE THE LANTERN. ATTEMPTS WERE ALSO MADE TO RAPIDLY SEAT THE RUBY COIL, BUT IT WAS UNSUCCESSFUL. SUBSEQUENTLY, PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. HOWEVER, WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED THAT IT HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN AND THE DIAGNOSTIC CATHETER WERE REMOVED WITH THE DETACHED RUBY COIL. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WILL BE BROUGHT BACK FOR THORACIC ENDOGRAFT AN

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10722941 ↗
• MalfunctionOct 16, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A RUBY COIL, A POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN AND THE DIAGNOSTIC CATHETER WERE REMOVED WITH THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A POD COIL, THE SAME DIAGNOSTIC CATHETER AND ANOTHER 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 10690646 ↗
• MalfunctionSep 17, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD PACKING COILS (PODJS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THREE RUBY COILS AND A PODJ SEPARATELY THROUGH THE PROXIMAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS AND PODJ BECAME STUCK. THEREFORE, THE RUBY COILS AND PODJ WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 10546240 ↗
• MalfunctionJul 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY THREE CENTIMETERS OF THE RUBY COIL THROUGH THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE HOSPITAL TECHNICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER; THE SAME ISSUE OCCURRED. THE RUBY COIL WAS THEREFORE REMOVED. IT WAS ALSO REPORTED THAT THE HOSPITAL TECHNICIAN RE-ATTEMPTED TO ADVANCE BOTH RUBY COILS ON THE BACK TABLE; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347750 ↗
• MalfunctionAug 28, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS THEN COMPLETED USING OTHER 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 8940759 ↗
• MalfunctionAug 28, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS THEN COMPLETED USING OTHER 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 8940750 ↗
• MalfunctionJan 4, 2019Separation 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 WAS UNABLE TO DETACH THE RUBY COIL USING THE HANDLE. THE RUBY COIL AND HANDLE WERE THEREFORE REMOVED AND WERE NOT USED IN THE PROCEDURE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8218474 ↗
• MalfunctionSep 12, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL THROUGH THE MICROCATHETER, DESPITE ATTEMPTING MULTIPLE TIMES. THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS 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 7869534 ↗
• MalfunctionMar 8, 2018Detachment Of Device Component; Retraction Problem; Failure to Advance; Detachment Of Device Component; Retraction Problem; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC ARTERY (AAA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN WAS THEN UNABLE TO ADVANCE A RUBY COIL THROUGH THE LANTERN, AND DURING AN ATTEMPT TO RETRACT THE RUBY COIL,IT UNINTENTIONALLY DETACHED WHILE PARTIALLY ADVANCED INTO THE LANTERN. THE PHYSICIAN THEREFORE PULLED THE DETACHED RUBY COIL OUT OF THE LANTERN. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY WHILE ADVANCING ANOTHER RUBY COIL THROUGH ITS INTRODUCER SHEATH, AND AFTER MULTIPLE FAILED ATTEMPTS TO ADVANCE, THE RUBY COIL INTRODUCER SHEATH WAS REMOVED FROM THE LANTERN. 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 7325846 ↗
• MalfunctionFeb 22, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING RUBY COILS AND POD6. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL BETWEEN THE ARTERIAL AND VENOUS CONNECTION IN A FIGURE 8 FASHION USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN AGGRESSIVELY APPLIED FORWARD TENSION ON THE LANTERN AND MOVED THE COIL IN AND OUT THE TREATMENT SITE. CONSEQUENTLY, THE PUSHER ASSEMBLY PET LOCK BECAME DAMAGED AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN ATTACHED A SYRINGE TO THE BACK OF THE LANTERN AND PULLED NEGATIVE PRESSURE BACK. THUS, THE DETACHED COIL WAS ASPIRATED OUT. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL AND POD6. BOTH COILS WERE ALSO ASPIRATED OUT AFTER THE UNINTENTIONAL DETACHMENT AND THE LANTERN REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. IT SHOULD BE NOTED THAT THERE WAS NO NOTED DAMAGE OR ISSUE WITH THE INITIAL LANTERN. THE PHYSICIAN JUST WANTED TO START FRESH WITH A NEW LANTERN. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7288915 ↗
• MalfunctionJan 16, 2018Physical Resistance; Difficult to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL INTO THE ANEURYSM, THE LANTERN DELIVERY MICROCATHETER (LANTERN) CAME OUT OF THE TARGET VESSEL DUE TO ITS POSITIONING; THEREFORE, THE RUBY COIL WAS REMOVED AND THE LANTERN REPOSITIONED. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING APPROXIMATELY ONE THIRD OF THE COIL INTO THE LANTERN; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7197777 ↗
• MalfunctionJul 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD8'S AND RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD8 AND TWO RUBY COILS OUT OF THEIR INTRODUCER SHEATHS AND INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE TECHNOLOGIST ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS OUT OF THEIR INTRODUCER SHEATHS. THEREFORE, THE POD8 AND RUBY COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6704512 ↗
• MalfunctionMar 16, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A "FAILURE OF INSTALLATION" OCCURRED WITH TWO RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. PLEASE NOTE THAT THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED SINCE THE EVENT OCCURRED IN 2015.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6409786 ↗
• MalfunctionMar 15, 2017Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A POD8 COIL PUSHER ASSEMBLY WAS BROKEN UPON REMOVAL FROM ITS DISPENSER HOOP. THEREFORE, THE POD8 COIL WAS SET ASIDE. THE PHYSICIAN THEN OPENED A RUBY COIL FOR THE PROCEDURE; HOWEVER, THE COIL WAS ACCIDENTALLY DROPPED ON THE FLOOR. THE BROKEN POD8 COIL PUSHER ASSEMBLY AND DROPPED RUBY COIL WERE FOUND PRIOR TO USE AND THEREFORE, THE POD8 COIL AND RUBY COIL WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6407091 ↗
• MalfunctionFeb 24, 2017Bent; Device Handling Problem; Bent; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE TECHNOLOGIST INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY WHILE REMOVING THE RUBY COIL FROM ITS DISPENSER HOOP. THE RUBY COIL PUSHER ASSEMBLY BECAME BENT PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6358884 ↗
• MalfunctionNov 21, 2016Separation Failure; Physical Resistance; Separation Failure; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, UPON REMOVING THE FIRST RUBY COIL FROM ITS PACKAGING, THE PHYSICIAN NOTICED IT WAS KINKED; THEREFORE, IT WAS NOT USED FOR THE PROCEDURE. THEREAFTER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A NEW RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THE RUBY COIL WAS UNABLE TO DETACH ONCE IN THE ANEURYSM. THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN WHILE RETRACTING THIS RUBY COIL. THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND A NEW RUBY COIL. THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE AND MAINTAINING CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6119027 ↗
• MalfunctionNov 21, 2016Bent; Physical Resistance; Device Handling Problem; Bent; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A RIGHT HYPOGASTRIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING 1/3 OF THE RUBY COIL OUT OF THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN BENT THE COIL PUSHER ASSEMBLY; THEREFORE, THE ENTIRE RUBY COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER¿S COILS AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND USED CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118881 ↗
• MalfunctionJul 26, 2016Failure to Advance; Physical Resistance; 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 DEPLOYED A RUBY COIL INTO THE ANEURYSM USING A LANTERN DELIVERY MICROCATHETER (LANTERN) BUT THOUGHT THAT THE COIL WAS UNDERSIZED AND DECIDED TO RESHEATH THE COIL. WHILE THE PHYSICIAN WAS RESHEATHING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN DID NOT MENTION ANY RESISTANCE WHILE ATTEMPTING TO RESHEATH THE COIL. THE ENTIRE LANTERN CONTAINING THE DETACHED COIL WAS THEN REMOVED. NEXT, A NEW LANTERN WAS OPENED AND ADVANCED INTO THE PATIENT. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE NEW LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED INTACT AND ANOTHER MANUFACTURER'S COIL WAS PLACED IN THE ANEURYSM. AFTER PLACING THE OTHER MANUFACTURER'S COIL, THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE BY DEPLOYING AND DETACHING THREE NEW RUBY COILS USING THE SECOND LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT HAVE A CONTINUOUS FLUSH AND WAS NOT USING A ROTATING HEMOSTASIS VALVE (RHV). HOWEVER, THE PHYSICIAN DID FLUSH BEFORE AND AFTER EVERY COIL. ADDITIONALLY,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5823540 ↗
• MalfunctionMar 9, 2016Contamination; Use of Device Problem; Contamination; Use of Device Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, TWO RUBY COILS TOUCHED A NON-STERILE ITEM AFTER THE HOSPITAL TECHNOLOGIST REMOVED THE COILS FROM THEIR DISPENSER HOOP. THE RUBY COILS BECAME NON-STERILE PRIOR TO USE AND THEREFORE, THEY WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 5491192 ↗
• MalfunctionMar 9, 2016Contamination; Use of Device Problem; Contamination; Use of Device Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, TWO RUBY COILS TOUCHED A NON-STERILE ITEM AFTER THE HOSPITAL TECHNOLOGIST REMOVED THE COILS FROM THEIR DISPENSER HOOP. THE RUBY COILS BECAME NON-STERILE PRIOR TO USE AND THEREFORE, THEY WERE NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 5490706 ↗
• MalfunctionNov 23, 2015Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A RUBY COIL THROUGH THE HUB OF ANOTHER MANUFACTURER'S MICROCATHETER AND 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 5244571 ↗
• MalfunctionSep 23, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS IN THE SPLENIC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE ATTEMPTING TO ADVANCE FIVE DIFFERENT RUBY COILS THROUGH ANOTHER MANUFACTURER'S MICROCATHETER AND WAS UNABLE TO DEPLOY THE RUBY COILS. THE RUBY COILS WERE REMOVED AND NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5098224 ↗