RUBY Coil RBY4C1650-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI M424RBY4C16500), received between Sep 18, 2015 and Nov 10, 2021 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (19 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PC), A NEW HANDLE, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS IN THE TARGET VESSEL USING THE HANDLE AND MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL, THE COIL WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER RUBY COIL AND FOUR POD PCS IN THE TARGET VESSEL USING THE HANDLE AND MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED ANOTHER POD PC TO THE TARGET VESSEL USING THE MICROCATHETER; HOWEVER, THE POD PC WAS DETERMINED TO BE TOO LONG. THEREFORE, THE POD PC WAS REMOVED INTACT. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER POD PC IN THE TARGET VESSEL USING THE SAME HANDLE AND MICROCATHETER. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12784222 ↗
• MalfunctionSep 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE MICROCATHETER. THEREFORE, BOTH RUBY COILS WAS REMOVED. 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 12474501 ↗
• MalfunctionSep 14, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE MICROCATHETER. THEREFORE, BOTH RUBY COILS WAS REMOVED. 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 12471166 ↗
• MalfunctionJul 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL ARTERY AND THE ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED FROM THE MICROCATHETER USING A GUIDEWIRE. NEXT, WHILE ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK AND SUBSEQUENTLY UNINTENTIONALLY DETACHED IN THE MICROCATHETER, WITH APPROXIMATELY HALF OF A CENTIMETER OF THE RUBY COIL IN THE PATIENT. THEREFORE, THE DETACHED RUBY COIL WAS REMOVED FROM THE MICROCATHETER USING THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A LIQUID EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207915 ↗
• MalfunctionFeb 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE TIP OF THE MICROCATHETER. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11287073 ↗
• MalfunctionJan 15, 2021Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE COILS IN THE VENOUS SACK OF THE AVM USING THE CATHETER. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING ANOTHER RUBY COIL APPROXIMATELY FOUR CENTIMETERS WITHIN THE INTRODUCER SHEATH AND THE RUBY COIL WOULD NOT ADVANCE. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS 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 11179933 ↗
• MalfunctionNov 13, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COILS WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATHS, AND THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 10840743 ↗
• MalfunctionNov 5, 2020Physical 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 PLACED A RUBY COIL INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE RUBY COIL. WHILE RETRACTING THE RUBY COIL TO REPOSITION IT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED ALL DEVICES FROM THE PATIENT AND THEN REMOVED THE RUBY COIL FROM THE LANTERN. THE PHYSICIAN THEN PLACED TWO RUBY COILS INTO THE ANEURYSM USING THE LANTERN. WHILE IMPLANTING THE LAST RUBY COIL (F93620) INSIDE THE ANEURYSM, THE RUBY COIL UNINTENTIONALLY DETACHED AND SUBSEQUENTLY, PART OF THE RUBY COIL WAS IN THE RENAL ARTERY. THEREFORE, THE PHYSICIAN PLACED A STENT TO HOLD PART OF THE RUBY COIL WITHIN THE VESSEL WALL. 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; No Consequences Or Impact To Patient

  MAUDE report 10792333 ↗
• MalfunctionOct 15, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICOCELE VEIN USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL INTO THE MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL WAS REMOVED FROM THE MICROCATHETER AND WAS UNABLE TO BE RE-SHEATHED ON THE BACK TABLE. 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; No Consequences Or Impact To Patient

  MAUDE report 10682824 ↗
• MalfunctionJul 28, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS, POD PACKING COILS (POD PCS), A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO IMPLANT A POD PC, THE SAME ISSUE OCCURRED. THEREFORE, THE POD PC AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME HANDLE 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 10336047 ↗
• MalfunctionJun 11, 2020Material 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, PHYSICIAN SUCCESSFULLY IMPLANTED SEVEN RUBY COILS. WHILE INTRODUCING THE NEXT RUBY COIL INTO THE LANTERN, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. THE RUBY COIL WAS RE-SHEATHED AND REMOVED WITHOUT INCIDENT. 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 10146098 ↗
• MalfunctionMay 28, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN; THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS 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 10099637 ↗
• MalfunctionJan 24, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DIAGNOSTIC CATHETER AND THE LANTERN IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO ADDITIONAL RUBY COILS THROUGH THE LANTERN, HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN THEN REMOVED THE DIAGNOSTIC CATHETER AND LANTERN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 9628942 ↗
• MalfunctionNov 11, 2019Material 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 RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN REPORTED THAT THE RUBY COIL WAS NOT ADVANCING SMOOTHLY. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT, AND WHILE PULLING BACK AND ADVANCING THE RUBY COIL, THE PHYSICIAN FELT THE RUBY COIL UNINTENTIONALLY DETACH IN THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO FLUSH IT USING A 3CC SYRINGE, BUT IT WOULD NOT ADVANCE FURTHER. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. AFTER REMOVAL, THE DISTAL END OF RUBY COIL WAS NOTICED TO BE DAMAGED. THE PHYSICIAN THEN CONTINUED THE PROCEDURE USING ADDITIONAL RUBY COILS. WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK IN THE AORTIC PORTION OF THE LANTERN. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT, AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN WHEN THE PHYSICIAN WAS PULLING BACK AND ADVANCING THE RUBY COIL. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307112 ↗
• MalfunctionMay 16, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL WITHIN A LANTERN DELIVERY MICROCATHETER (LANTERN), HOWEVER, THE COIL DID NOT APPEAR TO BE MOVING UNDER FLUOROSCOPY. THEREFORE, THE PHYSICIAN RETRACTED THE RUBY COIL AND FOUND THAT THE COIL HAD UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN NOTICED THAT THE LANTERN HAD RETRACTED BACK INTO THE NON-PENUMBRA GUIDE CATHETER. THE PHYSICIAN REMOVED THE CATHETER WITH THE LANTERN AND RUBY COIL INSIDE, AND THEN RE-INSERTED THE SAME CATHETER AND SAME LANTERN. A NEW RUBY COIL WAS THEN SUCCESSFULLY PLACED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL INTO THE LANTERN, HOWEVER, THE PHYSICIAN FELT RESISTANCE AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED WHILE LOADING THE COIL INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS 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 8615398 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY AND THE AORTA USING POD5S AND RUBY COILS. DURING THE PROCEDURE, THE FELLOW ACCIDENTALLY DROPPED A POD5 ON THE FLOOR WHILE REMOVING IT FROM THE PACKAGING HOOP. THE POD5 WAS DROPPED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS THEN CONTINUED USING A NEW POD5. THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE FELLOW THEN ACCIDENTALLY KINKED A RUBY COIL (F83494) WHILE REMOVING IT FROM THE PACKAGING HOOP. THE PHYSICIAN STILL ATTEMPTED TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, HOWEVER, WAS UNABLE TO. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED. THROUGHOUT THE REMAINDER OF THE PROCEDURE, THREE MORE RUBY COILS WERE INADVERTENTLY KINKED UPON REMOVAL FROM THEIR PACKAGING HOOPS AND, THEREFORE, NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8575028 ↗
• MalfunctionMar 21, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING RUBY COILS, THE RUBY COIL PUSHER WIRE BECAME BENT UPON REMOVAL FROM THE PACKAGING. THE RUBY COIL WAS, THEREFORE, NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8440665 ↗
• MalfunctionFeb 20, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS INTO A NON-PENUMBRA MICROCATHETER, THE RUBY COILS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATH; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356618 ↗
• MalfunctionFeb 20, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS INTO A NON-PENUMBRA MICROCATHETER, THE RUBY COILS WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATH; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356617 ↗
• MalfunctionDec 20, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL FOR REPOSITIONING. HOWEVER, UPON RETRACTION AND REDEPLOYMENT, THE RUBY COIL GOT "HUNG UP" AND SUBSEQUENTLY, UNINTENTIONALLY DETACHED WITH APPROXIMATELY HALF OF THE RUBY COIL IN THE LANTERN AND THE OTHER HALF IN THE ANEURYSM SAC. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PHYSICIAN THEN PERFORMED A SCAN AND NOTICED THAT THE ANEURYSM WAS COMPLETELY FILLED AND NO ADDITIONAL COIL WAS NEEDED. THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8186482 ↗
• MalfunctionOct 12, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING WAS COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERY PSEUDO ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL OUT OF ITS INTRODUCER INTO THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE. IT WAS REPORTED THAT THERE WAS A HARD STOP AND AFTER THREE FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED. 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 7963297 ↗
• MalfunctionJul 3, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE INTRODUCER SHEATH OF THE RUBY COIL WAS BENT UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE INTRODUCER SHEATH 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 7659498 ↗
• InjuryMay 31, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND STILL TRIED TO ADVANCE THE COIL; CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE PATIENT'S IMA. THE PHYSICIAN THOUGHT THE LANTERN WAS KINKED; HOWEVER, UPON REMOVAL NO KINK WAS OBSERVED ON THE LANTERN. THE MAJORITY OF THE DETACHED RUBY COIL WAS LEFT INSIDE THE IMA; THEREFORE, THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO SNARE THE DETACHED RUBY COIL OUT; HOWEVER, THE PHYSICIAN WAS UNABLE TO. THEREFORE, THE PROCEDURE ENDED AFTER THE PHYSICIAN LOST ACCESS WHILE TRYING TO ADVANCE THE SNARE DEVICE AND NOT BEING ABLE TO REGAIN ACCESS. THE IMA SEEMED PATENT AT THE END OF THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557841 ↗
• MalfunctionMay 18, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE RUBY COIL USING THE LANTERN. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN AND, CONSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THE PHYSICIAN, THEREFORE, REMOVED THE RUBY COIL AND LANTERN AND NOTICED THAT THE PROXIMAL END OF THE LANTERN HAD BECOME KINKED NEAR THE HUB OF THE NON-PENUMBRA CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, THE SAME SHEATH, NEW RUBY COILS, AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527997 ↗
• MalfunctionApr 17, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN MANUALLY FLUSHED THE LANTERN DELIVERY MICROCATHETER (LANTERN), AND THEN ATTEMPTED TO PLACE A RUBY COIL. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL PAST THE MIDDLE OF THE LANTERN. THE RUBY COIL AND LANTERN WERE THEREFORE REMOVED, AND THE PROCEDURE WAS THEN COMPLETED USING THE SAME 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 7437392 ↗