RUBY Coil RBY4C0835-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00814548018386), received between Mar 22, 2019 and Dec 5, 2025 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (17 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT LOBE OF THE LIVER USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE RUBY COIL WAS PARTIALLY PLACED IN THE TARGET LOCATION WHEN THE COIL UNINTENTIONALLY DETACHED. THE MICROCATHETER WAS RETRACTED SUCH THAT THE RUBY COIL WAS SITUATED INSIDE THE DIAGNOSTIC CATHETER. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL OUT OF THE DIAGNOSTIC CATHETER USING A GUIDEWIRE, BUT WAS UNSUCCESSFUL. WHILE REMOVING THE DIAGNOSTIC CATHETER, THE RUBY COIL FRACTURED. THE PHYSICIAN WAS ABLE TO REMOVE MOST OF THE FRACTURED COIL FROM THE DIAGNOSTIC CATHETER BY HAND. THE REMAINING PORTION OF THE FRACTURED COIL WAS LEFT IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726313 ↗
• MalfunctionApr 21, 2025Failure to Fold; Physical Resistance/Sticking; Premature Separation; Failure to Fold; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A 4F CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL THROUGH THE MID-SHAFT OF THE LANTERN. DESPITE THE RESISTANCE, THE PHYSICIAN WAS ABLE TO ADVANCE THE RUBY COIL INTO THE TARGET VESSEL; HOWEVER, THE RUBY COIL WAS NOT TAKING ITS INTENDED SHAPE. AFTER MULTIPLE ATTEMPTS TO RETRACT THE RUBY COIL, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN AND THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT, AND THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, FIVE POD PACKING COILS 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 21878383 ↗
• MalfunctionJul 15, 2024Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A RUBY COIL. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER APPLYING PRESSURE TO THE PUSHER ASSEMBLY OF THE RUBY COIL, THE PUSHER ASSEMBLY FRACTURED WITHIN THE MID-SHAFT OF THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN AND AFTER IT WAS FLUSHED OUT, THE RUBY COIL WAS FOUND TO BE UNINTENTIONALLY DETACHED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL 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 19746231 ↗
• MalfunctionMar 26, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS, A PACKING COIL (PC), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS AND ONE PC INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE PROXIMAL LENGTH OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE ANY FURTHER. WHILE ATTEMPTING TO REMOVE THE RUBY COIL, 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. 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 18984110 ↗
• MalfunctionDec 26, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PC), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS AND TWO POD PCS IN TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT THE GUIDEWIRE WAS EXTENDED PAST THE TARGET VESSEL FOR SUPPORT. WHEN THE PHYSICIAN BEGAN TO REMOVE THE GUIDEWIRE, ALL OF THE PREVIOUSLY PLACED COILS THAT WERE IMPLANTED MIGRATED TO THE MAIN SPLENIC ARTERY. AFTER PERFORMING AN ANGIOGRAM, THE PHYSICIAN DECIDED TO LEAVE THE COILS IN THE MAIN SPLENIC ARTERY. THE PROCEDURE HAD 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 18393354 ↗
• MalfunctionDec 29, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE MIDDLE OF THE LANTERN. THE PHYSICIAN CONTINUED TO ADVANCE THE RUBY COIL AGAINST RESISTANCE AND KINKED THE PUSHER WIRE. WHILE ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE COIL DID NOT FOLLOW THE PUSHER WIRE AND REPORTED THAT IT WAS UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, A SYRINGE WAS CONNECTED TO THE LANTERN CONTAINING THE DETACHED RUBY COIL. THE DEVICES WERE REMOVED TOGETHER WHILE NEGATIVE PRESSURE WAS APPLIED VIA THE SYRINGE. THE LANTERN WAS THEN FLUSHED AND RE-INSERTED INTO THE TARGET SITE. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER RUBY COIL OF THE SAME SIZE, AND FOUR ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075122 ↗
• MalfunctionDec 1, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE COIL WITH THE HANDLE; HOWEVER, THE RUBY COIL DID NOT DETACH AFTER THREE ATTEMPTS. THEREFORE, THE HANDLE WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT APPROXIMATELY TWENTY CENTIMETERS OF THE RUBY COIL REMAINED INSIDE THE TARGET VESSEL WHEN THE COIL DETACHED. THE PHYSICIAN DECIDED TO FLUSH THE RUBY COIL OUT OF THE MICROCATHETER AND INADVERTENTLY OCCLUDED A NON-TARGET VESSEL. THE PHYSICIAN USED ANOTHER RUBY COIL TO PUSH THE PREVIOUS RUBY COIL INTO THE TARGET VESSEL, AND A STENT GRAFT WAS PLACED OVER THE RUBY COILS. THE PROCEDURE WAS COMPLETED USING ONE RUBY COIL, FOUR POD PACKING COILS (POD PCS), A NEW HANDLE, 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 15899614 ↗
• MalfunctionSep 16, 2022Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GUIDE CATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL INTO THE TARGET LOCATION AND REPORTED THAT IT WAS NOT TAKING THE DESIRED SHAPE. THE PHYSICIAN ADVANCED AND RETRACTED THE PUSHER WIRE FOUR TO FIVE TIMES; HOWEVER, THE RUBY COIL DID NOT TRACK WITH THE PUSHER WIRE. THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED AND THE PHYSICIAN CONFIRMED THAT THE COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE RUBY COIL WAS FLUSHED OUT OF THE LANTERN ON THE BACK TABLE. WHILE ADVANCING THE NEXT RUBY COIL INTO THE TARGET VESSEL, THE COIL DID NOT TAKE THE DESIRED SHAPE. THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL AND NOTICED THAT THE COIL DID NOT TRACK WITH THE PUSHER WIRE. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED AND THE RUBY COIL WAS UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440711 ↗
• MalfunctionAug 29, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL APPROXIMATELY FORTY CENTIMETERS THROUGH THE MICROCATHETER AGAINST RESISTANCE AND, SUBSEQUENTLY, THE COIL BECAME STUCK. UPON RETRIEVAL, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. IT WAS NOTED THAT THE RUBY COIL PUSHER WIRE WAS BROKEN APPROXIMATELY 755 MM FROM THE DISTAL END AND THE INTRODUCER TIP WAS SLIGHTLY OVALIZED; HOWEVER, IT IS UNKNOWN WHEN THIS OCCURRED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER TO SUCCESSFULLY IMPLANT TEN NON-PENUMBRA COILS AND SIX POD PACKING COILS (POD PCS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311282 ↗
• MalfunctionMay 31, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) USING RUBY COILS, POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). 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 AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN THEN ADVANCED THE SAME LANTERN AND PLACED ANOTHER RUBY COIL IN THE TARGET LOCATION SUCCESSFULLY. NEXT, WHILE ADVANCING THE POD COIL INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE; THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 14547722 ↗
• MalfunctionApr 28, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AS SOON AS THE FIRST RUBY COIL WAS ADVANCED INTO THE MICROCATHETER AND CONTINUED TO EXPERIENCE RESISTANCE WHILE ADVANCING THE RUBY COIL TO THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL, AND UPON REMOVAL, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER AND THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ANOTHER RUBY COIL OF THE SAME SIZE, AN ADDITIONAL RUBY COIL, TWO POD PACKING COILS (POD PCS), AND SIX NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246124 ↗
• MalfunctionApr 13, 2022Physical 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. DURING THE PROCEDURE AFTER PLACING MULTIPLE COILS, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL. THE PHYSICIAN DECIDED TO RETRACT THE COIL AND, SUBSEQUENTLY; THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL WAS FOUND AT THE DISTAL END OF THE MICROCATHETER PARTIALLY STICKING OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH THE SAME MICROCATHETER AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107691 ↗
• MalfunctionOct 25, 2021Failure 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 SUBCLAVIAN ARTERY USING RUBY COILS, POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), 6F SHEATH, AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING A RUBY COIL FROM THE DISTAL TIP OF THE LANTERN TO THE TARGET LOCATION. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK, AND THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. HOWEVER, WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. IT WAS ALSO REPORTED THAT THE LANTERN WAS FLUSHED ON THE BACK TABLE. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN AND WHILE ADVANCING A POD COIL THROUGH THE MIDDLE OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND, THE POD COIL BECAME STUCK. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING POD PACKING COILS (POD PC), OTHER COILS, 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 12694323 ↗
• MalfunctionAug 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A 4.5F NON-PENUMBRA PARENT CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL OVER THE ROTATING HEMOSTASIS VALVE (RHV) OF THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE RUBY COILS, TWO POD PACKING COILS (POD PCS), THREE OTHER COILS, THE SAME RHV, ANOTHER MICROCATHETER, THE SAME CATHETER, AND THE SAME PARENT CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257625 ↗
• MalfunctionJul 30, 2021Failure 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 LEFT GONADAL VEIN USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED FOUR RUBY COILS INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL OUT OF THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED SOME RESISTANCE AND COULD NOT ADVANCE THE COIL FURTHER. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME BENT. THEREFORE, THE RUBY COIL 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 12252121 ↗
• MalfunctionMay 10, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A POD COIL IN THE TARGET VESSEL AND DECIDED TO USE A RUBY COIL AS THE SECOND COIL. THE LANTERN WAS FLUSHED, AND THE COIL WAS LOADED INTO THE LANTERN. AFTER PLACING THE RUBY COIL IN THE TARGET VESSEL, THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL USING THE HANDLE. THE TECHNOLOGIST CHECKED THE MARKERS ON THE PROXIMAL PORTION OF THE PUSHER ASSEMBLY AND NOTICED WHAT LOOKED LIKE FULL SEPARATION. THE PHYSICIAN THEN STEPPED ON FLUOROSCOPY AND STARTED TO REMOVE THE PUSHER ASSEMBLY. HOWEVER, THE RUBY COIL WAS NOT DETACHED. THE HOSPITAL TECHNOLOGIST THEN ATTEMPTED TO DETACH THE RUBY COIL BY HAND, CHECKING THE SEPARATION BETWEEN THE TWO MARKERS. THE HOSPITAL TECHNOLOGIST FELT THAT IT WAS ACCURATE SPACE (3CM) AND ATTEMPTED AGAIN, BUT THE RUBY COIL REMAINED ATTACHED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802478 ↗
• MalfunctionApr 7, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING APPROXIMATELY FIVE CENTIMETERS OF A RUBY COIL INTO THE LANTERN, THE RUBY COIL BECAME STUCK. THEREFORE, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11628063 ↗
• MalfunctionMar 8, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT RENAL ANEURYSM USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE PAST ITS INTRODUCER SHEATH; 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 11440394 ↗
• MalfunctionOct 22, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL, LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA COILS, AND NON-PENUMBRA ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE COILS IN THE TARGET VESSEL USING THE ANGIOGRAPHIC CATHETER. NEXT, THE PHYSICIAN INSERTED A RUBY COIL INTO THE LANTERN PRIOR TO INSERTING INTO THE ANGIOGRAPHIC CATHETER. THE LANTERN CONTAINING THE RUBY COIL WAS THEN INSERTED INTO THE ANGIOGRAPHIC CATHETER; HOWEVER, THE LANTERN BECAME STUCK IN THE MIDDLE OF THE ANGIOGRAPHIC CATHETER. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE RUBY COIL OUT FROM THE ANGIOGRAPHIC CATHETER AND THE RUBY COIL HAD DETACHED INSIDE THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN WITH THE SAME ANGIOGRAPHIC CATHETER AND OTHER 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 10722894 ↗
• MalfunctionOct 21, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING POD COILS, RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN INJECTED AN ABSORBABLE GELATIN SPONGE. WHILE ADVANCING THE FIRST POD COIL THROUGH THE MID-SHAFT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE POD COIL WAS REMOVED, AND THE PHYSICIAN IMPLANTED ANOTHER POD COIL. WHILE ADVANCING THE NEXT COIL, A RUBY COIL, THROUGH THE MID-SHAFT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL POD COILS, AND THE SAME 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 10714267 ↗
• MalfunctionSep 17, 2020Physical Resistance/Sticking; Premature Separation; 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 MOVING A RUBY COIL TO MAKE IT FORM, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. SUBSEQUENTLY, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER RUBY COIL AND THE SAME MICROCATHETER. WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AGAIN. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10551371 ↗
• MalfunctionAug 28, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, WHILE RE-ADVANCING THE SAME RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN AND SUBSEQUENTLY, THE LANTERN WENT OUT FROM THE TARGET LOCATION. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10468356 ↗
• MalfunctionAug 19, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL WAS INADVERTENTLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, A POD PACKING 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 10428794 ↗
• MalfunctionJul 17, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING RUBY COILS, POD PACKING COILS AND, LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN NOTICED THE RUBY COIL DID NOT TAKE IT INTENDED SHAPE. IT WAS REPORTED THAT THE PHYSICIAN RETRACTED AND REPOSITIONED THE RUBY COIL MULTIPLE TIMES; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL WAS REMOVED, AND A NEW RUBY COIL WAS SUCCESSFULLY PLACED IN THE VESSEL. NEXT, WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNICIAN NOTICED THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW RUBY COIL. AFTERWARDS, THE HOSPITAL TECHNICIAN REMOVED A POD PC FROM THE PACKAGING HOOP AND FOUND THE DISTAL PART OF THE PUSHER ASSEMBLY TO BE KINKED. THEREFORE, THE POD PC WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN PLACED A NEW POD PC IN THE VESSEL AND WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED RUBY COIL AND THE COI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10291926 ↗
• MalfunctionJul 17, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTIC VALVE USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO VISUALIZE THE DISTAL END OF THE LANTERN AFTER ADVANCING IT THROUGH THE CATHETER AND INTO THE NIDUS OF THE ARTERIOVENOUS MALFORMATION (AVM). AFTER AN UNSUCCESSFUL ATTEMPT TO INJECT CONTRAST THROUGH THE LANTERN, THE PHYSICIAN ATTEMPTED TO DELIVER A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE COIL BECAME STUCK. THE PHYSICIAN THEN DETERMINED THAT THE LANTERN HAD CURLED UP SEVERAL TIMES OVER IN THE NIDUS AND HAD BECOME KINKED, PREVENTING THE RUBY COIL FROM ADVANCING FURTHER THROUGH THE LANTERN. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT. 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 Consequences Or Impact To Patient

  MAUDE report 10287550 ↗