RUBY RBY2C2060-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00814548019284), received between Nov 15, 2018 and Jul 6, 2023 — classified as 1 death, 23 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACIC AORTA AND SUBCLAVIAN ARTERY USING A RUBY COIL, NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE ANGIOGRAPHIC CATHETER WAS ALSO REMOVED. ON THE BACK TABLE, UPON REMOVING THE RUBY COIL FROM THE MICROCATHETER, THE PHYSICIAN FOUND THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17275448 ↗
• MalfunctionJun 23, 2023Physical Resistance/Sticking; Premature Separation; 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), A RUBY COIL, AND A GUIDING CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE GUIDING CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN WOULD NOT ADVANCE PAST TO MID-SHAFT TO DISTAL END OF THE GUIDING CATHETER. THEREFORE, THE LANTERN WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW LANTERN THROUGH THE GUIDING CATHETER AND INTO THE TARGET VESSEL. NEXT, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL BECAME STUCK WITHIN THE MID-SHAFT OF THE LANTERN. WHILE REMOVING THE RUBY COIL BY HAND, THE PHYSICIAN FELT A SENSATION AND NOTICED UNDER FLUOROSCOPY THAT THE RUBY COIL HAD UNRAVELED AND UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED 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 17191085 ↗
• MalfunctionNov 23, 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. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TEN RUBY COILS. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MIDDLE OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, ONE OTHER 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 15854657 ↗
• MalfunctionSep 28, 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, POD PACKING COILS (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL AS THE FIRST COIL IN THE MIDDLE OF THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL; HOWEVER, WHILE RETRACTING, THE PHYSICIAN NOTICED THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN AND PLACED A NEW RUBY COIL IN THE TARGET VESSEL. NEXT, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN IN THE MIDDLE OF LANTERN; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. HOWEVER, UPON RETRACTING, THE POD PC HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW POD PC, THREE NON-PENUMBRA 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 15495973 ↗
• MalfunctionMar 18, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN FELT AN ISSUE WITH THE RUBY COIL AND ITS PUSHER ASSEMBLY AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL OF THE RUBY COIL, THE MICROCATHETER KICKED BACK AND SUBSEQUENTLY, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 13804865 ↗
• MalfunctionOct 19, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING EIGHT RUBY COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661727 ↗
• MalfunctionOct 19, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VENOUS-VARIX USING RUBY COILS. DURING THE PROCEDURE, THE OPERATOR KINKED THE PUSHER ASSEMBLY OF A RUBY COIL. IT WAS REPORTED THEY WERE UNABLE TO FULLY REMOVE THE INTRODUCER SHEATH FROM THE COIL SYSTEM. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661651 ↗
• MalfunctionJun 15, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD COILS, A RUBY COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING THE POD COIL APPROXIMATELY HALFWAY INTO THE LANTERN, THE HOSPITAL TECHNICIAN KINKED THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. NEXT, THE HOSPITAL TECHNICIAN INSERTED A RUBY COIL INTO THE LANTERN; HOWEVER, AFTER ADVANCING THE RUBY COIL APPROXIMATELY HALFWAY INTO THE LANTERN, THE SAME ISSUE OCCURRED. THE HOSPITAL TECHNICIAN KINKED THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW POD COILS AND POD PACKING COILS ALONG WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005584 ↗
• MalfunctionJun 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC VEIN USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WAS STUCK IN THE STARTING POSITION AND WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THEREFORE, IT 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 11921987 ↗
• MalfunctionMay 27, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY 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 THE RUBY COIL WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN RETRACTED AND READVANCED THE RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED TWO MORE TIMES. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL WOULD NOT ADVANCE ANY FURTHER. THE PHYSICIAN THEN RETRACTED AND READVANCED THE RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS ALSO 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 11895148 ↗
• MalfunctionJul 23, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL INTO THE ANEURYSM, THE MICROCATHETER BACKED OUT OF THE ANEURYSM. THEREFORE, THE RUBY COIL WAS RETRIEVED AND THE MICROCATHETER WAS RE-ADVANCED. WHILE RE-INTRODUCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317793 ↗
• MalfunctionJul 8, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD PACKING COIL (POD PC), RUBY COILS, AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD10 OUTFLOW OF THE ANEURYSM; HOWEVER, THE COIL WAS TOO LARGE FOR THE VESSEL. THEREFORE, THE POD10 WAS REMOVED AND THE PHYSICIAN SUCCESSFULLY PLACED A POD8. NEXT, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND, THEREFORE, THE POD PC WAS REMOVED, AND A NEW POD PC WAS PLACED IN THE VESSEL. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN; THEREFORE, THE PHYSICIAN RE-SHEATHED THE RUBY COIL AND TRIED TO ADVANCE THE SAME RUBY COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE LANTERN WAS FLUSHED AFTER EACH TIME A COIL WAS DELIVERED AND THERE WAS NO NOTICEABLE DAMAGE TO THE PUSHER ASSEMBLY TO THE POD10, POD PC AND, RUBY COIL WERE NOT KINKED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL POD COILS, POD PCS, 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 10248656 ↗
• MalfunctionJan 24, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE I ENDOLEAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL THROUGH THE LANTERN INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE RESULT. THEREFORE, THE RUBY COIL WAS RETRACTED, RE-SHEATHED AND PLACED IN A BOWL OF HEPARINIZED SALINE. LATER IN THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO REUSE THE PREVIOUSLY REMOVED RUBY COIL AND NOTICED THAT THE RUBY COIL WAS KINKED; THEREFORE THE RUBY COIL WAS NOT USED. NEXT, A NEW RUBY COIL WAS PLACED SUCCESSFULLY. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL IN THE TARGET VESSEL BUT DECIDED TO REPOSITION THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED, RE-SHEATHED AND RINSED IN SALINE. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED AND NOT USED. 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 9625512 ↗
• MalfunctionJan 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, A RUBY COIL WAS ADVANCED INTO THE LANTERN AND BECAME STUCK. THE RUBY COIL WAS THEN REMOVED. ANOTHER RUBY COIL WAS THEN ADVANCED INTO LANTERN AND THE SAME ISSUE OCCURRED. THIS RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ELEVEN OTHER PENUMBRA COILS USING THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560018 ↗
• MalfunctionJan 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS SLIGHTLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, A RUBY COIL WAS ADVANCED INTO THE LANTERN AND BECAME STUCK. THE RUBY COIL WAS THEN REMOVED. ANOTHER RUBY COIL WAS THEN ADVANCED INTO LANTERN AND BECAME STUCK IN THE SAME LOCATION. THIS RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ELEVEN 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 9560015 ↗
• MalfunctionDec 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER AND ENCOUNTERED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL PUSHER WIRE BECAME KINKED. THEREFORE, THE RUBY COIL WAS 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 9454547 ↗
• MalfunctionJul 31, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM, USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING 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 8848741 ↗
• MalfunctionMay 31, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE DISTAL END OF THE LANTERN AND EXPERIENCED RESISTANCE. THE RUBY COIL WAS THEN RETRACTED AND RE-ADVANCED WITHIN THE LANTERN, HOWEVER, RESISTANCE WAS EXPERIENCED WHEN RETRACTING AND RE-ADVANCING NEAR THE DISTAL END OF THE LANTERN. SUBSEQUENTLY, THE RUBY COIL BECAME STUCK INSIDE THE LANTERN. AN ATTEMPT WAS MADE TO REMOVE THE RUBY COIL FROM THE LANTERN, BUT THE RUBY COIL WAS STARTING TO BECOME DAMAGED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND LANTERN TOGETHER FROM THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THE LANTERN WAS STRETCHED AND POSSIBLY KINKED AT THE DISTAL END. THE RUBY COIL WAS THEN REMOVED FROM THE LANTERN AND WAS FOUND TO BE STRETCHED. BOTH DEVICES WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 8659134 ↗
• MalfunctionMay 2, 2019Device Damaged Prior to Use; Failure to Advance; Material Deformation; Device Damaged Prior to Use; Failure to Advance; 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 8575071 ↗
• MalfunctionMar 20, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A MEDICAL PROCEDURE USING RUBY COILS, THE 20X60 RUBY COIL BECAME KINKED UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE 20X60 RUBY COIL WAS FOUND PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8436860 ↗
• MalfunctionMar 7, 2019Positioning Failure; Physical Resistance/Sticking; Positioning Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A RUBY COIL, HOWEVER, THE COIL WOULD NOT HOLD ITS POSITION DUE TO THE HIGH FLOW OF THE VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A NEW RUBY COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN ATTEMPTED TO REUSE THE FIRST RUBY COIL, HOWEVER FELT RESISTANCE ADVANCING THE RUBY COIL INTO THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. A NEW RUBY COIL WAS THEN ADVANCED INTO THE TARGET LOCATION; HOWEVER, IT WOULD NOT SAFELY HOLD ITS POSITION DUE TO THE HIGH FLOW IN THE VESSEL AND, THEREFORE, THE COIL WAS REMOVED. THE PHYSICIAN THEN DID A CONTRAST INJECTION AND DECIDED TO END THE PROCEDURE BECAUSE THE EXISTING EMBOLIZATION WAS SUFFICIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402107 ↗
• DeathMar 1, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD14 AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A GUIDEWIRE INTO THE PROXIMAL PORTION OF THE TARGET VESSEL FOLLOWED BY A NON-PENUMBRA GUIDE CATHETER. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA MICROCATHETER OVER THE GUIDEWIRE INTO THE TARGET LOCATION, DISTAL TO THE PSEUDOANEURYSM, AND BEGAN EMBOLIZATION. WHILE ADVANCING A POD14 INTO THE TARGET VESSEL, THE POD14 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE POD14 WAS UNABLE TO BE RETRIEVED FROM THE MICROCATHETER; THEREFORE, THE MICROCATHETER WAS REMOVED. THE POD14 REMAINED PARTIALLY IN THE GUIDE CATHETER AND PARTIALLY IN THE SPLENIC ARTERY BEYOND THE PSEUDOANEURYSM. THE POD14 WAS RETRIEVED FROM WITHIN THE GUIDING CATHETER USING A SNARE DEVICE AND WAS REMOVED INTACT. AFTER RE-ACCESSING THE TARGET VESSEL, THE PHYSICIAN PERFORMED ARTERIOGRAPHY DEMONSTRATING EXTRAVASATION OF CONTRAST ORIGINATING FROM A RUPTURED PROXIMAL SPLENIC ARTERIAL PSEUDOANEURYSM. THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS RESULTING IN PROFOUND HEMODYNAMIC INSTABILITY, AND HAD NO PULSE. CARDIAC LIFE SUPPORT AND MULTIPLE BLOOD TRANSFUSIONS WERE PERF

  Patient problems: Blood Loss; Cardiac Arrest; Death

  MAUDE report 8381056 ↗
• MalfunctionFeb 22, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR PANCREATICODUODENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS AND OTHER COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW RUBY COIL INTO THE TARGET VESSEL AS THE FINAL COIL, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE ANEURYSM DUE TO THE DENSITY OF THE ALREADY PLACED COILS. THE PHYSICIAN THEN DECIDED TO REMOVE THE RUBY COIL; HOWEVER, WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE RUBY COIL AND THE PROCEDURE WAS ENDED, AS THE PHYSICIAN WAS SATISFIED WITH THE AMOUNT OF COILS ALREADY PLACED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362949 ↗
• MalfunctionNov 15, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE ANOTHER RUBY COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074154 ↗