RUBY Coil RBY4C0204-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI M424RBY4C02040), received between Aug 26, 2015 and Jul 3, 2024 — classified as 49 malfunctions.

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

• MalfunctionJul 3, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE COIL INTO THE TARGET LOCATION AND REPORTED THAT THE RUBY COIL WAS UNDERSIZED FOR THE VESSEL. THE PHYSICIAN REMOVED THE RUBY COIL FROM THE PATIENT AND SET IT ASIDE ON THE BACK TABLE. LATER, WHILE ATTEMPTING TO RE-ADVANCE THE SAME RUBY COIL INTO THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY FOUND THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL RUBY COILS 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 19669676 ↗
• MalfunctionAug 10, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED; THEREFORE, IT WAS REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12301282 ↗
• MalfunctionMar 13, 2020Failure 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, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA EMBOLIZATION AGENT (EMBOSPHERES). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER. WHEN THE RUBY COIL WAS PARTIALLY ADVANCED OUT OF THE MICROCATHETER, THE MICROCATHETER WAS KICKED BACK AND THE RUBY COIL DID NOT ADVANCE INTO THE VESSEL. THEREFORE, THE RUBY COIL WAS REMOVED AND EMBOSPHERES WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT CONTINUED TO EXPERIENCE BLEEDING AND WAS BROUGHT BACK THE NEXT DAY FOR ADDITIONAL EMBOLIZATION 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 9832382 ↗
• MalfunctionFeb 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK; THEREFORE, THE RUBY COIL AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9736058 ↗
• MalfunctionFeb 20, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK; THEREFORE, THE RUBY COIL AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735406 ↗
• MalfunctionJan 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA MICROCATHETER, RUBY COILS AND A POD6. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE RUBY COILS AND THE POD6 WERE ADVANCED THROUGH THE LANTERN AND THE MICROCATHETER SEPARATELY BUT BECAME STUCK. IT IS UNKNOWN HOW THE RUBY COILS AND THE POD6 WERE RETRIEVED. IT WAS ALSO REPORTED THAT THE LANTERN BROKE APART AND THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE BOTH PARTS OF THE LANTERN. ADDITIONALLY, THE RENEGADE WAS REPORTED TO BE OVALIZED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560927 ↗
• MalfunctionJan 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA MICROCATHETER, RUBY COILS AND A POD6. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, IT WAS REPORTED THAT THE RUBY COILS AND THE POD6 WERE ADVANCED THROUGH THE LANTERN AND THE MICROCATHETER SEPARATELY BUT BECAME STUCK. IT IS UNKNOWN HOW THE RUBY COILS AND THE POD6 WERE RETRIEVED. IT WAS ALSO REPORTED THAT THE LANTERN BROKE APART AND THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE BOTH PARTS OF THE LANTERN. ADDITIONALLY, THE RENEGADE WAS REPORTED TO BE OVALIZED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560868 ↗
• MalfunctionDec 16, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; 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, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN IN THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER PENUMBRA 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 9475676 ↗
• MalfunctionAug 12, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO WITHDRAW IT. THE RUBY COIL WAS THEN RETRACTED AND RESHEATHED; HOWEVER, IT DETACHED FROM ITS PUSHER ASSEMBLY OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8885433 ↗
• MalfunctionDec 21, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERALS BETWEEN THE AORTA AND PULMONAL ARTERY USING POD PACKING COILS (PODJS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE FIRST 30CM PODJ THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE PODJ WOULD NOT ADVANCE MORE THAN 20CM OUT OF THE LANTERN. THE PODJ WAS THEREFORE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A 15CM PODJ; HOWEVER, WHILE ATTEMPTING TO ADVANCE ANOTHER 30CM PODJ, USING THE SAME LANTERN, THE SAME RESISTANCE WAS EXPERIENCED AS WITH THE FIRST PODJ. THIS PODJ WAS, THEREFORE, ALSO REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER 15CM PODJ AND TWO RUBY COILS USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, IT WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. AFTER MAKING FURTHER ATTEMPTS TO PUSH THE RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE RUBY COIL WAS STILL UNABLE TO EXIT THE SHEATH AND 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 8189287 ↗
• MalfunctionNov 21, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  DURING PREPARATION FOR A MEDICAL PROCEDURE, A HOSPITAL STAFF ACCIDENTALLY BENT THE PUSHER WIRE OF A RUBY COIL WHILE REMOVING IT FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098153 ↗
• MalfunctionNov 2, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND RETRACTED A RUBY COIL MULTIPLE TIMES USING A NON-PENUMBRA MICROCATHETER AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEREFORE USED A SYRINGE TO CREATE NEGATIVE PRESSURE AND REMOVED THE RUBY COIL. 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 Consequences Or Impact To Patient

  MAUDE report 8033858 ↗
• MalfunctionAug 14, 2018Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; CONSEQUENTLY, THE RUBY COIL BECAME KINKED, THEREFORE IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL, AGAIN RESISTANCE WAS FELT; SUBSEQUENTLY THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER; THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE DETACHED COIL INSIDE AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER. 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 7781823 ↗
• MalfunctionJul 17, 2018Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE EMBOLIZATION COIL WAS PREMATURELY DETACHED IN THE PACKAGING HOOP OF THE RUBY COIL. THE DAMAGE TO THE RUBY COIL 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 7695540 ↗
• MalfunctionJun 13, 2018Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL BECAME STUCK AS THE PHYSICIAN WAS ADVANCING IT THROUGH A NON-PENUMBRA MICROCATHETER AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE AND THEN REINSERTED THE SAME MICROCATHETER. THE PHYSICIAN ATTEMPTED TO PLACE A NEW RUBY COIL, HOWEVER AGAIN THE COIL BECAME STUCK AND THEN UNINTENTIONALLY DETACHED. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE AND THEN COMPLETED THE PROCEDURE 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 7596906 ↗
• MalfunctionJun 13, 2018Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL BECAME STUCK AS THE PHYSICIAN WAS ADVANCING IT THROUGH A NON-PENUMBRA MICROCATHETER AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE AND THEN REINSERTED THE SAME MICROCATHETER. THE PHYSICIAN ATTEMPTED TO PLACE A NEW RUBY COIL, HOWEVER AGAIN THE COIL BECAME STUCK AND THEN UNINTENTIONALLY DETACHED. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE AND THEN COMPLETED THE PROCEDURE 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 7596903 ↗
• MalfunctionApr 25, 2018Bent; Device Damaged Prior to Use; Out-Of-Box Failure; Bent; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN FOUND THAT THE RUBY COIL (RUBY COIL) WAS BENT UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THREE NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7458195 ↗
• MalfunctionApr 9, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE COIL WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. IT WAS ALSO REPORTED THAT THE SAME ISSUE WAS ENCOUNTERED WITH TWO OTHER RUBY COILS. THE PROCEDURE WAS 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 7409735 ↗
• MalfunctionApr 5, 2018Detachment Of Device Component; Difficult or Delayed Activation; Physical Resistance; Detachment Of Device Component; Difficult or Delayed Activation; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS THEN UNABLE TO DETACH A RUBY COIL USING THE HANDLE. THEREFORE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL, HOWEVER, THE RUBY COIL STILL DID NOT DETACH. THE PUSHER ASSEMBLY WAS, THEREFORE, RETRACTED TO BE REMOVED, HOWEVER, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL RUBY COIL, THE SAME MICROCATHETER, AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7401473 ↗
• MalfunctionFeb 28, 2018Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED AN INITIAL RUBY COIL INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER WITHOUT AN ISSUE. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY A NEW RUBY COIL BUT IT WOULD NOT FORM CORRECTLY IN THE VESSEL SO HE DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN MENTIONED FEELING RESISTANCE. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AS IT WAS EXITING THE HUB OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PULL OUT THE DETACHED RUBY COIL AND DECIDED TO SWITCH TO A NEW NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN ADVANCED THE COIL ABOUT THREE QUARTERS OF THE WAY THROUGH THE MICROCATHETER AND THEN ENCOUNTERED RESISTANCE. CONSEQUENTLY, THE RUBY COIL BECAME STUCK AND WAS UNABLE TO ADVANCE FURTHER. THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTION, IT UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PHYSICIAN THEN MANUALLY INJECTED C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7303640 ↗
• MalfunctionFeb 20, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL WITHIN A NON-PENUMBRA MICROCATHETER, AND THEREFORE THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY 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 7284168 ↗
• MalfunctionJan 25, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN LEFT GASTRIC USING RUBY COILS (RUBY COILS). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL INTO THE HUB OF THE LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE THE RUBY COIL WAS 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 7219051 ↗
• MalfunctionJan 3, 2018Unraveled Material; Physical Resistance; Unraveled Material; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE ADVANCING A RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN), AND THEREFORE THE RUBY COIL WAS REMOVED. UPON REMOVAL, IT WAS REPORTED THAT THE RUBY COIL LOOKED AS IF IT WAS UNRAVELED. THE PROCEDURE WAS THEN 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 7162365 ↗
• MalfunctionDec 20, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED INITIAL RUBY COILS INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER AND THE HANDLE. THE PHYSICIAN WAS THEN UNABLE TO DETACH A NEW RUBY COIL USING THE SAME HANDLE. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, THE SAME HANDLE 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 7136420 ↗
• MalfunctionNov 7, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  WHILE PREPARING A RUBY COIL FOR AN EMBOLIZATION PROCEDURE, THE TECHNOLOGIST NOTICED THAT THE RUBY COIL PUSHER ASSEMBLY WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE KINKED PUSHER ASSEMBLY WAS FOUND PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS SET ASIDE AND NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7007376 ↗