RUBY Coil RBY4C0202-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI M424RBY4C02020), received between Nov 20, 2015 and Sep 28, 2021 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (15 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. 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 12543815 ↗
• MalfunctionApr 27, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS, POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL IN THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. WHEN RETRACTING THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A POD COIL THROUGH THE SAME LANTERN BUT EXPERIENCED RESISTANCE AND BENT THE PUSHER ASSEMBLY. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734837 ↗
• MalfunctionMar 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN WAS ADVANCING A RUBY COIL THROUGH THE MICROCATHETER WHEN THE RUBY COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. THE PHYSICIAN REINSERTED THE MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL IN THE TARGET LOCATION; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN THEREFORE, REMOVED THE RUBY COIL. SUBSEQUENTLY, THE PHYSICIAN INSERTED A THIRD RUBY COIL IN THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL SEGMENT OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS, ANOTHER 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 11520495 ↗
• MalfunctionNov 1, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND ATTEMPTED TO DETACH IT USING HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME HANDLE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269611 ↗
• MalfunctionAug 22, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING THE FOURTH RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. 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 8923054 ↗
• MalfunctionMay 17, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE INSIDE OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8619498 ↗
• MalfunctionFeb 6, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL PUSHER ASSEMBLY WAS INADVERTENTLY KINKED WHILE BEING REMOVED FROM THE DISPENSER HOOP. THE DAMAGE TO THE RUBY COIL PUSHER ASSEMBLY OCCURRED PRIOR TO USE AND, THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8310002 ↗
• MalfunctionOct 4, 2018Device Handling Problem; Device Fell; Device Handling Problem; Device Fell

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY DROPPED THE RUBY COIL FROM THE BACK TABLE UPON REMOVING IT OUT OF THE PACKAGING HOOP. THE RUBY COIL WAS DROPPED PRIOR TO USE, AND THEREFORE WAS NOT USED IN PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7936831 ↗
• MalfunctionSep 19, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL UNINTENTIONALLY DETACHED WHILE BEING RE-SHEATHED OUTSIDE OF THE PATIENT. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE PATIENT USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND ATTEMPTED TO RETRACT IT IN ORDER TO REPOSITION THE PX SLIM. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED AND OCCLUDED THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN DID NOT MAKE AN ATTEMPT TO RETRIEVE THE DETACHED RUBY COIL AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME PX SLIM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891004 ↗
• MalfunctionJul 5, 2018Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT A RUBY COIL SMOOTHLY WITHIN THE NON-PENUMBRA MICROCATHETER AND, 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 Consequences Or Impact To Patient

  MAUDE report 7664057 ↗
• MalfunctionMay 31, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT BECAUSE THE EXISTING PACKING DENSITY WAS SUFFICIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7557789 ↗
• 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 7409733 ↗
• 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 7409732 ↗
• MalfunctionApr 4, 2018Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED A RUBY COIL PUSHER ASSEMBLY; 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 Consequences Or Impact To Patient

  MAUDE report 7397903 ↗
• MalfunctionJan 3, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE GASTRODUODENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WOULD NOT DEPLOY; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162586 ↗
• InjuryDec 26, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE A RUBY COIL WAS BEING RETRACTED BACK INTO THE NON-PENUMBRA MICROCATHETER, IT UNINTENTIONALLY DETACHED. IT IS UNKNOWN IF THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE DETACHED RUBY COIL WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL 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 7145826 ↗
• MalfunctionDec 19, 2017Bent; Separation Failure; Bent; 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 ADVANCED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. AFTER THREE FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED AND INSPECTED. THE PHYSICIAN THEN NOTICED THAT THE RUBY COIL PUSHER ASSEMBLY WAS BENT. THEREFORE, THE PHYSICIAN DECIDED NOT TO REUSE THE RUBY COIL AND COMPLETED THE PROCEDURE BY PLACING GEL FOAM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7131310 ↗
• MalfunctionNov 16, 2017Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL FELL ON THE GROUND. THE RUBY COIL WAS DROPPED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7039269 ↗
• MalfunctionOct 20, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED INITIAL RUBY COILS INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A RUBY COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN THEN DEPLOYED A NEW RUBY COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. AFTER MULTIPLE FAILED ATTEMPTS, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL, THE SAME LANTERN 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 6966357 ↗
• MalfunctionSep 26, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT GASTRIC ARTERY PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL FULLY OUT OF THE NON-PENUMBRA MICROCATHETER AND INTO THE VESSEL, DESPITE MULTIPLE ATTEMPTS TO RE-POSITION THE RUBY COIL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SECOND RUBY COIL OUT OF THE MICROCATHETER AT ALL, DESPITE MULTIPLE ATTEMPTS; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS, THE SAME MICROCATHETER, AND GEL FOAM WAS DELIVERED TO EMBOLIZE THE VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895481 ↗
• MalfunctionSep 22, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED IN A BRANCH OF THE SUPERIOR FEMORAL ARTERY (SFA) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THEN ATTEMPTED TO DETACH THE COIL USING THE HANDLE. HOWEVER, AFTER MULTIPLE ATTEMPTS, THE RUBY COIL WAS UNABLE TO DETACH. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS 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 6888993 ↗
• MalfunctionAug 24, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. THEREFORE, THE RUBY COIL WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. PLEASE NOTE THAT THE MANUFACTURER HAS MADE AT LEAST THREE ATTEMPTS TO OBTAIN PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE PROCEDURE; HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE THE INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6818820 ↗
• MalfunctionAug 4, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FOUR RUBY COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND THE HANDLE. THE PHYSICIAN THEN DEPLOYED THE LAST RUBY COIL WITHOUT ANY RESISTANCE BUT WAS UNABLE TO DETACH THE 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 6768111 ↗
• MalfunctionJul 10, 2017Failure 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. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE THROUGH THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 6699442 ↗
• MalfunctionJul 5, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (RH1). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A RUBY COIL USING A RH1; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6688066 ↗