RUBY Coil RBY2C1857-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI M424RBY2C18570), received between Sep 29, 2015 and Nov 11, 2021 — classified as 1 injury, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (24 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A DUODENAL FISTULA (DF) USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE RETRACTING A RUBY COIL AND, SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD PACKING COIL (POD PC) AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800681 ↗
• MalfunctionJul 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL, IT WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SEVEN RUBY 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 12189392 ↗
• MalfunctionNov 20, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL USING A NON-PENUMBRA MICROCATHETER TO PACK THE AVF; HOWEVER, THE RUBY COIL KEPT FINDING THE OUTFLOW VESSEL RATHER THAN REMAINING WITHIN THE FISTULA AND, THEREFORE, THE RUBY COIL WAS REMOVED. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE DETACHED RUBY COIL INSIDE. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND WILL RESCHEDULE A PROCEDURE USING ANOTHER TECHNIQUE AT A LATER DATE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9348242 ↗
• MalfunctionOct 1, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE FIRST TWO RUBY COILS THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED TWO OTHER RUBY COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL BECAME STUCK IN THE MIDDLE OF THE LANTERN; THEREFORE, IT 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 9141873 ↗
• MalfunctionJun 26, 2019Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL NEAR THE DISTAL TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN) AND THE RUBY COIL BECAME STUCK. THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT IT. HOWEVER, WHILE RETRACTING THE RUBY COIL, IT BROKE AND BEGAN TO UNWIND. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND THE RUBY COIL TOGETHER. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS. THE PROCEDURE WAS THEN COMPLETED USING 13 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 8734934 ↗
• MalfunctionMay 16, 2019Premature Separation; Premature Separation

  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 8615394 ↗
• MalfunctionApr 12, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL INTO THE TARGET VESSEL AND REPORTED THAT IT WAS UNABLE TO DETACH USING THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL BUT WAS UNABLE TO. THE RUBY COIL WAS THEN REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN THEN USED SIX ADDITIONAL RUBY COILS AND THE SAME HANDLE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8508559 ↗
• MalfunctionJan 17, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VARICOCELE VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL HALFWAY THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN RE-POSITIONED THE LANTERN AND MADE ANOTHER ATTEMPT TO ADVANCE THE RUBY COIL, BUT THE SAME ISSUE OCCURRED. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE LANTERN WAS THEN FLUSHED AND THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256743 ↗
• MalfunctionDec 18, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA ANEURYSM (AAA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COIL AND THE MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS WITH THE BASE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174166 ↗
• MalfunctionDec 14, 2018Device Damaged Prior to Use; Device Handling Problem; Device Fell; Device Damaged Prior to Use; Device Handling Problem; Device Fell

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, PRIOR TO USE, A RUBY COIL WAS INADVERTENTLY DROPPED ON THE FLOOR UPON REMOVAL FROM THE DISPENSER HOOP; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8167088 ↗
• MalfunctionOct 12, 2018Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF NOTICED THE BLACK ALIGNMENT ZONE (PET LOCK) OF THE RUBY COIL WAS BENT UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE; THEREFORE, THE COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING 32 MORE RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7961813 ↗
• MalfunctionSep 28, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING TWO RUBY COILS THROUGH THE LANTERN AND, THEREFORE, THE RUBY COILS WERE REMOVED. 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 7920441 ↗
• MalfunctionSep 25, 2018Firing Problem

  A RUBY COIL FAILED TO DEPLOY. THERE WERE NO COMPLICATIONS. NOTES FROM THE PROCEDURE: FOLLOWING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC (TIPS) SHUNT CREATION, A KUMPE CATHETER WAS ADVANCED INTO THE SPLENIC VEIN AND A SPLENIC VENOGRAM PERFORMED. THIS DEMONSTRATED TWO LARGE GASTROESOPHAGEAL VARICES. USING A 5 FRENCH C2 CATHETER, THE FIRST OF THESE VARICES WAS SELECTED. UNDER FLUOROSCOPIC GUIDANCE, A NEST OF COILS WAS DEPLOYED TO OCCLUDE THIS VARIX. THE SECONDARY WAS THEN SELECTED, AND AGAIN UNDER FLUOROSCOPIC GUIDANCE A NEST OF COILS WAS DEPLOYED TO OCCLUDE THIS VARIX. FOLLOWING EMBOLIZATION OF THESE TWO VARICES, THE CATHETER WAS POSITIONED WITHIN THE SPLENIC VEIN AND A POST EMBOLIZATION VENOGRAM PERFORMED DEMONSTRATING NO FURTHER SIGNIFICANT VARICES. THE CATHETER WAS THEN REMOVED. PATIENT TOLERATED THE PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905067 ↗
• MalfunctionSep 7, 2018Positioning Failure; Separation Failure; Positioning 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 SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH A RUBY COIL USING THE HANDLE AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857488 ↗
• MalfunctionSep 7, 2018Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS; THEREFORE, THE LANTERN AND RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7857466 ↗
• MalfunctionJul 2, 2018Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY CONTAMINATED THE RUBY COIL AFTER IT SPRUNG PARTIALLY OFF THE BACK TABLE. NEXT, IT WAS NOTICED THAT TWO NEW RUBY COILS WERE KINKED UPON REMOVAL FROM THEIR PACKAGINGS. THE DAMAGES TO THE RUBY COILS WERE FOUND PRIOR TO USE AND THEREFORE, THEY WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7657326 ↗
• MalfunctionJul 2, 2018Device Damaged Prior to Use; Device Handling Problem; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY CONTAMINATED THE RUBY COIL AFTER IT SPRUNG PARTIALLY OFF THE BACK TABLE. NEXT, IT WAS NOTICED THAT TWO NEW RUBY COILS WERE KINKED UPON REMOVAL FROM THEIR PACKAGINGS. THE DAMAGES TO THE RUBY COILS WERE FOUND PRIOR TO USE AND THEREFORE, THEY WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7657325 ↗
• MalfunctionFeb 9, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE UNIPOLAR ILIACS USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE PX SLIM. THEREFORE, THE PX SLIM AND RUBY COIL WERE REMOVED. THE PHYSICIAN THEN PLACED A NEW PX SLIM AND ATTEMPTED TO RE-ADVANCE THE SAME RUBY COIL; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE. SUBSEQUENTLY, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7262249 ↗
• MalfunctionDec 29, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND RETRACTED THE COIL. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL, RESISTANCE WAS ENCOUNTERED AGAIN AND UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE RUBY COIL PUSHER ASSEMBLY WAS REMOVED AND THE DETACHED COIL WAS ASPIRATED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL RUBY COILS, THE SAME MICROCATHETER AND A 3CC FLUSH SYRINGE WITH NO ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155236 ↗
• MalfunctionNov 28, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN USED A LANTERN DELIVERY MICROCATHETER (LANTERN) TO DEPLOY AND DETACH MULTIPLE RUBY COILS TO THE TARGET LOCATION. THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN WITH A DIFFERENT TIP SHAPE TO CONTINUE THE PROCEDURE. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL USING THE LANTERN; THEN FELT RESISTANCE WHILE ADVANCING TWO NEW RUBY COILS MORE THAN TWO THIRDS OF THE WAY THROUGH THE LANTERN. THE RUBY COILS WERE THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065581 ↗
• MalfunctionNov 28, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN USED A LANTERN DELIVERY MICROCATHETER (LANTERN) TO DEPLOY AND DETACH MULTIPLE RUBY COILS TO THE TARGET LOCATION. THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN WITH A DIFFERENT TIP SHAPE TO CONTINUE THE PROCEDURE. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL USING THE LANTERN; THEN FELT RESISTANCE WHILE ADVANCING TWO NEW RUBY COILS MORE THAN TWO THIRDS OF THE WAY THROUGH THE LANTERN. THE RUBY COILS WERE THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065576 ↗
• MalfunctionNov 10, 2017Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A PELVIC ARTERIOVENOUS MALFORMATION USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND AN ATTEMPT WAS MADE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH ON THE BACK TABLE; HOWEVER, THE RUBY COIL WOULD STILL NOT ADVANCE OUT OF ITS SHEATH. THEREAFTER, 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 7021201 ↗
• MalfunctionNov 9, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA CATHETER IN THE TARGET VESSEL, THEN DEPLOYED AND DETACHED THE INITIAL RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). AFTER ADVANCING THE LAST RUBY COIL INTO THE TARGET VESSEL, THE RUBY COIL STARTED TO COIL INTO THE OUTFLOW AND CREATE A DENSE PACK AT THE NECK OF THE ANEURYSM; HOWEVER, THE PHYSICIAN FELT FRICTION BUT CONTINUED TO ADVANCE THE RUBY COIL PASS THE FRICTION. CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED AND THE RUBY COIL PUSHER ASSEMBLY BECAME BROKEN EXPOSING THE PULL WIRE. THEREFORE, THE PHYSICIAN PULLED ON THE PULL WIRE UNTIL IT REACHED AN END AND SEEMED TO BE COMPLETELY OUT OF THE LANTERN. HOWEVER, UPON STEPPING ONTO FLUOROSCOPY, THE PHYSICIAN NOTICED THAT THE RUBY COIL ALIGNMENT MARKER WAS STILL IN THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW THE LANTERN; HOWEVER, THE DETACHED COIL PROCEEDED TO PULL OUT OF THE LANTERN. THE PHYSICIAN THEN RE-ADVANCED AND REPOSITIONED THE LANTERN IN THE TARGET VESSEL. NEXT, THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DETACHED COIL OU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7015163 ↗
• MalfunctionAug 9, 2017Kinked; Device Damaged Prior to Use; Failure to Advance; Kinked; Device Damaged Prior to Use; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE RUBY COIL PUSHER ASSEMBLY WAS BENT UPON REMOVAL FROM THE DISPENSER HOOP. HOWEVER, THE PHYSICIAN CONTINUED TO USE THE RUBY COIL. WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) OF THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL THROUGH THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN WITHOUT RESISTANCE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778607 ↗
• MalfunctionAug 2, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, ATTEMPTED TO RETRACT THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN; THEREFORE, THE LANTERN WAS REMOVED WITH THE RUBY COIL INSIDE. THE PHYSICIAN FLUSHED THE LANTERN OUTSIDE OF THE PATIENT TO REMOVE THE RUBY COIL, AND THEN REINSERTED THE SAME LANTERN. UPON ATTEMPTING TO ADVANCE A SECOND RUBY COIL, THE PHYSICIAN AGAIN FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN; THEREFORE, THE PHYSICIAN REMOVED THE LANTERN WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS THEN COMPLETED USING A NON-PENUMBRA MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762341 ↗