RUBY Coil RBY4C0406-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI M424RBY4C04060), received between Dec 30, 2015 and Mar 4, 2021 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (8 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL, THE PHYSICIAN WAS UNABLE TO ADVANCE PAST THE PROXIMAL HUB OF THE LANTERN. 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; No Consequences Or Impact To Patient

  MAUDE report 11412819 ↗
• MalfunctionNov 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE RUBY COIL MIDWAY THROUGH THE MICROCATHETER, WHICH WAS INSIDE THE PATIENT. THEREFORE, THE RUBY COIL 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10844256 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH A NON-PENUMBRA MICROCATHETER; THEREFORE, THE RUBY COILS AND THE MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER PUSHABLE COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866278 ↗
• MalfunctionJun 5, 2019Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND 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 8672659 ↗
• MalfunctionSep 21, 2018Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL. DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN BENT THE PUSHER ASSEMBLY OF A RUBY COIL WHILE LOADING IT INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL 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 7898933 ↗
• InjuryAug 30, 2018Break; Migration; Physical Resistance/Sticking; Break; Migration; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL MAMMARY ARTERIES USING POD PACKING COILS (PODJS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ACCIDENTALLY KINKED THE PUSHER ASSEMBLY OF A PODJ WHILE ADVANCING INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER PODJ. LATER IN THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE LAST RUBY COIL, A COIL LOOP POPPED OUT INTO THE ORIGIN OF THE RIGHT INTERNAL MAMMARY ARTERY INTO THE RIGHT SUBCLAVIAN ARTERY. THE PHYSICIAN THEREFORE ATTEMPTED TO REMOVE THE RUBY COIL USING A SNARE DEVICE, HOWEVER, WHILE RETRACTING THE RUBY COIL WITHIN THE CATHETER, THE RUBY COIL BROKE. THE PHYSICIAN REMOVED THE SNARE WITH A PIECE OF THE COIL ATTACHED, A PIECE OF THE COIL STUCK WITHIN THE CATHETER, AND WITH ANOTHER PIECE INSIDE THE MAMMARY ARTERY WITH THE TAIL IN THE SUBCLAVIAN ARTERY. THE PHYSICIAN THEN MADE A NEW ACCESS POINT IN THE BRACHIAL ARTERY AND ADVANCED A NEW CATHETER TO THE RIGHT SUBCLAVIAN ARTERY. ANOTHER SNARE DEVICE WAS ADVANCED THROUGH THIS ACCESS SITE TO RETRIEVE THE REST OF THE RUBY COIL FROM THE SUBCLAVIAN ARTERY. ALL PIECES OF THE RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7834801 ↗
• MalfunctionJul 24, 2018Material Deformation; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED AS THE PHYSICIAN WAS TRYING TO INSERT THE RUBY COIL INTO THE MICROCATHETER ON THE BACK TABLE. 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 7716862 ↗
• MalfunctionJun 20, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RUBY COIL WAS DROPPED ON THE FLOOR WHEN IT WAS HANDING OFF TO THE HOSPITAL STAFF UPON REMOVAL FROM THE PACKAGING. THE RUBY COIL WAS DROPPED 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 7622411 ↗
• MalfunctionJun 6, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE INSERTING A RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME SEVERELY KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7573712 ↗
• MalfunctionMay 25, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN A NON-PENUMBRA MICROCATHETER AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN, THEREFORE, REMOVED THE MICROCATHETER WITH THE COIL INSIDE AND COMPLETED THE PROCEDURE USING A NEW MICROCATHETER AND 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 7545501 ↗
• MalfunctionMay 18, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE RUBY COIL BECAME STUCK AND WOULD NOT ADVANCE FURTHER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHERS 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 7526165 ↗
• MalfunctionApr 11, 2018Detachment Of Device Component; Retraction Problem; Detachment Of Device Component; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRACT A RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN). THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL AND FLUSHED THE COIL ONTO THE BACK TABLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7423576 ↗
• MalfunctionApr 10, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEEDING (GI BLEED) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO LOAD A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE PROXIMAL PART OF THE MICROCATHETER; THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE RUBY COIL. 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 7419901 ↗
• MalfunctionMar 7, 2018Separation 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 A 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 REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320321 ↗
• MalfunctionOct 26, 2017Detachment Of Device Component; Device Damaged Prior to Use; Out-Of-Box Failure; Detachment Of Device Component; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE INTRODUCER SHEATH UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS NOTICED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6981755 ↗
• MalfunctionSep 26, 2017Bent; 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, THE SCRUB TECHNOLOGIST NOTICED THAT A RUBY COIL WAS BENT IN MULTIPLE PLACES UPON REMOVAL FROM THE DISPENSER HOOP. IT WAS NOTED THAT THE RUBY COIL WAS BENT IN THE PACKAGE. THE DAMAGED RUBY COIL WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USE FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 6895462 ↗
• MalfunctionAug 2, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL AND FLUSHED THE COIL OUT. THE PHYSICIAN THEN RE-INSERTED THE LANTERN IN THE PATIENT¿S BODY AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COILS AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762320 ↗
• MalfunctionJul 6, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FEW FISTULAS OFF A MAIN ARTERIOVENOUS (AV) FISTULA USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DID NOT MENTION RESISTANCE BUT INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. IT WAS REPORTED THAT THE PHYSICIAN DID NOT USE SHORT CONTROLLED PUSHES WHILE ADVANCING THE RUBY COIL INTO THE LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6691486 ↗
• MalfunctionMay 4, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. IT WAS NOTED THAT THE PATIENT HAD VERY TORTUOUS ANATOMY. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL COILS INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN DID NOT MENTION ANY RESISTANCE; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MANUFACTURER¿S MICROCATHETER AND GEL FOAM. THERE WAS NO ALLEGED DEFICIENCY AGAINST THE LANTERN. THE PHYSICIAN WANTED TO USE A SMALLER MICROCATHETER TO FINISH THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546020 ↗
• MalfunctionFeb 24, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE LANTERN SHIFTED OUT OF PLACE; THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT AND RE-SHEATH THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN; THEREFORE THE LANTERN WAS REMOVED WITH THE RUBY COIL INSIDE. THE PHYSICIAN THEN DECIDED THAT THE PROCEDURE WAS COMPLETED AT THIS POINT. IN ADDITION, THE PHYSICIAN REPORTED NOT USING A ROTATING HEMOSTASIS VALVE AND NOT MAINTAINING CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6358310 ↗
• MalfunctionDec 21, 2016Detachment Of Device Component; Premature Activation; Malposition of Device; Detachment Of Device Component; Premature Activation; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT UTERINE ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN DID NOT RECALL EXPERIENCING ANY RESISTANCE; HOWEVER, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE TO FLUSH THE COIL OUT OF THE MICROCATHETER AND INTO A VESSEL. ALTHOUGH THE COIL WAS NOT IMPLANTED INTO THE TARGET VESSEL, THE PHYSICIAN DID NOT MAKE ANY ATTEMPTS TO RETRIEVE THE COIL BECAUSE THE LOCATION OF THE IMPLANTED COIL WAS NOT HARMFUL. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND THE SAME NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE AND DID NOT MAINTAIN A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6196247 ↗
• MalfunctionOct 19, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A RUBY COIL INTO THE GDA USING ANOTHER MANUFACTURER'S MICROCATHETER, THE COIL WAS UNABLE TO ADVANCE OUT OF THE END OF THE MICROCATHETER. THE PHYSICIAN MADE A FEW ATTEMPTS TO ADVANCE THE RUBY COIL OUT OF THE MICROCATHETER BUT ENCOUNTERED RESISTANCE. THE PHYSICIAN STATED THAT IT FELT LIKE THE COIL "HIT A WALL". THE RUBY COIL WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED USING GELFOAM AND THE SAME NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PHYSICIAN FLUSHED THE MICROCATHETER IN BETWEEN EACH COIL BUT DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6038867 ↗
• MalfunctionJul 6, 2016Kinked; 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 BACK END OF A RUBY COIL PUSHER ASSEMBLY WAS FOUND TO BE KINKED WHILE IN THE DELIVERY HOOP. THE KINKED PUSHER ASSEMBLY WAS FOUND PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5773397 ↗
• MalfunctionFeb 4, 2016Detachment Of Device Component; Failure to Advance; Physical Resistance; Difficult to Advance; Detachment Of Device Component; Failure to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL OUT OF THE PX SLIM AND INTO THE ANEURYSM; HOWEVER, THE RUBY COIL BECAME STUCK AND UNINTENTIONALLY DETACHED INSIDE THE PX SLIM. THE PHYSICIAN REMOVED THE DETACHED RUBY COIL AND THE PX SLIM FROM THE PATIENT AND COMPLETED THE PROCEDURE USING NEW RUBY COILS AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5411719 ↗
• MalfunctionDec 30, 2015Bent

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RUBY COIL PUSHER ASSEMBLY BENT AS THE HOSPITAL TECH WAS PULLING THE RUBY COIL OUT OF ITS HOOP. THE DAMAGED RUBY COIL WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. A SECOND RUBY COIL WAS OPENED FOR THE PROCEDURE; HOWEVER, IT WAS NOT IMPLANTED INTO THE PATIENT BECAUSE THE VESSEL WAS NOT SIZED CORRECTLY BY THE PHYSICIAN. THERE WERE NO ISSUES WITH THE SECOND RUBY COIL AND IT WAS ULTIMATELY NOT USED AFTER IT WAS OPENED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5337106 ↗