RUBY Coil RBY4C0315-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI M424RBY4C03150), received between Aug 26, 2015 and May 30, 2021 — classified as 3 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (31 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OBTURATOR ARTERY (OA) USING A RUBY COIL AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL OUT OF THE MICROCATHETER, THE MICROCATHETER KICKED BACK. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL FROM THE PATIENT AND REPOSITIONED THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COIL AGAIN AND THE SAME ISSUE OCCURRED. THE PHYSICIAN MADE A THIRD ATTEMPT TO PLACE THE RUBY COIL; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL WOULD NOT ADVANCE FURTHER INTO THE MICROCATHETER AND GOT STUCK. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER AND RUBY COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905881 ↗
• MalfunctionFeb 25, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  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 SUCCESSFULLY IMPLANTED TWO RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE THIRD RUBY COIL THROUGH THE MICROCATHETER IN THE LUMBAR ARTERY, THE PHYSICIAN EXPERIENCED RESISTANCE AND IMMEDIATELY STOPPED ADVANCING THE RUBY COIL FORWARD. WHILE ATTEMPTING TO WITHDRAW THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED AND WAS NOT RETRACTABLE THROUGH THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE RUBY COIL PUSHER ASSEMBLY TO PUSH THE DETACHED RUBY COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9750601 ↗
• MalfunctionSep 18, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  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 PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 9082509 ↗
• MalfunctionJul 26, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIAL COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN ADVANCED AND THEN RETRACTED A RUBY COIL THROUGH THE LANTERN AND RESISTANCE WAS ENCOUNTERED. WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL, THE PHYSICIAN PULLED BACK AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT. THE DETACHED RUBY COIL WAS REMOVED FROM THE LANTERN AND THE PROCEDURE WAS SUCCESSFULLY 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 8831783 ↗
• MalfunctionApr 5, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, AFTER ADVANCING THE RUBY COIL TO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER WITH A NON-PENUMBRA SHEATH, THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, IT WAS UNABLE TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH THE SAME HANDLE, SAME MICROCATHETER AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8487842 ↗
• MalfunctionMar 28, 2019Device Damaged Prior to Use; Device Fell; Device Damaged Prior to Use; Device Fell

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, PRIOR TO USE, A RUBY COIL WAS INADVERTENTLY DROPPED ON THE FLOOR UPON REMOVAL FROM THE STERILE PACKAGING; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8461646 ↗
• MalfunctionFeb 28, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED TWO RUBY COILS IN THE TARGET VESSEL USING THE HANDLE. WHEN ATTEMPTING TO DETACH THE THIRD RUBY COIL USING THE HANDLE, THE RUBY COIL COULD NOT BE DETACHED. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO 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 8377841 ↗
• MalfunctionDec 13, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). SUBSEQUENTLY, THE PUSHER ASSEMBLY OF TWO RUBY COILS WERE ACCIDENTALLY KINKED AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162142 ↗
• MalfunctionDec 13, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN). SUBSEQUENTLY, THE PUSHER ASSEMBLY OF TWO RUBY COILS WERE ACCIDENTALLY KINKED AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160077 ↗
• MalfunctionSep 6, 2018Failure 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 AND, THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE BY READJUSTING THE MICROCATHETER AND THEN SUCCESSFULLY PLACING MULTIPLE RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7852890 ↗
• MalfunctionJul 31, 2018Material Twisted/Bent; Physical Resistance/Sticking; Premature Separation; Material Twisted/Bent; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER LOADING A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE RUBY COIL BECAME STUCK INSIDE THE MICROCATHETER AND WOULD NOT MOVE FORWARD OR BACKWARD. SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT FROM THE FORCE OF PUSHING IT FORWARD. WHILE ATTEMPTING TO PULL THE RUBY COIL BACK, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND TWO ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736641 ↗
• MalfunctionJun 13, 2018Detachment 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 USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE ROTATING HEMOSTATIC VALVE (RHV) TO PULL OUT THE RUBY COIL FROM THE LANTERN. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER RUBY COIL. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN THE LANTERN AND, CONSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN AGAIN WAS ABLE TO REMOVE THE RUBY COIL BY HAND AFTER REMOVING THE RHV. THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN AND SUCCESSFULLY PLACED MULTIPLE RUBY COILS. HOWEVER, THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN ITS INTRODUCER SHEATH AND INTO THE LANTERN AND THOUGHT THAT THE PUSHER ASSEMBLY WAS DAMAGED, THOUGH NO SPECIFIC DAMAGE WAS NOTICED. THE PHYSICIAN THEREFORE REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596671 ↗
• MalfunctionJun 13, 2018Detachment 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 USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE ROTATING HEMOSTATIC VALVE (RHV) TO PULL OUT THE RUBY COIL FROM THE LANTERN. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER RUBY COIL. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN THE LANTERN AND, CONSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN AGAIN WAS ABLE TO REMOVE THE RUBY COIL BY HAND AFTER REMOVING THE RHV. THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN AND SUCCESSFULLY PLACED MULTIPLE RUBY COILS. HOWEVER, THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN ITS INTRODUCER SHEATH AND INTO THE LANTERN AND THOUGHT THAT THE PUSHER ASSEMBLY WAS DAMAGED, THOUGH NO SPECIFIC DAMAGE WAS NOTICED. THE PHYSICIAN THEREFORE REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596670 ↗
• MalfunctionJun 13, 2018Detachment 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 USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE ROTATING HEMOSTATIC VALVE (RHV) TO PULL OUT THE RUBY COIL FROM THE LANTERN. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER RUBY COIL. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN THE LANTERN AND, CONSEQUENTLY THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN AGAIN WAS ABLE TO REMOVE THE RUBY COIL BY HAND AFTER REMOVING THE RHV. THE PHYSICIAN THEN SWITCHED TO A NEW LANTERN AND SUCCESSFULLY PLACED MULTIPLE RUBY COILS. HOWEVER, THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL WITHIN ITS INTRODUCER SHEATH AND INTO THE LANTERN AND THOUGHT THAT THE PUSHER ASSEMBLY WAS DAMAGED, THOUGH NO SPECIFIC DAMAGE WAS NOTICED. THE PHYSICIAN THEREFORE REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD COILS, AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7596653 ↗
• MalfunctionMay 25, 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 FOUND THAT THE PUSHER ASSEMBLY OF THE RUBY COIL WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE RUBY COIL WAS FOUND PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS.

  Patient problems: No Patient Involvement

  MAUDE report 7545661 ↗
• MalfunctionMay 10, 2018Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance; Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN RETRACTED TO REMOVE A RUBY COIL FROM A LANTERN DELIVERY MICROCATHETER BECAUSE THE RUBY COIL WAS THE WRONG SIZE. HOWEVER, UPON RETRACTION, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. THE LANTERN WAS THEREFORE REMOVED WITH THE RUBY COIL INSIDE. THE PHYSICIAN THEN REINSERTED THE SAME LANTERN; HOWEVER, THE SAME ISSUE OCCURRED WITH ANOTHER 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 7504671 ↗
• MalfunctionApr 30, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC AND SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL WITHIN THE MICROCATHETER, AND THEREFORE THE PHYSICIAN REMOVED THE RUBY COIL, DESPITE FEELING RESISTANCE WHILE RETRACTING. THIS SAME ISSUE THEN OCCURRED WITH A SECOND RUBY COIL. THE PROCEDURE WAS COMPLETED USING NEW 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 7473749 ↗
• MalfunctionApr 25, 2018Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAXILLARY ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE THIRD RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN FLUSHED THE DETACHED COIL INTO THE TARGET VESSEL AND ENDED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7461153 ↗
• MalfunctionApr 24, 2018Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTICED THAT A RUBY COIL WAS DETACHED WHILE ATTEMPTING TO ADVANCE IT OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND A NON-PENUMBRA MICROCATHETER.

  Patient problems: No Patient Involvement

  MAUDE report 7456340 ↗
• MalfunctionApr 16, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BRANCH OF THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE TWO RUBY COILS THROUGH THE MICROCATHETER, AND THEREFORE THE RUBY COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 7434506 ↗
• MalfunctionApr 6, 2018Bent; Device Handling Problem; Bent; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC VARICOCELE USING RUBY COILS, DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN WAS AGGRESSIVE AND INADVERTENTLY BENT THE COIL¿S PUSHER ASSEMBLY; THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS ALSO REPORTED THAT ANOTHER RUBY COIL PUSHER ASSEMBLY BECAME BENT IN THE SAME MANNER. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7402939 ↗
• MalfunctionMar 16, 2018Detachment Of Device Component; Failure to Advance; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GASTROINTESTINAL BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND RETRACTED A RUBY COIL BACK INTO ITS INTRODUCER SHEATH. WHEN ATTEMPTING TO ADVANCE THE RUBY COIL LATER IN THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE IT OUT OF ITS INTRODUCER SHEATH. ANOTHER RUBY COIL WAS ALSO RETRACTED BACK INTO ITS INTRODUCER SHEATH, HOWEVER THE RUBY COIL UNINTENTIONALLY DETACHED UPON RETRACTION INTO THE INTRODUCER SHEATH. 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 7345981 ↗
• MalfunctionMar 16, 2018Detachment Of Device Component; Failure to Advance; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GASTROINTESTINAL BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND RETRACTED A RUBY COIL BACK INTO ITS INTRODUCER SHEATH. WHEN ATTEMPTING TO ADVANCE THE RUBY COIL LATER IN THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE IT OUT OF ITS INTRODUCER SHEATH. ANOTHER RUBY COIL WAS ALSO RETRACTED BACK INTO ITS INTRODUCER SHEATH, HOWEVER THE RUBY COIL UNINTENTIONALLY DETACHED UPON RETRACTION INTO THE INTRODUCER SHEATH. 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 7345874 ↗
• MalfunctionFeb 12, 2018Detachment Of Device Component; Retraction Problem; Failure to Advance; Physical Resistance; Detachment Of Device Component; Retraction Problem; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THREE RUBY COILS THROUGH A NON-PENUMBRA MICROCATHETER, AND THEREFORE, THE RUBY COILS WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL THROUGH THE MICROCATHETER, HOWEVER IT BECAME STUCK AND THEN UNINTENTIONALLY DETACHED AS THE PHYSICIAN WAS ATTEMPTING TO REMOVE IT. THE PHYSICIAN WAS UNABLE TO PLACE THE DETACHED RUBY COIL, AND THEREFORE THE MICROCATHETER WAS REMOVED WITH THE RUBY COIL INSIDE. THE PROCEDURE WAS ABORTED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263469 ↗
• MalfunctionFeb 7, 2018Detachment Of Device Component; Retraction Problem; Physical Resistance; Detachment Of Device Component; Retraction Problem; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) FOR A GASTROINTESTINAL (GI) BLEED USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED SEVERAL RUBY COILS USING THE LANTERN. THE PHYSICIAN DEPLOYED A RUBY COIL AND ATTEMPTED TO REPOSITION IT; HOWEVER THE PHYSICIAN FELT RESISTANCE AFTER ADVANCING THE RUBY COIL APPROXIMATELY 2CM OUT OF THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL; HOWEVER UPON RETRACTION, THE PHYSICIAN AGAIN FELT MORE RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE RUBY COIL INSIDE. AN ANGIOGRAM WAS THEN PERFORMED WHICH CONFIRMED ALL OF THE COIL WAS REMOVED AND THE TARGET VESSEL WAS SUFFICIENTLY OCCLUDED, AND THE PROCEDURE THEREFORE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7249929 ↗