RUBY Coil RBY2C0840-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI M424RBY2C08400), received between Sep 18, 2015 and Jun 3, 2021 — classified as 2 injuries, 42 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2021Break; Premature Separation; Break; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE RUBY COILS IN THE TARGET LOCATION. THE NEXT RUBY COIL WAS DETERMINED TO BE TOO LONG, AND THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHEN REMOVING THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE RENAL ARTERY AND PARTIALLY IN THE AORTA. THE RUBY COIL WAS SNARED AND SUBSEQUENTLY BROKE IN HALF. THE PHYSICIAN WAS THEN ABLE TO SNARE THE REMAINING COIL AND REMOVED IT FROM THE PATIENT. 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 11930567 ↗
• MalfunctionApr 12, 2021Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DESCENDING AORTA USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL WOULD NOT ADVANCE AND BECAME STUCK IN THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO REMOVE THE RUBY COIL; HOWEVER, WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THE COIL WAS FLUSHED OUT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649789 ↗
• MalfunctionJan 21, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE MICROCATHETER, THE RUBY COIL DETACHED FROM THE PUSHER ASSEMBLY WITHIN THE INTRODUCER SHEATH BEFORE ENTERING THE ROTATING HEMOSTASIS VALVE (RHV). THEREFORE, THE INTRODUCER SHEATH CONTAINING THE DETACH RUBY COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS 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 11211062 ↗
• MalfunctionDec 29, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. NEXT, THE PHYSICIAN ADVANCED A THIRD RUBY COIL INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT OF THE RUBY COIL. WHILE RETRACTING THE RUBY COIL TO REPOSITION IT, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING SIX ADDITIONAL PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089558 ↗
• MalfunctionSep 18, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN INTERNAL ILIAC ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO RUBY COILS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, THE NEXT RUBY COIL WAS PACKED INTO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE RUBY COIL USING THE HANDLE, THE RUBY COIL KEPT GETTING SUCKED BACK INTO THE MICROCATHETER. THE RUBY COIL WAS REMOVED. THE PHYSICIAN CONTINUED THE PROCEDURE USING ANOTHER RUBY COIL. WHILE ATTEMPTING TO DETACH THE RUBY COIL, THE SAME ISSUE OCCURRED, AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS AND THE SAME HANDLE. 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 10553392 ↗
• MalfunctionFeb 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER IN THE TARGET VESSEL, THE MICROCATHETER KICKED BACK; THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL TO IN ORDER TO REPOSITION THE MICROCATHETER. IT WAS REPORTED THAT THE RUBY COIL WAS RINSED IN SALINE AFTER REMOVAL. HOWEVER, WHILE ATTEMPTING TO RE-ADVANCE THE RUBY COIL INTO THE REPOSITIONED MICROCATHETER, THE RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; 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 9708223 ↗
• MalfunctionAug 28, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL, TOOK THE RUBY COIL OUT AND REINSERTED THE SAME MICROCATHETER INTO THE PATIENT'S BODY. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL AND THEN REMOVED THE RUBY COIL. 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 8940766 ↗
• 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 8734930 ↗
• MalfunctionJun 7, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND REPORTED THAT THE RUBY COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED 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 8678877 ↗
• MalfunctionMay 21, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERIPHERAL ANATOMY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL THROUGH ITS INTRODUCER SHEATH AND REPORTED THAT THE RUBY COIL WOULD NOT ADVANCE PAST THE HUB AND INTO A NON-PENUMBRA MICROCATHETER. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED 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 8628634 ↗
• MalfunctionFeb 22, 2019Retraction Problem; Failure to Advance; Physical Resistance/Sticking; Retraction Problem; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL MORE THAN 2/3 OF THE WAY THROUGH THE LANTERN. THE RUBY COIL WAS THEN RETRACTED AND RE-ADVANCED, HOWEVER IT BECAME STUCK AT THE SAME PLACE WITHIN THE LANTERN. THE RUBY COIL WAS THEN REMOVED AND THE LANTERN WAS FLUSHED. UPON ADVANCEMENT OF ANOTHER RUBY COIL THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THIS RUBY COIL WAS ALSO REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A THIRD RUBY COIL THROUGH THE LANTERN, AND THE SAME ISSUE AGAIN OCCURRED. THE THIRD RUBY COIL WAS THEN REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME LANTERN. AFTER THE PROCEDURE, THE RUBY COILS WERE INSPECTED AND WERE FOUND TO HAVE VISIBLE DISINTEGRATION OF THE COIL BRAID NEAR THE DETACHMENT ZONE. IT WAS ALSO REPORTED THAT NO PIECES OF THE DAMAGED COILS WERE LEFT IN THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362727 ↗
• MalfunctionFeb 12, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA CATHETER, THE RUBY COIL WAS COILING INSIDE THE CATHETER AND WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COILS; THEREFORE, THE RUBY COILS AND THE CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND 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 8331138 ↗
• MalfunctionJan 25, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED 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 8279650 ↗
• MalfunctionJan 11, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL BROKE UPON REMOVAL FROM THE DISPENSER HOOP. THE DAMAGED RUBY COIL WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8241937 ↗
• MalfunctionOct 28, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THREE RUBY COILS THROUGH THE HUB OF A NON-PENUMBRA MICROCATHETER AND, THEREFORE, THE MICROCATHETER AND RUBY COILS WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING AN AMPLATZER PLUG WITH THE GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8012368 ↗
• MalfunctionAug 2, 2018Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PULL THE DETACHED COIL OUT FROM THE HUB OF THE MICROCATHETER. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH FOUR OTHER RUBY COILS. IN ADDITION, THE PHYSICIAN SWITCHED TO A NEW MICROCATHETER, BUT THE ISSUE CONTINUED. THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT USING ANY COIL AFTER THE FIFTH RUBY COIL UNINTENTIONAL DETACHMENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7745000 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT ADVANCING INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT SAME ISSUE OCCURRED WITH FOUR OTHER RUBY COILS. UPON TURNING ON THE LIGHTS IN THE OPERATING ROOM, IT WAS NOTICED THAT THE EMBOLIZATION COILS WERE ON THE GROUND. IT WAS CONCLUDED THAT THE FIVE RUBY COILS, UNKNOWINGLY AT THE TIME, HAD DETACHED UPON REMOVAL FROM THE PACKAGING HOOPS PRIOR TO THE ATTEMPTS MADE TO ADVANCE THEM INTO THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL IN THE TARGET VESSEL AND USED A HANDLE TO SUCCESSFULLY DETACH IT; HOWEVER, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, 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 7580723 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Out-Of-Box Failure; Detachment Of Device Component; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ANEURYSM USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT ADVANCING INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT SAME ISSUE OCCURRED WITH FOUR OTHER RUBY COILS. UPON TURNING ON THE LIGHTS IN THE OPERATING ROOM, IT WAS NOTICED THAT THE EMBOLIZATION COILS WERE ON THE GROUND. IT WAS CONCLUDED THAT THE FIVE RUBY COILS, UNKNOWINGLY AT THE TIME, HAD DETACHED UPON REMOVAL FROM THE PACKAGING HOOPS PRIOR TO THE ATTEMPTS MADE TO ADVANCE THEM INTO THE MICROCATHETER. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL IN THE TARGET VESSEL AND USED A HANDLE TO SUCCESSFULLY DETACH IT; HOWEVER, IT WAS REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, 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 7580720 ↗
• MalfunctionMay 25, 2018Detachment Of Device Component; Kinked; Detachment Of Device Component; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED AND STOPPED ADVANCING. UPON PULLING BACK, THE RUBY COIL DETACHED IN ITS INTRODUCER SHEATH; THEREFORE, THE INTRODUCER SHEATH WAS REMOVED FROM THE MICROCATHETER. 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 7545625 ↗
• MalfunctionApr 11, 2018Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET LOCATION USING A LANTERN DELIVERY MICROCATHETER (LANTERN), HOWEVER THE RUBY COIL DID NOT TAKE ITS SHAPE. THE PHYSICIAN THEREFORE REMOVED THE RUBY COIL AND COMPLETED THE PROCEDURE 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 7422380 ↗
• MalfunctionMar 14, 2018Physical Resistance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY TO TREAT A TYPE II ENDOLEAK USING RUBY COILS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET LOCATION, AND THOUGH THE PHYSICIAN WAS USING CONTINUOUS FLUSH, BLOOD ENTERED THE INTRODUCER SHEATH OF A RUBY COIL AS THE TECHNICIAN ATTEMPTED TO ADVANCE THE RUBY COIL. THE TECHNICIAN FELT RESISTANCE ADVANCING THE RUBY COIL, AND THEREFORE THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS PLACED. THE PHYSICIAN REPOSITIONED THE LANTERN AND THEN ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER THE TECHNICIAN FELT RESISTANCE ADVANCING THE RUBY COIL WITHIN ITS INTRODUCER SHEATH, AND THEREFORE THE RUBY COIL WAS REMOVED. A NEW RUBY COIL WAS THEN SUCCESSFULLY PLACED. THE TECHNICIAN THEN AGAIN FELT RESISTANCE ADVANCING ANOTHER RUBY COIL WITHIN ITS INTRODUCER SHEATH, AND THE RUBY COIL WAS THEREFORE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN, A NEW RUBY COIL, A POD5, AND A POD PACKING COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7337711 ↗
• MalfunctionJan 17, 2018Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HYPOGASTRIC ARTERY USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COILS THROUGH THE LANTERN, THE HOSPITAL TECHNOLOGISTS INADVERTENTLY KINKED THE COILS PUSHER ASSEMBLIES; THEREFORE, THEY WERE REMOVED. THE PROCEDURE CONTINUED BY PLACING A NEW RUBY COIL IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH THE LANTERN, THE HOSPITAL TECHNOLOGIST INADVERTENTLY PULLED THE LANTERN OUT OF THE VESSEL WHICH CAUSED THE COIL TO UNINTENTIONALLY DETACH INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER PODJ 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 7200861 ↗
• MalfunctionJan 3, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE INITIALS COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT MID-WAY THROUGH THE PROCEDURE, THE PHYSICIAN DECIDED TO SWITCH TO A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO PLACE THE TWELFTH RUBY COIL INTO THE ANEURYSM USING THE NEW MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND RETRIEVED THE RUBY COIL BACK INTO THE MICROCATHETER. THE PHYSICIAN THEN REPOSITIONED THE MICROCATHETER AND RUBY COIL SEVERAL TIMES, THEN ATTEMPTED TO PUSH THE RUBY COIL INTO THE ANEURYSM; HOWEVER, DURING THE REPOSITIONING ATTEMPTS, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME SEVERELY KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ADDITIONAL RUBY COILS AND POD COILS WITHOUT ISSUES. IT SHOULD BE NOTED THAT THERE WAS NO NOTED DAMAGE TO THE LANTERN AFTER REMOVAL. THE PHYSICIAN JUST WANTED TO USE A NEW MICROCATHETER BECAUSE OF THE PATIENT ANATOMY TORTUOSITY. THERE WAS N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7162834 ↗
• MalfunctionNov 3, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED; 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 Consequences Or Impact To Patient

  MAUDE report 7000895 ↗
• MalfunctionOct 16, 2017Detachment Of Device Component; Physical Resistance; Detachment of Device or Device Component; Detachment Of Device Component; Physical Resistance; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN THE LUMBAR ARTERY USING A RUBY COIL. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE LANTERN WITH THE DETACHED COIL; HOWEVER, THE COIL UNRAVELED AND STAYED IN THE PATIENT¿S BODY. IT WAS REPORTED THAT PART OF THE DETACHED COIL WAS OUT OF THE ACCESS SHEATH AND THEREFORE, THE PHYSICIAN PULLED THE RUBY COIL OUT BY HAND. THE PROCEDURE WAS STOPPED AT THIS POINT. IN ADDITION, THERE WAS NO NOTED DAMAGE TO THE LANTERN AFTER REMOVAL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6952254 ↗