LP Coil System RBYLP0210Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00815948021761), received between Mar 17, 2020 and Dec 27, 2022 — classified as 41 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR UPPER GASTRIC ARTERY USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PENUMBRA COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN REMOVED THE HANDLE AND USED A NEW HANDLE TO DETACH THE SAME COIL. NEXT, WHILE ATTEMPTING TO EMBOLIZE THE VESSEL, THE PHYSICIAN NOTICED THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SALINE TO FLUSH THE MICROCATHETER AND PUSH THE DETACHED RUBY COIL LP INTO THE VESSEL. SUBSEQUENTLY, WHILE ADVANCING ANOTHER RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN NOTICED THE RUBY COIL LP STARTED TO TAKE ITS INTENDED SHAPE WITHIN THE MICROCATHETER. THEREFORE, RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS 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 16052428 ↗
• MalfunctionJun 29, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. HOWEVER, WHILE RETRACTING THE COIL, THE PHYSICIAN NOTICED THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DETACHED RUBY COIL LP WAS PARTIALLY IN THE MICROCATHETER AND PARTIALLY INSIDE THE TARGET LOCATION. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE RUBY COIL LP TO PUSH THE DETACHED PORTION OF THE COIL THAT WAS IN THE MICROCATHETER INTO THE TARGET VESSEL. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS ABLE TO PUSH MAJORITY OF THE DETACHED RUBY COIL LP INTO THE TARGET VESSEL; HOWEVER, THE PROXIMAL PORTION REMAINED OUTSIDE THE VESSEL. THE PHYSICIAN DETERMINED THE PROXIMAL PORTION OF THE RUBY COIL LP THAT WAS OUTSIDE THE VESSEL WAS SAFE AND DECIDED TO LEAVE THE COIL IN PLACE. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE VESSEL AND ATTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861152 ↗
• MalfunctionMar 9, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO REPOSITION THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A SALINE INJECTION TO PUSH THE RUBY COIL LP INTO THE VESSEL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716467 ↗
• MalfunctionDec 1, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE NEXT RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACHED IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP MIDWAY, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITH MOST OF THE RUBY COIL LP WITHIN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO LEAVE THE RUBY COIL LP IN PLACE. THE COIL EMBOLIZATION PORTION OF THE PROCEDURE WAS COMPLETED AT THIS POINT, THE PHYSICIAN THEN COMPLETED THE REST OF THE PROCEDURE USING BEADS 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 12912995 ↗
• MalfunctionNov 27, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE UPON INITIAL ADVANCEMENT OF THE COIL AND THAT RESISTANCE WAS STILL EXPERIENCED AFTER CHANGING THE PLACEMENT OF FINGERS ON THE PUSHER ASSEMBLY. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP; THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879932 ↗
• MalfunctionNov 22, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC AND OTHER FEEDERS FROM PROFUNDA ARTERY USING RUBY COIL LPS AND LP SYSTEM DETACHMENT HANDLE (HANDLE). IT SHOULD BE NOTED THAT THE PATIENT'S VESSEL WAS VERY SMALL AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE ON THE RUBY COIL LP WAS SEPARATED BY APPROXIMATELY 5MM BUT THE RUBY COIL LP WOULD NOT DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE BUT THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP; HOWEVER, A VESSEL SPASM OCCURRED AND THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS REPORTED THAT THE VESSEL SPASM WAS NOT DIRECTLY RELATED TO THE RUBY COIL LP AND WAS CONSIDERED RESOLVED. IT WAS ALSO REPORTED THAT THREE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858172 ↗
• MalfunctionNov 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS BECAME STUCK WHILE ADVANCING THROUGH THE MICROCATHETER. THEREFORE, BOTH RUBY COIL LPS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12821309 ↗
• MalfunctionNov 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS BECAME STUCK WHILE ADVANCING THROUGH THE MICROCATHETER. THEREFORE, BOTH RUBY COIL LPS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12819788 ↗
• MalfunctionNov 2, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTICED THE DETACHMENT ZONE ON THE PROXIMAL END FOR BOTH RUBY COIL LPS WAS SLIGHTLY SEPARATED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS WITH THE SAME HANDLE AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741315 ↗
• MalfunctionOct 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC BRANCHES USING A RUBY COIL LP AND A MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682571 ↗
• MalfunctionOct 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT GASTRIC BRANCH USING RUBY COIL LPS, PACKING COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE LEFT GASTRIC BRANCH USING THE FIRST MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP USING A NEEDLE DRIVER BUT, THE COIL STILL FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH FIVE RUBY COIL LPS AND FOUR PACKING COIL LPS IN THE TARGET LOCATION USING THE HANDLE. THEREFORE, THE PHYSICIAN USED THE NEEDLE DRIVER TO MANUALLY DETACH THE PACKING COIL LPS AND RUBY COIL LPS. NEXT, WHILE ATTEMPTING TO PLACE A RUBY COIL IN THE RIGHT GASTRIC BRANCH, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE TIP OF THE SECOND MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619508 ↗
• MalfunctionOct 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT AND RIGHT GASTRIC BRANCH USING RUBY COIL LPS, PACKING COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE LEFT GASTRIC BRANCH USING THE FIRST MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP USING A NEEDLE DRIVER BUT, THE COIL STILL FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH FIVE RUBY COIL LPS AND FOUR PACKING COIL LPS IN THE TARGET LOCATION USING THE HANDLE. THEREFORE, THE PHYSICIAN USED THE NEEDLE DRIVER TO MANUALLY DETACH THE PACKING COIL LPS AND RUBY COIL LPS. NEXT, WHILE ATTEMPTING TO PLACE A RUBY COIL IN THE RIGHT GASTRIC BRANCH, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE TIP OF THE SECOND MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619501 ↗
• MalfunctionSep 22, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE HANDLE MADE A CLICKING SOUND BUT THE RUBY COIL LP WOULD NOT DETACH FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE RUBY COIL LP BY USING A HEMOSTAT, BUT THE RUBY COIL LP STILL FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN ALSO TRIED DETACHING THE RUBY COIL LP BY USING A HEMOSTAT; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS OF A LARGER SIZE, A RUBY COIL DETACHMENT HANDLE, 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 12517040 ↗
• MalfunctionAug 27, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375821 ↗
• MalfunctionAug 26, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST ATTEMPTED TO ADVANCE A RUBY COIL LP OUT OF ITS INTRODUCER SHEATH; HOWEVER, THE RUBY COIL LP WOULD NOT ADVANCE AT ALL. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP 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 12375367 ↗
• MalfunctionAug 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERY (RIMA) USING RUBY COIL LPS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE PAST THEIR FRICTION LOCKS WITHIN THEIR INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS 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 12363249 ↗
• MalfunctionJul 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED ONE RUBY COIL LP INTO THE TARGET LOCATION. THEN WHILE ATTEMPTING TO ADVANCE OTHER TWO RUBY COIL LPS, THE RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITION WITHIN THEIR INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER NON-PENUMBRA COILS 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 12194319 ↗
• MalfunctionMay 30, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905894 ↗
• MalfunctionMay 14, 2021Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OFF POSTERIOR TIBIAL ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS UNABLE TO ADVANCE PAST THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO MODIFY HAND PLACEMENT WITH THE RUBY COIL LP TO DISENGAGE THE FRICTION LOCK TO TROUBLESHOOT; HOWEVER, WHILE TROUBLESHOOTING, THE RUBY COIL LP DETACHED FROM THE PUSHER ASSEMBLY BEFORE ENTERING THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE NEXT THREE RUBY COIL LPS PAST THE FRICTION LOCK. IT WAS ALSO REPORTED WHILE ATTEMPTING TO USE THE SAME TROUBLESHOOTING TECHNIQUE, ALL THREE RUBY COIL LPS DETACHED FROM THE PUSHER ASSEMBLY WITHIN THE INTRODUCER SHEATH BEFORE ENTERING THE MICROCATHETER. THEREFORE, ALL THREE RUBY COIL LPS WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, OTHER COILS, 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 11827302 ↗
• MalfunctionMay 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A RUBY COIL LP AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11809871 ↗
• MalfunctionMay 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS KINKED WHILE LOADING INTO THE MICRO-CATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787275 ↗
• MalfunctionApr 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11747034 ↗
• MalfunctionApr 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTROINTESTINAL BLEEDING (GI BLEED) USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATHS. THEREFORE, RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711302 ↗
• MalfunctionApr 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING A PACKING COIL LP, RUBY COIL LPS, AND MICROCATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT A PACKING COIL LP AND TWO RUBY COIL LPS WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS AND RUBY COIL LPS. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699859 ↗
• MalfunctionApr 15, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A TRANSARTERIAL ENDOLEAK USING RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO COILS. WHEN DEPLOYING THE THIRD AND FINAL COIL, A RUBY COIL LP, THE PUSHER ASSEMBLY WAS BENT PROXIMALLY ABOUT AN INCH FROM THE BLACK ALIGNMENT ZONE. THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL LP BY HAND BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAD ATTEMPTED TO GO BACK AND FORTH WITH THE END OF THE PUSHER ASSEMBLY, BUT THE RUBY COIL LP WOULD NOT DETACH. THEREFORE, THE PHYSICIAN PULLED THE RUBY COIL LP OUT. THE PROCEDURE WAS COMPLETED BY USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675950 ↗