LP Coil System RBYLP0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00815948021754), received between Jun 26, 2020 and Apr 28, 2025 — classified as 1 injury, 75 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (51 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MICRO VESSEL USING A RUBY COIL LP, A POD COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER, AND THE COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PHYSICIAN REINSERTED THE MICROCATHETER BACK INTO THE VESSEL AND WAS ADVANCING A POD COIL THROUGH THE MICROCATHETER. HOWEVER, THE POD COIL WOULD NOT ADVANCE OUT FROM THE MICROCATHETER, AND THE PHYSICIAN NOTICED THE POD COIL HAD UNINTENTIONALLY DETACHED. THE MICROCATHETER WAS REMOVED CONTAINING THE DETACHED POD COIL AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A NEW POD COIL, 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 21920765 ↗
• MalfunctionJun 28, 2024Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FIFTH TO SIXTH BRANCH OF THE RIGHT HEPATIC ARTERY USING A RUBY COIL LP, A LP SYSTEM DETACHMENT HANDLE (LP HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE LP HANDLE; HOWEVER, THE RUBY COIL LP DID NOT DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP, WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP FROM THE MICROCATHETER, THE RUBY COIL LP BECAME STUCK AND SUBSEQUENTLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL LP WAS REMOVED AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING 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 19639528 ↗
• MalfunctionMar 21, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LP, TWO LP SYSTEM DETACHMENT HANDLES (LP HANDLES), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE RUBY COIL LP USING THE LP HANDLE; HOWEVER, THE RUBY COIL LP DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SALINE TO PUSH THE RUBY COIL LP INTO THE TARGET LOCATION. NEXT, A SECOND RUBY COIL LP WAS ADVANCED TO THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL LP WITH ANOTHER HANDLE; HOWEVER, THE RUBY COIL LP COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE RUBY COIL LP WAS ALSO IMPLANTED IN THE TARGET LOCATION USING SALINE INJECTION. THE PROCEDURE WAS COMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588248 ↗
• MalfunctionMar 21, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LP, TWO LP SYSTEM DETACHMENT HANDLES (LP HANDLES), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE RUBY COIL LP USING THE LP HANDLE; HOWEVER, THE RUBY COIL LP DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SALINE TO PUSH THE RUBY COIL LP INTO THE TARGET LOCATION. NEXT, A SECOND RUBY COIL LP WAS ADVANCED TO THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL LP WITH ANOTHER HANDLE; HOWEVER, THE RUBY COIL LP COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE RUBY COIL LP WAS ALSO IMPLANTED IN THE TARGET LOCATION USING SALINE INJECTION. THE PROCEDURE WAS COMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588247 ↗
• MalfunctionSep 13, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A RADIOEMBOLIZATION PROCEDURE (Y90) IN THE LIVER USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. WHILE ATTEMPTING TO USE ANOTHER RUBY COIL LP, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RUBY COIL LP OUT OF ITS INTRODUCER SHEATH. SUBSEQUENTLY, WHILE ADVANCING THE SAME RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN AND THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND THE RUBY COIL LP PARTIALLY BROKE IN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A HEMOSTAT AND A SYRINGE AND REMOVED THE BROKEN RUBY COIL LP. IT WAS REPORTED THAT A PART OF THE COIL WAS ATTACHED TO THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING 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 15414486 ↗
• 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 14860848 ↗
• MalfunctionFeb 16, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COIL LP, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP. THE PHYSICIAN THEN PERFORMED A CONTRAST RUN AND NOTICED THAT THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER AND WAS PUSHED TO THE TARGET LOCATION BY THE FORCE OF CONTRAST. 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 13544658 ↗
• MalfunctionDec 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS, PACKING COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP AND PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH THE COILS USING THE HANDLE; HOWEVER, THE RUBY COIL LP AND PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP AND PACKING COIL LP AND DETACHED ANOTHER RUBY COIL LP AND PACKING COIL LP IN THE TARGET VESSEL WITHOUT ISSUE. WHILE ATTEMPTING TO DETACH ANOTHER RUBY COIL LP IN A LARGER VESSEL, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP AND SUCCESSFULLY DETACHED ANOTHER RUBY COIL LP IN THE TARGET VESSEL WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961009 ↗
• MalfunctionNov 18, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A MUSCULAR BRANCH OF THE LEFT BICEP USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THREE OTHER RUBY COIL LPS. THEREFORE, THE RUBY COIL LPS WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840706 ↗
• MalfunctionNov 2, 2021Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE RUBY COIL LP BROKE IN HALF. 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 12741060 ↗
• MalfunctionSep 28, 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 GASTRIC ARTERY USING RUBY COIL LPS. DURING THE PROCEDURE, WHEN THE HOSPITAL TECH WAS ADVANCING A RUBY COIL, THE COIL WAS STUCK IN THE INTRODUCER SHEATH. SUBSEQUENTLY, THEY BENT THE PUSHER ASSEMBLY, MAKING THE COIL UNABLE TO PUSH THROUGH INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541938 ↗
• MalfunctionSep 20, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATHS. THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LP COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496227 ↗
• MalfunctionSep 15, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FISTULA USING RUBY COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP THROUGH THE MICROCATHETER AND ATTEMPTED TO DETACH THE RUBY COIL LP. THE RUBY COIL LP WOULD NOT DETACH WITH THE HANDLE. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. A RUBY COIL WAS THEN ADVANCED THROUGH THE MICROCATHETER, BUT THE RUBY COIL BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478063 ↗
• MalfunctionSep 12, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PENUMBRA COILS INTO THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL LP AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457843 ↗
• MalfunctionSep 10, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECH KINKED THE RUBY COIL LP UPON ADVANCING IT INTO THE LANTERN. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP 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 12455796 ↗
• 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 12363247 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SEVERAL RUBY COIL LPS IN THE TARGET LOCATION USING THE HANDLE. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL LP IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP, THE SAME HANDLE 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 12344365 ↗
• MalfunctionJul 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY (LGA) USING RUBY COIL LPS. DURING THE PROCEDURE, FOUR RUBY COIL LPS WOULD NOT ADVANCE PAST THEIR FRICTION LOCKS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE 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 12228700 ↗
• MalfunctionJul 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY (LGA) USING RUBY COIL LPS. DURING THE PROCEDURE, FOUR RUBY COIL LPS WOULD NOT ADVANCE PAST THEIR FRICTION LOCKS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE 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 12228340 ↗
• MalfunctionJul 22, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED FROM THE HUB OF THE MICROCATHETER AND THE PHYSICIAN MADE ADDITIONAL ATTEMPTS TO ADVANCE THE COIL ON THE BACK TABLE WITHOUT SUCCESS. THEREFORE, THE RUBY COIL LP WAS NOT USED IN THE PROCEDURE. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL LP INTO THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED AND THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL 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 12208141 ↗
• MalfunctionJul 20, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE RUBY COIL LP IN THE TARGET VESSEL; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS ALSO REPORTED THAT THE DETACHMENT MECHANISM DID NOT FUNCTION PROPERLY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197570 ↗
• MalfunctionJul 19, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY 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. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189648 ↗
• MalfunctionJun 22, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTIC ENDOLEAK USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK, AND THE PUSHER ASSEMBLY KINKED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LP COIL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041716 ↗
• 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 11827270 ↗
• 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 11827254 ↗