LP Coil System RBYLP0415Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00815948021815), received between Jul 15, 2020 and Dec 31, 2024 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (25 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2024Migration; Difficult or Delayed Separation; Migration; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROXIMAL GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP AND A MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MINIMALLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE COIL MANUALLY; HOWEVER, THE RUBY COIL LP DID NOT DETACH. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO DETACH THE RUBY COIL LP BY PULLING HARDER ON THE PULL WIRE. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE RUBY COIL LP EVENTUALLY DETACHED BY RETRACTING THE PUSHER ASSEMBLY. HOWEVER, APPROXIMATELY FIVE CENTIMETERS OF THE COIL STILL REMAINED IN THE MICROCATHETER. THE PHYSICIAN THEN USED SALINE TO FLUSH THE REMAINING PART OF THE RUBY COIL LP INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE RUBY COIL LP WAS UNSTABLE AND MIGRATED TO A MORE DISTAL POSITION OF THE GDA. THE PHYSICIAN DECIDED TO LEAVE THE RUBY COIL LP IN THE DISTAL PART OF THE GDA SINCE THERE WERE ENOUGH COLLATERAL VESSELS IN THE SURROUNDING AREA THAT WOULD PROVIDE PERFUSION. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COIL LPS AND THE SAME MICROCATHETER. IT WAS REPORTED THERE WAS N

  Patient problems: Foreign Body In Patient

  MAUDE report 21049596 ↗
• MalfunctionNov 7, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A RUBY COIL LP, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COIL LPS INTO THE TARGET VESSEL USING THE HANDLE. WHILE ADVANCING A THIRD RUBY COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE ATTEMPTING TO RETRACT THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN USED A HEMOSTAT TO REMOVE THE LANTERN CONTAINING THE DETACHED RUBY COIL LP. AFTER REMOVAL OF THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WAS ALSO STRETCHED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED AT THIS POINT. IT WAS REPORTED THAT THE TARGET VESSEL WAS SUFFICIENTLY EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20635994 ↗
• MalfunctionJan 8, 2024Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING A RUBY COIL LP AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE RUBY COIL LP IN THE TARGET VESSEL. WHILE ADVANCING A SECOND RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP BECAME KINKED. WHILE RETRACTING THE RUBY COIL LP FOR REMOVAL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME MICROCATHETER AND 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 18469908 ↗
• MalfunctionMay 15, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE LUMBAR ARTERY TO USING RUBY COIL LPS, AN LP DETACHMENT HANDLE SYSTEM, AND A MICROCATHETER. IT WAS REPORTED THAT 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 WITH THE HANDLE; HOWEVER, THE RUBY COIL LP WOULD NOT DETACH. THEN, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP WITHOUT SUCCESS. NEXT, WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SALINE INJECTION TO PUSH THE RUBY COIL LP INTO THE TARGET LOCATION AND USED THE PUSHER ASSEMBLY TO PACK THE RUBY COIL LP INTO POSITION. NEXT, THE SAME ISSUE OCCURRED WITH A SECOND RUBY COIL. THEREFORE, THE RUBY COIL LP WAS ALSO IMPLANTED INTO THE TARGET LOCATION USING SALINE INJECTION AND THE PUSHER ASSEMBLY TO PACK THE RUBY COIL LP INTO POSITION. 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 16928456 ↗
• MalfunctionNov 14, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  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, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL LP THROUGH THE DISTAL END OF THE MICROCATHETER AND INTO THE TARGET VESSEL. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL LP INTO THE VESSEL; HOWEVER, THE SAME ISSUE OCCURRED. CONSEQUENTLY, THE PHYSICIAN WAS MANIPULATING THE RUBY COIL LP WHEN THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SALINE TO PUSH THE DETACHED RUBY COIL LP INTO THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN ADVANCED THE NEXT RUBY COIL LP, BUT THE COIL WOULD NOT ADVANCE PAST THE DISTAL END OF THE MICROCATHETER AGAIN; THEREFORE, BOTH THE RUBY COIL LP AND MICROCATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794451 ↗
• MalfunctionNov 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, TWO RUBY COIL LPS WOULD NOT ADVANCE PAST THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT ONE RUBY COIL LP IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901570 ↗
• MalfunctionNov 30, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OFF THE OVARIAN VEIN USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 12901485 ↗
• MalfunctionNov 22, 2021Failure to Advance; Failure to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12850641 ↗
• MalfunctionNov 8, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL LP AND RUBY COIL BECAME KINKED WHILE ADVANCING THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL LP AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775258 ↗
• MalfunctionOct 31, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND INFERIOR MESENTERIC ARTERY (IMA) ENDOLEAK SAC USING PACKING COIL LPS, RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE PACKING COIL LP USING A HEMOSTAT, BUT THE COIL STILL WOULD NOT DETACH. THEREFORE, THE PACKING COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH TWO RUBY COIL LPS IN THE TARGET LOCATION USING THE SAME HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO DETACH THE SAME RUBY COILS USING A NEW HANDLE, BUT THE TWO RUBY COIL LPS WOULD NOT DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE TWO RUBY COIL LPS USING A HEMOSTAT; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE TWO RUBY COIL LPS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW LP COILS WITH A HEMOSTAT AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725691 ↗
• MalfunctionOct 29, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; 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, THE HOSPITAL TECHNOLOGIST MADE MULTIPLE ATTEMPTS TO ADVANCE THE RUBY COIL LP OUT OF THE INTRODUCER SHEATH; HOWEVER, THE RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE FROM THE STARTING POSITION. 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 12724805 ↗
• MalfunctionOct 15, 2021Failure to Advance; Failure to Advance

  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, WHILE ATTEMPTING TO ADVANCE A RUBY COIL LP, THE 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 A SECOND RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. IT WAS REPORTED THAT THE HOSPITAL STAFF ATTEMPTED TO TROUBLESHOOT THE ISSUES BY REPOSITIONING THE PLACEMENT OF HANDS ON THE RUBY COIL LPS, FLUSHING THE RUBY COIL LPS, AND PULLING THE COILS BACK; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ONE RUBY COIL LP AND TWO PACKING COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642710 ↗
• MalfunctionSep 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY USING A RUBY COIL LP. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT AN ATTEMPT TO TROUBLESHOOT BY PULLING BACK ON THE PUSHER ASSEMBLY AND THEN RE-ADVANCING WAS MADE; HOWEVER, IT WAS UNSUCCESSFUL. 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 12530547 ↗
• MalfunctionJul 22, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT CORONARY ARTERY DISEASE (CAD) USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A 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. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL LP, THE SAME ISSUE OCCURRED; THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND PENUMBRA SMART COILS (SMART COIL). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211944 ↗
• MalfunctionJul 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS AND LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL LPS WERE REMOVED. DURING THE SAME PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH ANOTHER COIL USING THE HANDLE; THEREFORE, A NEW HANDLE WAS OPENED, AND THE COIL WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LP AND NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12192384 ↗
• MalfunctionJun 10, 2021Failure to Advance; Failure to Advance

  THE PROCEDURE WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL SUPERIOR MESENTERIC ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. 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 11977652 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  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, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL LP IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL LP IN THE MICROCATHETER, THE RUBY COIL LP WAS UNABLE TO ADVANCE FURTHER AFTER APPROACHING THE MIDPOINT OF THE MICROCATHETER. THE RUBY COIL LP WAS THEN REMOVED. SUBSEQUENTLY, ANOTHER RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11695368 ↗
• MalfunctionMar 27, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THREE RUBY COIL LPS WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN THE INTRODUCER SHEATH. THEREFORE, ALL THREE RUBY COIL LPS WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH 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 11579670 ↗
• MalfunctionMar 4, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK OF THE INFERIOR MESENTERIC ARTERY (IMA) AND SUPERFICIAL FEMORAL ARTERY (SFA) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A 5FR CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. 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 EVEN AFTER THE ALIGNMENT ZONE (PET LOCK) HAD SEPARATED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL LP TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; BUT THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. HOWEVER, WHILE RETRACTING THE RUBY COIL LP, THE PHYSICIAN NOTICED THE COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER UNDER FLUOROSCOPY. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO FLUSH THE RUBY COIL LP, BUT THE COIL WAS STUCK WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN ATTEMPTED TO PUSH THE RUBY COIL LP THROUGH THE MICROCATHETER USING THE PUSHER ASSEMBLY; HOWEVER, ACCESS WAS LOST WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11418309 ↗
• MalfunctionJan 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, BOTH RUBY COIL LPS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 11255055 ↗
• MalfunctionJan 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, BOTH RUBY COIL LPS WERE 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; No Consequences Or Impact To Patient

  MAUDE report 11255043 ↗
• MalfunctionDec 17, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP. 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 RUBY COIL. 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 11033176 ↗
• MalfunctionNov 22, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. AFTERWARDS, THE SAME ISSUE OCCURRED WITH THE SECOND RUBY COIL LP. THE RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. 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 10881656 ↗
• MalfunctionNov 17, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AFTER SEVERAL ATTEMPTS WERE MADE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS. 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 10857014 ↗
• MalfunctionNov 17, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED RUBY COIL LPS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL LP 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 10853766 ↗