LP Coil System RBYLP0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00815948021785), received between Jul 24, 2020 and May 27, 2025 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (23 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT COLIC BRANCH USING A RUBY COIL LP, A LP DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A DOUBLE ANGLE GLIDE WIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP USING THE MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP WITHOUT SUCCESS. IT WAS REPORTED THAT THE RUBY COIL LP PUSHER ASSEMBLY KINKED IN MULTIPLE LOCATIONS AND WAS EVENTUALLY CUT WITH SCISSORS; HOWEVER, THE COIL STILL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO RETRACT THE RUBY COIL LP, BUT THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. SALINE WAS THEN USED TO PUSH THE RUBY COIL LP 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22092549 ↗
• MalfunctionDec 12, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE. IT WAS REPORTED THAT THE BLACK MARKER BAND OF THE RUBY COIL LP WAS SEPARATED; HOWEVER, UPON RETRACTING THE RUBY COIL LP, THE PHYSICIAN NOTICED THE COIL WAS STILL ATTACHED TO THE PUSHER ASSEMBLY. AN ATTEMPT WAS MADE TO MANUALLY BREAK THE BACK END OF THE RUBY COIL LP AND REMOVE THE INNER DETACHMENT WIRE, BUT THE COIL STILL WOULD NOT DETACH. THE PHYSICIAN THEN PULLED BACK ON THE PUSHER ASSEMBLY WHEN THE RUBY COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE WITH SALINE TO PUSH THE DETACHED RUBY COIL LP INTO THE TARGET LOCATION AND SUCCESSFULLY IMPLANT THE COIL. IT WAS ALSO REPORTED THAT THE PHYSICIAN REMOVED AND SWITCH TO A NEW MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A POD COIL, SAME HANDLE, 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 18311277 ↗
• MalfunctionApr 7, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY USING RUBY COILS, RUBY COIL LPS, A POD COIL, A LP DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE POD COIL. IT WAS REPORTED THE PATIENT¿S ANATOMY WAS TORTUOUS. THE PHYSICIAN THEN ADVANCED A RUBY COIL USING THE MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE RUBY COIL USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE NEXT RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER AND THE RUBY COIL LP. CONSEQUENTLY, THE RUBY COIL LP UNINTENTIONALLY DETACHED IN THE RIGHT HEPATIC ARTERY. THEREFORE, THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO REMOVE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704207 ↗
• MalfunctionMar 8, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INTERNAL GLUTEAL PSEUDOANEURYSM USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER AND GEL FOAM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500652 ↗
• MalfunctionMay 21, 2022Physical Resistance/Sticking; Difficult or Delayed Separation; Premature Separation; Physical Resistance/Sticking; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), 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. IT WAS REPORTED THAT MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO ADVANCE THE RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL LP IN THE TARGET VESSEL USING THE HANDLE. THEN, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP BY BREAKING THE PUSHER ASSEMBLY IN SEVERAL LOCATIONS. IT WAS REPORTED THAT THE RUBY COIL LP DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE TARGET VESSEL. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE (0.035¿) THROUGH THE MICROCATHETER TO PUSH THE REST OF THE RUBY COIL LP OUT OF THE MICROCATHETER AND INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465960 ↗
• MalfunctionApr 5, 2022Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) TO TREAT A GASTROINTESTINAL (GI) BLEED USING PACKING COIL LPS, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE THE PACKING COIL LP, THE PHYSICIAN FELT THE PACKING COIL LP TO BE STIFF AND KICKING BACK AND WAS UNABLE TO PACK IT IN THE TARGET VESSEL. SUBSEQUENTLY, THE PACKING COIL LP UNINTENTIONALLY DETACHED, AND THE PHYSICIAN TRIED TO PUSH THE PACKING COIL LP USING THE PUSHER ASSEMBLY; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE PACKING COIL LP THEN DISLODGED THE PREVIOUSLY PLACED RUBY COIL LP AND THE RUBY COIL LP MIGRATED INTO A SMALL VESSEL IN THE SUPERIOR MESENTERIC ARTERY. THE PACKING COIL LP WAS LEFT PARTIALLY IN THE TARGET VESSEL AND PARTIALLY IN THE COMMON HEPATIC ARTERY. ATTEMPTS WERE MADE TO RETRIEVE THE PACKING COIL LP AND RUBY COIL LP BY USING A SNARE DEVICE WITHOUT SUCCESS. THE PHYSICIAN ALSO TRIED USING A BALLOON TO PUSH THE COILS INTO THE TARGET VESSEL; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE BLEEDING HAD STOPPED, AND NO ADDITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018079 ↗
• MalfunctionDec 6, 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, WHILE ADVANCING A RUBY COIL LP APPROXIMATELY TEN CENTIMETERS WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN PLACED A NEW RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE NEXT RUBY COIL LP APPROXIMATELY TEN CENTIMETERS WITHIN ITS INTRODUCER SHEATH, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE. 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 12933655 ↗
• 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858159 ↗
• 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 12850628 ↗
• MalfunctionNov 12, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR EPIGASTRIC ARTERY USING RUBY COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (LP HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A LP HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS, BUT IT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND THE SAME LP HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806067 ↗
• MalfunctionOct 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL STAFF KINKED THE RUBY COIL LP UPON INSERTING IT INTO THE LANTERN. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682840 ↗
• MalfunctionOct 21, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER BUT WAS SUBSEQUENTLY UNABLE TO DETACH THE RUBY COIL LP WITH THE HANDLE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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

  MAUDE report 12674182 ↗
• MalfunctionOct 13, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE IN THE LANTERN, AND THE PHYSICIAN EXPERIENCED RESISTANCE. 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 12627965 ↗
• MalfunctionOct 10, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL LP USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. AFTERWARDS, WHILE ADVANCING THE NEXT RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL LP FAILED TO DETACH USING THE HANDLE. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING TWO NEW RUBY COIL LPS, THE SAME HANDLE, AND A NEW 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 12602672 ↗
• MalfunctionAug 19, 2021Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, THE RUBY COIL LP DID NOT DEPLOY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE PROCEDURE WAS COMPLETED USING ANOTHER LP COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345614 ↗
• MalfunctionAug 12, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROEPIPLOIC ARTERY (GEA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITIONS WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL LPS WERE REMOVED. AFTERWARDS, THE TECHNICIAN AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE TWO RUBY COIL LPS OUT OF THEIR RESPECTIVE INTRODUCER SHEATHS ON THE BACK TABLE BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LPS WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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 12316461 ↗
• MalfunctionJul 14, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A GASTRODUODENAL BRANCH USING A RUBY COIL LP AND LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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

  MAUDE report 12164515 ↗
• MalfunctionJun 24, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LATERAL THORACIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL LP THROUGH THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN RESHEATHED THE RUBY COIL LP AND TRIED ADVANCING IT; HOWEVER, HE FELT RESISTANCE AGAIN. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN DECIDED TO USE ANOTHER RUBY COIL LP AND WAS ABLE TO DEPLOY 90% OF THE RUBY COIL LP IN THE TARGET LOCATION; HOWEVER, HE FELT RESISTANCE AND DECIDED TO ADJUST THE MICROCATHETER. HE FELT MORE RESISTANCE AND HENCE DECIDED TO REMOVE THE RUBY COIL LP. WHILE RETRACTING, THE RUBY COIL LP BROKE; HOWEVER THE COIL THAT WAS DEPLOYED WAS SUFFICIENT FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY LEAVING THE DEPLOYED COIL IN THE TARGET VESSEL AND IT WAS THE LAST COIL USED IN THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063972 ↗
• MalfunctionJun 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LATERAL THORACIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL LP THROUGH THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN RESHEATHED THE RUBY COIL LP AND TRIED ADVANCING IT; HOWEVER, HE FELT RESISTANCE AGAIN. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN DECIDED TO USE ANOTHER RUBY COIL LP AND WAS ABLE TO DEPLOY 90% OF THE RUBY COIL LP IN THE TARGET LOCATION; HOWEVER, HE FELT RESISTANCE AND DECIDED TO ADJUST THE MICROCATHETER. HE FELT MORE RESISTANCE AND HENCE DECIDED TO REMOVE THE RUBY COIL LP. WHILE RETRACTING, THE RUBY COIL LP BROKE; HOWEVER THE COIL THAT WAS DEPLOYED WAS SUFFICIENT FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY LEAVING THE DEPLOYED COIL IN THE TARGET VESSEL AND IT WAS THE LAST COIL USED IN THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063971 ↗
• MalfunctionJun 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS (RUBY COIL LP) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THEIR INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014256 ↗
• MalfunctionJun 16, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS (RUBY COIL LP) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE FROM THEIR INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014254 ↗
• MalfunctionJun 10, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) OF THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE OUT FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT 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 11976411 ↗
• MalfunctionJun 7, 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, A RUBY COIL LP WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATHS; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE OTHER RUBY COIL LP; THEREFORE, IT WAS ALSO 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 11952232 ↗
• MalfunctionJun 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT LUMBAR ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED OTHER LP COILS IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE A RUBY COIL LP IN THE TARGET VESSEL, THE HOSPITAL TECHNOLOGIST WAS UNABLE TO ADVANCE THE RUBY COIL LP PAST THE FRICTION LOCK. THE RUBY COIL LP WAS FLUSHED AT THE TRANSITION ZONE WITH SALINE AND THE COIL WAS STRAIGHTENED OUT BUT, THE RUBY COIL LP WOULD NOT ADVANCE FORWARD. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER LP 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 11935714 ↗
• MalfunctionJun 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL LP THROUGH THE LANTERN. THE RUBY COIL LP DID NOT EXIT THE LANTERN AND THE PHYSICIAN NOTICED THE COIL HAD BECOME COILED INSIDE THE LANTERN. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 11914350 ↗