LP Coil System RBYLP0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00815948021723), received between Jun 26, 2020 and Oct 23, 2025 — classified as 1 injury, 40 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A 0.016 GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE RUBY COIL LP INTO THE TARGET VESSEL. A SECOND RUBY COIL LP WAS ADVANCED BUT RETRACTED DUE TO A VASOSPASM. DESPITE ADMINISTRATION OF NITROGLYCERIN, THE RUBY COIL LP COULD NOT BE REPOSITIONED IN THE INTENDED LOCATION. THE MICROCATHETER CONTAINING THE RUBY COIL LP WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL LP WAS UNABLE TO RESHEATH COMPLETELY. THE PHYSICIAN ATTRIBUTED THE VASOSPASM DUE TO THE MANIPULATION OF THE GUIDEWIRE. 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: Vasoconstriction

  MAUDE report 23368430 ↗
• MalfunctionOct 22, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN LEFT EXTERNAL USING RUBY COIL LPS, A PACKING COIL LP, A LP DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COIL LPS AND ONE PACKING COIL LP IN THE TARGET VESSEL. THE PHYSICIAN ADVANCED THE NEXT RUBY COIL LP USING THE MICROCATHETER INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE COIL TWICE USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. HEMOSTATS WERE USED TO BEND THE RUBY COIL LP PUSHER ASSEMBLY, BUT THE EMBOLIZATION COIL STILL DID NOT DETACH. WHILE RETRACTING THE RUBY COIL LP, THE EMBOLIZATION COIL DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT AND FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. IT WAS REPORTED THAT THE PUSHER ASSEMBLY WAS FRACTURED. 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 23356395 ↗
• MalfunctionMay 17, 2024Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT COLIC ARTERY USING RUBY COIL LPS, A LP DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COIL LPS. THE NEXT RUBY COIL LP WAS ADVANCED USING THE MICROCATHETER INTO THE TARGET VESSEL AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL SEVERAL TIMES USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN SUCCESSFULLY FLUSHED THE DETACHED RUBY COIL LP INTO THE TARGET VESSEL USING A 3CC SYRINGE. 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 19345332 ↗
• 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 12840707 ↗
• MalfunctionOct 28, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS, 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 RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS 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 12712013 ↗
• MalfunctionOct 25, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE USING RUBY COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). IT WAS REPORTED THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A RUBY COIL LP WAS UNABLE TO DETACH WITH THE HANDLE. THE PHYSICIAN THEN MANUALLY DETACHED THE RUBY COIL LP WITH A HEMOSTAT AND IMPLANTED THE COIL. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH ANOTHER RUBY COIL LP WITH THE SAME HANDLE. IT WAS REPORTED THIS COIL WAS TOO LONG. THEREFORE, THE RUBY COIL LP WAS REMOVED. 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 12694958 ↗
• MalfunctionOct 13, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT HUMERUS TUMOR USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE LEFT AXILLARY AND BRACHIAL ARTERY, WHERE THE BRANCHES WERE FEEDING THE TUMOR, USING THE MICROCATHETER. A RUBY COIL LP WAS ADVANCED TO DESIRED TUMOR BRANCH BUT SUBSEQUENTLY WOULD NOT DETACH WITH THE HANDLE. MULTIPLE ATTEMPTS WERE PERFORMED WITHOUT DETACHMENT. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND THE SAME HANDLE. AFTER THE RUBY COIL LP WAS REMOVED FROM PATIENT, THE HOSPITAL INTERVENTIONAL RADIOLOGY (IR) TECH BROKE AND PULLED THE PUSHER ASSEMBLY TO MANUALLY DETACH THE COIL, BUT THE RUBY COIL LP WAS UNABLE TO DETACH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628406 ↗
• 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 12619473 ↗
• MalfunctionOct 12, 2021Separation Failure; Separation Failure

  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 12619467 ↗
• MalfunctionAug 25, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE THORACOACROMIAL ARTERY USING RUBY COIL LPS, PACKING COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS REPORTED THAT SEVERAL RUBY COIL LPS WERE PLACED SUCCESSFULLY BEFORE AND AFTER ENCOUNTERING THE ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12367358 ↗
• MalfunctionAug 20, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE TO TWO COILS IN THE TARGET LOCATION. SUBSEQUENTLY, THE NEXT COIL, A RUBY COIL LP, WOULD NOT DETACH WITH THE HANDLE OR MANUALLY. THEREFORE, THE RUBY COIL LP AND HANDLE WERE REMOVED. 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 12351100 ↗
• MalfunctionAug 11, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST ADVANCED THE RUBY COIL LP INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DID NOT LIKE THE INITIAL PLACEMENT OF THE RUBY COIL LP. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL LP TO REPOSITION IT, THE HOSPITAL TECHNOLOGIST BENT THE PUSHER ASSEMBLY OF THE RUBY COIL LP. 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 12307859 ↗
• MalfunctionJul 28, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROFUNDA FEMORAL ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL LP WITHIN THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL BECAME STUCK AFTER ADVANCING A SHORT DISTANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. 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 12242792 ↗
• MalfunctionJul 28, 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, A RUBY COIL LP WAS STUCK AND 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 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 12242634 ↗
• MalfunctionJul 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP ADVANCED SLIGHTLY IN THE INTRODUCER SHEATH BUT WOULD THEN STOP ADVANCING. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE A SECOND RUBY COIL LP THROUGH THE INTRODUCER SHEATH, AND THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS ALSO 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 12236007 ↗
• 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 12208144 ↗
• MalfunctionJun 14, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A DISTAL BRANCH OF THE LEFT PROFUNDA ARTERY USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A 6F NON-PENUMBRA SHEATH. 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. 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 11996566 ↗
• MalfunctionJun 3, 2021Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN LOST ACCESS TO THE TARGET VESSEL AND DECIDED RESHEATH THE RUBY COIL LP; HOWEVER, THE RUBY COIL COULD NOT BE RETRACTED BACK INTO ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED 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 11935438 ↗
• MalfunctionMay 8, 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 WAS UNABLE TO ADVANCE FROM THE STARTING POSITION IN THE 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 11795425 ↗
• MalfunctionMar 23, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE OUT FROM 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 11558023 ↗
• MalfunctionMar 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY 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 NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429749 ↗
• MalfunctionFeb 19, 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 NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL LP FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH AND REPORTED THAT THE RUBY COIL LP WOULD NOT ADVANCE AT ALL. THEREFORE, THE RUBY COIL LP WAS NOT USED IN THE PROCEDURE. 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; No Consequences Or Impact To Patient

  MAUDE report 11350941 ↗
• MalfunctionFeb 16, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11330761 ↗
• MalfunctionFeb 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRANCH OFF THE RIGHT COLIC ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL LP IN THE VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER. THEREFORE, IT 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; No Consequences Or Impact To Patient

  MAUDE report 11324232 ↗
• MalfunctionDec 18, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO RUBY COIL LPS THROUGH THE HUB OF THE MICROCATHETER. THEREFORE, BOTH RUBY COIL LPS WERE REMOVED. NEXT, THE PHYSICIAN PLACED A NEW RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER; HOWEVER, WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL LP, THE SAME ISSUED OCCURRED. THEREFORE, IT WAS 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; No Consequences Or Impact To Patient

  MAUDE report 11042136 ↗