LP Coil System RBYLP0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00815948021747), received between May 15, 2020 and Apr 27, 2023 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (28 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL LP INTO THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED WITHIN THE MICROCATHETER. SUBSEQUENTLY, WHILE RETRACTING, THE PHYSICIAN WAS STILL EXPERIENCING RESISTANCE AND THE RUBY COIL LP UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE RUBY COIL LP WAS SUCCESSFULLY REMOVED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NON-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 16828514 ↗
• MalfunctionMay 26, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE PROSTATIC VESSEL USING A RUBY COIL LP, LP SYSTEM DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP TO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE RUBY COIL LP USING A FORCEPS TO PULL THE PUSHER ASSEMBLY; HOWEVER, THE RUBY COIL LP STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. SUBSEQUENTLY, WHILE RETRACTING THE RUBY COIL LP, THE COIL UNINTENTIONALLY DETACHED IN THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL LP PUSHER ASSEMBLY AND INJECTED SALINE INTO THE MICROCATHETER TO PUSH THE DETACHED RUBY COIL LP INTO THE VESSEL. THE COIL EMBOLIZATION PART OF 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 14518254 ↗
• MalfunctionDec 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL LP AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE THE RUBY COIL LP AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. 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 12925994 ↗
• 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 12840691 ↗
• 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 12840593 ↗
• MalfunctionNov 8, 2021Failure to Advance; Material Deformation; Failure to Advance; 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 WAS UNABLE TO ADVANCE A RUBY COIL LP FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH AND, INADVERTENTLY KINKED 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. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771496 ↗
• MalfunctionNov 1, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CYSTIC ARTERY USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST BENT THE PUSHER ASSEMBLY OF THE RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727988 ↗
• MalfunctionNov 1, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CYSTIC ARTERY USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST BENT THE PUSHER ASSEMBLY OF THE RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727984 ↗
• MalfunctionOct 25, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE 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 MADE MULTIPLE ATTEMPTS 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 ANOTHER LP COIL, 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 12694974 ↗
• 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 12496050 ↗
• MalfunctionAug 12, 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 WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL LP 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 12316499 ↗
• MalfunctionJul 21, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTIC SAC USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL LP TO THE ANEURYSM SAC AND ATTEMPTED TO DETACH IT USING A NEW HANDLE, BUT THE RUBY COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE RUBY COIL LP DID NOT DETACH EVEN THOUGH THE BLACK SEGMENT ON THE BACK OF THE PUSHER ASSEMBLY WAS SEPARATED INTO TWO BLACK LINES. THEREFORE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE PUSHER ASSEMBLY WAS SNAPPED A COUPLE MORE TIMES, BUT THE COIL STILL DID NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. AN ANGIOGRAM WAS PERFORMED AND SHOWED THAT THE ENDOLEAK HAD STOPPED AND NO FURTHER COILING WAS NEEDED; THEREFORE, 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 12201078 ↗
• MalfunctionJul 21, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTIC SAC USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL LP TO THE ANEURYSM SAC AND ATTEMPTED TO DETACH IT USING A NEW HANDLE, BUT THE RUBY COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE RUBY COIL LP DID NOT DETACH EVEN THOUGH THE BLACK SEGMENT ON THE BACK OF THE PUSHER ASSEMBLY WAS SEPARATED INTO TWO BLACK LINES. THEREFORE, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP; HOWEVER, IT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE PUSHER ASSEMBLY WAS SNAPPED A COUPLE MORE TIMES, BUT THE COIL STILL DID NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. AN ANGIOGRAM WAS PERFORMED AND SHOWED THAT THE ENDOLEAK HAD STOPPED AND NO FURTHER COILING WAS NEEDED; THEREFORE, 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 12201076 ↗
• 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 12194318 ↗
• MalfunctionJul 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PACKING COIL LPS AND RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO GET A PACKING COIL LP AND RUBY COIL LP (F102510 AND F99270) TO ANCHOR AND FORM IN THE SMALL AREA OF THE GDA. SUBSEQUENTLY, THE PACKING COIL LP AND RUBY COIL LP WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A RUBY COIL LP (F99986); HOWEVER, THE COIL WAS UNABLE TO ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT BY HOLDING THE BLACK STRIPE DISTALLY, BUT WAS UNSUCCESSFUL. 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 12147015 ↗
• MalfunctionJun 3, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PACKING COIL LPS, RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO POSITION THE PACKING COIL LP INTO THE TARGET LOCATION, THE PACKING COIL LP BROKE. THEREFORE, THE PACKING COIL LP WAS REMOVED. NEXT, WHILE THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL LP WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE RUBY COIL LP FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND A NEW PACKING COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935496 ↗
• MalfunctionJun 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE AORTOPULMONARY COLLATERAL ARTERIES USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WAS UNABLE TO ADVANCE FROM THE STARTING POSITION OF 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 11931591 ↗
• MalfunctionMay 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE A RUBY COIL LP PAST THE FRICTION LOCK IN THE INTRODUCER SHEATH, AND THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN PROCEEDED TO USE ANOTHER RUBY COIL LP WHICH HAD THE SAME ISSUE. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809601 ↗
• MalfunctionMay 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE A RUBY COIL LP PAST THE FRICTION LOCK IN THE INTRODUCER SHEATH, AND THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN PROCEEDED TO USE ANOTHER RUBY COIL LP WHICH HAD THE SAME ISSUE. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809577 ↗
• MalfunctionMay 7, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A PACKING COIL LP. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794389 ↗
• MalfunctionApr 28, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A TRANS-ARTERIAL COIL EMBOLIZATION PROCEDURE FROM THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) USING PACKING COIL LPS, RUBY COIL LPS, PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT HAD POSSIBLE STENOSIS AND NARROWED VESSELS. DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT THE PACKING COIL LP AS THE FIRST COIL, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER. AFTER POSITIONING THE PACKING COIL LP IN THE TARGET LOCATION, THE COIL COULD NOT BE DETACHED USING THE HANDLE. IT WAS ALSO REPORTED THAT SEVERAL ATTEMPTS TO MANUALLY DETACH THE COIL FAILED; THEREFORE, THE PACKING COIL LP WAS REMOVED. WHILE ADVANCING A 2X4 RUBY COIL LP (F102505) THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE RUBY COIL LP WOULD NOT ADVANCE BEYOND THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO USE A SMART COIL WHICH HAD A SMALLER DIAMETER THAN THE PREVIOUS COILS. HOWEVER, RESISTANCE WAS ALSO ENCOUNTERED WHILE ADVANCING THE SMART C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739975 ↗
• MalfunctionApr 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. TWO RUBY COIL LPS WERE SUCCESSFULLY IMPLANTED IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE A THIRD RUBY COIL LP INTO THE TARGET VESSEL, THE RUBY COIL LP DETACHMENT HANDLE (HANDLE) WAS UNABLE TO DETACH IT. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE THIRD RUBY COIL LP WITHOUT SUCCESS. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER RUBY COIL LPS, 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 11636064 ↗
• MalfunctionApr 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING PENUMBRA COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PENUMBRA COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THEREFORE, THE COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED BY USING A LP PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606299 ↗
• MalfunctionMar 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE AT ALL FROM THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. IT WAS ALSO REPORTED THAT THE PHYSICIAN AND HOSPITAL TECHNICIAN ATTEMPTED TO TAKE THEIR FINGERS OFF THE FRICTION LOCK; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS 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; No Consequences Or Impact To Patient

  MAUDE report 11396766 ↗
• MalfunctionFeb 5, 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 PACKING COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS AND THREE PACKING COIL LPS WOULD NOT ADVANCE AT ALL FROM THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS AND THREE PACKING COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND NEW ADDITIONAL PACKING COIL LPS. 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 11288689 ↗