LP Coil System RBYLP0105Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00815948021730), received between Jan 29, 2020 and Mar 8, 2022 — classified as 52 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (38 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE AND IT CAME APART. THE PROCEDURE WAS COMPLETED USING OTHER 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 13694297 ↗
• MalfunctionDec 2, 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) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO ADVANCE A RUBY COIL LP THROUGH THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COIL LPS PAST THE HUB OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL LPS WERE REMOVED. 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 12920980 ↗
• MalfunctionDec 2, 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) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO ADVANCE A RUBY COIL LP THROUGH THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COIL LPS PAST THE HUB OF THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL LPS WERE REMOVED. 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 12920875 ↗
• MalfunctionOct 28, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC ARTERY PSEUDOANEURYSM USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE AT ALL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. IT WAS REPORTED THAT THE HOSPITAL TECHNOLOGIST ATTEMPTED TO TROUBLESHOOT THE ISSUE BY DIPPING THE RUBY COIL LP IN SALINE AND RETRACTING THE COIL BEFORE ADVANCING IT; HOWEVER, THE ISSUE WAS NOT RESOLVED. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST 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 12716715 ↗
• MalfunctionOct 26, 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 BRANCH OF INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL LP IN THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL LP WOULD NOT ADVANCE. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL LP BECAME BENT. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY 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 12701136 ↗
• MalfunctionOct 25, 2021Separation Failure; Separation Failure

  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 12694959 ↗
• MalfunctionOct 21, 2021Failure to Advance; Failure to Advance

  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, A RUBY COIL LP WAS UNABLE TO ADVANCE FROM THE HUB OF 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 12674135 ↗
• 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 12619443 ↗
• 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 12619439 ↗
• MalfunctionSep 24, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTRIC BLEED USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DETACH THE RUBY COIL LP BY USING THE HANDLE, THE ALIGNMENT ZONE HAD SEPARATED ON THE PUSHER ASSEMBLY BUT THE RUBY COIL LP DID NOT DETACH. THE PHYSICIAN THEN TRIED DETACHING THE RUBY COIL LP MANUALLY; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP OF THE SAME SIZE, 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 12530539 ↗
• MalfunctionSep 11, 2021Failure to Advance; 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, TWO RUBY COIL LPS WOULD NOT ADVANCE THROUGH THE HUB OF THE MICROCATHETER. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA PUSHABLE 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 12457568 ↗
• MalfunctionSep 11, 2021Failure to Advance; 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, TWO RUBY COIL LPS WOULD NOT ADVANCE THROUGH THE HUB OF THE MICROCATHETER. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA PUSHABLE 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 12457567 ↗
• MalfunctionAug 4, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL MESENTERIC VESSEL USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACE TWO RUBY COIL LPS IN THE TARGET VESSEL USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO PLACE THE NEXT RUBY COIL LP, THE PHYSICIAN NOTICED THE COIL WAS STUCK AND WOULD NOT ADVANCE AT ALL WITHIN THE 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 12277895 ↗
• 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 12235920 ↗
• 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 12228364 ↗
• 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 12228110 ↗
• MalfunctionJul 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS UNABLE TO BE PUSHED INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189716 ↗
• MalfunctionJul 19, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 12186909 ↗
• MalfunctionJul 8, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDOANEURYSM USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, THREE RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. SUBSEQUENTLY, THE SCRUB TECHNOLOGIST REMOVED THE RUBY COIL LPS FROM THE BACKSIDE OF THE INTRODUCER SHEATHS, CUT THE FRICTION LOCKS, AND BACKLOADED THE INTRODUCER SHEATHS. IT WAS REPORTED THAT, WHILE ATTEMPTING TO REMOVE ONE OF THE RUBY COIL LPS FROM THE BACKSIDE OF ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL LP DETACHED FROM ITS PUSHER ASSEMBLY ON THE BACK TABLE. THE PHYSICIAN THEN SUCCESSFULLY PLACED THE REMAINING TWO RUBY COIL LPS IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133218 ↗
• MalfunctionJul 8, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDOANEURYSM USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, THREE RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. SUBSEQUENTLY, THE SCRUB TECHNOLOGIST REMOVED THE RUBY COIL LPS FROM THE BACKSIDE OF THE INTRODUCER SHEATHS, CUT THE FRICTION LOCKS, AND BACKLOADED THE INTRODUCER SHEATHS. IT WAS REPORTED THAT, WHILE ATTEMPTING TO REMOVE ONE OF THE RUBY COIL LPS FROM THE BACKSIDE OF ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL LP DETACHED FROM ITS PUSHER ASSEMBLY ON THE BACK TABLE. THE PHYSICIAN THEN SUCCESSFULLY PLACED THE REMAINING TWO RUBY COIL LPS IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133213 ↗
• MalfunctionJul 8, 2021Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PSEUDOANEURYSM USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, THREE RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. SUBSEQUENTLY, THE SCRUB TECHNOLOGIST REMOVED THE RUBY COIL LPS FROM THE BACKSIDE OF THE INTRODUCER SHEATHS, CUT THE FRICTION LOCKS, AND BACKLOADED THE INTRODUCER SHEATHS. IT WAS REPORTED THAT, WHILE ATTEMPTING TO REMOVE ONE OF THE RUBY COIL LPS FROM THE BACKSIDE OF ITS INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL LP DETACHED FROM ITS PUSHER ASSEMBLY ON THE BACK TABLE. THE PHYSICIAN THEN SUCCESSFULLY PLACED THE REMAINING TWO RUBY COIL LPS IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133208 ↗
• MalfunctionJun 17, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PROCEDURE WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS AND PACKING COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP AND PACKING COIL LP WERE STUCK AT THE FRICTION LOCKS AND UNABLE TO ADVANCE WITHIN THE INTRODUCER SHEATHS. THEREFORE, THE COILS WERE 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 12018380 ↗
• MalfunctionJun 8, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POLYPECTOMY SITE USING RUBY COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT DETACH AFTER PLACEMENT. AFTER SEVERAL ATTEMPTS, THE COIL 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 11958187 ↗
• MalfunctionJun 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE USING RUBY COIL LPS. DURING THE PROCEDURE, UPON ATTEMPTING TO ADVANCE THE RUBY COIL LP WITHIN THE INTRODUCER SHEATH, THE HOSPITAL TECH NOTICED IT WOULD NOT MOVE. THEREFORE, THE 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 11953379 ↗
• MalfunctionMay 5, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH TWO OTHER RUBY COIL LPS; THEREFORE, THE RUBY COIL LPS WERE 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. IT WAS REPORTED THAT, UPON FURTHER DEMONSTRATION BY THE PENUMBRA SALES REPRESENTATIVE, ONE OF THE RUBY COIL LPS ADVANCED OUT OF ITS INTRODUCER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780498 ↗