LP Coil System RBYLP0315Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00815948021792), received between May 4, 2020 and Apr 7, 2023 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (16 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR TIBIAL VEIN USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL LP; HOWEVER, THE RUBY COIL LP UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE AND REMOVED THE RUBY COIL LP. THE PROCEDURE ENDED AT THIS POINT AS THE PHYSICIAN DETERMINED NO ADDITIONAL COILS WERE NEEDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16698338 ↗
• MalfunctionNov 12, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COIL LPS, AND A LP SYSTEM DETACHMENT HANDLE (LP HANDLE), A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP TO THE TARGET 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 THREE NEW RUBY COIL LPS, THE SAME LP 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 12801726 ↗
• MalfunctionNov 11, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING PACKING COIL LPS, RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, TWO PACKING COIL LPS AND ONE RUBY COIL LP WOULD NOT ADVANCE PAST THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE TWO PACKING COIL LPS AND ONE RUBY COIL LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS, 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 12800793 ↗
• MalfunctionNov 2, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN NOTICED THE DETACHMENT ZONE ON THE PROXIMAL END FOR BOTH RUBY COIL LPS WAS SLIGHTLY SEPARATED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS WITH THE SAME HANDLE AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741313 ↗
• MalfunctionOct 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) VESSEL USING PACKING COIL LP¿S, A RUBY COIL LP, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE TWO PACKING COIL LP¿S AND A RUBY COIL LP PAST THE HUB OF THE MICROCATHETER. THEREFORE, BOTH PACKING COIL LP¿S AND RUBY COIL LP WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PACKING COIL LPS, NEW 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 12639892 ↗
• 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 12602671 ↗
• MalfunctionSep 22, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. IT WAS REPORTED THAT THE HANDLE MADE A CLICKING SOUND BUT THE RUBY COIL LP WOULD NOT DETACH FROM THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE RUBY COIL LP BY USING A HEMOSTAT, BUT THE RUBY COIL LP STILL FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THE PHYSICIAN ALSO TRIED DETACHING THE RUBY COIL LP BY USING A HEMOSTAT; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS OF A LARGER SIZE, A RUBY COIL DETACHMENT HANDLE, 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 12517041 ↗
• MalfunctionSep 12, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP; HOWEVER, IT WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL LP DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN THEN INJECTED SALINE THROUGH THE MICROCATHETER TO SUCCESSFULLY PUSH THE DETACHED RUBY COIL LP INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL LP INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE RUBY COIL LP. WHILE REMOVING THE RUBY COIL LP, THE RUBY COIL LP UNRAVELED BUT THE PHYSICIAN WAS ABLE TO REMOVE THE RUBY COIL LP OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457833 ↗
• 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 12316460 ↗
• MalfunctionAug 2, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ACCESSORY USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS 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 12262754 ↗
• 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 12192377 ↗
• MalfunctionJun 22, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PHRENIC VEIN USING RUBY COIL LPS, A RUBY COIL LP DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COIL LPS FAILED TO DETACH USING THE HANDLE; THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. LATER, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. THE PROCEDURE WAS COMPLETED USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE, 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 12045906 ↗
• MalfunctionJun 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COIL LPS IN THE TARGET LOCATION USING THE MICROCATHETER. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE RUBY COIL WAS STUCK IN THE STARTING POSITION WITHIN THE INTRODUCER SHEATH. AFTER MAKING TWO MORE ATTEMPTS, THE PHYSICIAN REMOVED THE RUBY COIL LP. 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 12019124 ↗
• MalfunctionJun 15, 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, PACKING COIL LPS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE OTHER RUBY COIL LP AND PACKING COIL LP. THEREFORE, THE RUBY COIL LPS AND PACKING COIL LP 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 12000398 ↗
• MalfunctionJun 15, 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, PACKING COIL LPS, AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WOULD NOT ADVANCE FROM THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH THE OTHER RUBY COIL LP AND PACKING COIL LP. THEREFORE, THE RUBY COIL LPS AND PACKING COIL LP 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 12000396 ↗
• MalfunctionJun 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 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 11957996 ↗
• MalfunctionJun 3, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS (RUBY COIL LP) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE RUBY COIL LP WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. 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 11935460 ↗
• MalfunctionJun 3, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE INTO A HEART VESSEL USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST WAS UNABLE TO ADVANCE A RUBY COIL LP THROUGH THE INTRODUCER SHEATH AT ALL. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL LP KINKED; 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 11935348 ↗
• MalfunctionMay 17, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT DETACH WITH THE HANDLE. THE PHYSICIAN THEN ATTEMPTED TO USE A HEMOSTAT TO DETACH THE RUBY COIL LP BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING SIX 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 11832482 ↗
• 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 11579678 ↗
• MalfunctionFeb 19, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION 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; No Consequences Or Impact To Patient

  MAUDE report 11355772 ↗
• MalfunctionNov 25, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING A RUBY COIL LP. DURING THE PROCEDURE, ONE COIL WAS IMPLANTED INTO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL LP, IT WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO 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 10901765 ↗
• MalfunctionOct 12, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COIL LPS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL LP IN THE INTRODUCER SHEATH, THE RUBY COIL LP WOULD NOT MOVE AND WAS STUCK. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COIL LP AGAIN ON THE BACK TABLE, BUT THE RUBY COIL LP WAS STUCK. THE PHYSICIAN ATTEMPTED THE SAME PROCESS WITH TWO OTHER RUBY COIL LPS, AND THE SAME ISSUE OCCURRED. THEREFORE, THE THREE RUBY COIL LPS WERE NOT USED FOR THE REMAINDER FOR THE PROCEDURE. 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 10662397 ↗
• MalfunctionOct 2, 2020Failure 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 RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE AT ALL 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; No Consequences Or Impact To Patient

  MAUDE report 10623447 ↗
• MalfunctionSep 11, 2020Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ARTERIOVENOUS FISTULA (AVF) USING RUBY COIL LPS, GUIDE CATHETER AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE VESSEL USING THE MICROCATHETER; HOWEVER, THE RUBY COIL LP WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN REPOSITIONED THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE RUBY COIL LP; HOWEVER, THE COIL STILL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL LP INTO THE VESSEL; HOWEVER, AFTER MULTIPLE ATTEMPTS, THE SAME ISSUE OCCURRED AND, THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP, SAME MICROCATHETER AND SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10523456 ↗