LP Coil System RBYLP0430Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00815948021822), received between Mar 31, 2020 and Apr 12, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE RUBY COIL LP IN THE TARGET VESSEL, THE RUBY COIL LP HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE RUBY COIL LP WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE SAME ISSUE THEN OCCURRED WITH THE NEXT RUBY COIL LP AND THE COIL WAS 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 19098833 ↗
• MalfunctionJan 5, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL LP AND A MICROCATHETER (UNKNOWN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE RUBY COIL LP WOULD NOT ADVANCE OR RETRACT THROUGH THE MICROCATHETER. WHILE ATTEMPTING TO RETRACT THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 18460408 ↗
• MalfunctionOct 31, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) AND INFERIOR MESENTERIC ARTERY (IMA) ENDOLEAK SAC USING PACKING COIL LPS, RUBY COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE PACKING COIL LP USING A HEMOSTAT, BUT THE COIL STILL WOULD NOT DETACH. THEREFORE, THE PACKING COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO DETACH TWO RUBY COIL LPS IN THE TARGET LOCATION USING THE SAME HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO DETACH THE SAME RUBY COILS USING A NEW HANDLE, BUT THE TWO RUBY COIL LPS WOULD NOT DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE TWO RUBY COIL LPS USING A HEMOSTAT; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE TWO RUBY COIL LPS AND HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW LP COILS WITH A HEMOSTAT AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725692 ↗
• MalfunctionSep 12, 2021Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  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 12457831 ↗
• MalfunctionAug 24, 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, THE RUBY COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362919 ↗
• MalfunctionJul 22, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT CORONARY ARTERY DISEASE (CAD) USING RUBY COIL LPS, 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. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. WHILE ATTEMPTING TO ADVANCE THE NEXT RUBY COIL LP, THE SAME ISSUE OCCURRED; THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS AND PENUMBRA SMART COILS (SMART COIL). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211941 ↗
• MalfunctionJul 21, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COIL LPS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL LP, THE RUBY COIL LP DETACHED FROM ITS PUSHER ASSEMBLY WITHIN ITS INTRODUCER SHEATH PRIOR TO ENTERING THE LANTERN. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LP COIL 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 12207492 ↗
• MalfunctionJul 15, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A MICROCATHETER. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE OUT OF THE HUB OF THE MICROCATHETER. 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 12177219 ↗
• MalfunctionMay 19, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK SAC IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COIL LPS, PACKING COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A LANTERN THROUGH THE DIAGNOSTIC CATHETER AND THE LANTERN BECAME STUCK. THE LANTERN WAS REMOVED AND A NEW MICROCATHETER WAS USED. THE PHYSICIAN THEN ATTEMPTED TO DETACH A FIRST PACKING COIL LP USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN USED A NEW HANDLE; HOWEVER, THE PACKING COIL LP STILL FAILED TO DETACH. A HEMOSTAT WAS USED TO MANUALLY DETACH THE COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND PACKING COIL LP; HOWEVER, THE PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO ADVANCE A THIRD PACKING COIL LP BUT, THE SAME ISSUE OCCURRED. A FOURTH PACKING COIL LP WAS ADVANCED TO THE TARGET LOCATION BUT HAD DIFFICULTY DETACHING. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE COIL. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848412 ↗
• MalfunctionMay 14, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLIC ARTERIES USING A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT DETACH WITH THE HANDLE. THE PHYSICIAN THEN USED TWO HEMOSTATS TO DETACH THE RUBY COIL LP BY PULLING THE BACK END OF THE PUSHER ASSEMBLY. 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 11826093 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  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, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL LP IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL LP IN THE MICROCATHETER, THE RUBY COIL LP WAS UNABLE TO ADVANCE FURTHER AFTER APPROACHING THE MIDPOINT OF THE MICROCATHETER. THE RUBY COIL LP WAS THEN REMOVED. SUBSEQUENTLY, ANOTHER RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS ALSO 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

  MAUDE report 11695365 ↗
• MalfunctionApr 15, 2021Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER PLACING THE SHEATH INTO THE RIGHT COMMON FEMORAL ARTERY, A CATHETER WAS ADVANCED INTO THE CELIAC ARTERY AND THE MICROCATHETER WAS ADVANCED OVER THE GUIDEWIRE. AFTER REMOVING THE GUIDEWIRE, A 3 CC SYRINGE AS USED TO FLUSH THE MICROCATHETER AND SUBSEQUENTLY, A RUBY COIL LP WAS ADVANCED INTO THE MICROCATHETER. WHILE ADVANCING THE RUBY COIL LP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COIL BECAME STUCK APPROXIMATELY FIVE CENTIMETERS PROXIMAL TO THE TIP OF THE MICROCATHETER. THE PHYSICIAN RETRACTED THE RUBY COIL LP AND WAS UNABLE TO RE-ADVANCE IT; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE PROCEDURE. UPON REMOVAL, THE PHYSICIAN INADVERTENTLY BENT THE RUBY COIL LP PUSHER WIRE. AFTER FLUSHING THE MICROCATHETER USING THE SAME 3 CC SYRINGE, ANOTHER RUBY COIL LP WAS ADVANCED INTO THE SAME MICROCATHETER AND THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE RUBY COIL LP WAS ADVANCED INTO SALINE SOLUTION FOR CLEANING AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675478 ↗
• MalfunctionApr 15, 2021Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COIL LPS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, AFTER PLACING THE SHEATH INTO THE RIGHT COMMON FEMORAL ARTERY, A CATHETER WAS ADVANCED INTO THE CELIAC ARTERY AND THE MICROCATHETER WAS ADVANCED OVER THE GUIDEWIRE. AFTER REMOVING THE GUIDEWIRE, A 3 CC SYRINGE AS USED TO FLUSH THE MICROCATHETER AND SUBSEQUENTLY, A RUBY COIL LP WAS ADVANCED INTO THE MICROCATHETER. WHILE ADVANCING THE RUBY COIL LP, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE COIL BECAME STUCK APPROXIMATELY FIVE CENTIMETERS PROXIMAL TO THE TIP OF THE MICROCATHETER. THE PHYSICIAN RETRACTED THE RUBY COIL LP AND WAS UNABLE TO RE-ADVANCE IT; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE PROCEDURE. UPON REMOVAL, THE PHYSICIAN INADVERTENTLY BENT THE RUBY COIL LP PUSHER WIRE. AFTER FLUSHING THE MICROCATHETER USING THE SAME 3 CC SYRINGE, ANOTHER RUBY COIL LP WAS ADVANCED INTO THE SAME MICROCATHETER AND THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE RUBY COIL LP WAS ADVANCED INTO SALINE SOLUTION FOR CLEANING AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675472 ↗
• MalfunctionApr 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) IN THE GASTRODUODENAL ARTERY (GDA) USING A PACKING COIL LP, A RUBY COIL LP, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A PACKING COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A RUBY COIL LP; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW 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 11605641 ↗
• 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 11579656 ↗
• MalfunctionMar 26, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND A LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH A RUBY COIL LP WITH THE HANDLE, BUT THE RUBY COIL LP DID NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED BY 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 11575325 ↗
• MalfunctionMar 4, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK OF THE INFERIOR MESENTERIC ARTERY (IMA) AND SUPERFICIAL FEMORAL ARTERY (SFA) USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA MICROCATHETER, AND A 5FR CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. 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 EVEN AFTER THE ALIGNMENT ZONE (PET LOCK) HAD SEPARATED. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL LP TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; BUT THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. HOWEVER, WHILE RETRACTING THE RUBY COIL LP, THE PHYSICIAN NOTICED THE COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER UNDER FLUOROSCOPY. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO FLUSH THE RUBY COIL LP, BUT THE COIL WAS STUCK WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN ATTEMPTED TO PUSH THE RUBY COIL LP THROUGH THE MICROCATHETER USING THE PUSHER ASSEMBLY; HOWEVER, ACCESS WAS LOST WITH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11418307 ↗
• MalfunctionOct 30, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GASTRIC ARTERY (GDA) USING A PACKING COIL LP, A RUBY COIL LP, A NON-PENUMBRA SHEATH (5FR SHEATH), A NON-PENUMBRA CATHETER AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NON-PENUMBRA CATHETER WITH THE MICROCATHETER THROUGH THE NON-PENUMBRA SHEATH UP TO THE TARGET VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE RUBY COIL LP; HOWEVER, THE RUBY COIL LP WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PACKING COIL LP; HOWEVER, THE PACKING COIL LP ALSO WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. 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 10766759 ↗
• MalfunctionMar 31, 2020Material Deformation; Difficult or Delayed Separation; Material Deformation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP TO THE TARGET VESSEL USING THE MICROCATHETER AND MADE MULTIPLE ATTEMPTS TO DETACH IT USING THE HANDLE. HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL, AND IT WAS OBSERVED THAT THE BLACK ALIGNMENT ZONE ON THE HANDLE HAD MINIMAL SEPARATION; SUBSEQUENTLY, THE PHYSICIAN USED THEIR FINGERS TO PIN AND PULL THE PUSHER ASSEMBLY OF THE PACKING COIL LP TO MANUALLY DETACH IT. IN THE MIDDLE OF THE PROCEDURE, A RUBY COIL LP (F94634) WAS FOUND KINKED UPON REMOVAL FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL LP WAS FOUND PRIOR TO USE, AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN CONTINUED THE PROCEDURE, AND THE ISSUE WITH THE PACKING COIL LP OCCURRED WITH THREE ADDITIONAL PACKING COIL LPS AND TWO RUBY COILS LPS. ANOTHER HANDLE WAS OPENED AND USED WITH ATTEMPTS TO DETACH THE COILS, BUT IT IS UNKNOWN AT WHICH POINT THE SECOND HANDLE WAS USED; THEREFORE, THE COILS WERE ALSO MANUALLY DETACHED USING THE PIN AND PULL TECHNIQUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908826 ↗