LP Coil System RLPH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00815948021969), received between Mar 31, 2020 and Dec 1, 2021 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (31 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROSTATE ARTERY USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED THE NEXT RUBY COIL LP IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACHED IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE RETRACTING THE RUBY COIL LP MIDWAY, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITH MOST OF THE RUBY COIL LP WITHIN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO LEAVE THE RUBY COIL LP IN PLACE. THE COIL EMBOLIZATION PORTION OF THE PROCEDURE WAS COMPLETED AT THIS POINT, THE PHYSICIAN THEN COMPLETED THE REST OF THE PROCEDURE USING BEADS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913011 ↗
• MalfunctionNov 22, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC AND OTHER FEEDERS FROM PROFUNDA ARTERY USING RUBY COIL LPS AND LP SYSTEM DETACHMENT HANDLE (HANDLE). IT SHOULD BE NOTED THAT THE PATIENT'S VESSEL WAS VERY SMALL AND TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE BLACK ALIGNMENT ZONE ON THE RUBY COIL LP WAS SEPARATED BY APPROXIMATELY 5MM BUT THE RUBY COIL LP WOULD NOT DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP BUT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE BUT THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP; HOWEVER, A VESSEL SPASM OCCURRED AND THEREFORE, THE RUBY COIL LP WAS REMOVED. IT WAS REPORTED THAT THE VESSEL SPASM WAS NOT DIRECTLY RELATED TO THE RUBY COIL LP AND WAS CONSIDERED RESOLVED. IT WAS ALSO REPORTED THAT THREE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858139 ↗
• MalfunctionOct 12, 2021Mechanical Problem; Mechanical Problem

  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 12619493 ↗
• MalfunctionSep 28, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL LP USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MANUALLY DETACHED THE RUBY COIL LP SUCCESSFULLY BY BREAKING THE BACK END OF THE PUSHER ASSEMBLY. IT WAS REPORTED THAT THE SAME HANDLE WAS USED TO DETACH OTHER COILS. 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 12540964 ↗
• MalfunctionSep 22, 2021Mechanical Problem; Mechanical Problem

  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 12517046 ↗
• MalfunctionSep 15, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FISTULA USING RUBY COIL LPS, RUBY COILS, A LP SYSTEM DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP THROUGH THE MICROCATHETER AND ATTEMPTED TO DETACH THE RUBY COIL LP. THE RUBY COIL LP WOULD NOT DETACH WITH THE HANDLE. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. A RUBY COIL WAS THEN ADVANCED THROUGH THE MICROCATHETER, BUT THE RUBY COIL BECAME STUCK IN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12478075 ↗
• MalfunctionSep 12, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS, AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PENUMBRA COILS INTO THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL LP AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457844 ↗
• MalfunctionAug 31, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE RUBY COIL LP INTO THE ANEURYSM, THE RUBY COIL LP KICKED THE MICROCATHETER OUT OF THE TARGET VESSEL DUE TO THE RUBY COIL LP BEING BIG FOR THE SIZE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE ATTEMPTING TO RETRACT AND RECAPTURE THE RUBY COIL LP, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP AT MULTIPLE LOCATIONS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL LP DUE TO THE TORTUOUS ANATOMY OF THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A SMALLER RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS TO DETACH THE RUBY COIL LP USING A NEW HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12402275 ↗
• MalfunctionAug 31, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE RUBY COIL LP INTO THE ANEURYSM, THE RUBY COIL LP KICKED THE MICROCATHETER OUT OF THE TARGET VESSEL DUE TO THE RUBY COIL LP BEING BIG FOR THE SIZE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE ATTEMPTING TO RETRACT AND RECAPTURE THE RUBY COIL LP, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP AT MULTIPLE LOCATIONS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL LP DUE TO THE TORTUOUS ANATOMY OF THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A SMALLER RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS TO DETACH THE RUBY COIL LP USING A NEW HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12402102 ↗
• MalfunctionAug 19, 2021Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLLATERAL OF THE INTERNAL ILIAC ARTERY USING PACKING COIL LPS, RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA COIL , A NON-PENUMBRA MICROCATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL LP INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE. HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PACKING COIL LP WAS RETRACTED AND REMOVED. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER PACKING COIL LP. THEREFORE, THE PACKING COIL LP WAS ALSO REMOVED. THEN, THE PHYSICIAN ADVANCED THE NEXT PACKING COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE PACKING COIL LP USING A SURGICAL CLAMP. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED A NON-PENUMBRA COIL IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A SECOND HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE PH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344089 ↗
• MalfunctionAug 13, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PACKING COIL LPS, A LP SYSTEM DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THREE PACKING COIL LPS USING THE HANDLE; HOWEVER, ALL THREE PACKING COIL LPS FAILED TO DETACH. THE PHYSICIAN ALSO TRIED USING ANOTHER HANDLE BUT WAS UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE PACKING COIL LPS AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE FIRST HANDLE WORKED FINE WHILE PERFORMING A CLICK TEST; HOWEVER, WHILE TRYING TO DETACH THE COIL, THE HANDLE WOULD ONLY HALF CLICK AND SLOWLY RETURN TO ITS ORIGINAL POSITION WITHOUT DETACHING THE COIL. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL PACKING COIL LPS AND THE SECOND HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321330 ↗
• MalfunctionJul 21, 2021Mechanical Problem; Mechanical Problem

  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 12201079 ↗
• MalfunctionJul 21, 2021Mechanical Problem; Mechanical Problem

  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 12201077 ↗
• MalfunctionJul 19, 2021Mechanical Problem; Mechanical Problem

  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 12192391 ↗
• MalfunctionJun 22, 2021Mechanical Problem; Mechanical Problem

  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 12044318 ↗
• MalfunctionJun 18, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS AND AN LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP TO THE TARGET VESSEL AND ATTEMPTED TO DETACH THE RUBY COIL LP WITH THE HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PHYSICIAN THEN OPENED A NEW HANDLE AND WAS ABLE TO SUCCESSFULLY DETACH THE RUBY COIL LP. THE PROCEDURE WAS COMPLETED USING THE SECOND HANDLE AND 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 12028830 ↗
• MalfunctionMay 19, 2021Mechanical Problem; Mechanical Problem

  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 11848359 ↗
• MalfunctionMay 19, 2021Mechanical Problem; Mechanical Problem

  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 11848357 ↗
• MalfunctionApr 1, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA ANEURYSM (AAA) USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), A NON-PENUMBRA 5FR ANGIO CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE HANDLE MADE AN AUDIBLE CLICK, BUT THE RUBY COIL LP FAILED TO DETACH. THE HOSPITAL TECHNOLOGIST MADE THREE MORE ATTEMPTS TO DETACH THE RUBY COIL LP USING THE HANDLE, BUT THE RUBY COIL LP STILL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP; HOWEVER, IT WAS UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NEW RUBY COIL LP AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE, BUT THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SAME RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603069 ↗
• MalfunctionMar 8, 2021Mechanical Problem; Mechanical Problem

  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

  MAUDE report 11436845 ↗
• MalfunctionMar 4, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING A LP SYSTEM DETACHMENT HANDLE (HANDLE), LP COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A COIL IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO USE A SECOND HANDLE TO DETACH THE COIL; HOWEVER, THE COIL FAILED TO DETACH. AFTERWARDS, THE PHYSICIAN USED A THIRD HANDLE TO SUCCESSFULLY DETACH THE COIL. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL LP COILS AND THE SAME THIRD HANDLE. 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 11414591 ↗
• MalfunctionMar 4, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIOLUMBAR ARTERY USING A LP SYSTEM DETACHMENT HANDLE (HANDLE), LP COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A COIL IN THE TARGET LOCATION USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THE PHYSICIAN THEN ATTEMPTED TO USE A SECOND HANDLE TO DETACH THE COIL; HOWEVER, THE COIL FAILED TO DETACH. AFTERWARDS, THE PHYSICIAN USED A THIRD HANDLE TO SUCCESSFULLY DETACH THE COIL. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL LP COILS AND THE SAME THIRD HANDLE. 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 11414577 ↗
• MalfunctionDec 2, 2020Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER AND CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND USED A HANDLE TO DETACH IT, HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP AND HANDLE WERE REMOVED. THE PHYSICIAN THEN ENCOUNTERED THE SAME ISSUE WITH THE NEXT RUBY COIL LP AND HANDLE; THEREFORE, THE RUBY COIL LP, AND HANDLE WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER, AND CATHETER. 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 10933763 ↗
• MalfunctionDec 2, 2020Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLE), A NON-PENUMBRA MICROCATHETER AND CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION USING THE MICROCATHETER AND USED A HANDLE TO DETACH IT; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP AND HANDLE WERE REMOVED. THE PHYSICIAN THEN ENCOUNTERED THE SAME ISSUE WITH THE NEXT RUBY COIL LP AND HANDLE; THEREFORE, THE RUBY COIL LP AND HANDLE WERE ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER AND CATHETER. 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 10933707 ↗
• MalfunctionNov 22, 2020Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COIL LPS AND LP SYSTEM DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COIL LPS IN THE TARGET VESSEL, AND TWO HANDLE FAILED TO DETACH THE RUBY COIL LPS. IT IS UNKNOWN AT WHICH POINT THE PHYSICIAN SWITCHED TO A SECOND HANDLE. THEREFORE, THE RUBY COIL LPS AND HANDLE 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; No Consequences Or Impact To Patient

  MAUDE report 10881687 ↗