RUBY Coil RBY2C1660-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548019253), received between Jun 14, 2019 and Jan 24, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2025Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CORONARY ARTERY (RCA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE TARGET VESSEL WAS A HIGH FLOW AREA. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A SECOND COIL INTO THE LANTERN, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE PREVIOUSLY PLACED RUBY COIL BEGAN MOVING. THE RUBY COIL THEN MIGRATED FROM THE RCA TO THE RIGHT COMMON ILIAC ARTERY. THEREFORE, A SNARE WAS USED TO REMOVE THE RUBY COIL FROM THE PATIENT. THE PROCEDURE HAD 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 21234097 ↗
• MalfunctionOct 28, 2024Fracture; Physical Resistance/Sticking; Premature Separation; Fracture; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL PUSHER ASSEMBLY FRACTURED. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE PATIENT¿S VESSEL. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED RUBY COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A PLUG. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545922 ↗
• MalfunctionOct 9, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE SECOND RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT CONTINUED TO ADVANCE THE RUBY COIL. WHILE ADVANCING THE RUBY COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL STOPPED ADVANCING. THE PHYSICIAN THEN PULLED THE PUSHER ASSEMBLY OF THE RUBY COIL BACK AND NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PUSHER ASSEMBLY OF THE RUBY COIL WAS REPORTED TO BE DAMAGED WHILE PREPARING FOR RETURN. THE PROCEDURE WAS COMPLETED USING A TOTAL OF NINE ADDITIONAL RUBY COILS AND POD PACKING COILS (PACKING COIL), ALONG WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412806 ↗
• MalfunctionMar 14, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS, A POD COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A POD COIL AND A RUBY COIL IN THE TARGET LOCATION; HOWEVER, BOTH COILS WERE DETERMINED TO BE TOO SMALL FOR THE VESSEL AND WERE REMOVED. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL INTO THE VESSEL, BUT THE RUBY COIL WAS STILL DETERMINED TO BE TOO SMALL FOR THE VESSEL AND THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, WHILE REMOVING THE COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A AMPLATZER VASCULAR PLUG AND THE PHYSICIAN PERFORMED AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908957 ↗
• MalfunctionMay 12, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MESENTERIC ARTERY USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RUBY COIL INTO THE TARGET LOCATION AND DID NOT LIKE HOW IT WAS FORMING IN THE VESSEL. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE LANTERN AND PARTIALLY IN THE VESSEL. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE AND REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 16925103 ↗
• MalfunctionJun 16, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL FISTULA VENOUS POUCH IN THE RENAL ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL APPROXIMATELY 20 CENTIMETERS THROUGH THE DISTAL END OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT DUE TO THE HIGH FLOW NATURE OF THE FISTULA, BLOOD CAME BACK INTO THE MICROCATHETER WHERE IT CAUSED THE RUBY COIL TO GET STUCK AND DETACH. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS, A POD PACKING COIL (POD PC), 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 14720806 ↗
• MalfunctionMay 7, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST RUBY COIL NEAR THE DISTAL END OF THE MICROCATHETER. WHILE ATTEMPTING TO MOVE THE RUBY COIL BACK AND FORTH, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS NOT MOVING WITH THE PUSHER WIRE. AFTER REMOVING THE MICROCATHETER AND THE RUBY COIL FROM THE PATIENT, THE PHYSICIAN CONFIRMED THAT THE RUBY COIL WAS UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, ANOTHER RUBY COIL, AND THREE POD PACKING COILS (POD PCS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14323046 ↗
• MalfunctionJul 15, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 12173852 ↗
• MalfunctionMay 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA USING RUBY COILS AND NON-PENUMBRA MICROCATHETERS. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE MICROCATHETER, THE RUBY COIL BECAME STUCK AT THE DISTAL TIP OF THE INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, POD PACKING COILS (POD PC), FOUR OTHER COILS WITH THE SAME MICROCATHETERS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795422 ↗
• MalfunctionMar 8, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A PARENT CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PARENT CATHETER AND LANTERN IN THE TARGET LOCATION AND THEN FLUSHED THE LANTERN. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND DECIDED TO RETRACT THE RUBY COIL. HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE MID-SHAFT OF THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435860 ↗
• MalfunctionMar 3, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE HANDLE FAILED TO DETACH THE RUBY COIL. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL. IT IS UNKNOWN WHETHER THE SAME HANDLE WAS USED TO COMPLETE THE PROCEDURE. 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 11408272 ↗
• MalfunctionFeb 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST RUBY COIL BECAME STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN CONTINUED WITH THE PROCEDURE USING A SECOND RUBY COIL. HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW RUBY 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 11263334 ↗
• MalfunctionFeb 1, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE FIRST RUBY COIL BECAME STUCK AT THE DISTAL TIP OF ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN CONTINUED WITH THE PROCEDURE USING A SECOND RUBY COIL. HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NEW RUBY 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 11263299 ↗
• MalfunctionAug 19, 2020Physical Resistance/Sticking; Difficult or Delayed Separation; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN. THEN, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE DISTAL TIP OF THE LANTERN, AND SUBSEQUENTLY THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428495 ↗
• MalfunctionJun 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOGRAFT LEAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCE RESISTANCE AND SUBSEQUENTLY, NOTICED THAT THE PUSHER ASSEMBLY OF THE RUBY COIL HAD A SLIGHT BENT AND WOULD NOT ADVANCE. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEW RUBY COIL APPROXIMATELY 50 CENTIMETERS INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10192111 ↗
• MalfunctionJun 24, 2020Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOGRAFT LEAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCE RESISTANCE AND SUBSEQUENTLY, NOTICED THAT THE PUSHER ASSEMBLY OF THE RUBY COIL HAD A SLIGHT BENT AND WOULD NOT ADVANCE. THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEW RUBY COIL APPROXIMATELY 50 CENTIMETERS INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10192104 ↗
• MalfunctionApr 2, 2020Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL THORACIC ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING AND PULLING THE RUBY COIL TO ACHIEVE PROPER COILING. THE PHYSICIAN THEN DECIDED TO RETRACT THE RUBY COIL TO REPOSITION THE LANTERN; HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNRAVELED. IT WAS REPORTED THAT THE RUBY COIL WAS RETRACTED AGAINST RESISTANCE AND THE PHYSICIAN DID NOT NOTICE THAT THE RUBY COIL HAD UNRAVELED UNTIL THE COIL HAD REACHED THE HUB OF THE LANTERN. THEREFORE, THE PHYSICIAN PULLED THE PUSHER WIRE AND SUCCESSFULLY REMOVED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9917220 ↗
• MalfunctionSep 6, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS. IT WAS REPORTED THAT WHILE REMOVING THE RUBY COIL FROM THE PACKAGING HOOP, IT CAME OFF THE INTRODUCER SHEATH; HOWEVER, THE PHYSICIAN PUT THE RUBY COIL BACK INTO ITS INTRODUCER SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED STRONG RESISTANCE WHILE ADVANCING THE RUBY COIL THROUGH THE HUB OF THE LANTERN DELIVERY MICROCATHETER (LANTERN), THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS, A POD PACKING COIL (PODJ) AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970582 ↗
• MalfunctionJun 14, 2019Device Damaged Prior to Use; Device Fell; Device Damaged Prior to Use; Device Fell

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL WAS ACCIDENTALLY DROPPED UPON REMOVAL FROM ITS PACKAGING HOOP. THE CONTAMINATION OF THE RUBY COIL OCCURRED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8699722 ↗