RUBY Coil RBY4C1035-BRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00814548018669), received between Dec 11, 2018 and Feb 4, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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.

• MalfunctionFeb 4, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A 4F NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR RUBY COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. ANOTHER RUBY COIL WAS ADVANCED THROUGH THE MICROCATHETER AND TO THE TARGET VESSEL. HOWEVER, THE RUBY COIL DID NOT FIT IN THE VESSEL. AFTER SEVERAL ATTEMPTS TO RETRACT THE RUBY COIL, THE PHYSICIAN NOTICED VIA CONTRAST IMAGING AND BY FEEL THAT THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, POD PACKING COILS (PACKING 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 21305475 ↗
• MalfunctionOct 21, 2022Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FEMORAL ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MIDDLE OF THE LANTERN, RESISTANCE WAS ENCOUNTERED, THE COIL BECAME STUCK, AND THE PUSHER ASSEMBLY KINKED. UPON RETRACTION, THE RUBY COIL STRETCHED AND UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. AT THIS POINT, ANGIOGRAPHY SHOWED THAT BLEEDING HAD STOPPED AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650486 ↗
• MalfunctionNov 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, POD COILS, POD PACKING COILS (POD PC), A NON-PENUMBRA MICROCATHETER, AND A GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A POD COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN RETRACTED AND REMOVED THE RUBY COIL AND FLUSHED THE MICROCATHETER ON THE BACK TABLE. WHILE READVANCING THE RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED ANOTHER RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THREE POD PCS 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 12733991 ↗
• MalfunctionOct 1, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE RUBY COIL AS THE FIRST COIL PAST THE HUB OF THE LANTERN. CONSEQUENTLY, THE PHYSICIAN BROKE THE PUSHER ASSEMBLY AND DETACHED THE RUBY COIL INSIDE THE LANTERN. THEREFORE, THE LANTERN WAS CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, POD PACKING COILS (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 12565532 ↗
• MalfunctionJul 20, 2021Component Missing; Component Missing

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL INTO THE LANTERN, THE PHYSICIAN NOTICED THE RUBY COIL WAS NOT WITHIN THE INTRODUCER SHEATH WHEN ADVANCING THE PUSHER ASSEMBLY. IT WAS REPORTED THAT THE INTRODUCER SHEATH WAS RETRACTED TO VISUALIZE THE RUBY COIL; HOWEVER, THE COIL WAS NOT INSIDE THE INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE RUBY COIL WAS NOT IN THE PACKAGING HOOP OR PRODUCT BOX. 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 12196756 ↗
• MalfunctionJul 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS, A NON-PENUMBRA MICROCATHETER AND NON-PENUMBRA CATHETERS. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE MICROCATHETER WAS PLACED IN THE AVF SHUNT AND SUBSEQUENTLY, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DISTAL PART OF THE FIRST RUBY COIL IN THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD COIL, A RUBY COIL, AND A POD PACKING COIL (POD PC) WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105007 ↗
• MalfunctionFeb 1, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA ANGIOGRAPHIC CATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE NEXT RUBY COIL WITHIN ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, WAS UNABLE TO ADVANCE THE RUBY COIL PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, A POD PACKING COIL (POD PC), FOUR NON-PENUMBRA COILS, AND THE SAME LANTERN. 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 11262003 ↗
• MalfunctionDec 31, 2020Failure to Advance; Physical Resistance/Sticking; Premature Separation; Failure to Advance; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE RIGHT INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE LEFT IIA USING THE LANTERN. AFTERWARDS, THE PHYSICIAN PLACED THE LANTERN IN THE RIGHT IIA. AFTER ADVANCING THE NEXT RUBY COIL APPROXIMATELY TEN CENTIMETER THROUGH THE DISTAL TIP OF THE LANTERN, THE RUBY COIL BECAME STUCK. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL, TWO POD PACKING COILS (POD PCS) AND THE SAME LANTERN. 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 11100639 ↗
• MalfunctionAug 21, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature 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). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS, NARROWED AND CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL IN THE MIDDLE OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE 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 RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD COIL, THREE POD PACKING 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 10439871 ↗
• MalfunctionAug 8, 2020Break; Failure to Fold; Physical Resistance/Sticking; Break; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO FORM THE RUBY COIL BACK AND FORTH, BUT THE RUBY COIL DID NOT FORM WELL. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL TO SOAK IT IN SALINE. AS THE RUBY COIL WAS WITHDRAWN FROM THE LANTERN AND INTO THE INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE. ONCE ON THE BACK TABLE, UPON FLUSHING THE RUBY COIL OUT OF THE INTRODUCER SHEATH, THE RUBY COIL DETACHED FROM THE PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND IMPLANTED THREE RUBY COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT COIL, A POD PC, APPROXIMATELY 10 CM TO 20 CM INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFEC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382986 ↗
• MalfunctionMay 8, 2020Physical 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 AND LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND, THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE OF THE MICROCATHETER. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING POD PACKING COILS (POD PC) 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 10039518 ↗
• MalfunctionFeb 20, 2020Physical 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, POD PACKING COIL (PODJ) AND, NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS HIGHLY TORTUOUS, SLIGHTLY CALCIFIED AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL AND A PODJ IN THE TARGET VESSEL USING THE MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AFTER ADVANCING ANOTHER RUBY COIL AT APPROXIMATELY 10 TO 15 CENTIMETERS FROM THE DISTAL END OF THE INTRODUCER SHEATH AND DECIDED TO REMOVE THE RUBY COIL. HOWEVER, UPON REMOVAL OF THE RUBY COIL, THE PHYSICIAN NOTICED THAT THE RUBY COIL UNINTENTIONALLY DETACHED AT THE PROXIMAL END OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, POD PCS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735395 ↗
• MalfunctionOct 24, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING THE THIRD RUBY COIL INTO THE MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL. UPON RETRACTING THE RUBY COIL APPROXIMATELY THREE FOURTHS OF THE WAY BACK INTO ITS INTRODUCER SHEATH, IT DETACHED FROM ITS PUSHER ASSEMBLY WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TEN ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234504 ↗
• MalfunctionSep 18, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL. UPON ADVANCEMENT OF A RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT THE COIL TO REPOSITION IT, BUT REPORTED THAT IT UNINTENTIONALLY DETACHED IN THE TARGET LOCATION. THE SAME EVENT OCCURRED WITH THE NEXT RUBY COIL. HOWEVER, BOTH RUBY COILS WERE IMPLANTED SUCCESSFULLY AND THEREFORE REMAINED IN THE PATIENT. WHILE CHECKING A THIRD RUBY COIL ON THE BACK TABLE, THE PHYSICIAN FOUND THAT IT HAD DETACHED. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL RUBY COILS AND SIX OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082988 ↗
• MalfunctionSep 18, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL. UPON ADVANCEMENT OF A RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT THE COIL TO REPOSITION IT, BUT REPORTED THAT IT UNINTENTIONALLY DETACHED IN THE TARGET LOCATION. THE SAME EVENT OCCURRED WITH THE NEXT RUBY COIL. HOWEVER, BOTH RUBY COILS WERE IMPLANTED SUCCESSFULLY AND THEREFORE REMAINED IN THE PATIENT. WHILE CHECKING A THIRD RUBY COIL ON THE BACK TABLE, THE PHYSICIAN FOUND THAT IT HAD DETACHED. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL RUBY COILS AND SIX OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082971 ↗
• MalfunctionSep 18, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL. UPON ADVANCEMENT OF A RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT THE COIL TO REPOSITION IT, BUT REPORTED THAT IT UNINTENTIONALLY DETACHED IN THE TARGET LOCATION. THE SAME EVENT OCCURRED WITH THE NEXT RUBY COIL. HOWEVER, BOTH RUBY COILS WERE IMPLANTED SUCCESSFULLY AND THEREFORE REMAINED IN THE PATIENT. WHILE CHECKING A THIRD RUBY COIL ON THE BACK TABLE, THE PHYSICIAN FOUND THAT IT HAD DETACHED. THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FIVE ADDITIONAL RUBY COILS AND SIX OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9082957 ↗
• MalfunctionSep 9, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE IA ENDOLEAK USING A RUBY COIL. DURING THE PROCEDURE, WHILE PLACING THE RUBY COIL IN THE TARGET VESSEL, THE PHYSICIAN DETERMINED THAT THE RUBY COIL WAS OVERSIZED AND DECIDED TO REMOVE IT. HOWEVER, WHILE RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED IN THE HUB OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN PULLED THE DETACHED RUBY COIL OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THREE POD PACKING COILS, FOURTEEN OTHER COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976151 ↗
• MalfunctionJun 21, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING RUBY COILS AND POD PACKING COILS (POD PC). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN NOTICED THE FLOW OF BLOOD WAS PULLING THE RUBY COIL BACK INTO THE AORTA; THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A POD PC, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE POD PC WAS REMOVED. THERE WAS NO NOTICEABLE DAMAGE TO EITHER THE RUBY COIL OR POD PC. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COILS, POD PC 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 8723382 ↗
• MalfunctionDec 11, 2018Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO RUBY COILS INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN FOUND THAT THE PUSHER ASSEMBLY OF THE THIRD RUBY COIL, HAD BECOME KINKED WHILE ADVANCING THE RUBY COIL INTO THE LANTERN. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH 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 8150995 ↗