RUBY Coil RBY2C3260-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI M424RBY2C32600), received between Aug 21, 2015 and Sep 19, 2021 — classified as 2 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (47 reports).

1 other recall cover devices cleared under the same FDA submission (K103305); they may or may not involve this specific model.

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 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN MADE TWO ADDITIONAL ATTEMPTS TO RE-ADVANCE THE RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED. BOTH TIMES, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE MICROCATHETER. DURING THE SECOND ATTEMPT, THE PHYSICIAN PULLED THE RUBY COIL SO HARD THAT THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A 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 12493466 ↗
• MalfunctionNov 13, 2020Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT THE FOURTH RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL SEEMED STUCK. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO ADVANCE AND RETRACT THE RUBY COIL THROUGH ITS INTRODUCER SHEATH; HOWEVER, THE RUBY COIL ONLY ADVANCED A FEW CENTIMETERS INTO THE LANTERN BEFORE THE PUSHER ASSEMBLY BECAME STUCK. THEREFORE, THE RUBY COIL WAS REMOVED AND AFTERWARDS, IT WAS NOTICED THAT THE CONNECTION BETWEEN THE RUBY COIL AND ITS PUSHER ASSEMBLY WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, 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 10834543 ↗
• MalfunctionSep 18, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN OCCLUSION OF THE PELVIC VARICES USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND RUBY COILS. DURING THE PROCEDURE, THE DISTAL TIP OF THE PX SLIM BECAME DAMAGED WHILE IN USE IN THE PATIENT. SUBSEQUENTLY, A RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER AND WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 10557403 ↗
• MalfunctionSep 12, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING THE RUBY COIL INTO THE PX SLIM. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL RUBY COILS AND THE SAME PX SLIM. 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 10525904 ↗
• MalfunctionJul 24, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. THEN, THE PHYSICIAN ADVANCED THE NEXT RUBY COIL INTO THE TARGET VESSEL, IT WAS REPORTED THAT THE RUBY COIL WAS TOO LONG; THEREFORE, THE PHYSICIAN RE-SHEATHED THE RUBY COIL AND SAVED IT FOR LATER USE. THE PHYSICIAN THEN PLACED ANOTHER COIL INTO THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO RE-USE THE RUBY COIL THAT HAD BEEN RE-SHEATHED; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. 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 10322335 ↗
• MalfunctionJul 17, 2020Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE AORTA USING RUBY COILS, POD PACKING COILS (PODJS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT THE NEXT COIL, A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PLACED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT A PODJ INTO THE LANTERN, THE SAME ISSUE OCCURRED. THE PUSHER ASSEMBLY OF THE PODJ KINKED AND SUBSEQUENTLY, THE PODJ DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN PLACED ONE PODJ INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, THE PHYSICIAN ATTEMPTED TO INSERT A PODJ INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED; THEREFORE, THE PODJ WAS REMOVED. THE PROCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290785 ↗
• MalfunctionMay 27, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTA ENDOLOAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WAS INTRODUCED INTO THE LANTERN AND WAS UNABLE TO ADVANCE MORE THAN 20-30 CM. THEREFORE, THE RUBY COIL WAS REMOVED. THE NEXT RUBY COIL WAS UNABLE TO ADVANCE MORE THAN 30-40 CM INTO THE LANTERN. THEREFORE, THIS RUBY COIL WAS ALSO REMOVED. 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 10094181 ↗
• MalfunctionMay 27, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTA ENDOLOAK USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A RUBY COIL WAS INTRODUCED INTO THE LANTERN AND WAS UNABLE TO ADVANCE MORE THAN 20-30 CM. THEREFORE, THE RUBY COIL WAS REMOVED. THE NEXT RUBY COIL WAS UNABLE TO ADVANCE MORE THAN 30-40 CM INTO THE LANTERN. THEREFORE, THIS RUBY COIL WAS ALSO REMOVED. 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 10094179 ↗
• MalfunctionMar 25, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, NON-PENUMBRA COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL WOULD NOT ADVANCE OUT OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS, NON-PENUMBRA 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 9881058 ↗
• MalfunctionDec 27, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (MICROCATHETER). DURING THE PROCEDURE, WHILE ADVANCING THE RUBY COIL THROUGH THE LANTERN IN THE TARGET VESSEL, THE PHYSICIAN NOTICED THE PUSHER ASSEMBLY OF A RUBY COIL WAS KINKED APPROXIMATELY ONE-THIRD INTO THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL 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 9527327 ↗
• MalfunctionNov 18, 2019Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD10S AND A RUBY COIL DETACHMENT HANDLE (HANDLE). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS EXTREMELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO RUBY COILS IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO DETACH THE NEXT RUBY COIL IN THE TARGET VESSEL, THE HANDLE FAILED TO DETACH THE RUBY COIL; THEREFORE, THE PHYSICIAN MANUALLY DETACHED IT. THE SAME ISSUE OCCURRED FOR THE FOLLOWING RUBY COIL AND POD10; THE HANDLE FAILED TO DETACH RUBY COIL AND POD10; THEREFORE, THE PHYSICIAN MANUALLY DETACHED THEM. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339150 ↗
• MalfunctionAug 22, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO EMBOLIZE THE INFLOW ARTERY, THE PHYSICIAN ADVANCED A RUBY COIL (LOT # C15823) INTO THE TARGET VESSEL USING A LANTERN AND, ATTEMPTED TO DEPLOY THE COIL. HOWEVER, THE RUBY COIL WAS PROLAPSING INTO THE ANEURYSM SACK DUE TO THE HIGH FLOW VESSEL AND, THEREFORE, THE RUBY COIL WAS REMOVED, RINSED IN SALINE BOWL AND, RE-SHEATHED FOR LATER USE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THREE LARGER SIZE RUBY COILS (LOT #¿S C15907, F90316 AND, C14897) BUT THE SAME ISSUE OCCURRED AND, ALL THREE RUBY COILS WERE PROLAPSING INTO THE ANEURYSM SACK. THEREFORE, ALL THREE RUBY COILS WERE REMOVED, RINSED IN SALINE BOWL AND, RE-SHEATHED FOR LATER USE. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA BALLOON CATHETER INTO THE VESSEL, INFLATED THE BALLOON TO STOP THE FLOW AND ATTEMPTED TO ADVANCE THE PREVIOUS RUBY COILS (LOT #¿S C15907, F90316 AND, C14897, C15823); HOWEVER, ALL FOUR COILS WOULD NOT ADVANCE OUT OF THEIR INTRODUCER SHEATHS. IT WAS REPORTED THAT THE RUBY COILS WERE COAGULATED WITH BLOOD INSIDE THEIR IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923531 ↗
• MalfunctionJul 25, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, AFTER ADVANCING A RUBY COIL INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DECIDED TO REMOVE THE COIL AND USE A SLIGHTLY LARGER SIZE COIL. HOWEVER, WHILE RE-SHEATHING THE RUBY COIL ON THE BACK TABLE, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BROKE. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY 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 8826284 ↗
• MalfunctionMay 23, 2019Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER AND, CONSEQUENTLY, THE RUBY COIL BECAME KINKED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND COMPLETED THE PROCEDURE USING A NON-PENUMBRA EMBOLIC AGENT, NEW RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636612 ↗
• InjuryMay 21, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK SAC USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD PACKING COIL USING A LANTERN. A RUBY COIL WAS THEN INADVERTENTLY ADVANCED INTO THROMBUS WITHIN THE ENDOLEAK SAC AND, CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE DETACHED COIL, AND 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 8628329 ↗
• MalfunctionMay 10, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN COMMON ILIAC ARTERY USING A RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE DISTAL TIP OF THE LANTERN WAS FOUND TO BE KINKED UPON REMOVAL FROM THE PACKAGING AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. NEXT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL WITH A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600145 ↗
• MalfunctionFeb 22, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A COIL IN THE TARGET VESSEL. NEXT, A RUBY COIL WAS ADVANCED, THEN RETRACTED IN ORDER TO BE REPOSITIONED. UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN). THE LANTERN AND RUBY COIL WERE THEREFORE REMOVED FROM THE PATIENT, AND THE RUBY COIL WAS REMOVED FROM THE LANTERN. THE SAME LANTERN WAS THEN RE-ADVANCED INTO THE TARGET VESSEL AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8363371 ↗
• MalfunctionFeb 8, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL WAS UNABLE TO ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322152 ↗
• MalfunctionDec 28, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED TWO RUBY COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE DURING TWO ATTEMPTS TO ADVANCE A THIRD RUBY COIL ALL THE WAY THROUGH ITS INTRODUCER SHEATH AND INTO THE HUB OF THE MICROCATHETER. THE RUBY COIL WAS THEREFORE REMOVED AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SIX OTHER RUBY 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 8203932 ↗
• MalfunctionSep 11, 2018Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL TO THE TARGET LOCATION USING A LANTERN DELIVERY MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH THE RUBY COIL USING THE HANDLE AND, THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE. THE RUBY COIL WAS ABLE TO BE DETACHED USING THE NEW HANDLE, AND THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS, POD PACKING COILS (PODJS), THE SAME HANDLE, 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 7866674 ↗
• MalfunctionAug 13, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A GUIDEWIRE WAS LOADED INTO A LANTERN AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE LANTERN INTO THE GUIDE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE (RHV). HOWEVER, THE PHYSICIAN INADVERTENTLY KINKED THE TIP OF THE LANTERN; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE GUIDEWIRE INTO THE LANTERN ON THE BACK TABLE BUT THE KINK WAS SIGNIFICANT AND RESISTANCE WAS ENCOUNTERED WITH THE GUIDEWIRE. THEREFORE, THE PHYSICIAN OPENED A NEW LANTERN. WHILE LOADING A RUBY COIL INTO THE NEW LANTERN, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE THE PEEL AWAY SHEATH WITH THE FIRST LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779270 ↗
• MalfunctionAug 10, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERONEAL ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED AND BECAME STUCK WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COIL USING A SECOND LANTERN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL THROUGH THE LANTERN; HOWEVER, THE COIL BECAME STUCK IN THE MICROCATHETER AND WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PLACE A NEW RUBY COIL, HOWEVER AGAIN THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND OTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773074 ↗
• MalfunctionAug 10, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERONEAL ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED AND BECAME STUCK WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COIL USING A SECOND LANTERN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL THROUGH THE LANTERN; HOWEVER, THE COIL BECAME STUCK IN THE MICROCATHETER AND WAS REMOVED. THE PHYSICIAN ATTEMPTED TO PLACE A NEW RUBY COIL, HOWEVER AGAIN THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND OTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773002 ↗
• InjuryJul 31, 2018Break; Premature Separation; Break; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL TECHNICIAN INADVERTENTLY KINKED THE RUBY COIL ON THE BACK TABLE; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. WHILE ADVANCING A RUBY COIL IN THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER, THE HOSPITAL TECHNOLOGIST PULLED BACK THE MICROCATHETER AND LOST ACCESS TO THE ANEURYSM. THEREFORE, IT WAS DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTING A RUBY COIL OUT OF THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT HALF OF THE RUBY COIL WAS IN THE ANEURYSM AND THE OTHER HALF IN THE NATIVE VESSEL (ANTERIOR TIBIAL ARTERY TO SUPERFICIAL FEMORAL ARTERY). THEREFORE, THE PHYSICIAN DECIDED TO SNARE THE DETACHED COIL; HOWEVER, THE RUBY COIL BROKE IN HALF. THE PHYSICIAN WAS ABLE TO USE FORCEPS TO REMOVE THE REMAINING COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY 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 7737512 ↗
• MalfunctionJul 25, 2018Deformation Due to Compressive Stress; Inadequate User Interface; Deformation Due to Compressive Stress; Inadequate User Interface

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA USING RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL TECHNOLOGIST INADVERTENTLY KINKED TWO RUBY COILS PUSHER ASSEMBLIES WHILE ATTEMPTING TO ADVANCE THE COILS INTO A LANTERN DELIVERY MICROCATHETER (LANTERN); THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ADDITIONAL RUBY COILS, AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720366 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103305. One submission often covers many models, so check the product and lot details in each record.

• Z-1906-2011 · Mar 4, 2011 · Terminated
  Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is in