RUBY Coil RBY2C0520-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI M424RBY2C05200), received between Nov 19, 2015 and Mar 23, 2021 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2021Stretched; Physical Resistance/Sticking; Difficult or Delayed Separation; Stretched; Physical Resistance/Sticking; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE THE PHYSICIAN ADVANCED A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE RUBY COIL. UPON REMOVAL, THE RUBY COIL STRETCHED AND UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN PULLED THE RUBY COIL OUT BY THE FILAMENT WIRE. 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 11558282 ↗
• MalfunctionMar 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE RUBY COIL WAS REMOVED. 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 11499190 ↗
• MalfunctionOct 5, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN WAS UNABLE ADVANCE A RUBY COIL OUT OF THE LANTERN; THEREFORE, THE RUBY COIL WAS REMOVED. WHILE ATTEMPTING TO INSERT A NEW RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, WHILE ATTEMPTING TO PLACE A NEW RUBY COIL INTO THE TARGET VESSEL, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO SMALL; THEREFORE, THE RUBY COIL WAS REMOVED INTACT. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10628450 ↗
• MalfunctionMar 9, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. HOWEVER, THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITION OF THE RUBY COIL. WHILE RETRACTING THE RUBY COIL TO REPOSITION IT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN PUSHED THE DETACHED RUBY COIL INTO THE TARGET VESSEL. 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 9808889 ↗
• MalfunctionNov 13, 2019Failure to Fold; Failure to Fold

  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 ADVANCED A RUBY COIL TO THE TARGET VESSEL USING A LANTERN. HOWEVER, IT WOULD NOT FORM IN THE VESSEL; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER TWO RUBY COILS ONE BY ONE IN THE TARGET VESSEL, HOWEVER, THEY WOULD NOT FORM; THEREFORE, THEY WERE REMOVED. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY RESHEATHING THE RUBY COILS. THE PROCEDURE WAS COMPLETED USING A PLUG AND OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9316933 ↗
• MalfunctionAug 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ARTERIOVENOUS FISTULA (AVF) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE MULTIPLE TIMES WHILE ATTEMPTING TO LOAD THE RUBY COIL INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 8895303 ↗
• MalfunctionJun 18, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE PUSHER ASSEMBLY KINKED. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 8709565 ↗
• MalfunctionMay 8, 2019Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL WAS INADVERTENTLY KINKED UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 8591954 ↗
• InjuryMar 28, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING PREPARATION FOR THE PROCEDURE, THE HOSPITAL STAFF NOTICED THE PUSHER ASSEMBLY OF A RUBY COIL WAS BENT UPON REMOVAL FROM ITS PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL WAS NOTICED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING ANOTHER RUBY COIL OUT OF THE TIP OF THE MICROCATHETER AND INTO THE PATIENT'S HEPATIC ARTERY; AND CONSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED COIL, AND 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 8461311 ↗
• MalfunctionMar 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE IN THE RENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED INITIAL RUBY COILS IN THE TARGET VESSEL USING A NON-PENUMBRA 4F GUIDE CATHETER. WHILE ATTEMPTING TO PLACE ANOTHER RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL WOULD NOT STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL HAD ¿KNOTTED¿ ON ITSELF. THE PHYSICIAN THEN CONTINUED THE PROCEDURE BY PLACING ADDITIONAL RUBY COILS USING THE SAME GUIDE CATHETER. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE TARGET VESSEL, THE RUBY COIL WOULD NOT STAY IN PLACE DUE TO THE HIGH FLOW OF THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE RUBY COIL IN ORDER TO REPOSITION IT; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON REMOVAL, IT WAS NOTICED THAT THE RUBY COIL HAD ALSO ¿KNOTTED¿ ON ITSELF. AFTER THAT, THE PROCEDURE CONTINUED USING ADDITIONAL RUBY COILS. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE GUIDE CATHETER; THER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382182 ↗
• MalfunctionJul 3, 2018Failure to Fold; Kinked; Failure to Fold; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ACCESSORY RENAL ARTERY AND THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A POD6. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE INITIAL TWO COILS IN THE ACCESSORY RENAL ARTERY USING A NON-PENUMBRA ARTERY. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE MICROCATHETER, THE HOSPITAL TECHNOLOGIST EXPERIENCED RESISTANCE AND BENT THE RUBY COIL PUSHER ASSEMBLY TWICE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO PLACE A NEW RUBY COIL IN THE IMA, THE RUBY COIL WOULD NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED. WHILE ATTEMPTING TO RE-SHEATH THE RUBY COIL, THE HOSPITAL TECHNOLOGIST PULLED THE RUBY COIL PASSED THE FRICTION LOCK AND THE EMBOLIZATION COIL WAS COMING OUT OF THE PROXIMAL END OF THE INTRODUCER SHEATH. THE PHYSICIAN THEN ADVANCED A NEW RUBY COIL IN THE IMA; HOWEVER, THE RUBY COIL DID NOT TAKE ITS INTENDED SHAPE AND THEREFORE, WAS REMOVED. IT WAS REPORTED THE RUBY COIL PUSHER ASSEMBLY WAS KINKED. NEXT, THE PHYSICIAN ADVANCED TWO OTHER RUBY COILS IN THE IMA, BUT THE RUBY COILS DID NOT TAKE THEIR INTENDED SHAPE; THEREFORE, THEY WERE REMOVED. WHILE ADVANCING A POD6 INTO THE IMA, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659414 ↗
• MalfunctionApr 20, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE LOBE SEGMENT OF THE PULMONARY ARTERY USING RUBY COILS. DURING THE PROCEDURE, A RUBY COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER, AND THEREFORE THE MICROCATHETER WAS REMOVED WITH THE RUBY COIL INSIDE. THE PHYSICIAN THEN INSERTED A NEW NON-PENUMBRA MICROCATHETER, AND ATTEMPTED TO PLACE ANOTHER RUBY COIL, HOWEVER THE RUBY COIL WAS UNABLE TO DEPLOY. THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL RUBY COILS. ALTHOUGH THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT, MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FOR THE SECOND RUBY COIL. AS OF (B)(6) 2018, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7446115 ↗
• MalfunctionDec 27, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WAS UNABLE TO ADVANCE ANY FURTHER. UPON ATTEMPTING TO RETRACT THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN WITH THE DETACHED RUBY COIL FROM THE PATIENT AND FLUSHED OUT THE RUBY COIL, BEFORE REINSERTING THE LANTERN. HOWEVER, THIS SAME INCIDENT OCCURRED WITH THREE ADDITIONAL RUBY COILS. WHEN THE PHYSICIAN REMOVED THE LANTERN WITH THE FOURTH DETACHED RUBY COIL, A KINK WAS FOUND ON THE LANTERN. THE PROCEDURE WAS THEREFORE COMPLETED USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148199 ↗
• MalfunctionAug 1, 2017Kinked; Physical Resistance; Device Handling Problem; Kinked; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE AN INITIAL RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE TECHNOLOGIST INADVERTENTLY KINKED THE RUBY COIL PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS REMOVED AND 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 Consequences Or Impact To Patient

  MAUDE report 6758868 ↗
• MalfunctionMar 22, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE MANIPULATING THE RUBY COIL WITHIN THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND THE COIL UNINTENTIONALLY DETACHED IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED WITH ONLY THIS RUBY COIL. IT WAS REPORTED THAT THE PHYSICIAN USED AN RHV BUT DID NOT MAINTAIN CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6426080 ↗
• InjuryDec 21, 2016Detachment Of Device Component; Inadequacy of Device Shape and/or Size; Detachment Of Device Component; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING RUBY COILS. DURING THE PROCEDURE, UPON ATTEMPTING TO DEPLOY A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN REALIZED THAT THE COIL USED WASN¿T THE CORRECT SIZE; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, UPON RETRACTING THE RUBY COIL, IT UNINTENTIONALLY DETACHED AND BECAME LOST IN THE PATIENT'S BODY. DUE TO THE PATIENT BEING DISTRESSED, THE PHYSICIAN DIDN¿T HAVE TIME TO SNARE OUT THE DETACHED RUBY COIL AND THE PATIENT WAS TAKEN TO SURGERY. THE PHYSICIAN DID NOT MENTION ANY PARTICULAR RESISTANCE PRIOR TO THE COIL UNINTENTIONAL DETACHMENT. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT USE CONTINUOUS FLUSH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6195075 ↗
• MalfunctionNov 8, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ADVANCING A RUBY COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING FIVE NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6087856 ↗
• MalfunctionOct 19, 2016Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. IT WAS REPORTED THAT DURING THE PROCEDURE, TWO RUBY COILS BECAME STUCK IN THE OTHER MANUFACTURER'S MICROCATHETER. IT WAS ALSO REPORTED THAT ONE OF THE TWO RUBY COILS (LOT #F68237) "DEPLOYED" IN THE MICROCATHETER. BOTH RUBY COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER SYSTEM WITHOUT ANY FURTHER ISSUES. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6038780 ↗
• MalfunctionOct 19, 2016Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. IT WAS REPORTED THAT DURING THE PROCEDURE, TWO RUBY COILS BECAME STUCK IN THE OTHER MANUFACTURER'S MICROCATHETER. IT WAS ALSO REPORTED THAT ONE OF THE TWO RUBY COILS (LOT #F68237) "DEPLOYED" IN THE MICROCATHETER. BOTH RUBY COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER SYSTEM WITHOUT ANY FURTHER ISSUES. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT MAINTAIN A CONTINUOUS FLUSH DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6038767 ↗
• MalfunctionAug 10, 2016Bent; Device Operates Differently Than Expected; Bent; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A RENAL ARTERIOVENOUS MALFORMATION (AVM) USING POD4 COILS AND RUBY COILS. DURING THE PROCEDURE, WHILE DEPLOYING A POD4 COIL, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE COIL WAS FORMING INSIDE THE TARGET VESSEL AND DECIDED TO REMOVE THE COIL. THE PHYSICIAN THEN CHANGED THE SUPPORT CATHETER TO BETTER SUPPORT THE OTHER MANUFACTURER'S MICROCATHETER. WHILE ATTEMPTING TO RE-ADVANCE THE POD4 COIL INTO THE OTHER MANUFACTURER'S MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL INTO THE MICROCATHETER. THEREFORE, THE POD4 COIL WAS REMOVED AND A NEW RUBY COIL WAS OPENED TO CONTINUE THE PROCEDURE. WHILE DEPLOYING THIS RUBY COIL, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE COIL WAS FORMING INSIDE THE TARGET VESSEL AND DECIDED TO REMOVE IT. AS THE RUBY COIL WAS BEING RETRACTED FROM THE PATIENT, THERE WAS NO REPORT OF RESISTANCE; HOWEVER, THE RUBY COIL PUSHER ASSEMBLY BECAME BENT. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL 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 5867177 ↗
• MalfunctionApr 29, 2016Detachment Of Device Component; Separation Failure; Activation, Positioning or Separation Problem; Detachment Of Device Component; Separation Failure; Activation, Positioning or Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A RUBY COIL INTO THE ANEURYSM USING ANOTHER MANUFACTURER'S MICROCATHETER AND VISUALLY CONFIRMED THAT THE RUBY COIL WAS DETACHED FROM THE END OF THE RUBY COIL PUSHER ASSEMBLY. HOWEVER, THE PHYSICIAN DID NOT VERIFY WITH FLUOROSCOPY THAT THE COIL WAS DETACHED WHEN HE PULLED THE PUSHER ASSEMBLY OUT OF THE MICROCATHETER. ONCE THE PUSHER ASSEMBLY WAS REMOVED, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE RUBY COIL WAS NOT IN THE TARGET VESSEL. UPON INSPECTING THE HUB OF THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS HANGING OUT FROM THE END OF IT. THE PROCEDURE WAS COMPLETED USING SIX NEW RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AND ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5621216 ↗
• MalfunctionNov 19, 2015Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE ANOTHER MANUFACTURER'S MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE RUBY COIL AND CONTINUED THE PROCEDURE USING A NEW RUBY COIL 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 5237664 ↗