RUBY Coil RBY2C0430-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI M424RBY2C04300), received between Aug 14, 2015 and Nov 13, 2019 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (19 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 35 reports, in the reporter's own words as published by the FDA.

• 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 9317262 ↗
• MalfunctionAug 27, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A RUBY COIL INTO A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN WAS ABLE TO ADVANCE THE RUBY COIL OUT OF THE TIP OF ITS INTRODUCER SHEATH ON THE BACK TABLE AND THEN ATTEMPTED TO ADVANCE THE RUBY COIL INTO THE LANTERN AGAIN. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RUBY COIL INTO THE LANTERN AGAIN. THEREFORE, THE PROCEDURE WAS COMPLETED USING NEW COILS AND THE SAME LANTERN. IT WAS REPORTED THAT THE PHYSICIAN FLUSHED THE LANTERN BETWEEN EACH ATTEMPT TO ADVANCE THE RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7820448 ↗
• MalfunctionMay 3, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A POD5, A POD PACKING COIL (PODJ), RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A POD5 INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN DETERMINED THAT THE POD5 WAS OVERSIZED AND DECIDED TO RETRACT IT; HOWEVER, DURING THE RETRACTION, THE POD5 BECAME KINKED. THE PHYSICIAN THEN OPENED A PODJ AND ATTEMPTED TO ADVANCE IT THROUGH THE LANTERN; HOWEVER, THE PODJ KICKED THE LANTERN OUT OF THE ANEURYSM AND THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN SMOOTHLY ADVANCED A RUBY COIL WITHIN THE LANTERN UNTIL THE LAST ONE CENTIMETER FROM THE DISTAL TIP OF THE LANTERN AND THE PHYSICIAN THOUGHT THAT THERE MAY BE A KINK IN THE LANTERN; THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED. UPON REMOVAL, THE LANTERN WAS CONFIRMED TO BE KINKED. THE PROCEDURE WAS COMPLETED USING OTHER COILS, THE SAME DIAGNOSTIC CATHETER, A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7485442 ↗
• MalfunctionMar 1, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LARGE VARICOCELE USING RUBY COILS AND A POD5. DURING THE PROCEDURE, PRIOR TO USE, A RUBY COIL PUSHER ASSEMBLY BECAME KINKED WHILE BEING REMOVED FROM THE DISPENSER HOOP; THEREFORE IT WAS SET ASIDE AND THE PROCEDURE CONTINUED WITH OTHER COILS. THE PHYSICIAN THEN HAD DIFFICULTY ADVANCING A POD5 INTO THE EXISTING COIL MASS IN THE VARICOCELE DUE TO THE FACT THAT THE POD5 WAS THE WRONG SIZE; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER RUBY COILS AND THE SAME LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7307933 ↗
• MalfunctionJan 17, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL RUBY COILS INTO THE PATIENT USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING A NEW RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN DID NOT MENTION EXPERIENCING ANY RESISTANCE; HOWEVER, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE RUBY COIL INSIDE. THE SAME MICROCATHETER WAS THEN FLUSHED TO REMOVE THE DETACHED RUBY COIL. THEREAFTER, 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 7201959 ↗
• MalfunctionJan 2, 2018Detachment Of Device Component; Unraveled Material; Physical Resistance; Detachment Of Device Component; Unraveled Material; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT IT; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN AND STARTED TO COME APART IN THE LANTERN. THEREFORE, THE PHYSICIAN PULLED THE LANTERN OUT OF THE PATIENT¿S BODY WITH THE RUBY COIL PARTIALLY IN THE DIAGNOSTIC CATHETER. THE RUBY COIL EVENTUALLY CAME BACK OUT BUT HAD STARTED TO UNWIND. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7158703 ↗
• MalfunctionDec 27, 2017Inadequacy of Device Shape and/or Size; Failure to Advance; Inadequacy of Device Shape and/or Size; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE MESENTERIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, WHILE DEPLOYING A RUBY COIL INTO THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE COIL WAS THE INCORRECT SIZE. THEREFORE, THE PHYSICIAN REMOVED AND RE-SHEATHED THE COIL. LATER IN THE PROCEDURE, WHILE ATTEMPTING TO RE-DEPLOY THE RUBY COIL THAT WAS PREVIOUSLY RE-SHEATHED, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL BACK OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER. THE RUBY COIL WAS STUCK INSIDE ITS SHEATH AND THEREFORE, THE INTRODUCER SHEATH CONTAINING THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT RINSE THE RUBY COIL IN A SALINE BATH PRIOR TO ATTEMPTING TO RE-DEPLOY IT. 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 7150098 ↗
• MalfunctionNov 21, 2017Inadequacy of Device Shape and/or Size; Failure to Advance; Inadequacy of Device Shape and/or Size; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT ARM ARTERIOVENOUS MALFORMATION (AVM) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A RUBY COIL INTO THE AVM, THE PHYSICIAN DETERMINED THAT THE COIL WAS UNDERSIZED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND THE TECHNOLOGIST ATTEMPTED TO CLEAN THE COIL PRIOR TO RESHEATHING IT FOR LATER USE. HOWEVER, A LITTLE BLOOD MAY HAVE BEEN IN THE INTRODUCER SHEATH. THE PROCEDURE THEN CONTINUED USING OTHER COILS. SUBSEQUENTLY, WHEN THE PHYSICIAN ATTEMPTED TO USE THE RUBY COIL THAT WAS PREVIOUSLY RESHEATHED, THE COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN). 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 7051518 ↗
• MalfunctionNov 9, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF NOTICED THAT A RUBY COIL PUSHER ASSEMBLY WAS KINKED UPON REMOVAL FROM THE DISPENSER HOOP. THE DAMAGED RUBY COIL WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7014209 ↗
• MalfunctionOct 10, 2017Kinked; Device Handling Problem; Kinked; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RADIOLOGIC TECHNOLOGIST INADVERTENTLY KINKED A RUBY COIL PUSHER ASSEMBLY WHILE REMOVING THE RUBY COIL FROM ITS DISPENSER HOOP. THE PUSHER ASSEMBLY BECAME KINKED PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS.

  Patient problems: No Patient Involvement

  MAUDE report 6938635 ↗
• MalfunctionOct 4, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

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

  Patient problems: No Patient Involvement

  MAUDE report 6914251 ↗
• MalfunctionAug 28, 2017Entrapment of Device; Failure to Advance; Physical Resistance; Entrapment of Device; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK AT THE DISTAL END OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN REPOSITIONED THE MICROCATHETER AND ATTEMPTED TO RE-ADVANCE THE RUBY COIL. HOWEVER, THE RUBY COIL WOULD NOT MOVE; THEREFORE, IT WAS REMOVED. UPON RE-FLUSHING THE MICROCATHETER, THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS WITHOUT FURTHER ISSUES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6825501 ↗
• MalfunctionJun 27, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE AND CERVICAL ARTERIES USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A 6F SHEATH INTO THE TARGET VESSEL, THEN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) THROUGH THE SHEATH. WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL PUSHER ASSEMBLIES BECAME KINKED. THEREFORE, THE PHYSICIAN REMOVED BOTH RUBY COILS AND SUCCESSFULLY COMPLETED THE PROCEDURE 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 6672165 ↗
• InjuryMay 12, 2017Break; Positioning Failure; Unraveled Material; Break; Positioning Failure; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY REPOSITIONING THE RUBY COIL INSIDE THE GDA USING A NON-PENUMBRA MICROCATHETER BECAUSE OF TORTUOUS ANATOMY; CONSEQUENTLY, THE MICROCATHETER KICKED OUT OF THE ANEURYSM AND THE COIL BROKE AND UNRAVELED. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL WITH A SNARE DEVICE; HOWEVER WAS UNSUCCESSFUL. THE PHYSICIAN THEN REINSERTED THE SAME MICROCATHETER AND ATTEMPTED TO ADVANCE A NEW RUBY COIL TO CONTINUE THE EMBOLIZATION; HOWEVER, WHILE DEPLOYING, THE MICROCATHETER BACKED OUT AGAIN, AND THIS RUBY COIL ALSO BROKE AND UNRAVELED. THE PHYSICIAN ATTEMPTED TO SNARE THE BROKEN RUBY COIL, HOWEVER INADVERTENTLY DISSECTED THE VESSEL; THEREFORE, THE PROCEDURE WAS ENDED AT THIS POINT AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). AS OF (B)(6) 2017, THE PATIENT WAS CONSIDERED STABLE AND WAS DISCHARGED, AND WILL UNDERGO AN ADDITIONAL PROCEDURE TO PLACE A STENT OVER THE PARTIALLY PLACED RUBY COIL REMAINING INSIDE THE HEPATIC ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6563483 ↗
• MalfunctionApr 18, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH ANOTHER MANUFACTURER¿S MICROCATHETER, THE SCRUB TECHNOLOGIST EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS RE-SHEATHED. AFTER FLUSHING THE MICROCATHETER, A SECOND ATTEMPT WAS MADE TO ADVANCE THE SAME RUBY COIL THROUGH THE MICROCATHETER; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER AND INTO THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME MICROCATHETER. ADDITIONALLY, THE SCRUB TECHNOLOGIST BELIEVES THAT THE RUBY COIL MAY HAVE BEEN PULLED WITH TOO MUCH FORCE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6501408 ↗
• MalfunctionApr 4, 2017Failure to Advance; Physical Resistance; Patient-Device Incompatibility; Failure to Advance; Physical Resistance; Patient-Device Incompatibility

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. IT WAS REPORTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, AFTER ADVANCING AN INITIAL RUBY COIL HALF WAY THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE RUBY COIL WAS RETRACTED AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL COILS. THE PHYSICIAN BELIEVES THAT THE TORTUOSITY OF THE VESSEL CAUSED THE MICROCATHETER TO BECOME OVALIZED AND CINCH DOWN ON THE RUBY COILS, WHICH WAS WHY THEY WERE UNABLE TO BE ADVANCED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6458156 ↗
• MalfunctionApr 4, 2017Failure to Advance; Physical Resistance; Patient-Device Incompatibility; Failure to Advance; Physical Resistance; Patient-Device Incompatibility

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, AFTER ADVANCING AN INITIAL RUBY COIL HALF WAY THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL FURTHER. THEREFORE, THE RUBY COIL WAS RETRACTED AND THE MICROCATHETER WAS FLUSHED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED AND THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ADDITIONAL COILS. THE PHYSICIAN BELIEVES THAT THE TORTUOSITY OF THE VESSEL CAUSED THE MICROCATHETER TO BECOME OVALIZED AND CINCH DOWN ON THE RUBY COILS, WHICH WAS WHY THEY WERE UNABLE TO BE ADVANCED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6457854 ↗
• MalfunctionMar 16, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THREE RUBY COILS THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ADVANCED THE COILS A FEW CENTIMETERS INTO THE MICROCATHETER AND THEN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, THE RUBY COILS WERE UNABLE TO ADVANCE FURTHER AND WERE REMOVED. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ADDITIONAL COILS AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6412071 ↗
• MalfunctionMar 1, 2017Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (PODJ) AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A 135CM LANTERN (F69982) THROUGH A NON-PENUMBRA SHEATH, AND ADVANCED A RUBY COIL (F64580) THROUGH IT. THE PHYSICIAN THEN ATTEMPTED TO DETACH THE RUBY COIL USING A RUBY COIL DETACHMENT HANDLE (HANDLE); HOWEVER, THE RUBY COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW HANDLE TO DETACH THIS RUBY COIL AND THE NEW HANDLE FAILED TO DETACH THE RUBY COIL AS WELL; THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. BOTH HANDLES WERE ABLE TO SUCCESSFULLY DETACH OTHER RUBY COILS LATER IN THE PROCEDURE. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F62420) THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE RUBY COIL BECAME STUCK AND UNABLE TO ADVANCE OUT OF THE TIP OF THE LANTERN. THE PHYSICIAN THEN REMOVED THE RUBY COIL; HOWEVER, UPON REMOVAL, THE PHYSICIAN INADVERTENTLY BENT THE RUBY COIL PUSHER ASSEMBLY. UPON ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE SAME LANTERN, THE PHYSICIAN NOTICED THAT RUBY COIL BEC

  Patient problems: No Patient Involvement

  MAUDE report 6368387 ↗
• MalfunctionDec 19, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO REPAIR A PREVIOUSLY TREATED AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH A LANTERN DELIVERY MICROCATHETER(LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COILS WOULD NOT ADVANCE; THEREFORE, THEY WERE REMOVED. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT USE CONTINUOUS FLUSH; HOWEVER, MANUAL FLUSH WAS PERFORMED BEFORE EACH COIL INSERTION. IT WAS NOTED THAT THE PHYSICIAN TOOK TOO LONG TO INSERT THE COILS INTO THE LANTERN AND BLOOD ENDED UP GETTING INTO THE LANTERN. 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 6185613 ↗
• MalfunctionDec 19, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO REPAIR A PREVIOUSLY TREATED AORTIC ANEURYSM USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS THROUGH A LANTERN DELIVERY MICROCATHETER(LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COILS WOULD NOT ADVANCE; THEREFORE, THEY WERE REMOVED. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) AND DID NOT USE CONTINUOUS FLUSH; HOWEVER, MANUAL FLUSH WAS PERFORMED BEFORE EACH COIL INSERTION. IT WAS NOTED THAT THE PHYSICIAN TOOK TOO LONG TO INSERT THE COILS INTO THE LANTERN AND BLOOD ENDED UP GETTING INTO THE LANTERN. 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 6185611 ↗
• MalfunctionNov 22, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN) IN THE TARGET VESSEL WHEN THE DIAGNOSTIC CATHETER ABRUPTLY PULLED BACK DUE TO SIGNIFICANCE TORQUE IN A HIGHLY TORTUOUS SPLENIC ARTERY; THEREFORE THE PHYSICIAN RE-SHEATHED THE RUBY COIL IN ORDER TO REPOSITION THE LANTERN. HOWEVER, UPON ATTEMPTING TO REINSERT THE RUBY COIL INTO THE LANTERN, THE RUBY COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME LANTERN. THE PHYSICIAN REPORTED USING A ROTATING HEMOSTASIS VALVE, BUT NOT MAINTAINING CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6121030 ↗
• MalfunctionNov 8, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT A RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED FROM THE PATIENT AND THEN THE ENTIRE COIL WAS RETRIEVED FROM THE MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6087774 ↗
• MalfunctionOct 20, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN NOTICED THAT THE RUBY COIL WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER DESPITE MULTIPLE ATTEMPTS; THEREFORE, THE RUBY COIL WAS REMOVED AND RESHEATHED. THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND NEW RUBY COILS. THE PHYSICIAN REPORTED NOT USING A ROTATING HEMOSTASIS VALVE AND CONTINUOUS FLUSH WAS NOT MAINTAINED DURING THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6045694 ↗
• MalfunctionOct 7, 2016Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, IT BECAME STUCK INSIDE THE MICROCATHETER; THEREFORE, THE PHYSICIAN DECIDED TO RETRACT IT. HOWEVER, WHILE ATTEMPTING TO RETRACT THE RUBY COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. A SMALL PORTION OF THE RUBY COIL WAS HANGING OUTSIDE THE HUB OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO SECURE THE RUBY COIL AND REMOVE IT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER WITHOUT FURTHER ISSUES. IT WAS NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS VALVE (RHV) OR MAINTAIN 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 6011643 ↗