ORBIT GALAXY 640CR0830Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886704030454), received between Jul 7, 2017 and Oct 16, 2025 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Device Difficult to Setup or Prepare; Difficult to Advance; Device Difficult to Setup or Prepare; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THREE (3) COILS WERE USED, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 31358781), A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 31498857), AND A 9MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0925 / LOT UNKNOWN) ENCOUNTERED RESISTANCE AND COULD NOT BE RESHEATHED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-SEP-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ENDOVASCULAR EMBOLIZATION PROCEDURE WAS TARGETING THE ANTERIOR CEREBRAL ARTERY (ACA). THERE WAS NO VESSEL CALCIFICATION / TORTUOSITY. THE CONCOMITANT MICROCATHETER USED WAS A PROWLER 14 (CATALOG / LOT NUMBER NOT PROVIDED). A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE INTRODUCER OF THE COIL(S) WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT INT H CLEAR TUBE. THE TIPS OF THE INTRODUCER(S) WERE FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE COIL ADVANCEMENT. THE ISSUE THE COILS ENCOUNTERED WAS RESISTANCE WHILE PUSHING IN THE MICROCATHETER DURING THE ADVANCEMENT; AT THE PROXIMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318832 ↗
• MalfunctionJan 22, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO THE POSTERIOR COMMUNICATING ARTERY, AN 8X30 ORBIT GALAXY COIL (640CR0830, 31081161) BECAME WAS IMPEDED IN INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO MICROCATHETER (OTHER BRAND). THE PHYSICIAN FILLED THE ANEURYSM WITH A NEW COIL, A 3X8 ORBIT GALAXY XTRASOFT COIL (640CX0308, 31270225), IT WAS FOUND THAT THE SHAPE WAS NOT IDEAL (NO FURTHER CLARIFICATION WAS AVAILABLE). THE PHYSICIAN STARTED TO RETRACT THE COIL FOR ADJUSTING, BUT THE COIL COULD NOT BE RETRACTED TO THE INTRODUCER SHEATH. THEN, A NEW COIL, 6X20 ORBIT GALAXY (640CF0620, 31359780) WAS USED TO FILL THE ANEURYSM, BUT THE SAME ISSUE AS THE PREVIOUS COIL WAS ENCOUNTERED, WHICH CANNOT BE RETRACTED INTO THE INTRODUCER SHEATH. THE DOCTOR SWITCHED TO NON J&J COILS TO COMPLETE THE SURGERY. THE NON J&J MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 15 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 20-DEC-2024 INDICATED THAT POOR CONFORMABILITY LED TO THE RE-SHEATHING OF THE COILS. THE COIL INTRODUCER WAS CRACKED, NO COIL PROTRUSION FROM INTRODUCER. THE COILS WERE NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21208443 ↗
• MalfunctionJun 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN TRIED TO PLACE ONE COIL, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR0830 / 30606917) AND THE TIP WOULD NOT SIT WITHIN THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND). ANOTHER COIL, A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME (640CR0725 / 30848871) WAS PLACED INTO THE TARGET ANEURYSM BUT AT THE LAST FEW CM, THE COIL BECAME HARD TO ADVANCE AND THE PUSHER WIRE BROKE DURING THE ATTEMPT TO ADVANCE. IT WAS REPORTED THAT FLUSH LINES WERE MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR NEGATIVE PATIENT IMPACT. ON 19-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT (B)(6) WAS TREATING A LEFT INTERNAL CAROTID ARTERY (ICA) FISTULA. THE FISTULA WAS IRREGULAR, MEASURING 10MM X 18MM. THE HEADWAY® DUO .0165 MICROCATHETER (MICROVENTION) WAS USED FOR THE ENTIRE PROCEDURE. THE INFORMATION INDICATED THAT THE PUSHER WIRE BROKE IN TWO PIECES. THE WIRE WAS STILL EXPOSED OUT OF THE ROTATING HEMOSTASIS VALVE (RHV) THAT WAS CONNECTED TO THE MICROCATHETER AND WAS REMOVED EASILY. THERE WERE NOT VISIBLE KINKS OBSERVED ON THE MICROCATHETER. THERE WAS NO R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17146750 ↗
• MalfunctionApr 24, 2023Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE SECOND COIL, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / LOT# UNKNOWN) WAS IMPEDED IN THE MICROCATHETER. THE COIL WAS RETRACTED AND A NEW COIL WAS USED TO FILL THE ANEURYSM. THE PHYSICIAN ENCOUNTERED A LOT OF RESISTANCE WHEN THE FOURTH COIL, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR0830 / 30666505) WAS DELIVERED TO THE MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN WITHDREW THE COIL; IT WAS OBSERVED THAT THE COIL HAD PREMATURELY DETACHED IN THE MICROCATHETER AND REMAINED IN THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND THE MICROCATHETER. IT WAS REPORTED THAT THE MICROCATHETER WAS IN GOOD CONDITION. A NEW COIL AND A NEW MICROCATHETER WERE USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED BY APPROXIMATELY HALF AN HOUR. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 23-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE PULMONARY ARTERY. THE SECOND COIL, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR0830) DID NOT PREMATURELY DETACH AT THE DETACHMENT ZONE ON THE DEVICE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16796550 ↗
• MalfunctionApr 21, 2023Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHILE ADVANCING THE COMPLAINT COIL, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR0830 / 30848872), THERE WAS ¿SO MUCH RESISTANCE WHILE PUSHING THE COIL IN THE MICROCATHETER,¿ WHEN THE COIL WAS REMOVED, IT BECAME SEPARATED FROM THE PUSHER WIRE. THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE COMPLAINT COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6)2 023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING AN INTERNAL CAROTID ARTERY (ICA) OCCLUSION. THE INFORMATION INDICATED THAT THE COIL DID NOT PREMATURELY DETACH AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT. NO ADDITIONAL INTERVENTION WAS REQUIRED; THE COIL WAS REMOVED INSTANTLY. THE EVENT DID NOT RESULT IN A REDUCED / RESTRICTED BLOOD FLOW IN THE PARENT VESSEL. THERE WAS NO EVIDENCE OF THROMBOSIS. THE MICROCATHETER USED WAS A COMPETITOR PRODUCT. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH AN 8MM X 24CM ORBIT GALAXY COMPLEX FILL COIL (640CF0824). THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792432 ↗
• MalfunctionJan 26, 2023Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, AN 8X30 ORBIT GALAXY COIL (640CR0830, 30679276) BECAME STRETCHED WHILE RE SHEATHING, THE SIZE OF THE COIL WAS OVERSIZE ACCORDING TO THE CASE. THE SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. ANOTHER COIL WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245692 ↗
• MalfunctionDec 13, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN 8X30 ORBIT GALAXY COIL (640CR0830, 30666505) BECAME IMPEDED IN THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL (THE MICROCATHETER WAS NOT REPLACED) TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT INVESTIGATION OF THE DEVICE RECEIVED, THE DELIVERY TUBE (HYPO TUBE) WAS FOUND BROKEN. THE REPORTER CONFIRMED THAT NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THE SEPARATED HYPO-TUBE MAY BE CAUSED BY TRANSPORTATION AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969066 ↗
• InjuryNov 14, 2022Stretched; Difficult to Advance; Premature Separation; Stretched; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT A 67-YEAR-OLD MALE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA USING AN ORBIT GALAXY TDL CMPLX FRAME COIL 8X30 (CATALOG 640CR0830/LOT 30679276). THE PHYSICIAN STARTED TO EXPERIENCE SOME RESISTANCE WHILE USING THE DEVICE AND AT TIME OF FILLING IT WAS FOUND THAT THE COIL HAD PREMATURELY DETACHED DURING PLACEMENT AND SUBSEQUENTLY BECAME UNRAVELED/STRETCHED. THE PHYSICIAN WAS ABLE TO PULL BACK THE COIL SLIGHTLY AND THEN USED A SOLITAIRE AB (MEDTRONIC) STENT RETRIEVER TO REMOVE THE COIL COMPLETELY FROM THE PATIENT AFTER 3 OR 4 ATTEMPTS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE VESSEL SPASM (UNKNOWN LOCATION) DURING COIL CAPTURING. AFTER COMPLETE REMOVAL OF THE COIL, A CT SCAN REVEALED HEMORRHAGE (THE PATIENT WAS BLEEDING PREOPERATIVE, SO PHYSICIAN CANNOT ACCURATELY DETERMINE WHETHER IT IS A NEW POSTOPERATIVE BLEEDING). THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 2 HOURS. AFTER CONSULTATION WITH PATIENT'S FAMILY MEMBER, IT WAS AGREED TO PERFORM CRANIOTOMY FOR DECOMPRESSION AND HEMATOMA EVACUATION. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Coma; Intracranial Hemorrhage; Vasoconstriction

  MAUDE report 15787647 ↗
• MalfunctionJun 13, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE MIDDLE CEREBRAL ARTERY , AN 8X30 ORBIT GALAXY COIL (640CR0830, 30666505) BECAME IMPEDED IN AN ECHELON-10,45°TIP MICROCATHETER (MC). THE MC COULD NOT ADVANCE ANY MORE. THE PHYSICIAN SWITCHED TO A 7X25 ORBIT GALAXY COIL (640CR0725, 30628880) BUT THE SAME ISSUE OCCURRED. THE MICROCATHETER WAS REPLACED AND THE SAME PROBLEM REMAINED. THEN A NEW COMPETITOR DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THERE APPEARED TO BE ANY DAMAGE TO THE DEVICES AT ANY TIME. IT IS UNKNOWN IF THERE WAS ANYTHING OBSTRUCTING THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675966 ↗
• MalfunctionDec 14, 2021Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE LEFT POSTERIOR COMMUNICATING ARTERY, THE PHYSICIAN OPENED THE PACKAGE OF AN ORBIT GALAXY COIL (640CR0830, 30628881) AND OBSERVED THAT THE COIL WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED OUT. THE COIL WAS ALSO FOUND TO BE KINKED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12994004 ↗
• MalfunctionDec 8, 2021Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY, THE PHYSICIAN OPENED THE PACKAGE OF AN ORBIT GALAXY COIL (640CR0830, 30628881) AND OBSERVED THAT THE COIL WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED OUT. THE COIL WAS ALSO FOUND TO BE KINKED. THE COMPLAINT DEVICE WAS NOT CLINICALLY USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960024 ↗
• MalfunctionNov 18, 2021Positioning Failure; Positioning Problem; Premature Separation; Positioning Failure; Positioning Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WITH A RIGHT INTERNAL CAROTID ARTERY / OPHTHALMIC SEGMENT ANEURYSM WITH THE FOLLOWING DIMENSIONS: LENGTH: 7.8 MM, WIDTH: 5.0 MM, HEIGHT: 5.3 MM UNDERWENT COIL EMBOLIZATION. THE PHYSICIAN USED THE 8MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 30588113) AS THE FIRST COIL AND USED IT TO FILL THE ANEURYSM; IT WAS REPORTED THAT THE COIL ¿FELL OFF THE ANEURYSM¿ AND THE PHYSICIAN REMOVED THE COIL. WHEN THE COIL WAS ABOUT TO BE RETRACTED INTO THE INTRODUCER, IT BECAME PREMATURELY DETACHED OUTSIDE OF THE PATIENT¿S BODY. A NEW COIL WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12841144 ↗
• MalfunctionJul 14, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 7X25 ORBIT GALAXY COMPLEX FRAME COIL (640CR0725, 30337722) AND AN 8X30 ORBIT GALAXY COIL (640CR0830, 30286063) WERE NOT MOVING PROPERLY IN THE UNSPECIFIED MICROCATHETER. THERE WAS SO MUCH OF RESISTANCE IN DEPLOYING THE COILS. BOTH THE COIL AND CATHETER WERE REMOVED WITHOUT ADDITIONAL INTERVENTION, THERE WAS A LOSS OF CEREBRAL TARGET POSITION. ANOTHER COIL AND CATHETER WERE USED. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS ¿FINE¿ AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166202 ↗
• MalfunctionJun 1, 2021Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, AN 8X30 ORBIT GALAXY (640CR0830, LOT UNKNOWN) DETACHED INTO THE UNSPECIFIED MICROCATHETER (MC). THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 20 MINUTES. ANOTHER MICROCATHETER WAS USED WITH ANOTHER COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913217 ↗
• MalfunctionMar 12, 2021Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 8MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 30286063) WAS KINKED DURING THE PROCEDURE. THERE WAS NO REPORTED PROCEDURE DELAY AND THERE WAS NO PATIENT ADVERSE EVENT ASSOCIATED WITH THE REPORTED DEVICE ISSUE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475473 ↗
• MalfunctionFeb 3, 2020Difficult to Remove; Premature Separation; Difficult to Remove; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TRANSCATHETER STENT-ASSISTED EMBOLIZATION OF INTRACRANIAL ANEURYSM, THE 8MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 17673397) COULD NOT BE WITHDRAWN. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660119 ↗
• MalfunctionJul 24, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL COIL EMBOLIZATION TO A RUPTURED ANEURYSM AT THE MIDDLE CEREBRAL ARTERY (MCA), TORTUROUS VESSEL, AN 8X30 OG TDL CMPLX FRAME COIL BECAME STRETCHED WHILE BEING TAKEN OUT OF THE ANEURYSM. THE DEVICE WAS REMOVED FROM THE PATIENT ¿IN PROPER MANNER¿. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). NO EXCESSIVE FORCE WAS BEEN APPLIED TO THE DEVICE. THE DEVICE WAS BEING RESHEATHED BECAUSE THE COIL LENGTH WAS BIG ACCORDING TO ANEURYSM, SO USER WANTED TO CHANGE THE SIZE. THERE WERE NO DIFFICULTIES POSITING THE COIL AT THE TARGET VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822014 ↗
• MalfunctionJul 17, 2019Positioning Problem; Physical Resistance/Sticking; Positioning Problem; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, AN 8X30 OG TDL CMPLX FRAME COIL WAS BEING USED AS THE FIRST COIL BUT COULD NOT BE SHAPED AS EXPECTED. THE SURGEON WITHDREW THE COIL FOR RE-POSITION. BUT THEN THE COIL COULD NOT BE PUSHED INTO THE ANEURYSM. THE SURGEON USED ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799140 ↗
• MalfunctionMay 13, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN 8MM X 7 MM IRREGULAR SHAPE ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM) WITH SUBARACHNOID HEMORRHAGE, THE 8 MM X 30 CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 30083303) COULD NOT PASS THROUGH THE ECHELON 10 (MEDTRONIC) MICROCATHETER DURING COIL INSERTION THROUGH THE MICROCATHETER, BEFORE THE COIL EXITED THE MICROCATHETER. THE PHYSICIAN FOUND THAT THE COIL ALSO BECAME STRETCHED. THE COIL WAS REMOVED AND REPLACED BY ANOTHER FRAMING COIL; THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. PRIOR TO THE REPORTED EVENT, OTHER COILS WENT THROUGH THE MICROCATHETER WITHOUT ANY RESISTANCE. THERE WERE NO KINKS ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE EVENT; THERE WAS NO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COIL; THIS 8 MM X 30 CM ORBIT GALAXY COMPLEX FRAME COIL DID NOT EXIT THE MICROCATHETER. THERE WAS NO BLOOD FLOW RESTRICTION OR REDUCTION ASSOCIATED WITH THE REPORTED EVENT; NO ADDITIONAL INTERVENTION REQUIRED. IT WAS REPORTED THAT THE PRODUCT IS AV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605692 ↗
• MalfunctionJul 7, 2017Premature Activation; Premature Activation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PROWLER 14 MICROCATHETER (606151FX/17519954) AND A GALAXY FRAME 8X30 COIL (640CR0830/17473296) WERE USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM WHEN RESISTANCE WAS ENCOUNTERED WITH THE MICROCATHETER WHILE ADVANCING THE COIL AS THE COIL HAD PREMATURELY DEPLOYED IN THE MICROCATHETER. THE PHYSICIAN LOADED THE GALAXY FRAME 8X30 COIL (COMPLAINT PRODUCT 1) INTO THE PROWLER 14 MICROCATHETER (COMPLAINT PRODUCT 2), WHILE ADVANCING THE COIL THROUGH THE CATHETER, SIGNIFICANT RESISTANCE WAS MET AND THE COIL COULD NOT BE PUSHED OUT OF THE END OF THE MICROCATHETER. THE PHYSICIAN PULLED BACK ON THE DELIVERY WIRE TO RETRACT THE COIL. WHEN THE DELIVERY WIRE WAS PULLED OUT OF THE MICROCATHETER, THE COIL WAS NO LONGER ATTACHED AND WAS STUCK INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER, INTRODUCED A NEW PROWLER 14 INTO THE ANEURYSM AND DEPLOYED A NEW GALAXY FRAME 8X30 INTO THE ANEURYSM SUCCESSFULLY. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6694980 ↗