ORBIT GALAXY 640CF0620Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886704030348), received between Dec 14, 2016 and Jan 7, 2025 — classified as 1 death, 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Stretched” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 7, 2025Crack; Device Difficult to Setup or Prepare; Positioning Problem; Crack; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO THE POSTERIOR COMMUNICATING ARTERY, THE PHYSICIAN FILLED THE ANEURYSM WITH 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 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091508 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL (640CF0620 / 31338108) FILLED THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE DELIVERY TUBE LEAKED SALINE AT THE TIME OF THE ATTEMPTED COIL DETACHMENT. IT WAS REPORTED THAT THE DELIVERY TUBE BROKE INTO TWO PIECES. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) FROM THE PATIENT AND REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. TWO PHOTOS WERE INCLUDED IN THE COMPLAINT. THE PHOTOS WILL UNDERGO REVIEW BY THE PRODUCT ANALYSIS TEAM. ON 24-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE VESSEL THE TARGET ANEURYSM WAS LOCATED ON WAS THE INTERNAL CAROTID ARTERY (ICA). THE TARGET WAS AN UNRUPTURED ANEURYSM. WHEN THE COIL WAS REMOVED, IT WAS NOT DAMAGED IN ANY WAY. THE REPORTED ISSUE DID NOT RESULT IN ANY REDUCED / RESTRICTED BLOOD FLOW IN THE PARENT VESSEL. THE INFORMATION INDICATED THAT THE DEVICE WAS NOT SUBJECTED TO ANY FORCE DURING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773549 ↗
• MalfunctionMay 1, 2024Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID ANEURYSM, THERE WAS RESISTANCE WHILE PUSHING AN ORBIT GALAXY COIL (640CF0620, 30862483) ONTO A PROWLER SELECT LPES MICROCATHETER (606S155X, 31178991). THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 01-APR-2024 INDICATED THAT THE 15 MINUTES DELAY WAS CONSIDERED TO BE NOT CLINICALLY SIGNIFICANT. THE RESISTANCE WAS FIRST FELT AT THE MID SHAFT OF THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER (MC). A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE ORBIT GALAXY COIL (640CF0620, 30862483), THE DELIVERY TUBE (HYPO TUBE) - BROKEN WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222235 ↗
• MalfunctionApr 16, 2024Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, THERE WAS RESISTANCE WHILE PUSHING THE COIL, A 6MM X 20CM ORBIT GALAXY COMPLEX FILL (640CF0620 / 30862483) INTO THE MICROCATHETER. THE PROCEDURE WAS DELAYED BY 5 MINUTES. IT WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 14-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA). THERE WAS NO REMARKABLE ANATOMICAL / VESSEL CHARACTERISTIC SUCH AS CALCIFICATION / TORTUOSITY. THE REPORTED DELAY OF 5 MINUTES WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT. THE CONCOMITANT MICROCATHETER USED WAS A PROWLER SELECT LPES (606S155X / 31178991). THE MICROCATHETER WAS NOT REMOVED NOR REPLACED. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THE REPORTED ISSUE: 10MM X 30CM ORBIT GALAXY, 9MM X 25CM ORBIT GALAXY, AND 7MM X 21CM ORBIT GALAXY. THE COMPLAINT DEVICE DID NOT APPEAR DAMAGE AT ANY TIME; NO DAMAGE WAS NOTED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19121811 ↗
• MalfunctionJul 26, 2022Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE ATTEMPT TO RESHEATH THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL (640CF0620 / 30440215) FAILED DUE TO THE INTRODUCER SHEATH BECOMING SPLIT. THERE WAS NO DELAY TO THE PROCEDURE DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS THE INTERNAL CAROTID ARTERY (ICA). THE REASON FOR THE FAILED RESHEATHING ATTEMPT WAS DUE TO POOR CONFORMITY OF THE COIL. THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER (UNSPECIFIED BRAND). BASED ON THE ADDITIONAL INFORMATION RECEIVED RELATED TO THE POOR COIL CONFORMABILITY, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107690 ↗
• MalfunctionJun 20, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL (640CF0620 / 30688440) COULD NOT BE DETACHED. THE PHYSICIAN RAISED THE PRESSURE ON THE SYRINGE TO THE RED ZONE, BUT THE COIL STILL DID NOT DETACH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14746831 ↗
• InjuryDec 6, 2021Premature Separation; Premature Separation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A (B)(6) MALE PATIENT UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. DURING THE PROCEDURE, A SOLITAIRE AB (MEDTRONIC) STENT WAS DELIVERED TO THE TARGET ANEURYSM VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC). NEXT, THE PHYSICIAN STARTED TO FILL THE ANEURYSM WITH A 6MM X 20CM ORBIT GALAXY TDL COMPLEX FILL COIL (640CF0620, 30478001). AFTER ½ OF THE COIL WAS IN THE ANEURYSM SAC, THE PHYSICIAN FELT THE SHAPE OF THE COIL WAS NOT IDEAL. THE PHYSICIAN TRIED TO ADJUST THE POSITION OF THE COIL, BUT THE COIL PREMATURELY DETACHED. IMMEDIATELY, THE PHYSICIAN USED A SOLITAIRE AB STENT RETRIEVER (MEDTRONIC) TO REMOVE THE PREMATURELY DETACHED COIL FROM THE PATIENT. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE PREMATURELY DETACHED COIL WAS MISPLACED AND IS THUS NOT AVAILABLE FOR RETURN. IT IS UNKNOWN IF THE DELIVERY TUBE AND INTRODUCER WILL BE RETURNED FOR EVALUATION. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-NOV-2021 INDICATED THAT THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. REPORTEDLY, THERE WAS NO ISSUE ENCOUNTERED DURING POSITIONING OF THE COMPLAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932878 ↗
• MalfunctionAug 13, 2021Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WAS SUFFERING FROM A RIGHT INTERNAL CAROTID COMMUNICATING SEGMENT ANEURYSM UNDERWENT A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL (640CF0620 / 30478001) WAS ADVANCED THROUGH THE CONCOMITANT MICROCATHETER TO REACH THE TARGET POSITION, THE PHYSICIAN WAS ATTEMPTING TO ADJUST THE COIL, BUT IT PREMATURELY DETACHED. IT WAS REPORTED THAT THE PHYSICIAN DID NOT TOUCH THE SYRINGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 10 AUGUST 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET LESION WAS ON THE RIGHT INTERNAL CAROTID ARTERY (ICA) C6 SEGMENT; THE DIAMETER OF THE ANEURYSM IS 6MM. THE INFORMATION INDICATED THAT THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL PREMATURELY DETACHED AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT. THE EMBOLIC COIL DID NOT BECOME SEPARATED INTO TWO OR MORE PIECES. THE EVENT DID NOT RESULT IN REDUCED / RESTRICTED BLOOD FLOW IN THE PARENT VESSEL. THERE WAS NO EVIDENCE OF THROMBOSIS. THE COMPLAINT COIL WAS USED WITH THE FREPASS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12320904 ↗
• InjuryJul 29, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6) YEAR-OLD MALE PATIENT ((B)(6)) WITH NO RELEVANT MEDICAL HISTORY PRESENTED WITH A LEFT POSTERIOR CEREBRAL ARTERY FUSIFORM ANEURYSM (HUNT & HESS GRADE 1) AT THE INTERNAL CAROTID ARTERY ON (B)(6) 2020 AND SUBSEQUENTLY UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION USING A 4MM X 16MM ENTERPRISE 2 (ENCR401600 / 5876388) VASCULAR RECONSTRUCTION DEVICE (VRD) ON (B)(6) 2020. THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: MAXIMUM ANEURYSM DIAMETER 4MM AND NECK SIZE 2MM. THE PARENT VESSEL DIAMETER WAS 2.5MM. THE STENT AND UNSPECIFIED COILS WERE SUCCESSFULLY PLACED IN THE ANEURYSM. IMMEDIATE POST-PROCEDURE ASSESSMENT SHOWED RAYMOND-ROY SCORE OF CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. ROUTINE NEUROLOGICAL EXAMINATION PERFORMED PRIOR TO DISCHARGE ON (B)(6) 2020 REVEALED HUNT & HESS GRADE 0 (UNRUPTURED ANEURYSM) AND MODIFIED RANKIN SCALE (MRS) SCORE OF 0 (NO SYMPTOMS AT ALL). MODIFIED INFORMATION WAS RECEIVED ON 05 JUL 2021. THE INFORMATION INDICATED THAT THE PATIENT DEVELOPED AN INTRACRANIAL ANEURYSM ON (B)(6) 2021. THE ANEURYSM WAS CONSIDERED MODERATE IN SEVERITY AND REQU

  Patient problems: Aneurysm; Transient Ischemic Attack

  MAUDE report 12250199 ↗
• MalfunctionAug 13, 2020Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL (640CF0620 / 30312658) WAS THE FIRST COIL CHOSEN FOR THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN COULD NOT RECAPTURE THE COIL INTO THE INTRODUCER AFTER SEVERAL ATTEMPTS. ANOTHER 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404808 ↗
• MalfunctionJul 15, 2020Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 6X20 OG TDL CMPLX FILL COIL (640CF0620, 30359244) WAS BEING USED AS THE FIRST COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT THAT THE COIL WAS STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10275831 ↗
• MalfunctionJul 7, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM EMBOLIZATION PROCEDURE, THE 6MM X 20CM ORBIT GALAXY COMPLEX FILL COIL (640CF0620 / 30341950) BECAME STRETCHED IN THE TARGET CEREBRAL POSITION. THE PHYSICIAN WITHDREW THE COIL FROM THE PATIENT AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT AND COMPLICATION ASSOCIATED WITH THE REPORTED DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240096 ↗
• DeathApr 21, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING AN EMERGENT COIL EMBOLIZATION OF A RUPTURED CEREBRAL ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) IN A (B)(6)-YEAR-OLD FEMALE, A 6X20 ORBIT GALAXY TDL COMPLEX FILL (640CF0620/30232040) COIL FAILED TO DETACH. THE PHYSICIAN TRIED OTHER SYRINGES AND USED DIFFERENT PRESSURE (EVEN TO RED ZONE) BUT THE COIL STILL FAILED TO RELEASE. WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, THE COIL UNINTENDEDLY DETACHED FROM THE DELIVERY SYSTEM. THE REST OF THE COIL WAS LEFT IN THE PATIENT, AND THE PATIENT ULTIMATELY EXPIRED FROM A BLOCKAGE OF THE MIDDLE CEREBRAL ARTERY (MCA). TWO TRUFILL DCS II (635002/96331346) SYRINGES WERE USED DURING THE PROCEDURE. IT WAS REPORTED THAT AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE FELT BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS ALSO NO RESISTANCE ENCOUNTERED AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. PRIOR TO THIS COIL, NO OTHER COIL WENT THROUGH THE SAME MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REPORTING PHYSICIAN THINKS THAT THE FAILURE OF THE COIL TO DETACH

  Patient problems: Death; Infarction, Cerebral; Obstruction/Occlusion

  MAUDE report 9982231 ↗
• MalfunctionApr 12, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 6.6MM X 8MM IRREGULAR-SHAPED RIGHT INTERNAL CAROTID ARTERY ANEURYSM, THE 6MM X 20CM ORBIT GALAXY TDL COMPLEX FILL (640CF0620/30096538) COIL BECAME STUCK WHEN IT REACHED 2/3 OF THE UNSPECIFIED MICROCATHETER BODY/SHAFT. THE PHYSICIAN DID NOT OBSERVE ANY ¿WRINKLE¿ ON X-RAY, SO THE PHYSICIAN PULLED IT BACK AND RE-ADVANCED BUT WITHOUT SUCCESS. THE PHYSICIAN WITHDREW THE COIL FROM THE MICROCATHETER AND DISCOVERED THAT THE EMBOLIC COIL HAD STRETCHED. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT CONSEQUENCE. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE PROCEDURAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THAT THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE EMBOLIC COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE CAUSE OF THE EVENT IS NOT KNOWN OR SUSPECTED; HOWEVER, IT WAS REPORTED THAT THE USER HAD APPLIED UNDUE FORCE WHEN HANDLING THE DEVICES. THERE WERE NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511170 ↗
• MalfunctionFeb 5, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN IRREGULAR 4 MM X 6 MM ANEURYSM ON THE LEFT ANTERIOR COMMUNICATING ARTERY (ACA), WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE 6 MM X 20 CM ORBIT GALAXY COMPLEX FILL COIL (640CF0620 / 30090240), HE FOUND IT DIFFICULT TO ADVANCE THE COIL THROUGH THE MICROCATHETER (UNKNOWN BRAND). THROUGH FLUOROSCOPY, THE NOTED A KINK AT THE MICROCATHETER. THE PERFUSION ZONE IS NORMALLY PRESSURIZED. THE PHYSICIAN PULLED THE COIL BACK AND ATTEMPTED ADVANCE IT BUT WAS STILL FOUND IT DIFFICULT TO ADVANCE. THE PHYSICIAN PULLED THE COIL SYSTEM OUT AND FOUND IT STRETCHED. THE COIL WAS REPLACED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO LOSS OF TARGET POSITION. IT WAS REPORTED THAT THERE WAS NO RESISTANCE BETWEEN THE MICROCATHETER AND THE GUIDEWIRE DURING THE ACCESSING OF THE TARGET SITE; THERE WAS RESISTANCE WHEN THE COIL WAS BEING ADVANCED IN THE MICROCATHETER. IT WAS NOT KNOWN IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE WITH THE REPLACEMENT COIL. COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COIL WAS NOT SUSPECTED TO HAVE CONTRIBUTED TO THE REPORTED ISSUE. IT WAS REPORTED THAT THERE WAS NO ADDITIONAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8308372 ↗
• MalfunctionOct 18, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE 6MM X 20CM ORBIT GALAXY TDL COMPLEX FILL (640CF0620/17697694) HYDRAULIC COIL STRETCHED. THE PHYSICIAN REMOVED THE COIL WITHOUT INCIDENT AND USED ANOTHER SAME-SIZED COIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981028 ↗
• MalfunctionSep 20, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION TO TREAT A BRAIN ANEURYSM, THE ORBIT GALAXY COMPLEX FILL 6MM X 20CM COIL (640CF0620 / 17704416) COULD NOT BE DETACHED USING THE CONNECTING CABLE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896011 ↗
• MalfunctionOct 2, 2017Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ORBIT GALAXY COIL (640CF0620/17604577) COULD NOT BE DETACHED DURING THE PROCEDURE. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6908059 ↗
• InjuryDec 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY ENTERPRISE IDE STUDY, (B)(6) UNDERWENT STENT ASSISTED COIL EMBOLIZATION ON (B)(6) 2016. PRE-TREATMENT ANGIOGRAPHY REVEALED AN ANTERIOR CIRCULATION ANEURYSM ON RIGHT BIFURCATION OF THE MIDDLE CEREBRAL ARTERY. THE ANEURYSM WAS SACCULAR IN SHAPE WITH THE FOLLOWING DIMENSIONS: DOME HEIGHT 6.0 MM, DOME WIDTH 4.6 MM, NECK WIDTH 3.5 MM AND DOME TO NECK RATIO OF 1.7. THE INTERNAL DIAMETER OF THE PARENT VESSEL PROXIMAL TO THE ANEURYSM WAS 2.5 MM AND DISTAL TO THE ANEURYSM WAS 2.5 MM. ENTERPRISE 2 STENT (ENF402300/10665778) WAS PLACED AFTER WHICH TWO ORBIT GALAXY COILS (640CF0620/17534340 AND 17524240) WERE PLACED IN THE ANEURYSM. INTRAOPERATIVE ADVERSE EVENTS REPORTED WERE INTRACRANIAL HEMORRHAGE, RETROPERITONEAL BLEEDING AND HEMATOMA > 5 CM THAT OCCURRED AT THE ACCESS SITE THAT REQUIRED TREATMENT. IMMEDIATE POST-PROCEDURE ANGIOGRAPHY CONFIRMED THAT THE COIL MASS POSITION WAS MAINTAINED WITHIN THE SAC, THE PARENT ARTERY WAS PATENT AND THE ANEURYSM WAS OCCLUDED 90-99%. RAYMOND CLASS ASSESSMENT WAS 2; RESIDUAL NECK. THE ANEURYSM DIMENSIONS WERE; DOME HEIGHT 6.0 MM, DOME WIDTH 4.6 MM, NECK WIDTH 3.5 MM AND DOME TO NECK RATIO OF 1.7. THE INTERNAL DIAMETER OF THE PARENT VESSEL PRO

  Patient problems: Intracranial Hemorrhage; Thrombus

  MAUDE report 6173287 ↗
• InjuryDec 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6) STUDY, SUBJECT (B)(6) UNDERWENT STENT ASSISTED COIL EMBOLIZATION ON (B)(6) 2016. PRE-TREATMENT ANGIOGRAPHY REVEALED AN ANTERIOR CIRCULATION ANEURYSM ON RIGHT BIFURCATION OF THE MIDDLE CEREBRAL ARTERY. THE ANEURYSM WAS SACCULAR IN SHAPE WITH THE FOLLOWING DIMENSIONS: DOME HEIGHT 6.0 MM, DOME WIDTH 4.6 MM, NECK WIDTH 3.5 MM AND DOME TO NECK RATIO OF 1.7. THE INTERNAL DIAMETER OF THE PARENT VESSEL PROXIMAL TO THE ANEURYSM WAS 2.5 MM AND DISTAL TO THE ANEURYSM WAS 2.5 MM. ENTERPRISE 2 STENT (ENF402300/10665778) WAS PLACED AFTER WHICH TWO ORBIT GALAXY COILS (640CF0620/17534340 AND 17524240) WERE PLACED IN THE ANEURYSM. INTRAOPERATIVE ADVERSE EVENTS REPORTED WERE INTRACRANIAL HEMORRHAGE, RETROPERITONEAL BLEEDING AND HEMATOMA > 5 CM THAT OCCURRED AT THE ACCESS SITE THAT REQUIRED TREATMENT. IMMEDIATE POST-PROCEDURE ANGIOGRAPHY CONFIRMED THAT THE COIL MASS POSITION WAS MAINTAINED WITHIN THE SAC, THE PARENT ARTERY WAS PATENT AND THE ANEURYSM WAS OCCLUDED 90-99%. RAYMOND CLASS ASSESSMENT WAS 2; RESIDUAL NECK. THE ANEURYSM DIMENSIONS WERE; DOME HEIGHT 6.0 MM, DOME WIDTH 4.6 MM, NECK WIDTH 3.5 MM AND DOME TO NECK RATIO OF 1.7. THE INTERNAL DIAMETER OF THE PARENT VESSEL PRO

  Patient problems: Intracranial Hemorrhage; Thrombus

  MAUDE report 6173217 ↗