ORBIT GALAXY XTRASOFT 640CX0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886704030591), received between Oct 31, 2016 and Dec 3, 2025 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Stretched” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE SHAPE OF THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0306 / 31485464) WAS FOUND TO BE NOT IDEAL AFTER IT WAS USED TO FILL THE ANEURYSM. THE PHYSICIAN RETRACTED ONLY THE COIL, BUT THE OIL WAS FOUND TO BE UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL WITH ONE FROM ANOTHER BRAND TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 26-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A TORTUOUS AND NARROW ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY. NO NECK REMODELING WAS USED; A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED (THE NUMBER OF TIMES THIS HAD BEEN DONE WAS NOT PROVIDED). THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. PRIOR TO THIS COIL, ONE OTHER COIL WENT THROUGH THE MICROCATHETER WITHOUT RESISTANCE. INFORMATION RELATED TO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COIL COULD NOT BE OBTAINED. THERE WAS NO ADDITIONA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707851 ↗
• MalfunctionMar 26, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION TO AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A 3X6 ORBIT GALAXY XTRASOFT COIL (640CX0306, 31507404) WAS IMPEDED IN MIDDLE SECTION OF AN UNSPECIFIED THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. MODERATE TORTUOSITY OF INTERNAL CAROTID VESSEL WAS REPORTED. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697672 ↗
• MalfunctionAug 23, 2024Entrapment of Device; Stretched; Entrapment of Device; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE FIRST COIL USED WAS A 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0306 / 31275960), AND IT COULD NOT BE DEPLOYED BECAUSE IT BECAME TANGLED DURING THE DEPLOYMENT ATTEMPT. THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED ¿A SAME LIKE¿ PRODUCT¿ AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20054184 ↗
• InjuryApr 3, 2024Stretched; Migration; Stretched; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, AFTER IMPLANTATION OF THE FIRST STENT (UNSPECIFIED BRAND) THE PHYSICIAN FILLED THE ANEURYSM WITH THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 31032521). IT WAS REPORTED THAT THE COIL COULD NOT BE PLACED WELL AT THE TARGET SITE DUE TO THE ANEURYSM BEING LONG AND FUSIFORM IN SHAPE. THE PHYSICIAN ADJUSTED THE PLACEMENT OF THE COIL IN THE ANEURYSM SEVERAL TIMES AND THE COIL BECAME UNRAVELED / STRETCHED. THE PHYSICIAN DETACHED THE COIL AND RELEASED THE SECOND STENT (COMPETITOR BRAND) IN THE FIRST STENT. PART OF THE COIL OUTSIDE OF THE ANEURYSM WAS FIXED BETWEEN THE TWO STENTS AND THE PROCEDURE WAS COMPLETED. THE CONCOMITANT MICROCATHETER, AN SL-10® MICROCATHETER (STRYKER) WAS NOT REPLACED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION POST-OP. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 01-APR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET ANEURYSM WAS A RUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM THAT WAS FUSIFORM IN SHAPE. THERE WAS NO DIFFICULTY I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034252 ↗
• MalfunctionFeb 21, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30885233) WAS UNABLE TO BE RESHEATHED. THE PROCEDURE WAS DELAYED BY 2 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 01-JAN-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. AT THE ANEURYSM SITE, IT WAS DIFFICULT TO DEPLOY THE COIL; THEREFORE, THE COIL WAS RESHEATHED. THERE WAS NO DAMAGE NOTED ON THE INTRODUCER SHEATH. THE COIL WAS NOT NOTED TO BE PROTRUDING FROM THE INTRODUCER. THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. IT WAS NO NECESSARY TO REMOVE THE MICROCATHETER TO REMOVE THE COMPLAINT COIL. THE 2-MINUTE PROCEDURE DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON (B)(6) 2024. THE EMBOLIC COIL COMPONENT WAS NOTED TO BE STRETCHED AT THE PROXIMAL SECTION. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754844 ↗
• MalfunctionJul 28, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING OF THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30979131) FOR INSPECTION AND OBSERVED THAT THE MICROCATHETER SHAFT WAS KINKED / BENT. THE PHYSICIAN SWITCHED TO AN SL-10® MICROCATHETER (STRYKER) TO USE FOR THE PROCEDURE. IT WAS REPORTED THAT THE COMPLAINT COIL, AN 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0306 / 30592328) WAS IMPEDED IN THIS REPLACEMENT MICROCATHETER AND COULD NOT PASS THROUGH. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER; NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. AFTER MAKING SEVERAL ATTEMPTS, THE COIL WAS STILL IMPEDED IN THE MICROCATHETER, THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME SL-10® MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 28-JUL-2023. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420698 ↗
• MalfunctionJun 29, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL ORIGINALLY REPORTED THAT A CATHETER WAS KINKED AT ¿5CM FROM THE HUB OR TIP. WHEN IT WAS FIRST OPENED.¿ THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. ON (B)(6) 2023, THE PRODUCT ANALYSIS LAB RECEIVED THE RETURNED PACKAGE THAT CONTAINS AN ORBIT GALAXY COIL AND A TRUFILL SYRINGE. A REQUEST FOR CLARIFICATION RELATED TO THE PRODUCTS RECEIVED AND THE ORIGINAL EVENT DESCRIPTION DOCUMENTED IN THE COMPLAINT WAS MADE. A RESPONSE WAS RECEIVED FROM THE KOREAN AFFILIATES ON 28-JUN-2023 REVISING THE ORIGINAL REPORTED EVENT TO THE FOLLOWING: ¿AS A RESULT OF INQUIRING WITH LOGISTICS, IT WAS CONFIRMED THAT THE SYRINGE WAS INCLUDED BY MISTAKE AND WAS NOT RELATED TO THE DEFECTIVE PRODUCT.¿ A REQUEST WAS ALSO MADE TO UPDATE THE REPORTED EVENT TO THE FOLLOWING: ¿THIS COIL [3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0306 / 30620247)] WAS THE SECOND COIL. THE COIL COU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17228086 ↗
• MalfunctionApr 14, 2023Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0306 / 30758093) WAS USED. THE EMBOLIC COIL BECAME TWISTED WHILE IT WAS BEING DEPLOYED. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT ¿THERE WAS SOMETHING LIKE A KNOT AND IT WAS NOT AS USUAL. SO HE DECIDED TO TAKE THE COIL OUT.¿ THE PHYSICIAN USED ANOTHER ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748087 ↗
• MalfunctionJan 10, 2023Failure to Advance; Failure to Advance

  IMPEDED. IT WAS REPORTED THAT PATIENT WAS SUFFERED FROM VERTEBRAL ANEURYSM, SIZE IS AS FOLLOW: LENGTH 3.5MM, WIDTH 3.2MM, ANEURYSM NECK 2.8MM. AFTER ACCESS WAS ESTABLISHED, PHYSICIAN OPENED PACKAGING OF COIL, THEN PUSHED OUT THE COIL FOR INSPECTION AND IT APPEARED INTACT. DOCTOR FELT SOME RESISTANCE DURING PROCESS OF DELIVERING THE COIL TO MICROCATHETER (OTHER BRAND: EV3). THE COIL WAS IN TARGET POSITION AND FILLED IN THE ANEURYSM, BUT IT WAS IMPEDED IN MICROCATHETER WHEN 1/4 OF THE COIL WAS FILLED IN THE ANEURYSM AND COULD NOT BE FILLED ANY MORE. PHYSICIAN RETRACTED THE COIL AND SWITCHED OTHER BRAND (STRYKER) COIL TO FILL THE ANEURYSM. AFTER THAT, THE SECOND AND THIRD JNJ COIL WERE USED TO COMPLETE THE SURGERY SMOOTHLY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135212 ↗
• MalfunctionOct 7, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE COMPLAINT COIL, A 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30675887) WAS THE SECOND COIL USED. THE PHYSICIAN DECIDED TO PULL THE COIL OUT FOR RE-DEPLOYMENT AFTER TRYING A COIL OF ANOTHER SIZE FIRST. DURING THE ATTEMPT TO RESHEATH THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. IT WAS REPORTED THAT THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567968 ↗
• MalfunctionJul 25, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X6 ORBIT GALAXY XTRASOFT COIL (640CX0306, 30668573) COULD NOT BE DETACHED AFTER 3 ATTEMPTS. THE PHYSICIAN RETRACTED THE COIL AND A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094140 ↗
• MalfunctionMay 16, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION COIL EMBOLIZATION, THERE WAS MUCH OF RESISTANCE FELT WHILE PUSHING AN ORBIT GALAXY XTRASOFT 3X6 (640CX0306, 30579163) INTO THE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RESISTANCE WAS FIRST FELT DURING THE DEVICE ADVANCEMENT THROUGH THE MIDSHAFT OF THE PROWLER SELECT LPES 45 MICROCATHETER (606S155FX, 30623313). ANOTHER ORBIT GALAXY COIL WAS SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO AND AFTER THE ENCOUNTERED RESISTANCE. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THE TARGET VESSEL WAS THE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408065 ↗
• MalfunctionMar 11, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30592329) COULD NOT BE DETACHED. THE PHYSICIAN TRIED TO RAISE THE PRESSURE BUT THE COIL STILL FAILED TO DETACH. A NEW COIL WAS USED 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 13739053 ↗
• MalfunctionJan 11, 2022Positioning Failure; Device Difficult to Setup or Prepare; Difficult to Advance; Positioning Failure; Device Difficult to Setup or Prepare; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE POSTERIOR COMMUNICATING ARTERY (PCOM), THE DOCTOR TRIED TO DEPLOY AN ORBIT GALAXY XTRASOFT COIL (640CX0306, 30355736), HOWEVER, THE UNSPECIFIED MICROCATHETER (MC) KICKED BACK WHILE DEPLOYING. HENCE, THE DOCTOR TRIED TO REPOSITION THE CATHETER, THE DOCTOR DECIDED TO REMOVE THE COIL FROM THE ANEURYSM AND RE SHEATH IT BUT WHILE TRYING TO RE ZIP THE COIL, THE ORANGE ZIPPER WAS STIFF AND THE DOCTOR WAS UNABLE TO RE-ZIP IT. THE COIL WAS RETRIEVED WITH RESHEATHING. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY CONSEQUENCE OR INJURY TO THE PATIENT. THERE WAS NO PROCEDURE PROLONGATION DUE TO THE EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER. THERE WAS RESISTANCE MIDWAY DURING THE ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226700 ↗
• MalfunctionDec 16, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHEN THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30404159) WAS BEING DEPLOYED IN THE TARGET ANEURYSM, THE COIL BECAME STRETCHED. THE OPERATOR SUCCESSFULLY REMOVED THE COIL OUT OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY PROCEDURE DELAY DUE TO THE REPORTED ISSUE; IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020535 ↗
• MalfunctionDec 3, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30592328) BECAME UNRAVELED / STRETCHED IN THE MICROCATHETER. THE PHYSICIAN SWITCHED TO ANOTHER COIL OF A DIFFERENT BRAND TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929282 ↗
• MalfunctionDec 2, 2021Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFTD COIL (640CX0306, 30592329) DETACHED OUTSIDE OF THE PATIENT¿S BODY DURING THE PERIOD OF EXHAUST. THE PHYSICIAN SWITCHED TO A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915777 ↗
• MalfunctionAug 23, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2.5X5 ORBIT GALAXY XTRASOFT (640CX2505, 30536893), A 3X6 ORBIT GALAXY XTRASOFT (640CX0306, 30383962), AND A 2.5X5 ORBIT GALAXY XTRASOFT COIL (640CX2505, LOT UNKNOWN) COULD NOT DETACH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED AT THE TIME OF THE COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353866 ↗
• MalfunctionJun 2, 2021Stretched; Failure to Advance; Difficult to Advance; Stretched; Failure to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X6 ORBIT GALAXY XTRASOFT COIL (640CX0306, 30337725) COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920887 ↗
• MalfunctionMay 10, 2021Stretched; Failure to Advance; Difficult to Advance; Stretched; Failure to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30432545) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER AT THE SAME TIME AND AFTER INSPECTION, THE COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800263 ↗
• MalfunctionApr 23, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30498211) BECAME STRETCHED DURING DEPLOYMENT; AS A RESULT, THE PHYSICIAN REMOVED THE COIL FROM THE TARGET ANEURYSM. THERE WAS NO PROCEDURE DELAY AS A RESULT OF THE EVENT; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717868 ↗
• MalfunctionFeb 22, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X6 OG CMPLX XTRASOFT COIL (640CX0306, 30367469) WAS BEING USED AS A FIRST COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. DURING RE-SHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE PRODUCT INVESTIGATION OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358630 ↗
• MalfunctionDec 28, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30284961) WAS PREMATURELY DETACHED BEFORE THE GAUGE NEEDLE ON THE SYRINGE REACHED THE DETACHMENT ZONE, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078280 ↗
• MalfunctionDec 9, 2020Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3MM X 6CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30371451) BECAME PREMATURELY DETACHED IN THE CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978067 ↗
• MalfunctionNov 16, 2020Stretched; Stretched

  (B)(4) FAILED TO RE-SHEATH. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10844360 ↗