ORBIT GALAXY XTRASOFT 640CX3575Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886704030706), received between Nov 15, 2016 and Jun 12, 2026 — classified as 1 death, 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Stretched” (7 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Material Twisted/Bent

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL WERE ON THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 31586977) WAS KINKED WHEN THE PHYSICIAN TRIED TO INTRODUCE THE COIL INTO THE MICROCATHETER. THE COIL WAS SUCCESSFULLY REMOVED BEFORE IT WAS INTO A PATIENT'S BODY. THE PATIENT REMAINS ASYMPTOMATIC. THE PROCEDURE WAS SUCCESSFULLY DONE. 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. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 12-JUN-2026. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25490662 ↗
• DeathMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE FIRST COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31770622) AND THE SECOND COIL, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575 / 31770623) WERE PACKED WITHIN THE ANEURYSM. SUBSEQUENTLY, WHILE PACKING THE ANEURYSM WITH COILS FROM OTHER BRANDS, THE ANEURYSM RUPTURED AND BLEEDING WAS OBSERVED. THE PHYSICIAN IMPLANTED TWO STENTS (FROM OTHER MANUFACTURERS). A CRANIOTOMY WAS PERFORMED THEREAFTER. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ANEURYSM RUPTURED AFTER THE FIRST AND SECOND COIL WERE IMPLANTED AND DURING THE PACKING OF THE ANEURYSM WITH NON-CERENOVUS COILS. THE INFORMATIONAL ALSO INDICATED THAT THE PATIENT IS DECEASED; THE EXACT DATE OF DEATH IS UNKNOWN. THE PHYSICIAN CONSIDERED THE ANEURYSM RUPTURE TO BE UNRELATED TO CERENOVUS COILS. THERE WAS NO DELAY TO THE ENDOVASCULAR EMBOLIZATION PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Ruptured Aneurysm

  MAUDE report 25321571 ↗
• MalfunctionApr 14, 2026Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRACRANIAL COIL EMBOLIZATION PROCEDURE ON (B)(6) 2026, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 31593818) WAS USED, AND IT COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED. THE PROCEDURE WAS DELAYED BY ABOUT 5 MINUTES. 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. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 14-APR-2026, THE EVENT HAS BEEN DETERMINED TO BE USFDA MDR REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879767 ↗
• MalfunctionApr 23, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (COMPETITOR BRAND) WAS IN PLACE AND THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575 / 31467315) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON 09-APR-2025, IT WAS REPORTED BY THE CERENOVUS SALES REPRESENTATIVE THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896060 ↗
• MalfunctionFeb 6, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX3575, 31467303) BECAME IMPEDED IN INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO AN UNSPECIFIED MICROCATHETER (MC). THE DOCTOR RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322814 ↗
• MalfunctionJan 7, 2025Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX3575, 31395228) BECAME IMPEDED IN PROXIMAL OF MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 21-NOV-2024 STATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, MULTIPLE KINKED CONDITIONS WERE FOUND ON THE EMBOLIC COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092881 ↗
• MalfunctionJun 14, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 30880056) WAS THE FIRST COIL USED. IT WAS REPORTED THAT THE PHYSICIAN ¿DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. BECAUSE THE SIZE OF THE COIL WAS NOT APPROPRIATE WITH THE ANEURYSM. DURING RE-SHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. 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. THE PRODUCT WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 13-JUN-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536723 ↗
• MalfunctionApr 7, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE PUSHING THE COMPLAINT COIL, A 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575 / 30768931) IN THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). WHILE REMOVING THE COIL FROM THE MICROCATHETER, IT BECAME STRETCHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT WAS DELAYED BY 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704673 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A 65-YEAR-OLD FEMALE (SUBJECT 953-006) WITH A HISTORY OF CONTROLLED HYPERTENSION, IRRITABLE BOWEL SYNDROME (IBS), SEASONAL ALLERGIC RHINITIS, EPISTAXIS, GASTROESOPHAGEAL REFLUX DISEASE (GERD), ELEVATED FASTING BLOOD SUGAR PRESENTED WITH A SUBARACHNOID HEMORRHAGE (SAH) SECONDARY TO RUPTURED ANEURYSM (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION ON 20-OCT-2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM TO THE ANTERIOR CIRCULATION ANEURYSM, LOCATED ON THE RIGHT SIDEWALL OF THE ANTERIOR CEREBRAL ARTERY (ACA). THE MAXIMUM ANEURYSM DIAMETER WAS 5MM, THE NECK SIZE WAS 2MM, AND THE DOME-TO-NECK RATIO WAS 1.5MM, HEIGHT: 5MM AND DOME 3MM. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF ONE 3.5MM X 7.5CM ORBIT GALAXY (640CX3575 , 30379646 ) VIA A STRYKER SL-10 MICROCATHETER. THE STUDY COIL WAS SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 55.42% ANGIOSUITE PACKING DENSITY. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH A MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK (PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL

  Patient problems: Aneurysm

  MAUDE report 15987746 ↗
• MalfunctionAug 23, 2022Crack; Separation Failure; Crack; Separation Failure

  AS REPORTED BY THE FIELD, THE HUB OF A 3.5X7.5 ORBIT GALAXY XTARSOFT (640CX3575, 30615578) WAS CRACKED OR BROKEN. THE PHYSICIAN THINKS, BECAUSE OF THAT, THE DETACHMENT WAS NOT PROPERLY WORKING. AFTER DETACHMENT FAILURE, THE PHYSICIAN TOOK THE COIL OUT AND USED THE SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274750 ↗
• MalfunctionJun 10, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X7.5 ORBIT GALAXY XTRASOFT COIL (640CX3575, 30620252) WAS BEING USED AS A FIRST COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. BECAUSE THE SIZE OF THE COIL WAS NOT APPROPRIATE WITH THE ANEURYSM. DURING RESHEATHING 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 ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657256 ↗
• MalfunctionMay 20, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE THAT WAS TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE SIZE OF THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 30615578) WAS DETERMINED NOT TO BE THE PROPER SIZE FOR THE TARGET; THE INTENTION WAS TO REPLACE THE COIL, BUT THE INTRODUCER SHEATH BECAME SPLIT. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THE COMPLAINT DOCUMENTED THAT THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE; THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. DURING THE MICROSCOPIC INSPECTION, THE COIL WAS OBSERVED TO BE IN A KINKED CONDITION. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 20-MAY-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462904 ↗
• MalfunctionDec 15, 2021Fluid/Blood Leak; Device-Device Incompatibility; Fluid/Blood Leak; Device-Device Incompatibility

  AS REPORTED BY THE FIELD, THE DETACHMENT HUB OF AN ORBIT GALAXY XTRASOFT COIL (640CX3575, 30436668) WAS IMPACTED. THAT PART SEEMED DAMAGED AND DECIDED TO USE A NEW PRODUCT. THE PHYSICIAN USED SAME-LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS A CONNECTION MALFUNCTION BETWEEN THE HUB OF THE COIL AND THE LUER. ACCORDING TO THE USER, THE COIL HUB AND LUER DIDN¿T FIT PERFECTLY FOR COIL DETACHMENT AND SALINE SEEMED TO LEAK AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010464 ↗
• MalfunctionOct 1, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X7.5 ORBIT GALAXY XTRASOFT COIL (640CX3575, 30355739) WAS BEING USED AS THE THIRD COIL. THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING THE ORBIT GALAXY COIL THROUGH HEADWAY MICROCATHETER (MC). THE COIL WAS REMOVED AND A SAME-LIKE PRODUCT WAS USED. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE DELIVERY TUBE (HYPO TUBE) WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563443 ↗
• MalfunctionSep 21, 2021Fracture; Fracture

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE HYPOTUBE OF THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 30512986) WAS FOUND DAMAGED WHEN THE PHYSICIAN TOOK THE COIL FROM THE INTRODUCER FOR DEVICE INSPECTION. THE COIL COULD NOT BE RETRACTED. THE DEVICE WAS NOT USED IN THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION RECEIVED ON 10 SEPTEMBER 2021 INDICATED THAT THE DAMAGE OBSERVED ON THE HYPOTUBE WAS THAT IT CRACKED / FRACTURED. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE. IT WAS PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). IT WAS NOT DIFFICULT TO REMOVE THE DEVICE FROM THE PACKAGING. BASED ON THE ADDITIONAL INFORMATION THAT THE HYPOTUBE WAS CRACKED / FRACTURED, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508605 ↗
• MalfunctionSep 1, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3.5X7.5 OG CMPLX XTRASOFT COIL WAS BEING USED AS A FIRST COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10477958 ↗
• MalfunctionAug 11, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A 3.5MM X 4.5MM ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, IT WAS REPORTED THAT THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 30279406) BECAME STRETCHED FROM THE DISTAL END. THE COIL WAS REMOVED IN ITS ENTIRETY WITHOUT ADDITIONAL INTERVENTION, AND ANOTHER COIL WAS USED. NO OTHER DAMAGE WAS NOTED ON THE COIL WHEN IT WAS REMOVED. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE CONCOMITANT PROWLER SELECT LPES (606S155X / 30306197). THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED; THERE WAS NO RESISTANCE AT ANY TIME DURING THE COIL ADVANCEMENT THROUGH THE MICROCATHETER. OTHER COILS WERE DELIVERED THROUGH THE SAME MICROCATHETER PRIOR TO THE REPORTED ISSUE WITH THE COMPLAINT COIL. NO KINKS WERE NOTED ON THE MICROCATHETER THAT COULD HAVE CAUSED THE REPORTED STRETCHED CONDITION. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF ITS DISTAL END. A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND THE DELIVERY TUBE WAS VERIFIED WITH FLUOROSCOPY. COIL ENTANGLEMENT WITH P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393964 ↗
• MalfunctionJul 21, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 30334351) WAS CHOSEN AS THE FRAMING COIL, BUT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE MICROCATHETER AT THE SAME TIME FROM THE PATIENT. INSPECTION AFTER REMOVAL IT WAS OBSERVED THAT THE COIL WAS STRETCHED. THE PHYSICIAN USED ANOTHER 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL 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 10303116 ↗
• MalfunctionJul 2, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 30302571) WAS THE FIRST COIL USED IN THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN COULD NOT ADVANCE NOR RETRIEVE THE COIL. THE PHYSICIAN PULLED THE COIL AND THE MICROCATHETER (UNKNOWN BRAND) OUT OF THE PATIENT. AFTER INSPECTION, THE COIL WAS REPORTED TO BE IN STRETCHED CONDITION. THE PHYSICIAN REPLACED THE COIL WITH ANOTHER 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT NOR COMPLICATION ASSOCIATED WITH THE REPORTED DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224911 ↗
• MalfunctionJun 2, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, A 3.5X7.5 OG CMPLX XTRASOFT COIL (640CX3575, 30284964) WAS BEING USED AS THE FIRST COIL. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108436 ↗
• MalfunctionDec 18, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, BEFORE A 3.5X7.5 OG CMPLX XTRASOFT (640CX3575, 30173238) PASSED THROUGH THE Y CONNECTOR, THE PHYSICIAN FOUND THE COIL STRETCHED. THE COIL WAS CHANGED TO A NEW ONE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489330 ↗
• MalfunctionApr 1, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE DURING THE PROCEDURE, THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3575 / 17684939) HAD ISSUE WITH RESHEATHING / REZIPPING. THE REPORTED EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. NO ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE IS AVAILABLE. THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED AND KINKED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 4/1/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8471812 ↗
• MalfunctionMar 20, 2018Difficult To Position; Retraction Problem; Difficult To Position; Retraction Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE SURGEON WANTED TO ADJUST THE POSITION OF THE 2MM X 4CM ORBIT GALAXY HELICAL XTRASOFT (640HX0204/17673404) AND THE 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575/17685003) AS THE COILS WOULD NOT CONFORM TO THE WALLS OF THE ANEURYSM, BUT THE COILS COULD NOT BE WITHDRAWN BACK INTO THE UNSPECIFIED MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS AND MICROCATHETER BE REMOVED AS A UNIT. THE COILS WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THERE WAS NO LOSS OF CEREBRAL TARGET POSITION ASSOCIATED WITH THE EVENT. NO PATIENT COMPLICATION OCCURRED AS A RESULT OF THE EVENT. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COILS THROUGH THE MICROCATHETER. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO APPARENT KINKS IN THE MICROCATHETER. A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352798 ↗
• MalfunctionMar 20, 2018Material Separation; Stretched; Material Separation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, 3.5MM X 7.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3575/17704412) HYDRAULIC COIL STRETCHED. THE COIL STRETCHED PRIOR TO USE IN THE PATIENT; HOWEVER, THE EXACT TIMING WAS NOT REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. THE PRODUCT WAS NOT RESTERILIZED. NO ANOMALIES WERE NOTED WHEN THE PRODUCT WAS TAKEN OUT OF THE PACKAGE. THE PRODUCT WAS PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS CONFIRMED THAT THE SYRINGE LATCH MECHANISM WAS IN THE LOCKED POSITION. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352720 ↗
• MalfunctionNov 15, 2016Positioning Failure; Positioning Failure

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT VA-PICA AND ORBIT GALAXY COIL (640CX3575, 17323974) COULD NOT BE DETACHED. THE VESSEL TORTUOUSITY AND CALCIFICATION WERE UNKNOWN. A SHEATH INTRODUCER (TERUMO), A GUIDE WIRE (CHIKAI 14, ASAHI INTECC), A GUIDING CATHETER (6F ENVOY MPC), AND A MICRO CATHETER (SL 10) WERE ALSO USED FOR THIS PROCEDURE. A COIL (TARGET COIL, STRYKER) WAS IMPLANTED AS THE FRAMING COIL, AND THE ORBIT GALAXY (COMPLAINT PRODUCT) WAS DELIVERED TO THE LESION. HOWEVER THE COIL COULD NOT DETACH BY APPLYING NOMINAL PRESSURE. IT WAS CONFIRMED THAT THE PRESSURE ROSE UP TO THE NOMINAL PRESSURE AND WAS RELEASED FOR THREE ATTEMPTS, BUT THE COIL DID NOT DETACH. SO THE COIL WAS REMOVED FROM THE PATIENT AND NEW COIL WAS IMPLANTED. IN TOTAL, 6 TARGET COILS AND 2 GALAXY COILS WERE IMPLANTED. ACCORDING TO THE PHYSICIAN, THE PURGE WAS DONE TO THE COMPLAINT COIL AND IT WAS CONFIRMED THAT THERE WAS NO AIR IN THE JUNCTION PART. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6104966 ↗