ORBIT GALAXY XTRASOFT 640CX0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886704030638), received between Jan 17, 2017 and Jun 19, 2026 — classified as 1 injury, 29 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, THE PHYSICIAN DELIVERED AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640CX0408, LOT NUMBER: 31763941) IN A COMPETITOR¿S MICROCATHETER. THE COIL BECAME WAS IMPEDED IN THE PROXIMAL END OF THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A COMPETITOR¿S COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETERS WERE NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO PATIENT INJURY WAS ALLEGED IN ASSOCIATION WITH THE REPORTED EVENT. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (PRODUCT CODE: 606S255X). NO OTHER DEVICES WERE USED IN CONJUNCTION WITH THE MICROCATHETER BEFORE OR AFTER THE REPORTED RESISTANCE. THE TARGET VESSEL WAS THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, AND NO RELEVANT ANATOMICAL FACTORS WERE REPORTED. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME DURING THE PROCEDURE. CONTINUOUS FLUSH WAS MAINTAINED, AND IT WAS CONFIRMED THAT THE INTRODUCER TIP WAS PROPERLY INSTALLED INTO THE MICROCATHETER HUB AND SECURED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563659 ↗
• MalfunctionJun 8, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640CX0408, LOT NUMBER: 31606037) WAS PACKED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A NEW COIL TO COMPLETE THE SURGERY. THE COIL MICROCATHETER (COMPETITOR¿S BRAND) WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-JUN-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE EMBOLIC COIL DID NOT STRETCH OR BECAME DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430449 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE PACKAGING OF A 4X8 ORBIT GALAXY XTRASOFT COIL (640CX0408, 31438250) WAS INSPECTED AND FOUND IN IN GOOD CONDITION. THE PHYSICIAN PLANNED TO DELIVER THE COIL AND OBSERVED THAT FLUID ESCAPED FROM THE COIL INTRODUCER. THE DEVICE WAS NOT USED IN THE PATIENT. THE DOCTOR SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION STATES THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. NO DAMAGE TO THE DEVICE¿S PACKAGING WAS REPORTED. NO DIFFICULTIES IN REMOVING THE DEVICE FROM PACKAGING WAS REPORTED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004277 ↗
• MalfunctionJul 22, 2024Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX0408, 31074781) BECAME IMPEDED IN THE PROXIMAL END OF A PROWLER SELECT LPES MICROCATHETER (606S155X, 30763318) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR WITHDREW THE COIL, IT WAS FOUND THAT THE COIL WAS DETACHED IN THE MICROCATHETER (MC) PREMATURELY AND THE COIL REMAINED IN MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND MICROCATHETER FROM THE PATIENT AND REPLACED THEM WITH A NEW COIL AND A NEW MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-JUL-2024 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTERED RESISTANCE. THE MICROCATHETER DID NOT KINK. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793809 ↗
• MalfunctionJan 10, 2024Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE C5 SEGMENT OF INTERNAL CAROTID ARTERY, WHEN PARTIAL OF AN OG CMPLX XTRASOFT COIL 4X8 WAS FILLED IN THE ANEURYSM, THE UNSPECIFIED MICROCATHETER (MC) SHOULD BE REPOSITIONING, PHYSICIAN TRIED TO RETRACT THE COIL INTO INTRODUCER SHEATH, BUT THE COIL COULDN¿T BE WITHDRAWN BECAUSE OF THE ZIP STUCK. THE DOCTOR REMOVED THE COIL FROM PATIENT AND SWITCHED A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. ADDITIONAL INFORMATION WAS RECEIVED ON 01-NOV-2024 INDICATING THAT THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER. THE DELIVERY WIRE OR COIL WAS NOT NOTED TO BE PROTRUDING FROM THE INTRODUCER. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. NECK REMODELING WAS UTILIZED WITH A STENT. THE COIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484179 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA A HEALTH AUTHORITY. DURING A CORONARY PULMONARY ARTERY OCCLUSION PROCEDURE, THE PHYSICIAN USED A 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30723394) AND A THROMBUS OCCURRED. THE PROCEDURE WAS IMMEDIATELY STOPPED. ON 26-OCT-2023, IT WAS INDICATED THAT ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT IS NOT AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18051726 ↗
• MalfunctionNov 21, 2022Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE RIGHT INTERNAL CAROTID ARTERY, A 4X8 ORBIT GALAXY XTRASOFT COIL (640CX0408, 30456579) WAS ¿ABNORMAL¿ UNDER X-RAY DURING ITS DELIVERY TO ECHELON 10(1.7F/2.1F)-150CM MICROCATHETER (MC). THE PHYSICIAN RETRACTED THE COIL FOR INSPECTION AND FOUND IT UNRAVELED/STRETCHED. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY (THE MICROCATHETER WAS NOT REPLACED). THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE COIL THROUGH THE MICROCATHETER OR AT ANY TIME. PRIOR TO THIS COIL, OTHER COILS HAVE BEEN ABLE TO BE ADVANCED THROUGH THE SAME MICROCATHETER. THE COIL DID NOT SEPARATE INTO TWO PIECES. THE DEVICE WAS INSPECTED FOR DAMAGE PRIOR TO USE. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. IT IS UNKNOWN IF THE EVENT DELAYED THE PROCEDURE. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833970 ↗
• MalfunctionSep 1, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN APPROXIMATE 4MM ANEURYSM AT THE LEFT CAVERNOUS SINUS, A 4X8 ORBIT GALAXY XTRASOFT COIL (640CX0408, 30697746) WAS DELIVERED WITHIN A NON J&J MICROCATHETER (MC). WHEN THE COIL ADVANCED ONE HALF OF IT WITHIN MICROCATHETER, IT WAS IMPEDED IN MC AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN WITHDREW THE COIL A LITTLE AND TRIED TO DELIVER IT AGAIN, BUT IT STILL COULD NOT BE PUSHED. THE DOCTOR RETRACTED THE COIL AND OBSERVED IT RELEASED IN MICROCATHETER. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A FREPASS®MICROCATHETER INNER DIAMETER 0.0165 MC WAS USED. THE DELIVERY WIRE WAS ABLE TO PASS THROUGH THE MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE COIL DID NOT APPEAR DAMAGED AT ANY TIME. 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. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE BLOOD VESSELS WERE IN GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335301 ↗
• MalfunctionAug 15, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, PRIOR TO USE, A 4X8 ORBIT GALAXY XTRASOFT COIL (640CX0408, 30753131) DETACHED DURING FLUSHING. NO ADDITIONAL INFORMATION WAS PROVIDED UPON COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15226000 ↗
• MalfunctionApr 29, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT POSTERIOR COMMUNICATING ARTERY, A 4X8 ORBIT GALAXY XTRASOFT COIL (640CX0408, 30620249) PREMATURELY DETACHED. THE ANEURYSM SIZE: LENGTH: 3.7 MM, WIDTH: 3.1 MM. THE PHYSICIAN PUSHED COIL OUT FOR INSPECTION AND OBSERVED IT DETACHED. THE COIL WAS NOT USED IN THE PATIENT. A NEW COIL WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249819 ↗
• MalfunctionApr 28, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4X8 ORBIT GALAXY XTRASOFT (640CX0408, 30620249) 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 THE RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN DECIDED TO PULL IT OUT BECAUSE THE COIL'S SIZE WAS NOT APPROPRIATE WITH THE ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240632 ↗
• MalfunctionApr 18, 2022Stretched; Difficult to Advance; Positioning Problem; Stretched; Difficult to Advance; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED DURING THE PROCEDURE, THERE WAS SO MUCH RESISTANCE WHILE PUSHING THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30620249) IN THE MICROCATHETER. WHEN THE COIL WAS REMOVED, IT GOT STRETCHED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 18-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A 6MM IRREGULARLY SHAPED INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID ANEURYSM. A 4MM X 30MM ENTERPRISE STENT (CATALOG/LOT UNKNOWN) AND A PROWLER SELECT LPES (606S155X / 30573307) WERE USED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS DIFFICULTY POSITIONING THE COIL IN THE TARGET SITE, IT WAS REPORTEDLY DIFFICULTY TO GET THE COIL TO CONFORM TO THE ANEURYSM WALL; THE COIL WAS UNABLE TO CONFORM TO THE ANEURYSM WALL. THE COIL HAD NOT BEEN WITHDRAWN AND REPOSITIONED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. PRIOR TO THE ISSUE RELATED TO THE COMPLAINT COIL, ONE (1) COIL HAD GONE THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO KINKS ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138489 ↗
• MalfunctionNov 4, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 8CM COMPLEX XTRASOFT COIL (640CX0408 / 30425582) WAS THE FIRST COIL USED. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL. DURING THE ATTEMPT TO RESHEATH THE COIL, THE INTRODUCER FAILED TO BE RE-SHEATHED. THE PHYSICIAN DECIDED TO REMOVE THE COIL DUE TO ITS SIZE NOT BEING APPROPRIATE WITH THE TARGET ANEURYSM. 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 / 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. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED STRETCHED AND IN DAMAGED CONDITION. BASED ON THE PRODUCT ANALYSIS ON (B)(6) 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752837 ↗
• MalfunctionOct 19, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 4X8 ORBIT GALAXY XTRASOFT COIL (640CX0408, 30432546) WAS BEING USED AS THE SECOND COIL. HOWEVER, THE COIL 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, THE COIL TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655800 ↗
• MalfunctionJul 28, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR COILING PROCEDURE, THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30329331) BECAME STRETCHED DURING PLACEMENT IN THE TARGET ANEURYSM. THE COIL WAS REMOVED WITHOUT ANY INTERVENTION AND ANOTHER COIL WAS USED AS REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE PATIENT IS REPORTED AS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241169 ↗
• MalfunctionMar 24, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PLACEMENT OF THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30257848) FOR FRAMING AS A FIRST COIL WAS NOT PERFECT. THE PHYSICIAN DECIDED TO RETRACT THE COIL TO REDEPLOY IT AFTER TRYING ANOTHER COIL OF A DIFFERENT SIZE FIRST. DURING THE RESHEATHING OF THE COMPLAINT COIL, THE INTRODUCER COULD NOT BE ZIPPED BECAUSE THE RESHEATHING SYSTEM WAS IMPACTED. THE RESHEATHING / RE-ZIPPING PROCESS WAS DONE IN REGULAR SEQUENCE. THE PHYSICIAN USED ANOTHER 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE MALFUNCTION WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN DAMAGED CONDITION. BASED ON THE PRODUCT ANALYSIS 24 MARCH 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566268 ↗
• MalfunctionJan 4, 2021Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, IT WAS REPORTED THAT THE COIL OF A 7X25 OG TDL CMPLX FRAME COIL (640CR0725, 30396175) CANNOT BE FORMED AFTER PUSH-OUT. IT WAS REPORTED THAT THE COIL CANNOT BE FORMED AFTER PUSH-OUT. THE PHYSICIAN CHANGED THE DEVICE TO A 4X8 OG CMPLX XTRASOFT COIL (640CX0408, 30345369) AND THE SAME PROBLEM HAPPENED. THE PHYSICIAN CHANGED TO ANOTHER NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NOT PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109405 ↗
• MalfunctionOct 26, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30352243) WAS THE THIRD COIL USED; THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. AS A RESULT, THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION POST REMOVAL, THE COIL WAS OBSERVED TO BE IN STRETCHED CONDITION. THE PHYSICIAN USED ANOTHER 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10737738 ↗
• MalfunctionSep 3, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A OG CMPLX XTRASOFT COIL (640CX0408, 30257848) WAS BEING USED AS A FIRST COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE 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 10487497 ↗
• MalfunctionApr 22, 2020Retraction Problem; Retraction Problem

  HOLD FOR JORDAN 4.22AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 4X8 OG CMPLX XTRASOFT COIL (640CX0408, 30250554) FAILED TO RECAPTURE. THE DOCTOR USED A SAME KIND OF PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9985568 ↗
• MalfunctionNov 22, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30126881) WAS CHOSEN AS THE FRAMING COIL. THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL WHEN IT WAS DEPLOYED AND DECIDED THE RETRACT THE COIL. DURING RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN REPLACED THE COIL WITH ANOTHER 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363936 ↗
• MalfunctionMar 6, 2019Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY COMPLEX XTRASOFT 4MM X 8CM COIL (640CX0408 / 30069603), THE COIL INTRODUCER ON THE DEVICE COULD NOT BE RESHEATHED / RE-ZIPPED. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE EVENT; THERE WAS NO PROCEDURAL DELAY AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION IS NOT AVAILABLE. THE PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS KINKED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 2/28/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8396635 ↗
• MalfunctionJan 11, 2019Off-Label Use; Material Separation; Off-Label Use; Material Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A MULTIPLE AORTOPULMONARY COLLATERAL ARTERY (MAPCA) AT THE RIGHT INTERNAL THORACIC ARTERY, THE SHAPE OF THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0408/7650566) HYDRAULIC COIL DID NOT FIT IN THE TARGET LESION; THE COIL WAS RESHEATHED AND REINSERTED, BUT THE COIL WOULD NOT EXIT THE INTRODUCER. THEREFORE, THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT AND ADDITIONAL INTERVENTION WAS NOT REQUIRED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). IT WAS NOT REPORTED IF AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER, BUT THE DEVICE WAS REPORTEDLY PREPPED AND USED AS PER IFU. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT, BUT IT WAS NOT REPORTED IF THE DEVICE APPEARED DAMAGE DURING USE OR AFTER REMOVAL. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A PROGREAT (TERUMO) MICROCATHETER AND TRUFIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242208 ↗
• MalfunctionOct 3, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF A PARACLINOID INTERNAL CAROTID ARTERY ANEURYSM, THE 4X8 ORBIT GALAXY COMPLEX XTRASOFT (640CF0408/17610075) HYDRAULIC COIL WAS SELECTED FOR USE AS A FILLING COIL BUT THE COIL MIGRATED INTO AN UNINTENDED LOCATION THROUGH THE STRUT OF AN UNSPECIFIED STENT WHICH HAD BEEN PLACED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT MIGRATE FROM THE ANEURYSM BACK THROUGH THE STENT INTO THE PARENT VESSEL, BUT THE COIL WAS ACCIDENTALLY PLACED THROUGH THE STENT WHILE APPROACHING TO THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL, BUT THE ZIPPER BECAME STUCK AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE LENGTH OF PROCEDURAL DELAY WAS NOT REPORTED; HOWEVER, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. THERE WAS NO EVIDENCE OF FLOW RESTRICTION/REDUCTION DUE TO THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930030 ↗
• MalfunctionJan 16, 2018Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF ARTERIOVENOUS FISTULA (AVF) MIDDLE MENINGEAL ARTERY (MMA) ANEURYSM, THE 4 MM X 8 CM ORBIT GALAXY COMPLEX XTRASOFT HYDRAULIC DETACHABLE COIL SYSTEM (DCS) ((640CX0408/17415143) WAS INSERTED INTO THE SL10 (STRYKER) MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED IN THE MICROCATHETER. TWO (2) 3 MM TRUFILL COMPLEX PUSHABLE COILS (633-320X/17170206) WERE INSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER (UNKNOWN CATALOG AND LOT) AND RESISTANCE WAS ALSO FELT IN THE MICROCATHETER. THE COILS WERE REPLACED WITH COMPETITOR COILS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS MODERATELY TORTUOUS AND NOT CALCIFIED. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH HAD BEEN MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCTS WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVID

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7194195 ↗