ORBIT GALAXY XTRASOFT 640CX3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886704030690), received between Jan 13, 2017 and Jun 4, 2026 — classified as 3 injuries, 15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Stretched

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION TO A POSTERIOR COMMUNICATING ARTERY ANEURYSM, AN ENTERPRISE2 4MMX16MM VASCULAR RECONSTRUCTION DEVICE (PRODUCT CODE: ENCR401612, LOT NUMBER: 9854670) WAS IMPEDED IN DISTAL END OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (PRODUCT CODE: 606S255X, LOT NUMBER: 31700153) AND COULD NOT PASS THROUGH THE MICROCATHETER (MC). THE DOCTOR DIRECTLY REMOVED THE STENT AND MICROCATHETER TOGETHER FROM THE PATIENT AND SWITCHED A NEW STENT AND A NEW MICROCATHETER TO CONTINUE THE SURGERY. WHEN PACKING COIL IN THE ANEURYSM, A 3.5X9 ORBIT GALAXY XTRASOFT (PRODUCT CODE: 640CX3509, LOT NUMBER: 31651282) WAS UNABLE TO ROTATE RANDOMLY, THE DOCTOR ONLY RETRACTED THE COIL, IT WAS FOUND THAT THE COIL HAD BEEN UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO A SECOND COIL, A 3.5X5 ORBIT GALAXY XTRASOFT (PRODUCT CODE: 640CX3505, LOT NUMBER: 31527069) WHICH BECAME IMPEDED IN THE PROXIMAL END OF THE COIL MICROCATHETER (COMPETITOR¿S BRAND) AND COULD NOT ADVANCE ANY MORE. THE DOCTOR ONLY RETRACTED THE SECOND COIL AND FOUND THE DELIVERY WIRE OF THE SECOND COIL WAS KINKED/BENT. THE DOCTOR SWITCHED A THIRD COIL (COMPETITOR¿S BRAND) TO COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392878 ↗
• InjuryJan 24, 2025Stretched; Failure to Advance; Premature Separation; Stretched; Failure to Advance; Premature Separation

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN OG CMPLX XTRASOFT COIL 3.5X9 (640CX3509/ 31383720) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED IMPEDIMENT OF THE DETACHABLE COIL DELIVERY SYSTEM (DCS) IN MICROCATHETER WITH NO LOSS OF CEREBRAL TARGET POSITION, COIL-PREMATURE DETACHMENT, AND COIL- UNRAVELED/STRETCHED-IN MICROCATHETER. AFTER THE COIL DETACHED PREMATURELY, IT WAS FOUND THAT PART OF THE COIL WAS OUTSIDE THE ANEURYSM. THE DOCTOR THEN USED A STENT MICROCATHETER TO DELIVER A THROMBUS REMOVAL STENT (BOTH WERE OTHER BRANDS) TO CAPTURE THE COIL, THEN REMOVED THE COIL FROM PATIENT. A NEW COIL AND A NEW COIL MICROCATHETER (OTHER BRAND) WERE SWITCHED TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. THE EVENT WAS REPORTED AS SUCH, ¿IMPEDED IN MICROCATHETER & UNRAVELED/STRETCHED & PREMATURE DETACHMENT. IT WAS REPORTED THAT DURING PROCEDURE, COIL PASSED THROUGH COIL MICROCATHETER (OTHER BRAND) TIP AND TRIED TO FILL IN THE ANEURYSM, BUT THE COIL WAS IMPEDED IN THE COIL MICROCATHETER TIP AND COULD NOT ADVANCE ANY MORE. DOCTOR TRIED TO RETRACT THE COIL BUT OBSERVED THE COIL WAS UNRAVELED/STRETCHED. THE DOCTOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21230819 ↗
• MalfunctionNov 19, 2024Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ANEURYSM (ACOM), THE UNSPECIFIED MICROCATHETER (MC) KICKED BACK (MOVED OUT OF THE ANEURYSM) WHEN AN ORBIT GALAXY XTRASOFT COIL (640CX3509, 31178987) WAS DELIVERED IN THE PROXIMAL OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN ONLY RETRACTED THE COIL AND THEN PLACED THE MICROCATHETER AT THE TARGET SITE AND THEN DELIVERED THE SAME COIL AGAIN, THE COIL WAS IMPEDED IN MIDDLE SECTION OF THE 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. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 18-OCT-2024 INDICATED THAT 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. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723262 ↗
• MalfunctionJan 25, 2023Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, THE 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3509 / 30566749) BECAME DETACHED INSIDE THE MICROCATHETER (UNSPECIFIED BRAND) WHILE IT WAS BEING PUSHED INSIDE THE TARGET ANEURYSM. THE COIL WAS REMOVED FROM THE MICROCATHETER. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 18-JAN-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE PROCEDURE WAS TARGETING A RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM ON THE SUPRACLINOID SEGMENT. THE INFORMATION INDICATED THAT THE EMBOLIC COIL DID NOT DETACH AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT. THE ENTIRE EMBOLIC COIL WAS REPORTED TO PREMATURELY DETACHED FROM THE DELIVERY SYSTEM. THE EMBOLIC COIL DID NOT BECOME STRETCHED / UNRAVELED PRIOR TO THE PREMATURE DETACHMENT. THE REPORTED ISSUE DID NOT RESULT IN REDUCED / RESTRICTED BLOOD FLOW IN THE PARENT VESSEL. THE CONCOMITANT MICROCATHETER USED WAS A 150CM X 5CM 45-DEGREE PROWLER SELECT LPES (606S155FX / 30763314). IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244809 ↗
• MalfunctionJan 11, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX3509, 30753136) WAS BEING USED AS THE THIRD COIL. HOWEVER, THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING THE COIL. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE COIL HAS A SLIGHTLY DAMAGED CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137225 ↗
• MalfunctionMay 7, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE PERFORMED UNDER GENERAL ANESTHESIA, THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC) WAS PLACED IN THE TARGET POSITION. THE PHYSICIAN TRIED TO PUSH THE COMPLAINT COIL, A 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT (640CX3509 / 30517515) INTO THE MICROCATHETER BUT OBSERVED THAT THE COIL WAS IMPEDED IN THE MICROCATHETER HUB. THE COIL WAS RETRACTED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ECHELON 10 MICROCATHETER WAS NOT REMOVED WHEN THE COIL WAS REPLACED. THERE WAS NO DAMAGE OBSERVED ON THE COMPLAINT DEVICE AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER; A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE. ON (B)(6) 2022. CONFIRMATION WAS PROVIDED BY THE CERENOVUS SALES REPRESENTATIVE THAT THE COMPLAINT COIL WAS IMPEDED IN THE CONCOMITANT MICROCATHETER. STRYKER ELECTROLYTIC COIL WAS ALSO USED IN THE PROCEDURE. THE PHYSICIAN DID NOT NOTICE ANY DAMAGE. NO ADDITIONAL INFORMATION COULD B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324916 ↗
• MalfunctionOct 13, 2021Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET ANEURYSM ON THE BASILAR TIP THE 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3509 / 30517515) WAS USED, BUT THE PHYSICIAN DECIDED TO REMOVE THE COIL BECAUSE IT WAS DEEMED AN INAPPROPRIATE SIZE FOR THE TARGET ANEURYSM. THE CONCOMITANT MICROCATHETER WAS NOT REMOVED WITH THE COIL. DURING THE RESHEATHING, THE COIL FAILED TO BE RE-ZIPPED AND THE INTRODUCER SHEATH SPLIT. THERE WAS AN ADEQUATE, CONTINUOUS FLUSH THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE AT ANY TIME DURING THE COIL ADVANCEMENT THROUGH THE MICROCATHETER. ADDITIONAL INTERVENTION WAS NOT REQUIRED; THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED ISSUE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 13-OCT-2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628557 ↗
• 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 12250152 ↗
• MalfunctionJun 14, 2021Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN APPROXIMATELY 4MM NORMAL, SACCULAR ANEURYSM ON THE INTERNAL CAROTID ARTERY (ICA), WHEN THE 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3509 / 30436667) WAS BEING DEPLOYED INTO THE TARGET ANEURYSM VIA THE EXCELSIOR¿ SL-10¿ MICROCATHETER (STRYKER), THE COIL MADE A HELICAL SHAPE EVEN THOUGH THIS COIL IS NOT SUPPOSED TO FORM THIS SHAPE. AFTER THIS ISSUE WAS DETECTED DURING THE PROCEDURE MONITORING STEP, THE PHYSICIAN RETRACTED THE COIL AND REMOVED IT FROM THE PATIENT. ANOTHER ORBIT GALAXY COIL WAS USED AS A REPLACEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992786 ↗
• MalfunctionMay 10, 2021Packaging Problem; Positioning Problem; Packaging Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3509 / 30498214) AND THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30425579) WERE REMOVED FROM THEIR RESPECTIVE HOOPS, THE TIP OF THE COILS WERE PROTRUDING FROM THEIR RESPECTIVE INTRODUCERS. THE PHYSICIAN PULLED THE COILS BACK INTO THEIR INTRODUCERS AND WAS ABLE TO ADVANCE THE COILS. HOWEVER, WHEN THE COILS WERE IN THE ANEURYSM, BOTH OF THE COIL TIPS WOULD NOT MAKE ANY SHAPE. THE COILS WERE NOT USED FOR THE PROCEDURE. THE COILS WERE REPLACED AND THE SAME SIZE REPLACEMENT COILS WERE DELIVERED USING THE SAME CONCOMITANT SL-10® MICROCATHETER (STRYKER) WITHOUT ANY ISSUE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED DEVICE ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 28 APRIL 2021. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS OF CONVENTIONAL SPHERICAL SHAPE AND WAS APPROXIMATELY 4 MM IN DIAMETER. THE LOCATION OF THE ANEURYSM WAS NOT KNOWN, BUT IT WAS REPORTED THAT THE ANEURYSM LOCATION DID NOT HAVE ANY IMPACT ON THE REPORTED ISSUE. THERE WAS POSITIONING DIFFICULTY IN THAT WHEN THE COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798649 ↗
• MalfunctionSep 23, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A CEREBRAL ARTERY ANEURYSM, FOUR COILS, A 5X10 OG TDL CMPLX FILL (640CF0510, 30132962), A 7X25 OG TDL CMPLX FRAME (640CR0725, 30374735), A 4X12 OG TDL CMPLX FILL (640CF0412, 30348520) AND A 3.5X9 OG CMPLX XTRASOFT (640CX3509, 30282523) BECAME STUCK INSIDE THE HUB OF A PROWLER SELECT14 MICROCATHETER (PRODUCT/LOT NUMBER UNKNOWN). THE COILS ¿NEVER WENT PASSED THE MICROCATHETER HUB.¿ THEREFORE, THE MICROCATHETER (MC) NEVER ENTERED THE PATIENT¿S INTRACRANIAL SPACE. THE MICROCATHETER WAS REPLACED RESULTING IN LOSS OF CEREBRAL TARGET POSITIONING ALONG WITH THE FOUR COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT MICROCATHETER AND REPLACEMENT COILS. THESE COILS WERE NOT IMPLANTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573575 ↗
• MalfunctionAug 30, 2019Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3509 / 30135887) BECAME PREMATURELY DETACHED INSIDE THE MICROCATHETER (UNKNOWN BRAND). IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED ABNORMAL FRICTION DURING THE COIL ADVANCEMENT INTO THE MICROCATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8951746 ↗
• MalfunctionJun 24, 2019Separation Failure; Separation Failure

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION, OG CMPLX XTRASOFT COIL (640CX3509, 30135887) FAILED TO DETACH. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THIS WAS THE FIST COIL OF THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727460 ↗
• MalfunctionAug 28, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF THE ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM AT THE ANTERIOR CEREBRAL ARTERY (ACA) JUNCTION, WHILE THE PHYSICIAN WAS DEPLOYING THE ORBIT GALAXY COMPLEX XTRASOFT 3.5 MM X 9 CM COIL (640CX3509 / 17665790), THE MICROCATHETER (UNKNOWN BRAND) LOST ITS POSITION AND AS A RESULT, THE PHYSICIAN HAD TO REMOVE THE COIL. WHEN THE COIL WAS REMOVED, IT COULD NOT BE RESHEATHED. IT WAS CONFIRMED BY THE SALES REPRESENTATIVE THAT THE COIL DELIVERY SYSTEM WAS PREPARED WITHOUT ANY DIFFICULTY, THERE WAS NO DAMAGE ON THE COIL INTRODUCER, NO DAMAGE TO THE COIL. THE UNSHEATHING AND RESHEATHING ATTEMPT WAS PERFORMED WITHOUT EXCESSIVE FORCE. ANOTHER COIL WAS USED TO REPLACE THE ORBIT GALAXY COIL. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT RELATED TO THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7824533 ↗
• MalfunctionJun 27, 2018Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT WHEN THE PHYSICIAN TRIED TO CHECK THE SYRINGE DURING PREPARATION, PRIOR TO USE WITH THE OG CMPLX XTRASOFT COIL (640CX3509/17389194), A SALINE DROP WAS NOT VISIBLE AS THE SYRINGE GAUGE WAS AT NO. 1. THE SYRINGE HAD INITIALLY BEEN PURGED OF AIR AND IT WAS CONFIRMED THAT THERE WERE NO AIR BUBBLES IN THE BARREL OR EXTENSION TUBING OF THE SYRINGE. THE HUB OF THE DELIVERY TUBE WAS FLUSHED PRIOR TO CONNECTING IT WITH THE SYRINGE. AFTER PURGING, THE KNOB OF THE SYRINGE PRESSURIZED TO POSITION 2. THE PHYSICIAN WANTED TO SEE A DROP OF SALINE AT THE PROXIMAL END OF THE COIL HEAD PIECE IN ORDER TO ENSURE THERE IS NO MORE AIR IN THE DEVICE. NOTE: THIS EVENT WAS DEEMED MDR REPORTABLE AS A RESULT OF THE DEVICE EVALUATION FINDINGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643017 ↗
• MalfunctionAug 22, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PROWLER SELECT LPES (606S155FX/ 17280147) TIP WAS KINKED WHEN THE BOX WAS OPENED AND AN ORBIT GALAXY COIL (640CX3509/ 17478472) HAD RE-SHEATHING FAILURE, AND DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL WAS OUTSIDE THE INTRODUCER AND WAS STRETCHED. THE PROWLER PACKAGING WAS NOT DAMAGED AND THE DEVICE HAD BEEN PACKAGED SECURELY AS EXPECTED. THE ORBIT GALAXY DID NOT APPEAR DAMAGED IN ANY WAY. THE PHYSICIAN USED ANOTHER SAME SIZE PRODUCTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO POTENTIAL ADVERSE EVENTS. IT WAS REPORTED THAT THE DEVICES WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811007 ↗
• InjuryJan 24, 2017Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  THE CONTACT FROM THE FACILITY REPORTED THAT DURING COIL EMBOLIZATION OF AN IRREGULAR LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE ORBIT GALAXY COIL (640CX3509/17507916), THE 4TH COIL IN THE PROCEDURE, STRETCHED WHEN ADJUSTING. THE SURGEON DETACHED THE COIL. A PART OF THE COIL REMAINED IN THE PARENT ARTERY. THE SURGEON DEPLOYED A STENT TO ATTACH THE COIL TO THE ARTERY. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT ON THE PATIENT INJURY. THE DEVICE IS IMPLANTED AND NOT AVAILABLE FOR RETURN. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THREE OTHER COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THERE WERE NO KINKS IN THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED OR REPOSITIONED. IT IS UNCERTAIN WHETHER ENTANGLEMENT WITH PREVIOUS COILS MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6274800 ↗
• MalfunctionJan 13, 2017Stretched; Stretched

  AS REPORTED BY HEALTHCARE PROFESSIONAL, DURING PROCEDURE THESE COILS HAD RESHEATHING FAILURE. THE PHYSICIAN USED SAME LIKE PRODUCT TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE COIL REPORTED TO HAVE RESHEATHING FAILURE ORBIT GALAXY COMPLEX XTRA SOFT COIL 2.5X5 (640CX2505/ 17389186) AND ORBIT GALAXY XTRA SOFT COIL 3.5 X 9 (640CX3509/17381622 & 17425930) . IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6251348 ↗