ORBIT GALAXY XTRASOFT 640HX0206Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704030720), received between Sep 14, 2016 and Feb 25, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Stretched” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Entrapment of Device; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640HX0206, LOT NUMBER 31651283) THROUGH A NON J&J MICROCATHETER. THE COIL WAS UNABLE TO PASS THE DISTAL END OF THE MICROCATHETER (MC). UNDER FLUOROSCOPY, THE COIL APPEARED CLUSTERED INSIDE THE MICROCATHETER. THE PHYSICIAN RETRACTED AND REMOVED ONLY THE COIL, THEN REPLACED IT WITH A NEW COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED, AND NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-FEB-2026 INDICATED THAT THEY COULD NOT MOVE THE DEVICE AT ALL DUE TO THE RESISTANCE. THEY WERE NOT ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE DEVICE NOR THE CONCOMITANT DEVICE KINKED OR BENT PRIOR TO THE RESISTANCE OR NOTED AFTER REMOVAL FROM THE PATIENT. THE COIL HAD NOT BEEN WITHDRAWN OR REPOSITIONED. NECK REMODELING WAS NOT UTILIZED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443159 ↗
• MalfunctionNov 21, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE FIRST COIL, A 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT (640HX0206 / 31467317) WAS DELIVERED TO THE TARGET. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT IT WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL. THE SECOND COIL WAS PLACED AND DETACHED. A THIRD COIL, A 4MM X 10CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0410 / 31567754) WAS INTRODUCED INTO THE ANEURYSM, AND THIS THIRD COIL WAS ALSO UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL CONCOMITANT MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 19-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION OF A RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; BOTH COILS WERE STILL ATTACHED TO THEIR RESPECTIVE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF ANY BLOOD FLOW RESTRICTION / INT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23624782 ↗
• MalfunctionSep 2, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A MICROCATHETER (OTHER BRAND) WAS IN PLACE AND A ORBIT GALAXY COIL (640CF0306, 31168615) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND NEW COIL AND DETACHED SUCCESSFULLY. THEN THE DOCTOR DELIVERED THE THIRD COIL, A ORBIT GALAXY XTRASOFT (640HX0206, 31444522) BUT IT FAILED TO DETACH. THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH COIL, AN ORBIT GALAXY XTRASOFT (640HX0206, 31492321) WHICH HAD THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE FOURTH COIL ALONE AND SWITCHED A FIFTH COIL (OTHER BRAND) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-AUG-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED WITH EACH COIL. THE SAME DCB WAS USED SUCCESSFULLY WITH THE SUBSEQUENT COILS. ENTERPRISE VASCULAR RECONSTRUCTION STENTS WERE USED TO ASSIST ANEURYSM EMBOLIZATION. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COILS DID NOT STRETCH OR DAMAGED WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937946 ↗
• MalfunctionSep 2, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A MICROCATHETER (OTHER BRAND) WAS IN PLACE AND A ORBIT GALAXY COIL (640CF0306, 31168615) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND NEW COIL AND DETACHED SUCCESSFULLY. THEN THE DOCTOR DELIVERED THE THIRD COIL, A ORBIT GALAXY XTRASOFT (640HX0206, 31444522) BUT IT FAILED TO DETACH. THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH COIL, AN ORBIT GALAXY XTRASOFT (640HX0206, 31492321) WHICH HAD THE SAME ISSUE. THE DOCTOR ONLY RETRACTED THE FOURTH COIL ALONE AND SWITCHED A FIFTH COIL (OTHER BRAND) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 28-AUG-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED WITH EACH COIL. THE SAME DCB WAS USED SUCCESSFULLY WITH THE SUBSEQUENT COILS. ENTERPRISE VASCULAR RECONSTRUCTION STENTS WERE USED TO ASSIST ANEURYSM EMBOLIZATION. THE COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COILS DID NOT STRETCH OR DAMAGED WH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937908 ↗
• MalfunctionMar 21, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE COIL, A 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT (640HX0206 / 31438253) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN MADE AN UNSUCCESSFUL ATTEMPT TO DETACH THE COIL. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER FROM THE PATIENT FOR INSPECTION, THEN REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON 07-MAR-2025, THE CERENOVUS REPRESENTATIVE STATED THAT ADDITIONAL INFORMATION IS NOT AVAILABLE / UNOBTAINABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668669 ↗
• MalfunctionJan 12, 2024Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH THE FIRST COIL, A 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT (640HX0206 / 31028747), AND IT WAS OBSERVED THAT THE SHAPE OF THE COIL WAS DIFFERENT THAN EXPECTED. THE COIL CAME OUT IN THE SAME DIRECTION ALL THE TIME AND CANNOT BE ROTATED RANDOMLY. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A COMPETITOR BRAND COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 10-JAN-2024, LIMITED ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NO DAMAGE OBSERVED ON THE COIL WHEN IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509130 ↗
• MalfunctionNov 27, 2023Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640HX0206, 30780432) WAS PARTIALLY FILLED IN THE ANEURYSM, WHILE THE REST COIL WAS UNABLE TO FILL INTO THE ANEURYSM. THE PHYSICIAN WITHDREW THE COIL AND TRIED AGAIN; IT STILL COULD NOT BE FILLED IN THE ANEURYSM COMPLETELY. THE DOCTOR RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE COIL WAS FOUND TO BE UNRAVELED/STRETCHED. THE UNSPECIFIED MICROCATHETER (MC) WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208962 ↗
• MalfunctionJun 22, 2022Break; Positioning Failure; Failure to Advance; Break; Positioning Failure; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH THE 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT (640HX0206 / 30574616), THE COIL WAS RETRACTED TO THE INTRODUCER SHEATH SINCE THE POSITION OF THE CONCOMITANT MICROCATHETER WAS NOT STABLE. THE POSITION OF THE MICROCATHETER WAS ADJUSTED AND THE PHYSICIAN TRIED TO PUSH THE COIL TO MICROCATHETER, BUT THE COIL WAS IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED OUT. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 21-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CONCOMITANT MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). THE TARGET ANEURYSM WAS LOCATED ON THE LEFT VERTEBRAL ARTERY. THE MICROCATHETER WAS REMOVED WHEN THE COIL POSITION WAS ADJUSTED. IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS DAMAGED DURING ITS RECOVERY FROM THE PATIENT¿S BODY. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 21-JUN-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777338 ↗
• MalfunctionMay 31, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2X6 ORBIT GALAXY XTRASOFT COIL (640HX0206, 30651730) BECAME IMPEDED AND UNRAVELED/STRETCHED. THE COIL ARRIVED AT TARGET POSITION AND PASSED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN TRIED TO DETACH IT, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER AND COULD NOT ADVANCE ANY MORE. THE DOCTOR RETRACTED THE COIL AND OBSERVED THAT IT WAS UNRAVELED/STRETCHED. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549996 ↗
• MalfunctionApr 5, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2X6 ORBIT GALAXY COIL (640HX0206, 30574615) COULD NOT BE DETACHED, THE PHYSICIAN RAISED PRESSURE TO RED AREA, BUT THE COIL STILL COULD NOT DETACH. THE SECOND COIL, A 2X8 GALAXY XTRASOFT COIL (640HX0208, 30546086) HAD THE SAME ISSUE. THE THIRD DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014880 ↗
• MalfunctionDec 6, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640HX0206, 30571046) BECAME IMPEDED AND COULD NOT BE ADVANCED ANYMORE. THE COIL WAS RETRACTED, AND IT WAS FOUND TO BE UNRAVELED/STRETCHED. THE PHYSICIAN SWITCHED TO A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933215 ↗
• MalfunctionSep 1, 2021Product Quality Problem; Failure to Advance; Positioning Problem; Product Quality Problem; Failure to Advance; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM INTERVENTIONAL EMBOLIZATION, THE PHYSICIAN WAS FILLING THE ANEURYSM WITH A 2X6 ORBIT GALAXY XTRASOFT COIL (640HX0206, 30522112). THE SHAPE OF THE COIL WAS NOT IDEAL, WITHDREW THE COIL OUTSIDE OF THE PATIENT¿S BODY. THE SURGEON TRIED TO PUSH THE COIL INTO THE UNSPECIFIED MICROCATHETER (MC) AGAIN, BUT IT BECAME STUCK IN INTRODUCER, COULD NOT ENTER THE MICROCATHETER. AFTER SEVERAL ATTEMPTS, FAILED. SWITCHED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NOT PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SHAPE OF THE COIL WAS NOT CORRECT OR DIFFERENT THAN EXPECTED. THE COIL FAILED TO CONFORM TO THE ANEURYSM WALL. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL THE LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408137 ↗
• MalfunctionJul 15, 2021Stretched; Failure to Advance; Difficult to Advance; Stretched; Failure to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT COIL ((B)(4)) WAS THE THIRD COIL IN THE PROCEDURE. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT WAS OBSERVED THAT THE COIL HAD BECOME STRETCHED. THE PHYSICIAN USED ANOTHER COIL 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 12178546 ↗
• MalfunctionNov 19, 2020Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT COIL ((B)(4)) WAS THE SECOND 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 42MM X 6CM ORBIT GALAXY HELICAL XTRASOFT COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10872364 ↗
• MalfunctionNov 4, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION, A 2X6 OG HELICAL XTRSOFT COIL (640HX0206, 30286061) COULDN'T BE DETACHED. THERE WAS LEAKAGE IN THE JOINT BETWEEN THE COIL BODY AND PULLER ROD. THE PHYSICIAN WITHDREW THE COIL OUTSIDE OF THE PATIENT¿S BODY. CHANGED TO ANOTHER NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURED REPORTED. ADDITIONAL INFORMATION INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DETACHABLE CONTROL BOX (DCB) WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS AND THE SAME CABLE WAS ALSO USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE ACTUAL COIL WAS NOT STRETCHED OR DAMAGED WHEN REMOVED. THERE WAS NO PREPPING DIFFICULTY. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. IT WAS NECESSARY TO REMOVE CONCOMITANT DEVICES WITH THE COMPLAINT DEVICE. ADEQUATE FLUSH WAS BEEN MAINTAINED THROUGH THE DEVICES. THE EVENT PROLONGED THE PROCEDURE BY 10 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785623 ↗
• MalfunctionDec 11, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, DURING INSERTION OF THE COIL THROUGH THE MICROCATHETER, THE 2MM X 6CM ORBIT GALAXY HELICAL XTRASOFT COIL (640HX0206 / 3215696) WAS STRETCHED IN THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC). IT WAS REPORTED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND MICROCATHETER DURING WHILE THE TARGET SITE WAS BEING ACCESSED. THERE WAS NO KINKS ON THE MICROCATHETER THAT COULD HAVE CAUSED THE REPORTED ISSUE; THERE WAS NO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS AS IT WAS REPORTED THAT NO OTHER COILS WENT THROUGH THE MICROCATHETER PRIOR TO THE COMPLAINT COIL. IT WAS ALSO REPORTED THAT THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED; THE COIL DID NOT EXIT THE MICROCATHETER WHEN THE ISSUE WAS ENCOUNTERED. THE PHYSICIAN WITHDREW THE ENTIRE COIL AND THE MICROCATHETER TOGETHER OUTSIDE OF THE PATIENT¿S ANATOMY LOSING THE TARGET POSITION. THERE WAS NO OTHER DAMAGE NOTED ON THE COIL WHEN IT WAS REMOVED; THE COIL WAS NOT DETACHED. A NEW COIL WAS USED WITH THE ORIGINAL ECHELON¿ 10 MICROCATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO BLOOD FLOW RESTRICTION OR REDUCT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9452109 ↗
• MalfunctionMay 10, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 2X6 ORBIT GALAXY HELICAL XTRASOFT (640HX0206/17487284) HYDRAULIC DETACHABLE COIL DELIVERY SYSTEM DID NOT MOVE FREELY IN THE UNSPECIFIED MICROCATHETER AND GOT STUCK. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502518 ↗
• MalfunctionMar 23, 2017Fracture; Physical Resistance; Fracture; Physical Resistance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE THE PUSHER WIRE OF AN ORBIT GALAXY HELICAL XSOFT 2 X 6 COIL BROKE WHEN THE COIL WAS BEING PUSHED INTO AN ANEURYSM. THE PROCEDURE WAS FOR COIL EMBOLIZATION OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY. THE DELIVERY WIRE BROKE INTO TWO SEPARATE PIECES. IT WAS REPORTED THAT THERE WAS SOME RESISTANCE WHEN ADVANCING THE COIL. THERE WERE NO DAMAGES NOTED ON THE MICROCATHETER (COMPETITOR¿S DEVICE) PRIOR TO USE OR UPON REMOVAL; AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. OTHER COILS WERE USED WITH SAME CATHETER WITHOUT ANY DIFFICULTY PRIOR TO THE COMPLAINT COIL. THE MICROCATHETER WAS WITHDRAWN TO REMOVE THE COMPLAINT COIL AND THE PROCEDURE WAS POST-POSTPONED TO ANOTHER DATE. THE ANEURYSM WAS COILED WITH A RESIDUAL NECK. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427763 ↗
• MalfunctionSep 14, 2016Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING ELECTIVE COILING OF A RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY, PHYSICIAN REPORTED A STRETCHED COIL. PHYSICIAN HAD PREVIOUSLY PLACED 4 GALAXY COILS THROUGH A PROWLER LPES 45 DEGREE MICROCATHETER WITHOUT INCIDENT WHEN HE ATTEMPTED TO PLACE THE FINAL "FINISHING" COIL, A GALAXY XTRASOFT 2X6 ((B)(4)). PHYSICIAN REPORTED THAT DURING THE SECOND ATTEMPT TO REPOSITION THE COIL, IT APPEARED THAT THE COIL PREMATURELY DETACHED. IT WAS THEN DETERMINED THAT THE COIL HAD STRETCHED NOT DETACHED, WHEN A STRETCHED SEGMENT WAS PUSHED INTO THE LEFT MIDDLE CEREBRAL ARTERY CAUSING A TEMPORARY OCCLUSION. PHYSICIAN RETRIEVED THE COIL WITH AN ALLIGATOR SNARE AND REMOVED THE ENTIRE SEGMENT OF COIL. PHYSICIAN DID NOT REPORT ANY ABNORMALITIES WITH THE COIL DURING PREP OR INITIAL ADVANCEMENT. CONTINUOUS FLUSH WAS MAINTAINED. THERE WERE NO PATIENT INJURIES DUE TO THE REPORTED EVENT. THE PATIENT IS A (B)(6) YEAR OLD FEMALE WHOSE VESSELS WERE REPORTED TO BE OF LOW TORTUOSITY. THE PATIENT WAS A HUNT HESS GRADE 5 AT ADMISSION AND REMAINS HOSPITALIZED, RECOVERING. THE COMPLAINT PRODUCT IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5949308 ↗