ORBIT GALAXY XTRASOFT 640CX0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886704030546), received between Jan 17, 2017 and Aug 18, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Stretched” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE DEVICE AND ITS PACKAGING WERE INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION. DURING THE PROCEDURE, THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 31583651) WAS USED, AND IT FILLED IN THE ANEURYSM. DURING THE ATTEMPT TO DETACH, THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL, AND IT WAS NOTED TO HAVE BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL AND COMPLETED THE PROCEDURE USING THE SAME MICROCATHETER (COMPETITOR BRAND). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 11-AUG-2025, IT WAS REPORTED BY THE CERENOVUS REPRESENTATIVE THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835291 ↗
• MalfunctionAug 14, 2025Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE DEVICE AND ITS PACKAGING WERE INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION. DURING THE PROCEDURE, THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 31583783) WAS USED, AND IT FILLED IN THE ANEURYSM. DURING THE ATTEMPT TO DETACH, THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL, AND IT WAS NOTED TO HAVE BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL AND COMPLETED THE PROCEDURE USING THE SAME MICROCATHETER (COMPETITOR BRAND). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 07-AUG-2025, IT WAS INDICATED THAT ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22807371 ↗
• MalfunctionJul 9, 2025Activation Problem; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AFTER A 2X2 ORBIT GALAXY XTRASOFT COIL (640CX0202, 31487305) WAS FILLED IN THE ANEURYSM, THE COIL WAS IMPEDED IN THE DISTAL END OF AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT BE FURTHER FILLED. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460958 ↗
• MalfunctionJul 7, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0202 / 31540292) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS NOT ABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2025, IT WAS INDICTED THAT ADDITIONAL INFORMATION RELATED TO THE REPORTED PROCEDURE AND THE REPORTED DEVICE ISSUE IS NOT AVAILABLE AND CANNOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22417569 ↗
• MalfunctionAug 24, 2023Device Difficult to Setup or Prepare; Difficult to Advance; Device Difficult to Setup or Prepare; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE FOLLOWING COILS WERE USED: THE HYPOTUBE OF THE FIRST COIL, A 9MM X 30MM ORBIT GALAXY COMPLEX FRAME COIL (640CR0930 / 30706306) REPORTEDLY BROKE WHILE ¿PUSHING THE COIL THROUGH THE CATHETER.¿ ANOTHER COIL, A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 30868860) COULD NOT BE RESHEATHED. ON 10-AUG-2023, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA). THE HYPOTUBE OF THE 9MM X 30MM ORBIT GALAXY COMPLEX FRAME COIL (640CR0930 / 30706306) BECAME KINKED, THEN FRACTURED INTO TWO WHILE THE COIL WAS BEING PUSHED THROUGH THE MICROCATHETER. THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 30868860) HAD POSITIONING DIFFICULTY WHICH PROMPTED THE REPORTED FAILED ATTEMPT TO RESHEATH. THERE WAS RESISTANCE DURING THE ADVANCEMENT OF BOTH COILS THROUGH THE MICROCATHETER, THE RESISTANCE WAS AT THE MID-SHAFT OF THE MICROCATHETER. THE INFORMATION INDICATED THAT NECK REMODELING WAS NOT USED. THE MICROCATHETER WAS LEFT IN PLACE AND THE COILS WERE REPLACED. THE PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFULLY COMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17620832 ↗
• MalfunctionJun 10, 2022Material Separation; Positioning Problem; Material Separation; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, ANGIOGRAPHY CONFIRMED THE FEMALE PATIENT EXPERIENCED AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE PROWLER SELECT LPES (606S155X, 30503118) MICROCATHETER (MC) ARRIVED AT THE UPPER THIRD OF THE ANEURYSM, THE PHYSICIAN FILLED THE ANEURYSM WITH A COIL SMOOTHLY AND THEN FILLED A SECOND COIL SUCCESSFULLY AGAIN. ANGIOGRAPHY CONFIRMED THAT THERE WAS NO DENSE EMBOLISM. THEN A 2X2 ORBIT GALAXY XTRASOFT COIL (640CX0202, 30526759) WAS SELECTED AS THE LAST FILLING COIL. SINCE THERE WAS A LITTLE SPACE LEFT IN THE TUMOR FOR THE FIRST-TIME DELIVERY, THE PHYSICIAN ATTEMPTED SEVERAL TIMES FOR ADJUSTING. THE COIL STILL COULD NOT FILL THE ANEURYSM COMPLETELY, THE DOCTOR RETRACTED THE COIL AND TRIED TO ADJUST. AFTER REPEATED DELIVERIES, THE DELIVERY WIRE OF THE STENT BROKE INTO TWO PARTS. THE COIL WAS RETRACTED, AND A NEW COIL WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS DIFFICULTY GETTING THE COIL TO CONFORM TO THE ANEURYSM WALL. THE COIL APPEARS TO BE A DIFFERENT COIL WIND THAN EXPECTED. THE COIL DID NOT APPEAR TO BE DAMAGE WHILE IN THE ANEURYSM WHICH COULD HAVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655141 ↗
• InjuryJun 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6)-YEAR-OLD MALE PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF CONTROLLED HYPERLIPIDAEMIA, HYPERTENSION, CURRENT SMOKER SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM WITH HUNT & HESS GRADE 1, MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 6.4MM, DOME 6.5MM, MAXIMUM ANEURYSM DIAMETER 8.6MM, NECK SIZE 3.3MM, AND DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.4MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX (6) CERENOVUS COILS: A 4MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0410 / 30396173), A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 30393990), A 7MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0715 / 304722037), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30396174), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30451949), AND A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0202 / 30432544) VIA A PROWLER SELECT PLUS MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESS

  Patient problems: Aneurysm

  MAUDE report 14603856 ↗
• MalfunctionAug 5, 2021Device Difficult to Setup or Prepare; Failure to Advance; Material Twisted/Bent; Device Difficult to Setup or Prepare; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION TO THE OPHTHALMIC SEGMENT, A 2X2 ORBIT GALAXY XTRASOFT COIL (640CX0202, 30409478) BECAME IMPEDED AND FAILED TO BE ZIPPED. IT WAS REPORTED THAT AFTER A TAIJIEWEIYE COIL WAS SUCCESSFULLY IMPLANTED WITH THE USE OF AN ECHELON-10 STRAIGHT MICROCATHETER (MC), THE PHYSICIAN THEN INSERTED THE COMPLAINT COIL BUT HE FOUND IT HARD TO MOVE THE SECOND COIL IN THE MICROCATHETER AND THE DELIVERY WIRE WAS BENT. THE PHYSICIAN PLANNED TO WITHDRAW THE COIL SYSTEM, BUT THE COIL¿S BODY COULDN¿T BE ZIPPED, AND THE DELIVERY WIRE WAS BROKEN. THE COIL SYSTEM DIDN¿T ARRIVE IN THE PATIENT¿S BODY. ALL THIS HAPPENED OUTSIDE OF THE BODY. THE PHYSICIAN CHANGED TO ANOTHER NEW COIL SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NOT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RESISTANCE OCCURRED AT THE DOCKING POINT OF THE INTRODUCER AND RHV. THE DEVICE WAS ABLE TO BE REMOVED THROUGH MC. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION AS THE EVENT OCCURRED OUTSIDE THE PATIENT¿S BODY. THE MC WAS NOT DAMAGED DURING THE MANIPULATION OF THE DEVICE. NOTHING WAS NOTICED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281260 ↗
• MalfunctionAug 2, 2021Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, 2X2 ORBIT GALAXY XTRASOFT COIL BECAME UNRAVELED/STRETCHED IN THE UNSPECIFIED MICROCATHETER (MC). IT WAS REPORTED THAT THE COIL WAS ADVANCED THROUGH THE MC AND ARRIVED AT THE TARGET POSITION. STARTED FILLING THE ANEURYSM WITH THE COIL BUT THE PHYSICIAN OBSERVED THAT THE MC¿S POSITION MOVED A LITTLE, TRIED TO ADJUST IT, BUT THE COIL WAS FOUND TO BE UNRAVELED/STRETCHED IN THE MC. THE SURGEON SWITCHED TO ANOTHER DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. PHOTOS OF THE DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12259984 ↗
• MalfunctionDec 23, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN REPORTED THAT THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 30225616) WAS HARD TO ADVANCE AFTER REACHING 50 CM IN THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND FOUND THAT IT WAS HARD TO RETRACT. THE COIL WAS WITHDRAWN FROM THE PATIENT¿S BODY AND THE PHYSICIAN FOUND THAT THE COIL HAD STRETCHED. A NEW COIL WAS USED 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 9511743 ↗
• MalfunctionOct 14, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN INTRACRANIAL ANEURYSM, THE 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0202 / 17682253) COULD NOT BE DETACHED. THE PHYSICIAN USED THE MICROCATHETER (COMPETITOR BRAND) TO WITHDRAW THE COIL AND PULLED THE COIL/MICROCATHETER SYSTEM OUT OF THE PATIENT. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM; THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED. THE EVENT DID NOT RESULT IN AN INTERRUPTION OF BLOOD FLOW. IT WAS REPORTED THAT THE SYRINGE USED WITH THIS COIL PRESSURIZED AS INTENDED, AND BEFORE ATTEMPTING TO DEPLOY THIS COIL, THE SYRINGE DID NOT EXCEED THE GREEN ZONE / POSITION 3. THE SYRINGE WAS NOT TAKEN TO THE RED ALTERNATIVE DETACHMENT ZONE BEYOND THE GREEN ZONE AFTER THE COIL FAILED TO DETACH IN THE GREEN ZONE OF THE SYRINGE. FLUOROSCOPY WAS NOT USED TO VERIFY THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR THE DELIVERY TUBE. NOTHING ELSE WAS DONE IN ATTEMPT TO DETACH THE COIL. THE COIL WAS REPLACED WITH A NEW COIL AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL MICROCATHETER WITHOUT ANY PATIENT ADVERSE EVENT OR PROCEDURAL-RELATED PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188843 ↗
• MalfunctionApr 12, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 4.1MM X 4MM RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN FOUND IT DIFFICULT TO ADVANCE THE 2MM X 2CM ORBIT GALAXY XTRASOFT (640CX0202/30096541) COIL THROUGH THE BODY/SHAFT (APPROX 10CM) OF THE UNSPECIFIED MICROCATHETER AND NOTICED THE EMBOLIC COIL HAD STRETCHED UNDER X-RAY. THE COIL WAS REMOVED FROM THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE OR FLOW RESTRICTION/REDUCTION. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE PROCEDURAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND AN ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WERE NO KINKS IN THE CONCOMITANT MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE COIL HAD NOT EXITED OR DEPLOYED FROM THE MICROCATHETER. THE EMBOLIC COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511208 ↗
• MalfunctionNov 8, 2018Premature Separation; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 2X2 ORBIT GALAXY COMPLEX XTRASOFT (640CX0202/30003308) HYDRAULIC COIL DETACHED DURING PREPARATION. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PRODUCT WILL BE RETURNED FOR EVALUATION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050853 ↗
• MalfunctionAug 20, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING COIL EMBOLIZATION PROCEDURE, THE ORBIT GALAXY COMPLEX XTRASOFT 2MM X 2CM COIL (640CX0202 / 17682252) COULD NOT ADVANCE OUT OF THE MICROCATHETER. THE COIL WAS WITHDRAWN, AND IT WAS FOUND STRETCHED. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797923 ↗
• MalfunctionJul 30, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE ORBIT GALAXY COMPLEX XTRASOFT COIL 2MM X 2CM (640CX0202 / 30006827) COULD NOT BE ADVANCED THROUGH THE PROWLER SELECT LPES, 150CM X 5CM, 2 MARKERS, J TIP MICROCATHETER (606S155JX / 17680649). THE COIL WAS NOT UNRAVELED/STRETCHED WHEN IT WAS REMOVED FOR REPLACEMENT; NO DAMAGE WAS OBSERVED ON THE COIL. THERE WAS NO KINK OR BENT OBSERVED ON THE MICROCATHETER. THE DEVICE WAS PREPPED AND USED PER THE INSTRUCTION FOR USE (IFU) WITH ADEQUATE AND CONTINUOUS FLUSH MAINTAINED THROUGH THE CATHETER. THE PHYSICIAN REPLACED BOTH THE COIL AND THE MICROCATHETER AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PROCEDURAL DELAY AND THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733334 ↗
• MalfunctionOct 13, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT AN OG CMPLX XTRASOFT COIL (640CX0202/17487282) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN DURING A PROCEDURE. THIS COIL WAS THE FIRST COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949391 ↗
• MalfunctionOct 11, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN PULLED THE ORBIT GALAXY COIL (640CX0202/ 17530083) AND UNSPECIFIED MICROCATHETER AT THE SAME TIME AND AFTER INSPECTION, THE COIL WAS FOUND TO BE STRETCHED. THERE WERE NO POTENTIAL PATIENT ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939455 ↗
• MalfunctionAug 2, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT AN OG CMPLX XTRASOFT COIL (640CX0202/17621276) WAS USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) WHEN THE COIL COULD NOT BE SHAPED AS EXPECTED. THE SURGEON ADJUSTED THE COIL A FEW TIMES AND THE COIL STRETCHED. THE SURGEON WITHDREW THE COIL AND USED A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759789 ↗
• MalfunctionApr 20, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COILING OF A MIDDLE CEREBRAL ARTERY ANEURYSM AN ORBIT GALAXY COMPLEX XTRASOFT 2X2 COIL STRETCHED. IT WAS REPORTED THAT THE PHYSICIAN PULLED THE ORBIT GALAXY COIL AND THE UNKNOWN MICROCATHETER AT THE SAME TIME. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. AFTER INSPECTION, IT WAS NOTED THAT THE COIL WAS STRETCHED. IT IS UNKNOWN AT WHAT STEP OF THE PROCEDURE THE COIL STRETCHED. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME LIKE COIL. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE EXPERIENCED WHEN THE COIL WAS ADVANCED, REPOSITIONED OR WITHDRAWN. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. THERE WERE NO KINKS ON THE CATHETER AND OTHER COILS WERE SUCCESSFULLY USED WITH THE SAME CATHETER PRIOR TO THE COMPLAINT COIL. IT WAS REPORTED THAT THE MICROCATHETER WAS REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE CATHETER AND A ONE TO ONE RELATIONSHIP BETWEEN THE COIL & DELIVERY TUBE WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6508058 ↗
• MalfunctionApr 20, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COILING OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM AN ORBIT GALAXY COMPLEX XTRASOFT 2X2 COIL STRETCHED. IT WAS REPORTED THAT THE PHYSICIAN PULLED THE ORBIT GALAXY COIL AND THE UNKNOWN MICROCATHETER AT THE SAME TIME. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. AFTER INSPECTION, IT WAS NOTED THAT THE COIL WAS STRETCHED. IT IS UNKNOWN WHEN THE COIL STRETCHED. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME LIKE COIL. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET. THERE WAS NO RESISTANCE EXPERIENCED WHEN THE COIL WAS ADVANCED, REPOSITIONED OR WITHDRAWN. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. THERE WERE NO KINKS ON THE CATHETER AND OTHER COILS WERE SUCCESSFULLY USED WITH THE SAME CATHETER PRIOR TO THE COMPLAINT COIL. IT WAS REPORTED THAT THE MICROCATHETER WAS REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE CATHETER AND A ONE TO ONE RELATIONSHIP BETWEEN THE COIL & DELIVERY TUBE WAS NOT VERIFIED WITH FL

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6507964 ↗
• MalfunctionJan 17, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION AN OG COMPLEX XTRASOFT COIL 2X2 COULD NOT BE DETACHED. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE THE LIGHT DID NOT ILLUMINATE AND THE AUDIBLE SIGNAL DID NOT BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COIL WAS WITHDRAWN AND A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DCB USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COMPLAINT COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND NO STRETCHING OF THE COIL WAS NOTED. THERE WAS NO REPORT ON THE PATIENT INJURY AND PATIENT OUTCOME WAS REPORTED TO BE FINE. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6255600 ↗