ORBIT GALAXY 640CF0510Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886704030294), received between Oct 10, 2016 and Jun 25, 2026 — classified as 18 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. How this data works · Data updated Oct 13, 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 25, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A COMPETITIVE MICROCATHETER (MC) WAS IN PLACE AN ORBIT GALAXY COIL (PRODUCT CODE: 640CF0505, LOT NUMBER: 31204208) WAS DELIVERED TO TARGET SITE. THE COIL WAS PACKED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND COIL, ANOTHER ORBIT GALAXY (PRODUCT CODE: 640CF0510, LOT NUMBER: 31211764) AND TRIED TO DETACH IT, BUT THE SECOND COIL WAS ALSO UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED TO A THIRD COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUN-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB AND CONTROL CABLES WERE NOT USED WITH THE SUBSEQUENT COILS. THE COILS WERE ATTACHED TO THE COIL DELIVERY SYSTEMS WHEN REMOVED FROM THE PATIENT. THE COILS WERE NOT STRETCHED OR 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 25623086 ↗
• MalfunctionMar 30, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE SHAFT OF AN ORBIT GALAXY (PRODUCT CODE: 640CF0510, LOT NUMBER: UNKNOWN) BROKE. THERE WAS NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714309 ↗
• MalfunctionFeb 5, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN ATTEMPTED TO ADVANCE A ORBIT GALAXY COIL (PRODUCT CODE: 640CF0510, LOT NUMBER: 31606031) THROUGH A MICROCATHETER (NON COMPANY BRAND). THE COIL BECAME IMPEDED AT THE PROXIMAL END OF THE MICROCATHETER (MC) AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN THEN RETRACTED THE COIL WITHOUT RESISTANCE, REMOVED IT FROM THE SYSTEM, AND REPLACED IT WITH A NEW COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE REPLACEMENT COIL. THE MICROCATHETER REMAINED IN USE AND WAS NOT EXCHANGED. NO PATIENT INJURY OR ADVERSE CLINICAL IMPACT WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JAN-2026 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE MICROCATHETER WAS A SL-10. A SYNCHRO MICRO GUIDE WIRE WAS SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THE TARGET VESSEL WAS THE C7 SEGMENT (COMMUNICATING SEGMENT) OF THE INTERNAL CAROTID ARTERY. THE VESSEL WAS RELATIVELY TORTUOUS. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269323 ↗
• MalfunctionMay 2, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE OG TDL CMPLX FILL COIL 5X10 (640CF0510/UNK) COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. NO PATIENT INJURY 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 21950561 ↗
• MalfunctionSep 11, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN FILLED THE ANEURYSM WITH AN ORBIT GALAXY COIL (640CF0510, 31047859). HOWEVER, IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED AND REMOVED THE COIL AND MICROCATHETER (OTHER BRAND) FROM THE PATIENT. THEN THE PHYSICIAN SWITCHED A NEW COIL, A NEW MICROCATHETER AND A NEW SYRINGE TO COMPLETE THE SURGERY. THE SURGERY WAS PROLONGED ABOUT 30 MINUTES. THE PATIENT IS IN A STABLE CONDITION NOW. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 09-SEP-2024 INDICATING THAT THIS WAS THE FIRST COIL USED IN THE PROCEDURE. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THERE WAS RESISTANCE ENCOUNTERED PRIOR TO THE COIL BECOMING UNRAVELED. THE 30 MINUTES SURGERY PROLONGATION WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193199 ↗
• MalfunctionFeb 20, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0510 / 30856377) WAS THE FIRST COIL USED. THE COIL REPORTEDLY COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME AND AFTER INSPECTION, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. THE PHYSICIAN USED A ¿SAME LIKE¿ PRODUCT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739880 ↗
• MalfunctionDec 14, 2023Stretched; Positioning Problem; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, IT WAS DIFFICULT TO POSITION THE 5MM X 10CM OBIT GALAXY COMPLEX FILL COIL (640CF0510 / 30827933) IN THE TARGET SITE AND THE COIL DID NOT CONFORM TO THE ANEURYSM WALL. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 13-DEC-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A 52-YEAR-OLD FEMALE. THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (BRAND NAME IS NOT OBTAINABLE). THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED ISSUE. THE REPLACEMENT COIL WAS ANOTHER 5MM X 10CM OBIT GALAXY COMPLEX FILL COIL (640CF0510). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332750 ↗
• MalfunctionMay 15, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, AN ORBIT GALAXY COIL (640CF0510, 30763724) WAS AT COIL ATTACHMENT POINT, WHEN PHYSICIAN USED SYRINGE TO DETACH THE COIL. IT WAS FOUND THAT THE COIL WAS UNABLE TO DETACH. THE DOCTOR TRIED AGAIN, BUT THE COIL WAS STILL NOT ABLE TO DETACH. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A PRE-DEPLOYMENT ELECTRICAL TESTING PERFORMED WAS PERFORMED. THE SAME DCB AND CONTROL CABLE WAS SUCCESSFUL WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL DID NOT STRETCH OR DAMAGE WHEN REMOVED FROM THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE INTERNAL CAROTID VESSEL WAS TORTUOUS, THE ANEURYSM WAS LOCATED IN THE ANTERIOR COMMUNICATING, RUPTURED ANEURYSM. ANEURYSM SIZE: LENGTH: 6.5 MM, WIDTH: 5.1 MM, NECK: 3.4 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929512 ↗
• MalfunctionAug 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, SALINE WAS LEAKING FROM THE HUB OF THE 5MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0510 / 30697545) AND AS A RESULT, THE PHYSICIAN COULD NOT DETACH THE COIL DUE TO INSUFFICIENT PRESSURE. IT WAS REPORTED THAT THE PHYSICIAN ¿FELT SOMETHING WRONG WITH THE HUB.¿ THE COIL WAS REMOVED FROM THE PATIENT AND ANOTHER OF THE SAME PRODUCT WAS USED AS REPLACEMENT AND 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 15219032 ↗
• MalfunctionApr 12, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0510 / 30546078) FAILED TO DETACH EVEN THOUGH THE SYRINGE WAS WORKING CORRECTION. IT WAS REPORTED THAT THE PROCEDURE DID NOT RESULT IN ANY PROCEDURE DELAY AND IT WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET WAS A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE INFORMATION INDICATED THAT THE COIL WAS DETACHED AFTER DEPLOYMENT IN THE ANEURYSM. INFORMATION REGARDING WHETHER THE POSITION OF THE COIL WAS ACCEPTABLE OR NOT WAS NOT PROVIDED. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND IT WAS NOT STRETCHED WHEN IT WAS REMOVED. THE INFORMATION INDICATED THAT THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE EVENT DID NOT RESULT IN ANY INTERRUPTION IN BLOOD FLOW. THE SYRINGE WAS FILLED FROM A DEDICATED SOURCE OF SALINE. THE SAME SYRINGE WAS LATER USED TO SUCCESSFULLY DETACHED COILS FOLLOWING THIS EVENT. IT WAS INDICATED THAT BEFORE ATTEMPTING TO DEPLOY THIS COIL, THE SYRINGE DID E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087833 ↗
• MalfunctionJun 1, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO RESHEATH THE 5MM X 10CM ORBIT GALAXY COMPLEX FILL COIL (640CF0510 / 30461368), BUT THE RESHEATHING ATTEMPT WAS NOT SUCCESSFUL DUE TO THE MALFUNCTION OF THE SHEATH. THE PHYSICIAN COULD NOT RETRACT THE COIL BACK INSIDE THE SHEATH AND THE ZIPPER SYSTEM WAS NOT PROPERLY WORKING. THE PHYSICIAN USED ANOTHER 5MM X 10CM ORBIT GALAXY COMPLEX FILL COIL AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR 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 IN DAMAGE / STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 31 MAY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917655 ↗
• 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 10573556 ↗
• MalfunctionDec 29, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM, THERE WAS RESISTANCE FELT IN THE INTRODUCER SHEATH OF AN ORBIT GALAXY COMPLEX FILL (640CF0510, 17604574), AND DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL WAS STRETCHED. THE GUIDING CATHETER AND 2 MICROCATHETERS WERE USED WITH AN INITIAL COIL (GALAXY 5MMX15CM), BUT THE COIL WAS TOO LONG FOR THE LESION. THE COIL WAS REPLACED WITH THE COMPLAINT ORBIT GALAXY AND IT WAS ATTEMPTED TO BE DELIVERED, BUT THERE WAS RESISTANCE FELT IN THE INTRODUCER SHEATH. IT WAS DIFFICULT TO INSERT THE COIL. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE). 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 PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. NO FURTHER INFORMATION WAS AVAILABLE.

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

  MAUDE report 7153753 ↗
• MalfunctionOct 26, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ANEURYSM, TWO ORBIT GALAXY COMPLEX FILL COILS (CATALOG 640CF0510, LOTS 17604575 AND 17599451) HAD RESISTANCE WITHIN THE SL 10 MICROCATHETER AND DURING PRODUCT ANALYSIS, LOT 17604575 WAS FOUND TO HAVE COIL STRETCHING . A MICROCOIL (MICRUSFRAMEC) WAS IMPLANTED AS A FRAME, THEN THE ORBIT GALAXY (LOT 17604575) WAS INSERTED TO THE MICROCATHETER. HOWEVER, THERE WAS STRONG RESISTANCE FELT IN THE MIDDLE PART OF THE MICROCATHETER AND IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS FLUSHED AND A GUIDEWIRE WAS INSERTED. THEN THE SECOND ORBIT GALAXY (LOT 17599451) WAS INSERTED; HOWEVER, THERE WAS RESISTANCE FELT AT ITS PROXIMAL PART AND THE COMPLAINT COIL WAS REPLACED WITH A NEW MICROCOIL (GALAXY). 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 PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6981394 ↗
• MalfunctionJun 1, 2017Crack; Crack

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A FRACTURE AT THE PROXIMAL HUB OF AN OG TDL CMPLX FILL COIL (640CF0510/17535711) WAS FOUND DURING PREPARATION AND THE DISTAL TIP OF AN ENVOY GUIDING CATHETER (67125805D/LOT UNKNOWN) WAS KINKED UPON OPENING THE BOX. THE PHYSICIAN USED ANOTHER OF THE SAME SIZE PRODUCTS AND COMPLETED THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604556 ↗
• MalfunctionMar 8, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY RESISTANCE WAS EXPERIENCED WHEN USING TWO OG COMPLEX FILL 5X10 COILS AND ONE OG XTRASOFT 4X8 COIL. THE PATIENT¿S VESSELS WERE NOT CALCIFIED. THE OG COMPLEX FILL 5X10 COIL (COMPLAINT PRODUCT1) WAS INSERTED INTO THE MICRO CATHETER BUT IT GOT STUCK AT THE PROXIMAL PORTION. THE PHYSICIAN TRIED TO ADVANCE THE COIL BUT THERE WAS STRONG RESISTANCE AND THE DELIVERY WIRE WAS BROKEN. THE COIL WAS REPLACED WITH ANOTHER ONE (COMPLAINT PRODUCT2, SAME LOT NUMBER) BUT THE SAME ISSUE OCCURRED WITH IT. THE COIL WAS REPLACED WITH ANOTHER COIL A OG XTRASOFT 4X8 COIL (COMPLAINT 3). HOWEVER IT GOT STUCK AT THE DISTAL PORTION OF THE MICRO CATHETER AND THERE WAS STRONG RESISTANCE FELT. THEREFORE THE COIL WAS REPLACED WITH ANOTHER ONE (COMPETITOR'S PRODUCT). 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 PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6389091 ↗
• MalfunctionMar 8, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY RESISTANCE WAS EXPERIENCED WHEN USING TWO OG COMPLEX FILL 5X10 COILS AND ONE OG XTRASOFT 4X8 COIL. THE PATIENT¿S VESSELS WERE NOT CALCIFIED. THE OG COMPLEX FILL 5X10 COIL (COMPLAINT PRODUCT 1) WAS INSERTED INTO THE MICRO CATHETER BUT IT GOT STUCK AT THE PROXIMAL PORTION. THE PHYSICIAN TRIED TO ADVANCE THE COIL BUT THERE WAS STRONG RESISTANCE AND THE DELIVERY WIRE WAS BROKEN. THE COIL WAS REPLACED WITH ANOTHER ONE (COMPLAINT PRODUCT2, SAME LOT NUMBER) BUT THE SAME ISSUE OCCURRED WITH IT. THE COIL WAS REPLACED WITH ANOTHER COIL A OG XTRASOFT 4X8 COIL (COMPLAINT 3). HOWEVER IT GOT STUCK AT THE DISTAL PORTION OF THE MICRO CATHETER AND THERE WAS STRONG RESISTANCE FELT. THEREFORE THE COIL WAS REPLACED WITH ANOTHER ONE (COMPETITOR'S PRODUCT). 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 PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6389085 ↗
• MalfunctionOct 10, 2016Device Difficult to Setup or Prepare; Failure to Prime; Device Difficult to Setup or Prepare; Failure to Prime

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, AIR WAS FOUND IN THE HUB OF THE ORBIT GALAXY COMPLEX FILL (640CF0510/17430048). THE MICROCATHETER HAD BEEN DELIVERED TO THE LESION THROUGH THE GUIDING CATHETER, AND THE COMPLAINT COIL WAS PREPARED IN ACCORDANCE WITH THE IFU. DURING THE PREPARATION, AIR WAS FOUND AT ITS HUB. THE COIL WAS REPLACED WITH ANOTHER COIL (SAME SIZE). 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 DEVICE WAS PREPPED AND THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6013473 ↗