ORBIT GALAXY 640CR0725Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886704030447), received between Jun 18, 2018 and Apr 3, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Fracture; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A PROCEDURE ON (B)(6) 2026, THE 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 31557207) ENCOUNTERED A LOT OF RESISTANCE DURING ITS DEPLOYMENT. THE PUSHER WIRE BROKE WHILE THE COIL WAS BEING PUSHED. THE COIL WAS REMOVED AND REPLACED WITH A NEW COIL OF A DIFFERENT SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780971 ↗
• MalfunctionFeb 2, 2026Stretched; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A COIL EMBOLIZATION, AFTER AN ORBIT GALAXY COIL (PRODUCT CODE: 640CR0725, LOT NUMBER: 31540290) PARTIALLY PASSED A NON-J&J MICROCATHETER, THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE COIL AND MICROCATHETER (MC) FROM THE PATIENT AND FOUND THE COIL WAS UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY WITH THE ORIGINAL MICROCATHETER. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. IT WAS REPORTED THAT BEFORE THE PROCEDURE, THE DEVICE OUTER PACKAGING AND THE DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-FEB-2026 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. A SL-10 MICROCATHETER WAS USED. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINIUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240241 ↗
• MalfunctionOct 16, 2025Device 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, THREE (3) COILS WERE USED, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 31358781), A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 31498857), AND A 9MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0925 / LOT UNKNOWN) ENCOUNTERED RESISTANCE AND COULD NOT BE RESHEATHED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 11-SEP-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE ENDOVASCULAR EMBOLIZATION PROCEDURE WAS TARGETING THE ANTERIOR CEREBRAL ARTERY (ACA). THERE WAS NO VESSEL CALCIFICATION / TORTUOSITY. THE CONCOMITANT MICROCATHETER USED WAS A PROWLER 14 (CATALOG / LOT NUMBER NOT PROVIDED). A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE INTRODUCER OF THE COIL(S) WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT INT H CLEAR TUBE. THE TIPS OF THE INTRODUCER(S) WERE FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE COIL ADVANCEMENT. THE ISSUE THE COILS ENCOUNTERED WAS RESISTANCE WHILE PUSHING IN THE MICROCATHETER DURING THE ADVANCEMENT; AT THE PROXIMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312523 ↗
• MalfunctionDec 4, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  HOLD FOR DN 12/11THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME (640CR0725 / 30790718) PASS THROUGH THE TIP OF THE MICROCATHETER (UNSPECIFIED BRAND); THE PHYSICIAN TRIED TO FILL THE COIL IN THE ANEURYSM, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN RETRACTED THE COIL AND OBSERVED THAT IT HAD BECOME UNRAVELED / STRETCHED. THE PHYSICIAN SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 20-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE MIDDLE CEREBRAL ARTERY (MCA). A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. PER THE INFORMATION, ¿AFTER COIL PASSED THROUGH MICROCATHETER TIP, PHYSICIAN TRIED TO FILL THE COIL IN THE ANEURYSM, BUT THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT ADVANCE ANYMORE.¿ PRIOR TO THE ISSUE WITH THE COMPLAINT COIL, OTHER COILS DID GO THROUGH THE SAME MICROCATHETER WITHOUT ISSUE, THE QUANTITY OF COILS THAT WENT THROUGH WAS NOT SPECIFIED. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18262395 ↗
• MalfunctionNov 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, PRIOR TO PATIENT USE, THE PHYSICIAN FLUSHED AN ORBIT GALAXY COIL (640CR0725, 30753124) AND OBSERVED THE FLUID ESCAPED FROM AN UNINTENDED LOCATION ON PROXIMAL OF THE COIL. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211656 ↗
• MalfunctionNov 15, 2023Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE ADVANCING THE COMPLAINT COIL, A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 30842969) INSIDE THE CONCOMITANT MICROCATHETER TO THE ANEURYSM SITE. THE COIL WAS REMOVED AND REPLACED. THE PROCEDURE WAS REPORTED BE SUCCESSFULLY COMPLETED WITH A 5-MINUTE DELAY. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 08-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THE TARGET VESSEL WAS THE ANTERIOR COMMUNICATING ARTERY (ACOM) WITH TORTUOUS ANATOMY. THAT THE RESISTANCE WAS FIRST FELT DURING THE DEVICE ADVANCEMENT INSIDE THE CONCOMITANT MICROCATHETER (COMPETITOR DEVICE) AT MID-SHAFT. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE ADVANCEMENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. PER THE INFORMATION, AFTER THE REPORTED ISSUE ANOTHER 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725) WAS USED WITH THE SAME MICROCATHETER. THE INFORMATION INDICATED THAT THE MICROCATHETER WAS REMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145832 ↗
• MalfunctionJun 30, 2023Migration; Premature Separation; Migration; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY COIL (640CR0725, 30790718) WAS BEING USED AS THE LAST COIL TO FILL THE ANEURYSM. DURING THE PROCESS OF FILLING THE ANEURYSM, THE COIL WAS DETACHED PREMATURELY. PHYSICIAN USED A MICRO GUIDING WIRE TO FILL THE ANEURYSM WITH THE REMAINING PORTION OF THE COIL AND COMPLETED THE SURGERY. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239715 ↗
• MalfunctionMay 18, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WITH THE TARGET VESSEL BEING THE INTERNAL CAROTID ARTERY (ICA) IN THE 67-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPERTENSION, IT WAS REPORTED THAT THREE (3) 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COILS (640CR0725) FROM THE SAME LOT NUMBER (30842969) ENCOUNTERED RESISTANCE DURING COIL ADVANCEMENT AT THE HUB OF THE 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30864991). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED ON THE MICROCATHETER; VIA ADDITIONAL INFORMATION RECEIVED ON 17-APR-2023, IT WAS INDICATED THAT THE MICROCATHETER WAS NOT REMOVED OR REPLACED. THE INFORMATION ALSO INDICATED THAT THE FACILITY HAS SOME ISSUE WITH COMPLEX FRAME COILS REGULARLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COIL OF ANOTHER SIZE WITHOUT ANY DELAY OR ADDITIONAL INTERVENTION. ON 10-MAY-2023, THE THREE COMPLAINT COILS WERE RETURNED FOR EVALUATION. BASED ON THE PRODUCT ANALYSES COMPLETED ON 17-MAY-2023, THE INVESTIGATION FINDINGS ASSOCIATED WITH TWO OF THE THREE COILS MEET USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957055 ↗
• MalfunctionMay 18, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE WITH THE TARGET VESSEL BEING THE INTERNAL CAROTID ARTERY (ICA) IN THE 67-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPERTENSION, IT WAS REPORTED THAT THREE (3) 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COILS (640CR0725) FROM THE SAME LOT NUMBER (30842969) ENCOUNTERED RESISTANCE DURING COIL ADVANCEMENT AT THE HUB OF THE 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30864991). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED ON THE MICROCATHETER; VIA ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, IT WAS INDICATED THAT THE MICROCATHETER WAS NOT REMOVED OR REPLACED. THE INFORMATION ALSO INDICATED THAT THE FACILITY HAS SOME ISSUE WITH COMPLEX FRAME COILS REGULARLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COIL OF ANOTHER SIZE WITHOUT ANY DELAY OR ADDITIONAL INTERVENTION. ON 10-MAY-2023, THE THREE COMPLAINT COILS WERE RETURNED FOR EVALUATION. BASED ON THE PRODUCT ANALYSES COMPLETED ON 17-MAY-2023, THE INVESTIGATION FINDINGS ASSOCIATED WITH TWO OF THE THREE COILS MEET USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956857 ↗
• MalfunctionMay 5, 2023Fracture; Failure to Advance; Fracture; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN TRIED TO PLACE ONE COIL, AN 8MM X 30CM ORBIT GALAXY COMPLEX FRAME (640CR0830 / 30606917) AND THE TIP WOULD NOT SEAT WITHIN THE HUB OF THE MICROCATHETER (UNSPECIFIED BRAND). ANOTHER COIL, A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME (640CR0725 / 30848871) WAS PLACED INTO THE TARGET ANEURYSM BUT AT THE LAST FEW CM, THE COIL BECAME HARD TO ADVANCE AND THE PUSHER WIRE BROKE DURING THE ATTEMPT TO ADVANCE. IT WAS REPORTED THAT FLUSH LINES WERE MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR NEGATIVE PATIENT IMPACT.ON 19-APR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT DR. KVAMME WAS TREATING A LEFT INTERNAL CAROTID ARTERY (ICA) FISTULA. THE FISTULA WAS IRREGULAR, MEASURING 10MM X 18MM. THE HEADWAY® DUO .0165 MICROCATHETER (MICROVENTION) WAS USED FOR THE ENTIRE PROCEDURE. THE INFORMATION INDICATED THAT THE PUSHER WIRE BROKE IN TWO PIECES. THE WIRE WAS STILL EXPOSED OUT OF THE ROTATING HEMOSTASIS VALVE (RHV) THAT WAS CONNECTED TO THE MICROCATHETER AND WAS REMOVED EASILY. THERE WERE NOT VISIBLE KINKS OBSERVED ON THE MICROCATHETER. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881793 ↗
• MalfunctionMar 7, 2023Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 30675883) COULD NOT BE PUSHED INTO THE END OF THE MICROCATHETER. ¿IN VITRO EXAMINATION, DISTAL END OF THE INTRODUCER SHEATH WAS FOUND SPLIT LATERALLY, AND A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY.¿ THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. 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 COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 07-MAR-2023. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER TITLE 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16500399 ↗
• MalfunctionNov 10, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANEURYSM TO THE ANTERIOR COMMUNICATING ARTERY, A 7X25 ORBIT GALAXY COIL (640CR0725, 30734738) BECAME IMPEDED IN THE TIP OF A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606-S255X, 30743230) AND COULD NOT ADVANCE OR WITHDRAW. THE PHYSICIAN RETRACTED THE COIL AND MICROCATHETER, THEN SWITCHED TO A NEW COIL (THE MICROCATHETER WAS NOT REPLACED) TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE TO THE MICROCATHETER DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THERE WAS NO DAMAGE NOTED TO THE COIL. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771417 ↗
• MalfunctionJun 13, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE MIDDLE CEREBRAL ARTERY , AN 8X30 ORBIT GALAXY COIL (640CR0830, 30666505) BECAME IMPEDED IN AN ECHELON-10,45°TIP MICROCATHETER (MC). THE MC COULD NOT ADVANCE ANY MORE. THE PHYSICIAN SWITCHED TO A 7X25 ORBIT GALAXY COIL (640CR0725, 30628880) BUT THE SAME ISSUE OCCURRED. THE MICROCATHETER WAS REPLACED AND THE SAME PROBLEM REMAINED. THEN A NEW COMPETITOR DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THERE APPEARED TO BE ANY DAMAGE TO THE DEVICES AT ANY TIME. IT IS UNKNOWN IF THERE WAS ANYTHING OBSTRUCTING THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675953 ↗
• MalfunctionMay 19, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A CAROTID-CAVERNOUS FISTULA (CCF) EMBOLIZATION, WHEN USING AN ECHELON 10 MICROCATHETER (MC), THE PHYSICIAN DEPLOYED A 6X15 ORBIT GALAXY COIL AND A 6X20 ORBIT GALAXY COIL. THEN TRIED TO DEPLOY TWO 7X25 ORBIT GALAXY COILS (640CR0725, 30579160) AND A 6X20 ORBIT GALAXY COIL (640CR0620, 30451950). ALL THREE COILS FACED RESISTANCE IN THE MICROCATHETER MIDWAY. THE 6X20 ORBIT GALAXY COIL DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN REMOVED ALL THESE COILS AND COMPLETED THE CASE. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NONE OF THE COILS KINKED OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE CONCOMITANT DEVICE USED WITH THE PRODUCT DID NOT KINK OR BEND AT ANY TIME. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO REMOVAL OF THE MC OR SUBSEQUENT LOSS OF CEREBRAL TARGET POSITION DUE TO THE EVENTS. THE SAME MC WAS USED TO COMPLETE THE PROCEDURE. A 6X15 AND A 6X20 ORBIT GALAXY COILS WERE USED SUCCESSFULLY WITH THE CONCOMITANT DEVICE PRIOR TO THE ENCOUNTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435339 ↗
• MalfunctionDec 6, 2021Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, WHEN THE 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 30556571) ARRIVED AT THE MIDDLE PART OF THE CONCOMITANT MICROCATHETER, IT COULD NO LONGER BE ADVANCED. THE PHYSICIAN FOUND THAT THE COIL HAD ALREADY DETACHED IN THE MICROCATHETER. THE COMPLAINT DEVICE WAS REMOVED AND REPLACED; THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. PHOTOS OF THE COMPLAINT DEVICE WERE INCLUDED IN THE FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934513 ↗
• MalfunctionOct 7, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, A 7X25 ORBIT GALAXY COMPLEX FRAME COIL (640CR0725, 30532540) BECAME STUCK INSIDE THE PROWLER SELECT LPES 45 MICROCATHETER (606S155FX, 30335061). THE COIL WAS NOT ¿PUSHING AHEAD¿ INSIDE THE MICROCATHETER. AN ORBIT GALAXY (640CR0725, 30498209) ALSO BECOME IMPEDED WITH THE SAME MC. THE DEVICES WERE REMOVED, AND ANOTHER COIL WERE USED. THERE WAS A SURGERY DELAYED OF 15 MINUTES DUE TO THE REPORTED EVENTS. THE MC WAS REMOVED BUT USED AGAIN TO DEPLOY OTHER COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. NO PATIENT INJURY WAS REPORTED. THERE APPEARED TO BEING NO DEVICE DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS NOT FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589895 ↗
• MalfunctionOct 7, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, A 7X25 ORBIT GALAXY COMPLEX FRAME COIL (640CR0725, 30532540) BECAME STUCK INSIDE THE PROWLER SELECT LPES 45 MICROCATHETER (606S155FX, 30335061). THE COIL WAS NOT ¿PUSHING AHEAD¿ INSIDE THE MICROCATHETER. AN ORBIT GALAXY (640CR0725, 30498209) ALSO BECOME IMPEDED WITH THE SAME MC. THE DEVICES WERE REMOVED, AND ANOTHER COIL WERE USED. THERE WAS A SURGERY DELAYED OF 15 MINUTES DUE TO THE REPORTED EVENTS. THE MC WAS REMOVED BUT USED AGAIN TO DEPLOY OTHER COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. NO PATIENT INJURY WAS REPORTED. THERE APPEARED TO BEING NO DEVICE DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS NOT FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE BEEN APPLIED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589894 ↗
• MalfunctionJul 14, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 7X25 ORBIT GALAXY COMPLEX FRAME COIL (640CR0725, 30337722) AND AN 8X30 ORBIT GALAXY COIL (640CR0830, 30286063) WERE NOT MOVING PROPERLY IN THE UNSPECIFIED MICROCATHETER. THERE WAS SO MUCH OF RESISTANCE IN DEPLOYING THE COILS. BOTH THE COIL AND CATHETER WERE REMOVED WITHOUT ADDITIONAL INTERVENTION, THERE WAS A LOSS OF CEREBRAL TARGET POSITION. ANOTHER COIL AND CATHETER WERE USED. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS ¿FINE¿ AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166198 ↗
• MalfunctionJun 28, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A SUPPORT ASSISTED COIL EMBOLIZATION, A 7X25 ORBIT GALAXY COIL (640CR0725, 30451951) COULDN¿T CROSS THROUGH THE INTRODUCER. THE PHYSICIAN CHANGED TO ANOTHER 8X30 ORBIT GALAXY COIL (640CR0830, 30465908) BUT IT ALSO FAILED. THE PHYSICIAN SWITCHED TO A THIRD ONE TO COMPLETE THE OPERATION. THERE WAS NOT INJURY REPORT. A ECHELON 10/0.017"/0° MICROCATHETER WAS USED. NO OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER (MC) PRIOR TO THE ENCOUNTERED RESISTANCE. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE COMPLAINT COIL DID NOT APPEAR TO BE DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. BASED ON THE DEVICE ANALYSIS OF THE 7X25 ORBIT GALAXY, THE DELIVERY TUBE (HYPOTUBE) WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076242 ↗
• InjuryMay 19, 2021Premature Separation; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, A 5MM X 7CM CASHMERE 14 (CRC14050730/S14303) COIL FAILED TO RETURN TO THE INTRODUCER SHEATH (I.E., REZIPPED). THE PHYSICIAN REPLACED THE COIL TO CONTINUE THE OPERATION. THEN, A 7MM X 25CM ORBIT GALAXY TDL COMPLEX FRAME (640CR0725/30451951) COIL UNINTENDEDLY DETACHED BEFORE ARRIVING TO THE TARGET POSITION. THE PHYSICIAN UTILIZED A MICROWIRE TO PUSH THE PREMATURELY DETACHED COIL INTO THE TARGET ANEURYSM. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848295 ↗
• MalfunctionMar 12, 2021Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 30374735) WAS KINKED DURING THE PROCEDURE. THERE WAS NO REPORTED PROCEDURE DELAY AND THERE WAS NO PATIENT ADVERSE EVENT ASSOCIATED WITH THE REPORTED DEVICE ISSUE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475487 ↗
• 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 11109393 ↗
• 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 10573563 ↗
• MalfunctionSep 10, 2020Migration; Migration

  AS REPORTED VIA THE (B)(6) STUDY, DURING THE ENDOVASCULAR COIL EMBOLIZATION TARGETING AN UNRUPTURED ANEURYSM ON THE POSTERIOR CIRCULATION, POSTERIOR CEREBRAL ARTERY WITH THE FOLLOWING DIMENSIONS: PARENT VESSEL DIAMETER IS 4MM, 8.3MM HEIGHT, 5.7MM DOME, 8.3MM MAXIMUM ANEURYSM DIAMETER, 3.2MM NECK SIZE AND A 1.8MM DOME TO NECK RATIO (DERIVED), THERE WAS DEPLOYMENT DIFFICULTY AND MIGRATION WITH A 7MMX25CM OG TDL CMPLX FRAME COIL (B)(4). THE COIL WAS NOT IMPLANTED. THERE WAS ALSO POSITIONING DIFFICULTY AND MIGRATION WITH AN ORBIT GALAXY (UNKNOWN PRODUCT/LOT). THERE WAS NO DEVICE-RELATED SERIOUS ADVERSE EVENT (SAE). THE FOLLOWING STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE: 6MM X 20CM ORBIT GALAXY (LOT#30383959), 4MM X 8CM ORBIT GALAXY (LOT# 30191119) AND A 3MM X 6CM ORBIT GALAXY (LOT# 30341959). THE CASE REPORT FORM (CRF) LISTS THE FOLLOWING COILS AS USED BUT NOT IMPLANTED: ORBIT GALAXY (LOT# 30374735), ORBIT GALAXY (LOT# 30309530), AND ORBIT GALAXY (LOT# 30375689). THE CRF ALSO INDICATES THAT THE REASON ADDITIONAL COILS WERE NOT IMPLANTED WAS DUE TO ¿COIL RESISTANCE/FRICTION¿, NO LOSS OF ACCESS. THIS WILL BE FURTHER INVESTIGATED. THE CERENOVUS STUDY COILS ADVANCED BEYON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515273 ↗
• MalfunctionSep 10, 2020Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL ANEURYSM EMBOLIZATION, A 7X25 OG TDL CMPLX FRAME COIL (640CR0725, 30239314) BROKE FROM THE DETACHMENT ZONE. SOME RESISTANCE WAS FELT BETWEEN THE COIL, AND THE CATHETER WHILE PULLING THE COIL BACK IT BROKE. THE PROCEDURE WAS DELAYED BY 10-15 MINUTES DUE TO THE EVENT. ANOTHER COIL WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THE 7X25 OG TDL CMPLX FRAME COIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION FROM THE PATIENT.

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

  MAUDE report 10514723 ↗