GALAXY G3 GLX122535Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704077619), received between Feb 21, 2017 and Jan 23, 2025 — classified as 7 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 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.

• MalfunctionJan 23, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 XSFT 2.5MM X 3.5CM COIL (GLX122535, LOT UNKNOWN) FAILED TO DETACH. ALL OTHER CNV COILS REALIZED ELECTRICAL CONTACT TO DETACHMENT SYSTEM AND DETACHED WITHOUT ANY PROBLEMS. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 16-JAN-2025 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DETACHABLE CONTROL BOX (DCB) AND CABLE WERE SUCCESSFULLY USED WITH SUBSEQUENT COILS. THE INVOLVED COIL WAS REMOVED FROM THE PATIENT WITH NO CONSEQUENCES. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218412 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY (CNV_2017_01), A 49-YEAR-OLD MALE (B)(6) WITH NO RELEVANT MEDICAL HISTORY, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WITH A MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2023. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.8MM, DOME 7MM, MAXIMUM ANEURYSM DIAMETER 8.2MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH EIGHT (8) CERENOVUS COILS: A GALAXY G3 6MM X 15CM (GLY120615/30715066), A GALAXY G3 XSFT 2.5MM X 3.5CM (GLX122535/30563820), A GALAXY G3 MINI 2MM X 3CM (GLM920030/30878377), A GALAXY G3 XSFT 4MM X 8CM (GLX120408/30901816), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/30719529), A GALAXY G3 XSFT 3.5MM X 9CM (GLX123509/30571102), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/30526863), AND A GALAXY G3 MINI 2MM X 4CM (GLM920040/30830570) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED IN THE CRF. IMMED

  Patient problems: Aneurysm

  MAUDE report 19448084 ↗
• MalfunctionMay 8, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / 30789547) WAS STRETCHED AT THE A2 AREA. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271620 ↗
• MalfunctionOct 12, 2023Break; Break

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE FOR A SUBARACHNOID HEMORRHAGE (SAH) AT THE ANTERIOR COMMUNICATING ARTERY (ACOMM), THE COMPLAINT COIL, A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / 30498785) WAS USED AS A FIRST COIL. THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS ADVANCED TO THE ANEURYSM. WHEN IT WAS ATTEMPTED TO RETRIEVE THE COIL, IT COULD NOT BE RE-SHEATHED AS THE INTRODUCER (PEEL) GOT DAMAGED. THE 2.5MM X 3.5CM GALAXY G3 XSFT WAS REPLACED WITH A NEW ONE. THE PROCEDURE WAS CONTINUED AND COMPLETED, WITH NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT NECK REMODELING WAS NOT UTILIZED. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER (MC). NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920686 ↗
• MalfunctionJul 19, 2023Separation Failure; Migration; Separation Failure; Migration

  AS REPORTED BY THE FIELD, DURING A RETREATMENT OF A COIL EMBOLIZATION OF INTERNAL CAROTID - ANTERIOR CHOROIDAL ARTERY ANEURYSM, A 6FR UNSPECIFIED ANGIOCATHETER AND 6FR FUBUKI XF WERE IN COMBINATION AND ADVANCED INTO COMMON CAROTID ARTERY. THE 6FR ANGIOCATHETER WAS REMOVED AND INSERTED CERULEANDD6 INTO THE INTERNAL CAROTID ARTERY. INSERTED SL10 MICROCATHETER AND SHORYU BALLOON CATHETER INTO CERULEANDD6 INTERMEDIATE CATHETER, AND ADVANCED THE SL10 INTO THE ANEURYSM. THE GALAXY G3 XSFT 2.5MM X 3.5CM COIL (GLX122535, 30429065) WAS USED AS THE FIRST COIL AND ATTEMPTED TO IMPLANT. AFTER REWINDING SEVERAL TIMES, DETACHED THE COIL, BUT THE TIP OF THE SL10 COIL OR THE TIP OF THE DELIVERY SYSTEM SEEMED TO BE ATTACHED TO THE COIL. THEN THE SL10 TIP GOT BENT AND COULD NOT RECOVERED. WHEN A NEW CHIKAI14 WAS OPENED AND INSERTED INTO SL10, ENTANGLED TIP WAS RESOLVED AND RECOVERED NORMAL FORM, BUT A PART OF THE COIL PROTRUDED INTO THE INTERNAL CAROTID ARTERY. THE PROCEDURE WAS TERMINATED AFTER DETERMINING THAT FURTHER MANIPULATION WOULD HAVE A RISK. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE CHIKAI10 GUIDEWIRE, FUBUKI XF 6FR GUIDING CATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349924 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT (B)(6)), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987123 ↗
• MalfunctionDec 13, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / 30504559) WAS THE SECOND COIL USED. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED ANOTHER 2.5MM X 3.5CM GALAXY G3 XSFT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974082 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BASED ON THE MODIFIED INFORMATION RECEIVED ON (B)(6) 2022, COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING COILS WERE IMPLANTED: AN 8MM X 16.1CM MICRUSFRAME 10 (MFR100816 / L15372), A 5MM X 15CM GALAXY G3 (GLY120515 / 30517632), A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / K10121), A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / L16158), A 5MM X 15CM GALAXY G3 (GLY120515 / K10721), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / K10380), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / L16495) VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGIN

  Patient problems: Aneurysm; Ischemia Stroke

  MAUDE report 15936882 ↗
• MalfunctionJun 30, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535 / 30670805) WAS INSERTED INTO THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER), BUT RESISTANCE BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER WAS ENCOUNTERED. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED AND REPLACED WITH A COMPETITOR COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 10-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CONCOMITANT MICROCATHETER WAS NOT REMOVED WHEN THE COMPLAINT COIL WAS REMOVED. THE COMPLAINT DEVICE DID NOT APPEAR DAMAGE. THE DEVICE COULD STILL BE MOVED WHEN THE RESISTANCE WAS ENCOUNTERED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 30-JUN-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881829 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6) FEMALE (SUBJECT 01208-006) WITH NO TARGETED MEDICAL HISTORY, EXCEPT BEING A SMOKER, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT ANEURYSM IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY ON (B)(6) 2021. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2021, THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.1MM, DOME 6.3MM, MAXIMUM ANEURYSM DIAMETER 6.3MM, NECK SIZE 1.9MM, AND THE DOME-TO-NECK RATIO OF 3.3MM. THE PARENT VESSEL DIAMETER WAS NOT DONE. THE FOLLOWING COILS WERE IMPLANTED VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC): ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/ 30532733), ONE 4MM X 12CM GALAXY G3 (GLY120412/30541491), ONE 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535/30546472), ONE 2MM X 4MM GALAXY G3 MINI (GLM920040/30558132), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/30558365), AND ONE 2MM X 2MM GALAXY G3 XSFT (GLX120202/L16466). ONE 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525/30541484) WAS USED, BUT NOT IMPLANTED. MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED A TOTAL OF THREE TIMES. HEPARIN WAS ADMINIS

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516767 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A (B)(6) FEMALE PATIENT WITH A HISTORY OF CARDIAC ARRHYTHMIA, CONTROLLED HYPERTENSION, ACTIVE SMOKING, LUNG CANCER, CLASS 3 OBESITY (BMI 42 KG/M2), AND INTRACRANIAL ANEURYSMS (TOTAL OF 4) UNDERWENT COIL EMBOLIZATION OF A RECURRENT UNRUPTURED LEFT ANTERIOR CEREBRAL ARTERY (ACA) ANEURYSM ON (B)(6) 2021. THE PATIENT EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTRA-ARTERIAL TIROFIBAN WAS ADMINISTERED, AND THE EVENT IS RESOLVING. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE SEVERITY OF THE EVENT WAS ENTERED AS MILD. PER THE PRINCIPAL INVESTIGATOR (PI), THE RELATIONSHIP OF THE EVENT TO THE STUDY DEVICE WAS CAUSAL. THE EVENT WAS CONSIDERED SERIOUS BECAUSE IT REQUIRED MEDICAL INTERVENTION. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH COILS ON (B)(6) 2020; THE ANEURYSM WAS RUPTURED AT THE TIME OF PRESENTATION. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2021 REVEALED AN UNRUPTURED LEFT ACA BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS ANEURYSM HEIGHT 3.0MM, DOME 2.3MM, MAXIMUM ANEURYSM DIAMETER 3.0MM, NECK SIZE 1.4MM, AN

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thromboembolism

  MAUDE report 13266766 ↗
• InjuryJan 3, 2022Separation Failure; Migration; Premature Separation; Separation Failure; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A RECURRENT INTERNAL CAROTID (IC)-POSTERIOR COMMUNICATION ARTERY (PC) ANEURYSM, A 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535 / 30532642) FAILED TO DETACH AND THEN BECAME UNINTENDEDLY DETACHED IN THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AT THE TIME OF RETRIEVAL. A 4.5MM X 21CM NEUROFORM ATLAS® STENT SYSTEM (STRYKER) HAD BEEN IMPLANTED, AND ONE LOOP OF THE COIL DEVIATED FROM THE STENT AND PROTRUDED INTO THE PARENT VESSEL. AN ADDITIONAL 4.5MM X 21CM NEUROFORM ATLAS® STENT SYSTEM WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN STATED THAT HE/SHE WILL FOLLOW-UP WITH THE PATIENT WITH MEDICAL TREATMENT. THE COMPLAINT COIL IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ON 22 DEC 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO DIFFICULTY POSITIONING THE COIL IN THE ANEURYSM. THE PROTRUSION INTO THE PARENT VESSEL DID NOT RESULT IN RESTRICTION OF BLOOD FLOW NOR IN THROMBOSIS. THERE WAS NO INFORMATION ABOUT THE COIL BEING STRETCHED WHEN IT WAS REMOVED. WHEN THE COIL BECAME PREMATURELY DETACHED, ONE LOOP OF THE COIL WENT OVER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13145523 ↗
• MalfunctionJul 28, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, THE DELIVERY SYSTEM OF A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505, L15293) AND A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535, L13110) IS CAUSING SOME CONCERNS, THE COILS DO NOT FILL THE ANEURYSM AS WELL AS THE USER WAS HOPING. IT IS DIFFICULT TO POSITION THEM; THEY ARE EITHER PROTRUDING INTO A VESSEL OR THEY ARE DIFFICULT TO BE FULLY ADVANCED. THE USER REPORTED THAT SOMETIMES THEY CANNOT ADVANCE A COIL FULLY AND IT¿S NOT DUE TO SIZING, PERHAPS IT IS INDEED DUE TO THE DELIVERY SYSTEM. THE CATHETER KICK BACK IS VERY CONCERNING. THE SYSTEM, ESPECIALLY THE DELIVERY WIRE FEELS VERY STIFF. IT¿S REQUIRING SOME MANIPULATION. DEPLOYMENT OF COILS TAKES TOO LONG, AS THEY ARE NOT EASY TO HANDLE, WHICH PRESENTS A RISK OF CLOT FORMING. THERE WAS NO PATIENT INJURY REPORTED. IMAGING WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332249 ↗
• MalfunctionJan 7, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION AT THE INTERNAL CAROTID ARTERY (ICA), THE 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535 / L12367) WAS INSERTED INTO THE SL-10® MICROCATHETER (STRYKER), BUT THERE WAS RESISTANCE FELT. THE COMPLAINT COIL WAS RESHEATHED, BUT IT GOT STUCK ON A Y-CONNECTOR AND THE COIL BECAME UNRAVELED DURING THE RESHEATHING ATTEMPT. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560398 ↗
• MalfunctionNov 1, 2019Stretched; Unraveled Material; Stretched; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535 / L13093) WAS USED BUT IT BECAME STUCK IN THE CARNELIAN® MARVEL® NON-TAPER MICROCATHETER (TOKAI MEDICAL PRODUCTS) AND BECAME UNRAVELED. THE MICROCATHETER WAS RETRACTED SLOWLY AND THE COIL WAS REMOVED AND REPLACED WITH ANOTHER COIL TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268891 ↗
• MalfunctionOct 23, 2019Premature Separation; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT ACA, DURING ADVANCEMENT THROUGH A RESTER MICROCATHETER (MC), THERE WAS RESISTANCE WITH A 2.5MM X 3.5CM GALAXY G3 XSFT COIL (GLX122535, L13257). THE COMPLAINT COIL WAS USED AS THE FIRST COIL. THE PHYSICIAN ATTEMPTED TO PULL OUT THE COIL DELIVERY SYSTEM, BUT IT PREMATURELY DETACHED. THE COMPLAINT COIL WAS REMOVED WITH THE MC AND A COMPETITIVE COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE THE COIL. THERE WAS NO CLINICALLY SIGNIFICANT PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. THE DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGES WERE CONFIRMED PRIOR TO USE. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9224004 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6)-YEAR OLD FEMALE (PATIENT (B)(6)), WITH A HISTORY OF HEADACHES, CONTROLLED HYPERTENSION, CHRONIC BACK PAIN, PANIC ATTACKS, AND BREAST CANCER UNDERWENT COIL EMBOLIZATION OF A MIDLINE ANTERIOR COMMUNICATING ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED SEVERE INTRAOPERATIVE ANEURYSM RUPTURE. HEPARIN REVERSAL WAS PERFORMED WITH THE ADMINISTRATION OF PROTAMINE SULFATE AND PLATELETS. IT WAS LAST REPORTED THAT THE PATIENT IS RECOVERING FROM THE EVENT. THE PRIMARY INVESTIGATOR FELT THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE (S). ON (B)(6) 2019, ANGIOGRAPHY REVEALED AN UNRUPTURED ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY BIFURCATION. THE ANEURYSM HEIGHT WAS 6.6MM AND DOME WAS 6.3MM. THE MAXIMUM ANEURYSM DIAMETER WAS 6.6MM, NECK SIZE WAS 2.8MM AND DOME-TO-NECK RATIO WAS 2.3MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XTRASOFT, ONE 2.5MM X 3.5CM GALAXY G3 XTRASOFT, TWO 2.0MM X 2.0CM GALAXY G3 XTRASOFT, AND SEVEN COMPETITOR COILS VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE PATIENT SUFFERED FROM AN INTRAOPERATIVE ANEURYSM RUPTURE, WHICH WAS CONSIDERED BY THE INVESTIGATOR WAS

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 8888160 ↗
• MalfunctionSep 13, 2018Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHEN THE COIL, A GALAXY G3 XSFT 2.5MM X 3.5CM (GLX122535 / L11855) WAS INTRODUCED INTO THE MICROCATHETER (ECHELON¿10 MICROCATHETER, MEDTRONIC), RESISTANCE WAS FELT, AND THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE COIL SYSTEM IN THE MICROCATHETER. THE PHYSICIAN DECIDED TO PULL THE COIL SYSTEM OUT OF THE MICROCATHETER, THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE COIL WAS EASILY REMOVED AND ON INSPECTION, IT WAS NOTICED THAT THE COIL WAS TORN AT THE DISTAL PART, AND A SMALL PIECE OF THE COIL REMAINED IN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE TORN PIECE OF COIL FROM THE MICROCATHETER. IT WAS CONFIRMED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND PRIOR TO THE REPORTED ISSUE, AT LEAST TWO COILS WERE ADVANCED THROUGH THE MICROCATHETER WITHOUT RESISTANCE. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO FLOW RESTRICTION OR REDUCTION DUE TO THE REPORTED ISSUE; THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR ANY SIGNIFICANT CLINICAL DELAY THAT RESULTED FROM THE REPORTED ISSUE. IT WAS REPORTED THAT ALL PIECES OF THE COIL SYSTEM ARE AVAIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874032 ↗
• MalfunctionFeb 21, 2017Difficult or Delayed Positioning; Stretched; Difficult or Delayed Positioning; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE IT WAS DISCOVERED THAT A GALAXY G3 XSFT COIL WAS STRETCHED. THE COIL WAS PARTIALLY DEPLOYED INTO AN ANEURYSM THROUGH A COMPETITOR¿S ANEURYSM. THE COIL WAS REMOVED AND UPON REMOVAL THE COIL APPEARED TO HAVE STRETCHED. THE COIL WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO SERIOUS INJURIES TO THE PATIENT. THERE WERE NO MEDICAL INTERVENTIONS OR SURGICAL DELAYS DUE TO THE REPORTED EVENT. THE CATHETER AND THE COMPLAINT IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6347394 ↗