GALAXY G3 GLX120406Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886704077725), received between May 8, 2017 and Jan 18, 2024 — classified as 8 injuries, 13 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. 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.

• MalfunctionJan 18, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE COMPLAINT COIL, A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30513170) WAS THE SECOND COIL SELECTED IN AN ENDOVASCULAR EMBOLIZATION PROCEDURE. THE COIL COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN; THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED ¿A SAME LIKE¿ PRODUCT 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 18539757 ↗
• InjuryJun 14, 2023Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  EVENT DETAILS DATE OF DEFICIENCY: (B)(6) 2023; ALERT DATE:(B)(6) 2023; COUNTRY OF EVENT: US; PROCEDURE: ENDOVASCULAR COILING WITH MICRUSFRAME/GALAXY ; DATE OF PROCEDURE: (B)(6) 2022 ; EVENT DESCRIPTION: DEVICE MALFUNCTION ¿ REFER TO THE ¿ADDITIONAL PATIENT DETAILS¿; THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 60-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING (CURRENT SMOKER) UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION BRANCH ANEURYSM WITH A HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.4MM, DOME 10.5MM, MAXIMUM ANEURYSM DIAMETER 10.5MM, NECK SIZE 4.9MM, AND DOME-TO-NECK RATIO OF 2.1MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: AN 11MM X 18.9CM MICRUSFRAME 18 (MFR181118 / 30422246), A 5MM X 9.7CM MICRUSFRAME 10 (MFR100509 / 30537019), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30478878), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / 30379819), A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060 / 30624675), AND A 2.00MM X 6.00CM GALAXY G3 MINI (GLM920060

  Patient problems: Aneurysm

  MAUDE report 17131997 ↗
• MalfunctionMay 19, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM LOCATED ON THE BASILAR ARTERY, THE COMPLAINT COIL, A 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406/30526856) WAS INSERTED INTO THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER), BUT THE COIL GOT STUCK ON THE MICROCATHETER. THE PHYSICIAN DELIVERED WIRES TO CONFIRM IF THERE WAS ANY MALFUNCTION INSIDE OF THE MICROCATHETER, AND THERE WERE NO PROBLEMS. THE ISSUE OCCURRED BEFORE THE COMPLAINT COIL WAS INSERTED INTO THE PATIENT. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS DONE. ON 29-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THERE WAS NO DAMAGE REPORTED IN THE DEVICE, AND NO EXCESSIVE FORCE HAD BEEN APPLIED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS SLIGHTLY STRETCHED AND WITH SOME KINKED CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960868 ↗
• InjuryDec 30, 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 35-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPERTENSION (NOT CONTROLLED) AND MIGRAINES, UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 7MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7MM, NECK SIZE 1.0MM, AND DOME-TO-NECK RATIO OF 5.7MM. THE PARENT VESSEL DIAMETER WAS 4.5MM. PER THE CASE REPORT FORM (CRF) AND CLINICAL DATABASE, THE COIL EMBOLIZATION WAS PERFORMED WITH THE FOLLOWING THREE (3) CERENOVUS COILS: A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / 30686618), A 5MM X 10CM GALAXY G3 (GLY120510 / 30670811) AND A 4MM X 6CM GALAXY G3 XSFT (GLX120406 / 30370441). THE COILS WERE DELIVERED AND IMPLANTED VIA A CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). IN THE OPINION OF THE PRINCIPAL INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DE

  Patient problems: Aneurysm

  MAUDE report 16078060 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM AND EXPERIENCED INTRAOPERATIVE ANEURYSM RUPTURE. DETAILS OF THE PROCEDURE: A 6F SHUTTLE SHEATH WAS INSERTED VIA THE FEMORAL ARTERY AND DELIVERED TO THE VERTEBRAL ARTERY (VA). A 6F SOFIA PLUS CATHETER (MICROVENTION) WAS THEN DELIVERED TO THE PROXIMAL BASILAR ARTERY AS A DISTAL ACCESS CATHETER (DAC). THE PULSERIDER 10T, 2.7 ¿ 3.5MM ANRD (211D/3056488803) WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER (606S255X/30250996), BUT TORQUE WAS NOT APPLIED WELL. THE PULSE RIDER DIRECTION WAS NOT PROPER, AND THE DIRECTION WAS ADJUSTED BY APPLYING TORQUE WHILE RETRACTING THE DEVICE INTO THE PROWLER SELECT PLUS MICROCATHETER. THIS WAS ATTEMPTED THREE TIMES, BUT THE ORIENTATION DID NOT CHANGE. THE PHYSICIAN REMOVED THE PULSERIDER FROM THE PATIENT ONCE AND REINSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER. THE PROWLER SELECT PLUS WAS REPLACED WITH A HEADWAY 27 MICROCATHETER (MICROVENTION) BECAUSE THE COMPLAINT MICROCATHETER DID NOT ORIENT IN THE SAME WAY WHEN DEPLOYED AND DID NOT CHANGE EVEN WHEN TORQU

  Patient problems: Aneurysm

  MAUDE report 14270010 ↗
• MalfunctionFeb 3, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING AN INTRACRANIAL COIL EMBOLIZATION, A GALAXY G3 XSFT COIL 4MM X 6CM (GLX120406, 30513170) COULD NOT EASILY BE INTRODUCED INTO A PROWLER SELECT LPES 45 DEG TIP MICROCATHETER (606-S155FX, 30422138). WHEN PULLING THE COIL BACK TO INTRODUCE AGAIN INTO THE MICROCATHETER (MC), THE COIL BECAME STRETCHED. THE INTRACRANIAL PROCEDURE WAS FINISHED SUCCESSFULLY WITH A NEW PROWLER SELECT AND A NEW COIL. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441823 ↗
• MalfunctionDec 4, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN UNRUPTURED INTERNAL CAROTID-POSTERIOR COMMUNICATING ANEURYSM, THE 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / 30399444) WAS USED AS A FRAMING COIL. IT WAS RESHEATHED BECAUSE THE SIZE DID NOT FIT THE TARGET LESION. HOWEVER, IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE COIL WAS UNRAVELED. TO AVOID RISK, THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. ON 25-NOV-2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THE PROCEDURE DATE WAS (B)(6)2021. THE SIZE OF THE COIL DID NOT FIT THE LESION. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL WHEN IT WAS REMOVED. THE REPORTED EVENT DID NOT RESULT IN ANY BLOOD FLOW RESTRICTION / REDUCTION. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930864 ↗
• InjuryAug 25, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH NO REPORTED RELEVANT MEDICAL HISTORY UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 4.3MM, DOME 3.7MM, MAXIMUM ANEURYSM DIAMETER 4.5MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406 / K10045), ONE 3MM X 4CM GALAXY G3 MINI (GLM930040 / L17272), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / L15184), ONE 2.5MM X 3.5CM GALAXY G3 MINI (GLM925035 / S15122), ONE 2MM X 3CM GALAXY G3 MINI (GLM920030 / L13933), AND ONE COMANECI STENT VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER). INTRAOPERATIVELY A SEVERE THROMBOEMBOLIC EVENT OCCURRED. PER THE PRINCIPAL INVESTIGATOR THE EVENT WAS CONSIDERED SERIOUS HOWEVER NOT RELATED TO THE STUDY DEVICE. SURGICAL INTERVENTION OF A THROMBECTOMY AND AGGROSTAT MEDICATION ADMINISTRATION WAS REQ

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 12366405 ↗
• InjuryJul 28, 2021Entrapment of Device; Entrapment of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, A 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / 30504555) WAS DETACHED AS THE FIRST COIL TO FRAME THE ANEURYSM SAC. THE DELIVERY WIRE OF THE COIL WAS FULLY REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND COIL (SIZE / BRAND / MANUFACTURER NOT SPECIFIED) BUT STRONG RESISTANCE WAS ENCOUNTERED AT THE TIP OF THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). AS A RESULT OF THIS PHENOMENON, THE PHYSICIAN REMOVED THE SECOND COIL AND ADVANCED THE GUIDEWIRE TO PUSH THE FIRST 4MM X 6CM GALAXY G3 XSFT COIL THAT WAS STUCK NEAR THE TIP OF THE MICROCATHETER. FINALLY, THE FIRST COIL WAS SUCCESSFULLY ADVANCED INTO THE TARGET ANEURYSM. THE SECOND COIL WAS ALSO ABLE TO BE ADVANCED INTO THE TARGET ANEURYSM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY DELAY IN THE PROCEDURE DUE TO THE REPORTED EVENT. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE 4MM X 6CM GALAXY G3 XSFT COIL REMAINS IMPLANTED AND IS THUS, NOT AVAILABLE TO BE RETURNED. ON 27 JULY 2021, ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239457 ↗
• InjuryMar 31, 2021Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF CORONARY ARTERY DISEASE (CAD), FOCAL NEUROLOGICAL DEFICITS, HEADACHES, PERIPHERAL VASCULAR DISEASE, HEADACHES, AND INTRACRANIAL ANEURYSM UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF A RECURRENT LEFT POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE TARGET ANEURYSM HAD BEEN PREVIOUSLY TREATED WITH UNSPECIFIED COILS ON (B)(6) 2019. 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2020 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIA: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. RETREATMENT OF THE TARGET ANEURYSM WAS SUBSEQUENTLY PERFORMED DUE TO RESIDUAL ANEURYSM ON (B)(6) 2021. A 24CM COMPETITOR COIL WAS IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS OR STUDY DEVICE DEFICIENCIES. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED AN UNRUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS:

  Patient problems: Aneurysm

  MAUDE report 11594906 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF A LEFT SIDE WALL POSTERIOR COMMUNICATING ARTERY (PCA) (ANTERIOR CIRCULATION) ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED LEFT PCA ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.1MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 5.1MM, NECK SIZE 2.0MM, AND DOME-TO-NECK RATIO 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L16293), ONE 2MM X 2CM GALAXY G3 (GLY120202/L12097), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L12616), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L11355), AND ONE 1MM X 1CM GALAXY G3 MINI (GLM910010/L14466) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE WITH 24.09% ANGIOSUITE PACKING DENSITY. ACCORDING TO THE CASE REPORT FORM (CRF), THERE WAS NO REPORTED MICROCATHETER KICKBACK. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH MODIFIED RAYMOND-ROY SCORE OF CLASS I: COMPLETE =

  Patient problems: Aneurysm

  MAUDE report 11236973 ↗
• MalfunctionDec 4, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF THE ACCESSORY BLOOD VESSEL ON THE PULMONARY ARTERY IN A (B)(6) YEAR-OLD CHILD WITH A HISTORY OF PEDIATRIC CONGENITAL HEART DISEASE, THE 150CM X 5CM PROWLER SELECT LPES 45° TIP MICROCATHETER (606S155FX / 30401517) WAS DELIVERED TO THE SIDE OF THE COLLATERAL VESSEL OF THE LEFT PULMONARY ARTERY AND THREE COILS: A 1.5MM X 4CM GALAXY G3 MINI COIL AND TWO 3MM X 6CM GALAXY G3 XSFT COILS WERE IMPLANTED TO EMBOLIZE THE PARENT VESSEL. THE PROWLER SELECT LPES MICROCATHETER WAS FLUSHED AND THE COMPLAINT COIL, A 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / 30363060) WAS USED AS THE FOURTH COIL. HOWEVER, THERE WAS RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MIDDLE PART OF THE MICROCATHETER WHEN THE COIL WAS BEING ADVANCED. THE PHYSICIAN KEPT ADVANCING THE DELIVERY WIRE, BUT THE DELIVERY WIRE CAME OUT FROM PART OF THE INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL BUT WAS NOT ABLE TO RESHEATH THE COIL, SO THE COIL WAS REMOVED FROM THE MICROCATHETER. ANOTHER 4MM X 6CM GALAXY G3 XSFT COIL (LOT# UNKNOWN) WAS USED AFTER THE MICROCATHETER WAS FLUSHED, BUT THE SAME ISSUE OCCURRED, AND THE COIL WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946883 ↗
• MalfunctionNov 4, 2020Unraveled Material; Unraveled Material

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM FOR TYPE II ENDOLEAKE AFTER A STENT-GRAFT IMPLANTATION, COILING EMBOLIZATION STARTED AT THE PERIPHERAL BLOOD VESSEL OF THE SUPERIOR GLUTEAL ARTERY AND THE INFERIOR GLUTEAL ARTERY. A 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406, L10867) BECAME UNRAVELED WHEN IT WAS ADVANCING IN THE LESION. THE UNRAVELED COIL WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER SAME SIZED COIL (GLX120406). THE PROCEDURE CONTINUED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786014 ↗
• MalfunctionSep 14, 2020Stretched; Unraveled Material; Stretched; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / L15158) WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU); THE COIL WAS RETRACTED ONCE BUT IT BECAME UNRAVELED. ADDITIONAL INFORMATION WAS PROVIDED BY THE SALES REP INDICATING THAT THE COIL UNRAVELING HAPPENED OUTSIDE THE MICROCATHETER, IN THE BLOOD VESSEL. THERE WAS NO PARTICULAR FACTOR THAT WOULD REQUIRE FORCE ON IT. THE PHYSICIAN WAS TAKING ADVANTAGE OF THE COIL CHARACTERISTICS. THE COIL UNRAVELED AFTER IT WAS ¿REWINDED¿ SEVERAL TIMES INSIDE THE ANEURYSM. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529137 ↗
• MalfunctionJun 23, 2020Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / L13752) WAS INSERTED INTO THE CONCOMITANT MICROCATHETER (ENCHON) BUT THERE WAS RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE COMPLAINT COIL WAS RETRACTED BUT IT BECAMSE UNRAVELED INSIDE THE MICROCATHETER AND COULD NOT BE REMOVED FROM THE PATIENT; THE COIL WAS REMOVED TOGETHER WITH THE CONCOMITANT MICROCATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10186801 ↗
• MalfunctionMar 17, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY JUNCTION (IC-PC), THE 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / L13784) WAS USED AS THE TENTH COIL, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE AND THE COIL DID NOT DETACH. THE PHYSICIAN ATTEMPTED SEVERAL TIMES, BUT THE SAME ISSUE CONTINUED. PRIOR TO THIS COIL, ANOTHER 4MM X 6CM GALAXY G3 XSFT COIL FROM THE SAME LOT WAS USED AS THE NINTH COIL AND IT WAS IMPLANTED WITHOUT ANY ISSUE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL, A 4MM X 8CM GALAXY G3 XSFT COIL (GLX120408) AND THIS REPLACEMENT COIL DETACHED AND WAS IMPLANTED IN THE TARGET ANEURYSM WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITH TWELVE COILS SUCCESSFULLY IMPLANTED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9842540 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE (B)(6), A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR CEREBRAL ARTERY (ACA) BIFURCATION ANEURYSM ON (B)(6) 2019 AND EXPERIENCED INTRAOPERATIVE ANEURYSM RE-RUPTURE AFTER PLACING A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/L13753) COIL. THE RUPTURE RESOLVED ON THE SAME DAY WITH TEMPORARY BALLOON OCCLUSION AND FURTHER COILING. PER THE PRINCIPAL INVESTIGATOR (PI), THE EVENT WAS MODERATE IN SEVERITY AND WAS POSSIBLY RELATED TO THE STUDY DEVICE. THERE WAS ALSO A THROMBOEMBOLIC EVENT AT THE NECK OF THE ANEURYSM (AT THE TRANSITION OF THE RIGHT ANTERIOR COMMUNICATING ARTERY AND THE A2 SEGMENT OF THE LEFT ACA). THE PATIENT WAS ASYMPTOMATIC (ONLY OBSERVED ANGIOGRAPHICALLY) AND INTEGRILIN IIB IIIA WAS ADMINISTERED FOR 24-HOURS. ON (B)(6) 2019, ANGIOGRAPHY REVEALED A RUPTURED ANEURYSM AT THE LEFT ACA BIFURCATION. THE ANEURYSM HEIGHT WAS 2.0MM AND DOME WAS 3.2MM. THE MAXIMUM ANEURYSM DIAMETER WAS 4.4MM, NECK SIZE WAS 3.1MM AND DOME-TO-NECK RATIO WAS 1.0MM. THE PARENT VESSEL DIAMETER WAS 2.5MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 6CM GALAXY G3 XSFT (GLX120406/L13761), ONE 2.5MM X 5CM GAL

  Patient problems: Thromboembolism

  MAUDE report 9751393 ↗
• MalfunctionOct 8, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE VERTEBRAL ARTERY, THE PHYSICIAN ATTEMPTED TO WIND THE 4MM X 6CM GALAXY G3 XSFT COIL (GLX120406 / L13368) AS IT WAS COMING OUT FROM THE TIP OF THE CONCOMITANT MICROCATHETER. HOWEVER, THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER AND THE MICROCATHETER KICKED BACK. THERE WAS STRONG RESISTANCE EXPERIENCED WHILE THE COIL WAS DELIVERED TO THE TARGET LESION. AS A RESULT, THE PHYSICIAN REPLACED THE COIL AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATION OR ADVERSE EVENT. THE 4MM X 6CM GALAXY G3 XSFT COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 9/23/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167550 ↗
• MalfunctionMar 1, 2018Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO RETREAT AN ANEURYSM OF THE MIDDLE CEREBRAL ARTERY (MCA), ¿A LOT¿ OF RESISTANCE WAS FELT WHILE PUSHING THE LAST 1CM OF A GALAXY G3 XSFT (GLX120406, L10709), CAUSING THE HEADWAY DUO MICROCATHETER (MC) TO KICK BACK. THE MC DID COME OUT OF THE ANEURYSM AND THERE WAS LOSS OF CEREBRAL TARGET POSITION. THIS WAS THE FIRST COIL AND WAS SUCCESSFULLY DETACHED. THEN THE THIRD COIL, AN ORBIT GALAXY G3 MINI (GLM915030, S15107) DID NOT DETACH ON THE FIRST AND SECOND TRIAL. THE THIRD COIL WAS PLACED. THERE WAS NO REPORT OF PATIENT INJURY OR ADDITIONAL INTERVENTION REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO SURGICAL DELAYED DUE TO THE REPORTED EVENT. THE DEVICES WILL NOT BE RETURNED AS THEY WERE IMPLANTED. A GALAXY G3 MINI COIL (GLM920040) WAS ALSO IMPLANTED AS THE SECOND COIL WITH NO ISSUES. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITH THE UNKNOWN TYPE OF DETACHMENT CONTROL BOX (DCB) AND CONNECTING CABLE. THE SAME DCB AND CONNECTING CABLE WAS USED TO DETACH SUBSEQUENT COILS. ADDITIONAL INFORMATION CLARIFIED THAT THE HEADWAY DUO MC WAS PUSHED OUT OF THE ANEURYSM BY THE STIFFNESS OF THE COIL. THE CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307557 ↗
• MalfunctionMay 9, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE 3 SPECTRA GALAXY COILS WOULD NOT ADVANCE AFTER BEING PLACED INTO THE CATHETER AND BEING PARTIALLY IN THE ANEURYSM. THE PROCEDURE WAS RECOILING AN A-2 SEGMENT ANEURYSM, THE PATIENT¿S CEREBRAL ANATOMY WAS REPORTED TO BE VERY TORTUOUS. EACH COIL BECAME IMPOSSIBLE TO PUSH FORWARD AFTER REPEATED ATTEMPTS. EACH COIL ADVANCED EASILY THOUGH THE SHEATH AND UP THE CATHETER (COMPETITOR¿S DEVICE) UNTIL HALF OF EACH COIL WAS PLACED INTO THE ANEURYSM. FRICTION WAS FELT ON EACH THE GALAXY 3 COILS UNTIL COIL WAS UNABLE TO BE ADVANCED. EACH COIL WAS EASILY REMOVED, FOLLOWED BY A LEGACY MICRUS COIL WITH NO PROBLEMS. 17 MICRUS LEGACY COILS WERE PLACED WITHOUT INCIDENT BEFORE AND FOLLOWING THE 3 GALAXY 3 COILS. THE SAME CATHETER WAS USED DURING THE ENTIRE CASE FOR THE SPECTRA COIL, LEGACY MICRUS COILS AND ONE COMPETITOR¿S COIL. THERE WERE NO SURGICAL DELAYS DUE TO THE REPORTED EVENT AND THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THERE WERE NO DAMAGES NOTED ON THE COIL OR THE CONCOMITANT DEVICES PRIOR TO USE OR ON REMOVAL. ADEQUATE FLUSH WAS USED AND MAINTAINED THOUGH OUT THE CASE. S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6553751 ↗
• MalfunctionMay 8, 2017Premature Activation; Premature Activation

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WITH TWO MICRUS FRAMES 10 3.5 X 6.6 COILS (MFR100356/ C40274R) AND TWO GALAXY G3 XSFT 4 MM X 6 CM COILS (GLX120406/LOT# S11626 AND S11362) FAILED TO RE-SHEATH. THE PROCEDURE WAS COIL EMBOLIZATION OF THE COMMUNICATING SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE ANEURYSM MEASURED 4.75 X 3.75. AFTER THE COMPETITOR¿S MICROCATHETER WAS PLACED, THE COIL WAS PREPARED (MICRUS FRAME S 10 3.5 X 6.6 LOT #C40274R) AND AFTER SUFFICIENT FLUSHING (DROPLETS APPEARING AT THE GREEN/CLEAR TRANSITION ON THE DELIVERY TUBE) THE DOCTOR ADVANCED THE COIL ONLY TO HAVE IT GET STUCK IN THE CATHETER JUST AFTER PASSING THE HUB. AFTER 3 ATTEMPTS TO RE-FLUSH AND INSERT, WE FINALLY TRIED ANOTHER MICRUS FRAME S 10 3.5 X 6.6 (LOT NUMBER C40274R) AND THE SAME THING HAPPENED. THE PHYSICIAN SWITCHED TO G3 XTRA SOFT 12- 4 X 6. AFTER FLUSHING AND ADVANCING TO THE TIP OF THE MICROCATHETER, THE ECHELON CATHETER KICKED OUT OF THE ANEURYSM WITH THE BALLOON INFLATED. THE DOCTOR REMOVED THE COIL WHICH WAS REPORTED TO BE NECESSARY TO REPOSITION THE ECHELON BACK INTO THE ANEURYSM VIA A GUIDEWIRE, HOWEVER THE COIL COULD NOT BE RE-SHEA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6551382 ↗