GALAXY G3 GLY120510Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704077503), received between Sep 24, 2018 and Apr 28, 2025 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionApr 28, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 10CM GALAXY G3 COIL (GLY120510 / 2772404S) WAS IMPEDED IN THE DISTAL END OF THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND COULD NOT PASS THROUGH THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND MICROCATHETER FROM THE PATIENT AND REPLACED IT WITH A COMPETITOR BRAND COIL TO COMPLETE THE PROCEDURE WITH THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 10 MINUTES. ON 16-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET WAS THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE VESSEL WAS REPORTED TO BE TORTUOUS AND WITH CALCIFICATION. THE INFORMATION CONFIRMED THE REPORTED ISSUE IS RELATED TO THE 5MM X 10CM GALAXY G3 COIL FROM LOT 2772404S. THE CONCOMITANT MICROCATHETER WAS OF A COMPETITOR BRAND (UNSPECIFIED). IT WAS ALSO INDICATED THAT COMPETITOR BRAND COIL (UNSPECIFIED) WAS SUCCESSFULLY USED WITH THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE REPORTED 10-MINUTE PROCEDURE EXTENSION WAS NOT CLINIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923179 ↗
• MalfunctionSep 9, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 5MM X 10CM COIL (GLY120510, 31035669) FAILED TO DETACH. PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE FAILURE DID NOT OCCUR DURING PRE-DEPLOYMENT ELECTRICAL CHECK. THE SAME DETACHMENT CONTROL BOX) DCB) AND THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL DID NOT STRETCH OR BECAME DAMAGED WHEN REMOVED. THE PROCEDURE WAS DELAYED BY 4-5 MINUTES, AND IT WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171094 ↗
• MalfunctionAug 7, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 5MM X 10CM COIL (GLY120510, 30901827) DID NOT DEPLOY. THEREFORE, IT WAS PULLED OUT OF THE PATIENT A PLACED BACK INTO PACKAGE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469764 ↗
• MalfunctionJul 24, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  AS REPORTED BY THE FIELD, AFTER THE COIL EMBOLIZATION TO THE POSTERIOR COMMUNICATING ARTERY, A GALAXY G3 5MM X 10CM COIL (GLY120510, 30683258) AND CONFIRMING DETACHMENT OF THE COIL, RESISTANCE WAS FELT IN THE MICROCATHETER DURING RETRIEVAL OF THE COIL DELIVERY WIRE. WHEN THE WIRE WAS FORCIBLY PULLED OUT, THE WIRE WAS RETRIEVED WITH THE AREA AROUND THE DETACHMENT PART OF THE DELIVERY WIRE SEPARATED. SUBSEQUENTLY, THE NEXT COIL COULD NOT BE INSERTED INTO THE MICROCATHETER (PHENOM17), AND THE MICROCATHETER WAS ALSO REPLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW COIL AND MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379076 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16139557 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138212 ↗
• 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 DEVIC

  Patient problems: Aneurysm

  MAUDE report 16078061 ↗
• MalfunctionOct 31, 2022Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION USING THE BALLOON ASSIST OF ANEURYSM, A GALAXY G3 5MM X 10CM COIL (GLY120510, 30517631) WAS PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL WAS RE-SHEATHED BECAUSE THE COMPLAINT COIL WAS UNABLE TO BE FRAMED AS INTENDED FOR ANEURYSM. HOWEVER, THE SHEATH GOT TORN AND UNABLE TO BE RESTORED AND RE-SHEATHED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE IS A MICROCATHETER (ECHELON). ADDITIONAL INFORMATION RECEIVED FURTHER CLARIFIED THAT THE PHYSICIAN STARTED TO WIND THE COIL IN THE ANEURYSM BUT THE WINDED COIL WAS NOT INTENDED SHAPE AS EXPECTED. THERE WAS NO REPORT OF RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER (MC). THE MC WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MC. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699182 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APPROACH

  Patient problems: Ischemia Stroke

  MAUDE report 13497630 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT PATIENT UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM AND EXPERIENCED THROMBOEMBOLISM DURING THE PROCEDURE. INTRA-ARTERIAL PRASUGREL, OZAGREL, AND UROKINASE WERE ADMINISTERED AS TREATMENT. THE PHYSICIAN MADE AN ATTEMPT TO RECANALIZE THE LEFT A2 WITH THE GUIDEWIRE AND MICROCATHETER, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. THE LEFT A2 WAS NOT ABLE TO BE CAPTURED. IMAGING SHOWED SLOW FLOW BUT ENHANCED LEFT A2. IT WAS STATED ¿WHEN THE GUIDEWIRE WAS INDUCED IN THE LEFT IC ON THE SIDE OF THE PATIENT¿S BODY AND IMAGING WAS PERFORMED, IT WAS NOT CONFIRMED AT THE LEFT A2, BUT IT WAS CONFIRMED THAT COLLATERALS DERIVED FROM THE MCA REGION AND THE PERIPHERY OF THE LEFT A2, WHICH WAS ENHANCED FROM THE LEFT IC EARLIER.¿ THE PROCEDURE WAS COMPLETED. CONCOMITANT DEVICES INCLUDED A 6F SHUTTLE SHEATH (COOK MEDICAL), 6F CERULEAN DD6 CATHETER (MEDIKIT), REBAR 18 MICROCATHETER (MEDTRONIC), AND SL-10 MICROCATHETER (STRYKER). THE PULSERIDER 10T, 2.7- 3.5MM ANRD (211D/3051697701) WAS DEPLOYED AT THE LEFT A2 PARTIALLY INTRA-ANEURYSMAL (HYBRID APPROACH

  Patient problems: Ischemia Stroke

  MAUDE report 13497523 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) MALE PATIENT WITH A HISTORY OF SMOKING (PREVIOUS) AND MANDIBULAR CANCER UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2019 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTEGRILIN/ASPIRIN WAS ADMINISTERED, AND NEUROFORM ATLAS STENT (STRYKER) WAS IMPLANTED. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2019 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 7.5MM, DOME 7.2MM, MAXIMUM ANEURYSM DIAMETER 7.5MM, NECK SIZE 5.9MM, AND DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 7MM X 13.9CM MICRUSFRAME 10 (MFR100713 / L13000), A 7MM X 21CM GALAXY G3 (GLY120721 / L13249), A 5MM X 10CM GALAXY G3 (GLY120510 / L12927), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / L13613), A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / L11233), AND A 2.00MM X

  Patient problems: Thromboembolism

  MAUDE report 13101885 ↗
• MalfunctionOct 4, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 5MM X 10CM COIL (GLY120510, L16069) WAS BEING USED FOR FRAMING. THE PHYSICIAN FELT SOME SENSE OF DISCOMFORT (I.E. RESISTANCE) WHILE MANIPULATING THE COIL BACK AND FORTH FOR SEVERAL TIMES, THERE IS NO INFORMATION WHERE THE RESISTANCE WAS FELT. THE SITUATION DIDN¿T CHANGE, SO THE COIL WAS WITHDRAWN FROM THE PATIENT. CONTINUOUS IRRIGATION WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE USED MICROCATHETER WAS SL10, GUIDE CATHETER WAS ROADMASTER (GOODMAN). RESHIPMENT PICTURES WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE DEVICE DID NOT APPEAR 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 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 VISUAL ANALYSIS OF THE PICTURES RECEIVED, THE DEVICE CONTAINS FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569295 ↗
• InjuryJul 21, 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 A HISTORY OF UNCONTROLLED HYPERTENSION AND ACTIVE SMOKING UNDERWENT COIL EMBOLIZATION OF A RUPTURED WIDE-NECKED LEFT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 3) ON (B)(6) 2019. AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6) 2020, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. ON (B)(6) 2020, THE PATIENT SUBSEQUENTLY UNDERWENT A BALLOON-ASSISTED COIL EMBOLIZATION DUE TO INCREASE IN ANEURYSM SIZE. A TOTAL OF 19 COMPETITOR COILS WERE IMPLANTED WITH MODIFIED RAYMOND-ROY SCORE OF CLASS IIIB. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. ON (B)(6) 2019, IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED POSTERIOR CIRCULATION ANEURYSM ON THE LEFT SIDE WALL OF THE PCA WITH THE FOLLOWING DIMENSIONS: HEIGHT 8.7MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 11.1MM, NECK SIZE 6.0MM, AND DOME-TO-NECK RATIO 1.9MM.

  Patient problems: Aneurysm

  MAUDE report 12207742 ↗
• MalfunctionFeb 25, 2021Material Rupture; Stretched; Material Rupture; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN UNRUPTURED CEREBRAL ANEURYSM, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH AN 8F GUIDING SHEATH (UNKNOWN BRAND). A GUIDING CATHETER (UNKNOWN BRAND) WAS ADVANCED TOWARD THE VERTEBRAL ARTERY (VA). A .072 NAVIEN¿ INTRACRANIAL SUPPORT CATHETER (MEDTRONIC) WAS DELIVERED TO THE VA-UNION, THEN TWO MICROCATHETERS, A HEADWAY® 17 MICROCATHETER (MICROVENTION-TERUMO) AND A PROWLER SELECT PLUS MICROCATHETER WERE DELIVERED TO THE ANEURYSM AT THE BASILAR ARTERY (BA) TIP. A PULSERIDER DEVICE (UNKNOWN CATALOG/SIZE) WAS IMPLANTED AT THE ANEURYSM NECK. THE HEADWAY® 17 MICROCATHETER APPROACHED THE ANEURYSM AND COIL EMBOLIZATION COMMENCED. THE 5MM X 10CM GALAXY G3 COIL (GLY120510 / L11802) WAS USED, BUT IT WAS NOT ABLE TO BE WINDED AS INTENDED. THE COMPLAINT COIL WAS RESHEATHED. AT THE SAME TIME, THE DELIVERY WIRE WAS EXPOSED THROUGH THE COIL INTRODUCER. THE PHYSICIAN ATTEMPTED TO RESHEATH BUT COULD NOT RESHEATH THE COIL. IT WAS REPLACED AND THE PROCEDURE WAS CONTINUED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ADEQUATE AND CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO BLOOD FLOW R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382320 ↗
• MalfunctionSep 29, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID ARTERY (ICA), THE 5MM X 10CM GALAXY G3 COIL (GLY120510 / L16525) WAS USED BUT RESISTANCE WAS FELT WHEN IT WAS DELIVERED TO THE TARGET LESION BEFORE PEELING AWAY. THE COMPLAINT COIL BECAME UNRAVELED OUTSIDE OF THE MICROCATHETER AROUND THE FLUOROSAVER. THE PHYSICIAN REPLACED THE COIL; THE PROCEDURE WAS COMPLETED WITH A COMPETITOR COIL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10600985 ↗
• InjuryAug 11, 2020Adverse 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 HEADACHES, MIGRAINES, AND ANXIETY PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) ON (B)(6) 2019 AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) BIFURCATION ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RUPTURED MIDLINE ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.7MM, DOME 8.1MM, MAXIMUM ANEURYSM DIAMETER 8.1MM, NECK SIZE 2.8MM, AND DOME-TO-NECK RATIO 2.9MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/UNKNOWN LOT #), ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/ L13333), ONE 2MM X 2CM GALAXY G3 XSFT (GLX120202/L13330), ONE 2.5MM X 4.5CM GALAXY G3 MINI (GLM925045/S15174), ONE 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/L15425), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L14685), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L15571), TWO 1MM X 2CM GALAXY G3 MINI (GLM910020/L14855), TWO 1MM X 2.5CM GALAXY G3 MINI (GLM910025/L13971), ONE 1MM X 1

  Patient problems: Stroke/CVA

  MAUDE report 10391204 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD MALE (SUBJECT 913-004) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020 REQUIRING REPEAT COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME 10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME 10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME 14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL

  Patient problems: No Code Available

  MAUDE report 10240007 ↗
• MalfunctionNov 11, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A SUBARACHNOID HEMORRHAGE (SAH), THE 5MM X 10CM GALAXY G3 COIL (GLY120510 / L12892) WAS USED WITH THE SL-10® 45° MICROCATHETER (STRYKER), BUT THE DETACHABLE COIL DELIVERY SYSTEM (DCS) BECAME STUCK IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND NOTED THAT IT HAD UNRAVELED. THE COIL WAS REPLACED, AND THE REPLACEMENT COIL ALSO BECAME UNRAVELED. THE PROCEDURE WAS COMPLETED WITH THE TARGET COIL (STRYKER) THROUGH THE ECHELON MICROCATHETER (MEDTRONIC). THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307100 ↗
• MalfunctionSep 24, 2018Separation Failure; Premature Separation; Separation Failure; Premature Separation

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION OF AN ANEURYSM, A TOTAL OF THREE THERMO-MECHANICAL COILS (TWO 1MM X 2CM GALAXY G3 MINI GLM910020/L11499 AND ONE 5MM X 10CM GALAXY G3 GLY120510/L11802) FAILED TO DETACH IN THE TARGET SITE. THE SEQUENCE OF EVENTS/TIMELINE IS UNKNOWN, BUT THE USER DID CHANGE THE CONNECTING CABLE (UNK CATALOG & LOT) AND DETACHMENT CONTROL BOX (UNK CATALOG & LOT) DURING THE REPORTED EVENT WITH THE SAME RESULT. NO OTHER COILS WERE DEPLOYED BEFORE OR AFTER THE REPORTED ONES WITH THE SAME CONNECTING CABLE; HOWEVER, IT WAS REPORTED THAT THE DCB HAS BEEN USED TO DETACH SUBSEQUENT COILS AND HAS OPERATED AS INTENDED. THE COILS WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER VENDOR. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COILS AND CONNECTING CABLE HAVE BEEN RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902486 ↗