GALAXY G3 GLY120615Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886704077534), received between Jan 3, 2019 and Aug 6, 2024 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL INTRODUCER SHEATH ON THE 6MM X 15CM GALAXY G3 (GLY120615 / 30810126) WAS BROKEN DURING THE RESHEATHING. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 06-AUG-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921480 ↗
• 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 19447959 ↗
• InjuryJun 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT MIDDLE CEREBRAL ARTERY (MCA) SIDE WALL ANEURYSM ON (B)(6) 2022 2022. THE HUNT & HESS GRADE WAS 3, THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSIONS OF THE TARGET ANEURYSM WAS AS FOLLOWS: HEIGHT 4.1MM, DOME 5.1MM, MAXIMUM ANEURYSM DIAMETER 5.6MM, NECK SIZE 2.2MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 1.7MM. COIL EMBOLIZATION WAS PERFORMED USING THREE (3) CERENOVUS COILS: A 4MM X 7.5CM MICRUSFRAME 10 (MFR100407 / 30686615), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30483248), AND A 2MM X 2CM GALAXY G3 XSFT (GLX120202 / 30583817) VIA AN SL-10® MICROCATHETER (STRYKER). 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. IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS DURING THE INDEX PROCEDURE. ON (B)(

  Patient problems: Aneurysm

  MAUDE report 17093003 ↗
• MalfunctionMar 23, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A COIL EMBOLIZATION THAT WAS TARGETING AN ENDOLEAK, AN APPROACH WAS MADE VIA A TRIPLE COAXIAL SYSTEM. A SHEATH WAS INSERTED AND THE COMPLAINT COIL, A 6MM X 15CM GALAXY G3 COIL (GLY120615 / 30670813) WAS BEING DELIVERED THROUGH A MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS) WITH CONTINUOUS FLUSH MAINTAINED, BUT INTENSE RESISTANCE WAS FELT AFTER THE COMPLAINT COIL ADVANCED APPROXIMATELY 5CM. THE COMPLAINT COIL WAS REMOVED AND CHECKED; PART OF THE COIL WAS UNRAVELED; THE COMPLAINT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE COMPLAINT DEVICE IS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16606178 ↗
• InjuryFeb 13, 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

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 68-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ISCHEMIC STROKE, HEADACHES, CONTROLLED HYPERLIPIDAEMIA, CONTROLLED HYPERTENSION, AND HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED FUSIFORM ANEURYSM ON THE SIDEWALL OF THE LEFT INTERNAL CAROTID ARTERY (ICA), WITH THE PARENT ARTERY LOCATION ON C7 (COMMUNICATING SEGMENT); THE SIZE OF THE TARGET ANEURYSM IS AS FOLLOWS: HEIGHT 12.5MM, DOME 9MM, MAXIMUM ANEURYSM DIAMETER 12.5MM, NECK SIZE 2MM, AND DOME-TO-NECK RATIO (DERIVED) 4.5MM. THE MODIFIED RANKIN SCALE (MRS) SCORE OF 2 ON (B)(6) 2021. COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING NINE (9) CERENOVUS COILS WERE DELIVERED VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) AND IMPLANTED: A 7MM X 21CM GALAXY G3 (GLY120721 / 30399454), A 6MM X 15CM GALAXY G3 (GLY120615 / 30409555), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L15756), A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / L16656), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30624678), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30490139), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30624678), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30508852), AND A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L155

  Patient problems: Aneurysm; Hydrocephalus

  MAUDE report 16369001 ↗
• InjuryJan 17, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A 54-YEAR-OLD FEMALE (SUBJECT (B)(6) WITH NO TARGETED MEDICAL HISTORY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2022. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE SCORE WAS 0 AND THE HUNT & HESS GRADE WAS 2 - MODERATE TO SEVERE HEADACHE, NUCHAL RIGIDITY, AND NO NEUROLOGIC DEFICIT OTHER THAN CRANIAL NERVE PALSY. THE DIMENSIONS OF THE ANTERIOR CEREBRAL ARTERY ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT OF 8.5 MM, DOME 8.1 MM, MAXIMUM ANEURYSM DIAMETER OF 8.1 MM, NECK SIZE OF 2.6 MM, AND THE DOME-TO-NECK RATIO OF 3.1 MM. THE PARENT VESSEL DIAMETER WAS 1.7 MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH FOUR (4) CERENOVUS COILS VIA AN SL-10 MICROCATHETER (STRYKER). THE COILS WERE THE FOLLOWING: ONE 8MM X 13.6MM MICRUSFRAME S (MFR180813/K10699), ONE 6 MM X 15 CM GALAXY G3 (GLY120615/K10390), ONE 4 MM X 12 CM GALAXY G3 (GLY120412/30637578), AND ONE GALAXY G3 XTRASOFT (GLX120306/30603573). HEPARIN WAS ADMINISTERED. THE SUBJECT DID NOT EXPERIENCE INTRA-OPERATIVE RUPTURE OR THROMBOEMBOLIC EVENTS. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COM

  Patient problems: Aneurysm

  MAUDE report 16189553 ↗
• MalfunctionDec 14, 2022Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH), THE DOUBLE CATHETER TECHNIQUE WAS USED FOR THE COIL EMBOLIZATION OF THE TARGET ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE FIRST COIL, A 6MM X 15CM GALAXY G3 (GLY120615 / 30526872) WAS USED AS A FRAMING COIL WITH THE FIRST MICROCATHETER (UNSPECIFIED BRAND), HOWEVER, THE COIL WAS UNABLE TO BE DETACHED. THEREFORE, IT WAS REPORTED THAT A SECOND COIL, A 3.5MM X 9CM GALAXY G3 (GLY123509 / LOT# UNKNOWN) WAS USED TOGETHER WITH ANOTHER MICROCATHETER (UNSPECIFIED BRAND). AN ATTEMPT TO IMPLANT THE SECOND COIL, BUT IT BECAME ENTANGLED WITH THE FIRST COIL. THIS COIL WAS MOVED BUT IT UNRAVELED. THE COIL WAS THEN REMOVED ¿BY BEING COVERED WITH THE MICROCATHETER¿ AND THE SECOND COIL WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH NEW COIL(S). THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE COMPLAINT REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. THE FOLLOWING WERE LISTED AS CONCOMITANT DEVICES: EXCELSIOR® SL-10® MICROCATHETER (STRYKER), Y-CONNECTOR (TERUMO), AND AN ENPOWER DCB 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983412 ↗
• InjuryOct 5, 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 68-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE SACCULAR ANEURYSM AT THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY ON 29-JUL-2021. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5.5MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 8.4MM, NECK SIZE 4.3MM, AND THE DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.8MM. COIL EMBOLIZATION WAS PERFORMED WITH A TOTAL OF TEN (10) COILS. THE FOLLOWING SIX (6) CERENOVUS COILS WERE IMPLANTED: ONE 7MM X 21CM GALAXY G3 (GLY120721 / L15699), ONE 6MM X 15CM GALAXY G3 (GLY120615 / L13589), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L13315), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L13521), ONE 3MM X 6CM GALAXY G3 MINI (GLM930060 / L13936) AND ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / L13672). IN ADDITION, FOUR (4) 2MM X 3CM TARGET® 360 NANO¿ COIL (STRYKER) WERE ALSO IMPLANTED. ALL COILS WERE DELIVERED VIA THE HEADWAY® 17 MICROCATHETER (MICROVENTION). A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED. THERE WAS NO INTRA-OPERATIVE ANEURYSM RUPTURE

  Patient problems: Ischemia Stroke

  MAUDE report 15547511 ↗
• InjuryJun 14, 2022Deformation 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 PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF DIABETES, CONTROLLED HYPERTENSION, BEING A PREVIOUS SMOKER, DEPRESSION, HEPATITIS C, AND CHRONIC BACK PAIN, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) SACCULAR ANEURYSM WITH MODIFIED RANKIN SCALE (MRS) SCORE 2 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 11.5MM, DOME 9.8MM, MAXIMUM ANEURYSM DIAMETER 10.8MM, NECK SIZE 7.1MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.5MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ L16383), A GALAXY G3 6MM X 10CM (GLY120610/L13911), A GALAXY G3 6MM X 15CM (GLY120615/K10645), A GALAXY G3 6MM X 20CM (GLY120620/L14866), A GALAXY G3 8MM X 24CM (GLY120824/30530863), GALAXY G3 7MM X 15CM (GLY120715/L15636), GALAXY G3 9MM X 25CM (GLY120925/L13514), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/304943930, A GALAXY G3 XSFT 3MM X 4CM (GLX120304/30370440), AND A 2.5MM X 4MM GALAXY G3 XTRASOFT (30371932). THREE (3) NON- CERENOVUS COILS WERE USED: TWO TARGET 360 ULTRA AND ONE TARGET 360 NANO (ALL STRYKER). A NEUROFORM AT

  Patient problems: Aneurysm

  MAUDE report 14687374 ↗
• MalfunctionMay 13, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A CEREBRAL COIL EMBOLIZATION AT THE ANEURYSM FOR IAN INTERNAL CAROTID-POSTERIOR ARTERY (ICPC), A 6MM X 15CM GALAXY G3 COIL (GLY120615, 30522186) WAS INSERTED INTO THE PHENOM, MEDTORNIC MICROCATHETER (MC) AS A FILLING COIL. THE INTRODUCER SHEATH WAS PLACED ON THE HUB OF THE MICROCATHETER, AND THE WHITE PART WAS PULLED FOR RELEASE AND THE COIL LOCKED. HOWEVER, IT SEEMED TO BE FULLY ENGAGED AND WAS NOT ABLE TO BE PULLED AT ALL. IT WAS THEN PULLED WITH STRONG FORCE, BUT THE INTRODUCER SHEATH BECAME DAMAGED AND UNUSABLE. THERE WAS NO EFFECT ON THE PATIENT BECAUSE THE DEFECT OCCURRED BEFORE USE OF THE COIL IN THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398919 ↗
• MalfunctionJan 5, 2022Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A RUPTURED ANEURYSM FOR THE VA-PICA BIFURCATION, A RANDOM LOOP OF A GALAXY G3 6MM X 15CM COIL (GLY120615, 30522186) WAS ASSUMED AND IT WAS EMBOLIZED, BUT THE CHARACTERISTICS OF THE RANDOM LOOP WAS NOT ABLE TO BE UTILIZED. THE PROCEDURE WAS ACCEPTABLE EMBOLIZATION, AND IT COMPLETED SAFELY. ANEURYSM SIZE OF RIGHT VA-PICA BIFURCATION WAS 10*6.8*5.6. IT WAS UNCLEAR IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS NOT NOTED TO BE UNRAVELED/STRETCHED. THERE WAS NO DAMAGE REPORTED TO THE MICROCATHETER THAT COULD HAVE CAUSED THE DEPLOYMENT DIFFICULTY. IT IS UNKNOWN THE FINAL POSITION OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169243 ↗
• 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 12207732 ↗
• MalfunctionMay 21, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM, THE 6MM X 15CM GALAXY G3 COIL (GLY120615 / L16408) WAS USED AS THE FIRST COIL. IT WAS INSERTED INTO A CONCOMITANT SL-10¿ MICROCATHETER (STRYKER), BUT THERE WAS RESISTANCE FELT. AS A RESULT, THE COIL WAS RESHEATHED. IT WAS CONFIRMED THAT THE COIL AND THE JUNCTION PART APPEARED TO BE STRAIGHT AND THERE WAS A POSSIBILITY THAT THE COIL HAD BECOME UNRAVELED. IT WAS REPLACED WITH ANOTHER 6MM X 15CM CERENOVUS COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866173 ↗
• MalfunctionApr 28, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL COIL EMBOLIZATION, TWO A 4X5MM MICRUSFRAME COILS WERE USED SUCCESSFULLY AS THE FIRST AND SECOND COILS WITH A HEADWAY 17 MICROCATHETER (MC). HOWEVER, A 6MM X 15CM GALAXY G3 COIL (GLY120615, L16321), A 6MM X 11.9CM MICRUSFRAME10 COIL (MFR100611, L10198) AND A 6MM X 26CM MICRUSFRAME10 COIL (MFR100626, L10199) BECAME STUCK WITH THE MC. THE PHYSICIAN REMOVED THE COILS THROUGH THE MC AND COMPLETED THE PROCEDURE SUCCESSFULLY BY USING THE SAME MC AND A COMPETITOR¿S COIL. IT IS UNKNOWN IF THE EVENT RESULTED IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO PATIENT CONSEQUENCES. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE REPORTED EVENTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ALL THREE COILS WERE STRETCHED AFTER WITHDRAWING. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. FIRST, RESISTANCE WAS FELT AND THEN THE DEVICE WAS TOTALLY BEFORE FLUORO SAFE DISTANCE WAS SOMETHING 20 CM FROM RHV. THERE WAS NO NOTICE OF ANYTHING OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005344 ↗
• MalfunctionApr 21, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE VA FOR CEREBROVASCULAR TREATMENT BY DOUBLE CATHETER TECHNIQUE, A 6MM X 15CM GALAXY G3 COIL (GLY120615, L13589) WAS USED AS THE FIRST COIL. IT WAS INSERTED INTO A CONCOMITANT MICROCATHETER (SL-10, STRYKER) AS THE SHEATH INTRODUCER WAS PRESSED AGAINST THE HUB OF THE MICROCATHETER. THE COIL WAS RE-WINDED SEVERAL TIMES BUT IT WAS NOT FLAMED AS INTENDED. IT WAS RE-SHEATHED AND THE PHYSICIAN ATTEMPTED TO MAKE A FLAME WITH A CONCOMITANT MICROCATHETER (PHENOM). THE USER ATTEMPTED TO RE-SHEATH THE COMPLAINT COIL WHICH WAS INSIDE THE SL-10 MICROCATHETER. HOWEVER, THE COIL WAS EXPOSED FROM A PART OF THE SHEATH AND IT WAS NOT ABLE TO BE RE-SHEATHED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO PROLONGATION OF THE PROCEDURE THAT WAS CLINICALLY SIGNIFICANT DUE TO THE EVENTS. ADEQUATE FLUSH WAS MAINTAINED. THE USER DID NOT APPLY EXCESSIVE FORCE WHILE UNSHEATHING OR RESHEATHING. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9981271 ↗
• MalfunctionMar 10, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 6MM X 15CM GALAXY G3 COIL (GLY120615, L12528) WAS BEING USED AS A SECOND COIL BUT IT BECAME STUCK ON THE SHEATH INTRODUCER WHEN THE COIL WAS PUSHED FROM THE SHEATH INTRODUCER. THE COMPLAINT COIL WAS INSERTED INTO A CONCOMITANT MICROCATHETER (SL10, STRYKER), HOWEVER, THE COMPLAINT COIL GOT STUCK ON THE MICROCATHETER AND IT BECAME UNRAVELED. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9811018 ↗
• MalfunctionSep 25, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM (UNKNOWN SITE), A 6MM X 15CM GALAXY G3 (GLY120615, L12845) WAS BEING USED AS A FIRST FRAMING COIL AND ATTEMPTED TO BE DETACHED FOR IMPLANT IN THE TARGET LESION. THE GREEN SYSTEM READY LIGHT OF THE ENPOWER DETACHABLE CONTROL BOX 2 (DCB2000500, C46054 ILLUMINATED GREEN. HOWEVER, WHEN THE DETACHMENT BUTTON WAS PRESSED, THE GREEN SYSTEM READY LIGHT ILLUMINATED RED, AND COIL DID NOT DETACH. THE COMPLAINT COIL WAS REMOVED. THERE WAS NO PATIENT INJURY REPORTED. AN ENPOWER CONTROL CABLE (ECB00018200, L15918) WAS ALSO USED IN THIS CASE. PRELIMINARY PICTURES OF THE DCB, CONTROL CABLE AND MICROCOIL WERE RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9115379 ↗
• MalfunctionFeb 14, 2019Stretched; Separation Failure; Detachment of Device or Device Component; Material Twisted/Bent; Stretched; Separation Failure; Detachment of Device or Device Component; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE USER CONNECTED THE 6MM X 15CM GALAXY G3 (GLY120615/L12856) COIL DELIVERY SYSTEM TO THE CONTROL CABLE (UNK CATALOG & LOT), THE GREEN ¿SYSTEM READY¿ LIGHT ILLUMINATED, THE COIL WAS THEN ADVANCED TO THE ANEURYSM, AND THE ¿DETACH¿ BUTTON WAS PRESSED, BUT THE EMBOLIC COIL REMAINED ATTACHED. THE USER REPEATED THIS FIVES TIMES, BUT THE COIL FAILED TO DETACH. THE CONTROL CABLE WAS REPLACED, BUT THERE WAS STILL NO DETACHMENT OF THE COIL. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT NEED FOR ADDITIONAL INTERVENTION. THE CONTROL CABLE WAS NOT USED TO DETACH SUBSEQUENT COILS. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE LENGTH OF TIME THAT THE SURGERY WAS DELAYED TO THE EVENT WAS NOT REPORTED. IT IS NOT KNOWN IF THE USER CHANGED THE DETACHMENT CONTROL BOX (DCB) AT ANY POINT DURING THE REPORTED EVENT, BUT THE SAME DCB WAS USED TO DETACH SUBSEQUENT COILS. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. IT WAS NOT REPORTED IF THE COIL OR CONTROL CABLE APPEARED DAMAGED AT ANY TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341716 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA THE STERLING STUDY THAT PATIENT (B)(6), EXPERIENCED A STROKE. THE (B)(6)-YEAR OLD FEMALE PATIENT WITH A HISTORY OF CARDIAC ARRHYTHMIA, HYPERLIPIDEMIA, HYPERTENSION, ISCHEMIC STROKE, AND NO HISTORY OF PRIOR SURGICAL OR NEUROVASCULAR INTERVENTIONS FOR THE TARGET ANEURYSM HAD PRESENTED WITH AN 11 MM X 6 MM LEFT SIDEWALL INTERNAL CAROTID ARTERY UNRUPTURED ANEURYSM WITH A 6 MM DOME, 2.3 MM NECK AND 2.6 MM DOME TO NECK RATIO. THE PARENT VESSEL DIAMETER WAS 4.4 MM AND THE MODIFIED RANKIN SCORE WAS 0. THE PATIENT UNDERWENT THE INDEX PROCEDURE ON 1/7/2019, WHICH INVOLVED THE PLACEMENT OF A 6 MM X 15 CM GALAXY G3 COIL (GLY120615 / L12715), A 5 MM X 15 CM GALAXY G3 COIL (GLY120515 / L10159), AND A 4 MM X 10 CM GALAXY G3 XSFT COIL (GLX120410 / L13035). HEPARIN AND PROTAMINE WERE ADMINISTERED. NO THROMBOEMBOLIC EVENT WAS REPORTED. THE PACKING DENSITY AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOCALC) WAS 4.2%. ACCORDING TO THE INVESTIGATOR, THE TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE WITH NO EVIDENCE OF DEVICE-RELATED ADVERSE EVENTS OR DEVICE MALFUNCTIONS DURING THE PROCEDURE. THE MODIFIED RAYMOND-ROY CLASSIFICATION (MRRC) WAS CLASS II (RESIDUAL NECK). THE

  Patient problems: Infarction, Cerebral

  MAUDE report 8274407 ↗
• MalfunctionJan 3, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM OF A PATIENT WHO PRESENTED WITH A SUBARACHNOID HEMORRHAGE (SAH), THE 6MM X 15CM GALAXY G3 (GLY120615/L12238) THERMO-MECHANICAL COIL WAS DELIVERED TO THE TARGET LESION AS A FRAMING COIL, BUT THE SHAPE OF THE COIL DID NOT FIT AND THE COIL PARTIALLY CAME OUT OF THE ANEURYSM INTO THE PARENT VESSEL. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL, BUT THE DELIVERY WIRE PROTRUDED FROM THE INTRODUCER AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8211858 ↗