GALAXY G3 GLM920040Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10886704080305), received between Feb 12, 2018 and Jan 31, 2025 — classified as 15 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Stretched” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K171862); they may or may not involve this specific model.

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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL SHAPE OF THE 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30937895) WAS FOUND NOT IDEAL AFTER IT FILLED IN THE ANEURYSM. THE PHYSICIAN RETRACTED THE COIL AND DELIVERED IT AGAIN, BUT THE COIL WAS IMPEDED IN THE TIP OF THE MICROCATHETER AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED ONLY THE COIL AND FOUND THAT THE COIL HAD BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL AND SUCCESSFULLY FILLED THE ANEURYSM WITH THE REPLACEMENT COIL. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21284457 ↗
• MalfunctionDec 10, 2024Difficult to Advance; Positioning Problem; Material Split, Cut or Torn; Difficult to Advance; Positioning Problem; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH), AFTER THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS PLACED INTO THE TARGET ANEURYSM, THE 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30830566) WAS USED AS THE FIRST COIL. THE COIL WAS REWOUND INSIDE THE ANEURYSM IN AN ATTEMPT TO RETRIEVE IT, BUT IT COULD NOT BE RESHEATHED AS THE INTRODUCER SHEATH GOT DAMAGED. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 10-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE REASON THAT LED TO THE COIL NEEDING TO BE RESHEATHED WAS ¿POSITIONING DIFFICULTY. THE FRAME WAS UNABLE TO BE FORMED PROPERLY, SO [THE COIL WAS REWOUND SEVERAL TIMES].¿ DURING THE COIL REWINDING, THE MICROCATHETER CAME OUT OF THE ANEURYSM AND THE COIL HAD TO BE RESHEATHED. THE INTRODUCER WAS SPLIT. THERE WAS NO RESISTANCE AT ANY DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THE INFORMATION STATED NO NECK REMODELING WAS USED. THE MICROCATHETER WAS RE-INTRODUCED INTO THE PATIENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 10-DEC-2024,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898841 ↗
• 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 19448235 ↗
• MalfunctionAug 22, 2023Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN 3/5 OF A 4MM X 23MM ENTERPRISE 2 (ENCR402312 / 7212914) WAS RELEASED, THE STENT TIP DID NOT OPEN OR EXPAND AS INTENDED. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31007918) FROM THE PATIENT¿S ANATOMY AND OBSERVED THAT THE MICROCATHETER HAD BECOME KINKED / BENT. THE PHYSICIAN SWITCHED TO NEW DEVICES AND CONTINUED THE PROCEDURE. THE SECOND STENT WAS SEMI-RELEASED IN THE PATIENT, AND COILS WERE USED TO FILL THE ANEURYSM. WHEN THE PHYSICIAN WAS DELIVERING THE THIRD COIL, A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30865673), IN THE ANEURYSM, THE COIL WAS FOUND TO HAVE BECOME UNRAVELED / STRETCHED. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS A 4MM X 3.5MM X 3.8MM UNRUPTURED ANEURYSM. THERE WERE NO VESSEL NOR ANEURYSM FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17598760 ↗
• MalfunctionAug 21, 2023Break; Failure to Advance; Break; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 2MM X 4CM COIL (GLM920040, 30742416) COULD NOT BE ADVANCED FROM THE SHEATH AND SUBSEQUENTLY BROKE FROM THE SHEATH. AFTER THAT IT COULD NO LONGER BE PLACED. A NEW COIL WITH THE SAME DIMENSIONS AND PROPERTIES THEN WENT SMOOTHLY. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583960 ↗
• MalfunctionJul 13, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AFTER A GALAXY G3 MINI 2MM X 4CM COIL (GLM920040, 30836570) ENTERED THE HEADWAY MICROCATHETER (MC), IT CANNOT BE DELIVERED. IT IS SUSPECTED THAT IT IS ROLLED UP IN THE CATHETER. BECAUSE IT CANNOT BE PUSHED FORWARD, THE COIL STRETCHES. BECAUSE IT IS STUCK IN THE MICRO CATHETER, IT CANNOT ENTER OR EXIT, SO THE PRODUCT CANNOT BE RETRIEVED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE GALAXY G3 MINI WAS ¿STUCK¿ IN THE MC. THE RESISTANCE WAS FELT AT THE NEAR THE DISTAL TIP. THE COIL WAS REMOVED WITH THE MC. NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE DEVICE FORM THE PATIENT. THE MICROCATHETER DID NOT KINK. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS ABOUT A 20 MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316787 ↗
• MalfunctionJun 5, 2023Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION AT THE LUMBAR ARTERY FOR PRE-STENTGRAFT. A MICROCATHETER (LANTERN) WAS USED. A GALAXY G3 MINI 2MM X 4CM COIL (GLM920040, 30396210) WAS RE-SHEATHED. THE GALAXY G3 WAS INSERTED INTO A Y CONNECTOR AND THE WIRE ADVANCED BUT THERE WAS STRONGER RESISTANCE FELT THAN USUAL BUT THE PHYSICIAN KEPT INSERTING THE COMPLAINT DEVICE. HOWEVER, THE CONNECTOR PART GOT TORN. THIS ISSUE OCCURRED BEFORE THE DEVICES WERE INSERTED INTO THE PATIENT. THE COMPLAINT DEVICE WAS REMOVED FROM THE MICROCATHETER (MC). THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THE PREOPERATIVE EMBOLIZATION COMPLETED, AND STENT GRAFT WAS IMPLANTED. A CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE MC. THE LESION WAS THE LUMBAR ARTERY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NECK REMODELING WAS NOT UTILIZED. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE CORE WIRE IS FOUND BROKEN AND THE EMBOLI COIL WAS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061140 ↗
• MalfunctionMay 17, 2023Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, AFTER THROMBUS RETRIEVAL, A NEW ANEURYSM WAS FOUND AT MIDDLE CEREBRAL ARTERY. THEREFORE, COIL EMBOLIZATION PROCEDURE WAS CONDUCTED USING A GALAXY G3 MINI COIL (GLM920040, 30624674) WAS INSERTED, BUT FAILED TO CONFORM TO THE ANEURYSM WALL AS EXPECTED. ATTEMPTED TO RETRIEVE IT, BUT THE COIL GOT PEELED AWAY AND COULD NOT RE-SHEATHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER NEW COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. AN EXSELSIOR SL10 MICROCATHETER WAS USED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MC. NO NECK REMODELING WAS UTILIZED. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945795 ↗
• MalfunctionDec 12, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE IN A PATIENT WHO WAS SUFFERING FROM A SMALL NARROW NECKED ANEURYSM AT THE BIFURCATION OF THE MIDDLE CEREBRAL ARTERY, THE COMPLAINT COIL, A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30768308) WAS USED AS THE LAST COIL TO FILL THE ANEURYSM. THE PHYSICIAN DELIVERED THE COMPLAINT COIL INTO AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC) AND ATTEMPTED TO FILL THE ANEURYSM, BUT THE SHAPE OF THE COIL WAS NOT IDEAL. THE PHYSICIAN RETRACTED THE COIL INTO THE INTRODUCER SHEATH AND TRIED TO FILL THE ANEURYSM AGAIN. THE COMPLAINT COIL WAS IMPEDED IN THE PROXIMAL MARKER OF THE MICROCATHETER AND COULD NOT FURTHER ADVANCE. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE MICROCATHETER WAS REMOVED AND REPLACED. THE COMPLAINT DEVICE DID NOT APPEAR DAMAGED. NOTHING WAS OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE INFORMATION INDICATED THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE EVENT MEETS THE REPORTABILITY CRITERIA AS A ¿MALFUNCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963888 ↗
• MalfunctionNov 3, 2022Failure to Advance; Failure to Advance

  LOG. AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 MINI 2MM X 4CM COIL (GLM920040, 30641969) PASSED THROUGH THE NON J&J MICROCATHETER (MC) AND THE PHYSICIAN STARTED TO DETACH IT, BUT IT WAS IMPEDED IN TIP OF MICROCATHETER AND COULD NOT BE DETACHED. THE DOCTOR RETRACTED THE COIL AND DELIVERED IT INTO MICROCATHETER AGAIN, BUT THE COIL WAS IMPEDED IN DISTAL END OF MICROCATHETER AND COULD NOT ADVANCE ANY MORE. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS NOT FOUND PREMATURELY DETACHED WHEN REMOVING DEVICE. IT WAS NECESSARY TO REMOVE/REPLACE THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS SEVERELY STRETCHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721375 ↗
• InjurySep 20, 2022Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2022, DURING A PULSERIDER STENT-ASSISTED COIL EMBOLIZATION WITH THE TARGET ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS DELIVERED TO THE TARGET REGION AND DEPLOYED. THE PHYSICIAN ATTEMPTED TO FRAME THE ANEURYSM BY USING A 4MM X 8CM MICRUSFRAME 14 COIL (MFR140408 / LOT# UNKNOWN). HOWEVER, THE COIL DID NOT FIT WELL, SO THE COIL WAS REMOVED FROM THE PATIENT¿S BODY. ON THE SECOND ATTEMPT, THE PHYSICIAN ATTEMPTED TO COMPLETE THE FRAMING BY CHANGING THE MICROCATHETER SHAPE AND THE COIL SIZE / TYPE WITH THE FOLLOWING COILS: A 3.5MM X 9CM GALAXY G3 XSFT (GLX123509 / LOT# UNKNOWN), A 3MM X 8CM HYDROSOFT® COIL (MICROVENTION-TERUMO), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / LOT# UNKNOWN). HOWEVER THESE COILS ALSO DID NOT FIT WELL SO THEY WERE REMOVED FROM THE PATIENT¿S BODY. IN ADDITION, THE PHYSICIAN ALSO NOTICED THAT THE DEPLOYED PULSERIDER ANRD DID NOT SUFFICIENTLY COVER THE ANEURYSM NECK, THEREFORE, THE PHYSICIAN ALSO REMOVED THE PULSERIDER ANRD. ON THE THIRD ATTEMPT, THE PHYSICIAN TRIED THE BALLOON-ASSIST TECHNIQUE. THE PHYSI

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15456510 ↗
• MalfunctionAug 29, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 4CM GALAXY G3 COIL (GLM920040, 30532638) ARRIVED AT TARGET POSITION AND THE PHYSICIAN STARTED TO DETACH IT, BUT THE COIL COULD NOT BE DETACHED. THE DOCTOR CHANGED TWO DETACHMENT CONTROL BOXES (DCB) TO DETACH IT, BUT IT STILL DID NOT WORK. THE COIL WAS RETRACTED, AND A NEW COIL WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311904 ↗
• 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 42-YEAR-OLD FEMALE (B)(6) 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 ADMINISTERED DU

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516628 ↗
• MalfunctionMay 23, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2MM X 4CM GALAXY G3 COIL (GLM920040, K10750) WAS BEING USED AS THE SECOND COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470303 ↗
• 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 14270041 ↗
• 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 14270014 ↗
• InjuryApr 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 71-YEAR-OLD MALE PATIENT WITH A HISTORY OF CLASS 2 OBESITY (BMI 35 KG/M2) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH HUNT & HESS GRADE 1 ON (B)(6) 2021. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.9MM, DOME 3.5MM, MAXIMUM ANEURYSM DIAMETER 5MM, NECK SIZE 2.4MM, AND DOME-TO-NECK RATIO OF 1.5MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS SPECTRA COILS: A 5 MM X 15 CM GALAXY G3 (GLY120515 / 30513182), A 3 MM X 8 CM GALAXY G3 XSFT (GLX120308 / L14664), A 3 MM X 6 CM GALAXY G3 XSFT (GLX120306 / 30490139), A 2 MM X 6 CM GALAXY G3 MINI (GLM920060 / 30392250), A 1.5 MM X 2 CM GALAXY G3 MINI (GLM915020 / L14683), AND A 2 MM X 4 CM (GLM920040 / 30379814) VIA AN SL-10® MICROCATHETER (STRYKER). MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED THREE TIMES DURING THE PROCEDURE. HEPARIN WAS ADMINISTERED INTRAOPERATIVELY. 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 WITH 69% ANGIOSUITE PACKING DE

  Patient problems: Aneurysm

  MAUDE report 14078937 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A 58-YEAR-OLD FEMALE UNDERWENT PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF A RECURRENT RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AND EXPERIENCED INTRAOPERATIVE THROMBUS FORMATION AT THE ANEURYSM NECK. THE THROMBUS WAS NOTED TO BE PROTRUDING INTO THE PARENT VESSEL. USING A SCEPTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON (MICROVENTION), THE COIL MASS WAS PUSHED UP TO THE ANEURYSM SIDE, AND THE DELIVERY TO THE ANEURYSM NECK WAS IMPROVED. THE THROMBUS ALSO DECREASED, AND BLOOD FLOW IMPROVED, SO ANTIPLATELET DRUGS WERE PRESCRIBED. THE PATIENT'S CLINICAL COURSE WAS MONITORED. POST-PROCEDURE, THERE WERE NO REMARKABLE FINDINGS. IT WAS LAST REPORTED THAT THE PATIENT IS HOSPITALIZED. THE ATTENDING PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THIS EVENT AND THE PULSERIDER ANRD IS AS FOLLOWS: ¿IT WOULD HAVE BEEN BETTER IF PULSERIDER HAD BEEN PUSHED MORE FIRMLY INTO THE MOTHER'S VEIN; BECAUSE IT WAS SLIGHTLY SWEET, THE COIL WAS CLOGGED UP TO THE VERY END OF THE ANEURYSM NECK, AND AS A RESULT, PULSERIDER DOWN IN THE MOTHER'S VEIN. COMPARED TO THE STENT, THE COIL OF PULSERIDER WAS INSERTED MORE AND

  Patient problems: Thromboembolism

  MAUDE report 14048401 ↗
• MalfunctionMar 14, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE EVENT WAS REPORTED VIA THE STERLING STUDY. A (B)(6) FEMALE PATIENT UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON (B)(6) 2021. COIL EMBOLIZATION WAS PERFORMED. A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / 30392736) WAS USED BUT IT WAS NOT IMPLANTED DUE TO COIL MIGRATION. THE EMBOLIZATION CONTINUED WITH THE IMPLANTATION OF A 2.50MM X 4.50CM GALAXY G3 MINI (GLM925045 / 30393182). WHEN A 1.50MM X 3.00CM GALAXY G3 MINI (GLM915030 / 30383045) WAS CHOSEN, THE COIL WAS ALSO NOT IMPLANTED DUE TO MIGRATION. THIS COIL WAS FOLLOWED BY A 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / 30466099) WHICH WAS ALSO NOT USED BECAUSE THE COIL MIGRATED. THE PROCEDURE CONTINUED WITH THE IMPLANTATION OF STRYKER COILS IN THE FOLLOWING ORDER: TWO (2) 1MM X 3CM TARGET 360 NANO COILS, TWO (2) 1MM X 2CM TARGET 360 NANO COILS, AND A AND A 1MM X 3CM TARGET 360 NANO COIL. THE REPORTED COIL MIGRATION ISSUE DID NOT RESULT IN ADVERSE EVENT OR PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759663 ↗
• MalfunctionJan 24, 2022Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN REPORTEDLY FELT A LITTLE RESISTANCE WHEN THE 2.00MM X 4.00CM GALAXY G3 MINI COIL (GLM920040/30517611) ARRIVED AT THE DISTAL END OF THE MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN ATTEMPTED TO DETACH THE COIL AT THE TARGET POSITION, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13335037 ↗
• 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) YEAR OLD 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

  Patient problems: Thromboembolism

  MAUDE report 13101821 ↗
• InjuryDec 27, 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) FEMALE PATIENT WITH A HISTORY OF CONGESTIVE HEART FAILURE (CHF), DIABETES, CONTROLLED HYPERTENSION, HYPOTHYROIDISM, GASTROESOPHAGEAL REFLUX DISEASE (GERD), SLEEP APNEA, LIVER CIRRHOSIS, ESOPHAGEAL VARICES, OSTEOPOROSIS, IDIOPATHIC PULMONARY FIBROSIS (IPF), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), AND CLASS 1 OBESITY (BMI 30 KG/M2) UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2021 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. MEDICATION WAS ADMINISTERED AS TREATMENT. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 2, UNCHANGED FROM BASELINE. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE ACOM BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 9.7MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 6.6MM, NECK SIZE 3.6MM, AND DOME-TO-NECK RATIO OF 2.3MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 10MM X 30CM

  Patient problems: Thromboembolism

  MAUDE report 13090776 ↗
• MalfunctionNov 4, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.00MM X 4.00CM GALAXY G3 MINI COIL (GLM920040 / 30498774) WAS THE LAST COIL USED; THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL. DURING THE ATTEMPT TO RESHEATH THE COIL, THE INTRODUCER FAILED TO BE RE-SHEATHED. THE PHYSICIAN USED ¿A SAME LIKE PRODUCT¿ AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT / COMPLICATION. 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. DURING THE VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 03-NOV-2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753758 ↗
• InjuryJun 16, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD MALE PATIENT WITH A HISTORY OF ANKYLOSING SPONDYLITIS UNDERWENT COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. THE HUNT & HESS GRADE SCORE WAS A 2 AND MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. AT THE 180-DAY (6-MONTH) FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED ON (B)(6) 2021 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MRS SCORE WAS UNCHANGED. ON (B)(6) 2021, THE PATIENT UNDERWENT RETREATMENT OF THE TARGET ANEURYSM DUE TO THE RESIDUAL ANEURYSM. THREE COMPETITOR COILS WERE IMPLANTED WITH RAYMOND-ROY CLASS I: COMPLETE = COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE ADVERSE EVENTS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2021. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2020 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY SACCULAR ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.2MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7.0MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO 1.3MM. THE PARENT VESSEL DIAMETER WAS 3.0MM. COIL EMBOLIZATION WAS THEN PERFORMED WITH

  Patient problems: Aneurysm

  MAUDE report 12013586 ↗
• MalfunctionMay 10, 2021Break; Positioning Failure; Break; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CEREBRAL ANEURYSM STENT-ASSISTED COIL EMBOLIZATION PROCEDURE WITH A 4.7MM X 5.4MM ANEURYSM ON THE VERTEBRAL ARTERY-POSTERIOR INFERIOR CEREBELLA ARTERY (VA-PICA), A SYSTEM APPROACHED WAS MADE TO THE LESION WITHOUT ANY PROBLEM. A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED TO START THE COIL EMBOLIZATION. THE FIRST COIL USED WAS A 4 MM X 8 CM TARGET® SOFT COIL (STRYKER) FOLLOWED BY A 3.5MM X 7.5CM GALAXY G3 XSFT COIL AS THE SECOND COIL. THE COMPLAINT COIL, A 2.00MM X 4.00CM GALAXY G3 MINI COIL (GLM920040 / 30407099) WAS USED AS THE THIRD COIL. PREPARATION WAS COMPLETED AS PER THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL BEGAN TO WIND OUT OF THE TARGET LESION. THE PHYSICIAN THOUGHT THAT THE POSITION OF THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) WAS NOT PROPER, AND THEREFORE, AN ATTEMPT TO RESHEATH THE COIL WAS MADE BUT THE SHEATH BECAME DAMAGED. THE COMPLAINT COIL WAS REPLACED WITH A 2.5MM X 2.5CM GALAXY G3 XSFT COIL. A 1.5MM X 2CM TARGET® NANO¿ COIL (STRYKER) WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171862. One submission often covers many models, so check the product and lot details in each record.

• Z-2280-2019 · May 16, 2019 · Terminated
  GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).