GALAXY G3 GLY120620Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886704077541), received between Dec 7, 2016 and Nov 14, 2023 — classified as 6 injuries, 18 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A 6MM X 4MM AN ANEURYSM AT THE LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, WHEN A GALAXY G3 6MM X 20CM COIL (GLY120620, 30757515) WAS MOSTLY FILLED IN THE ANEURYSM, THE PHYSICIAN OBSERVED THAT THE COIL BECAME UNRAVELED/STRETCHED. THE DEVICE ENCOUNTERED SOME RESISTANCE IN AN ECHELON-10 MICROCATHETER (MC). AFTER SEVERAL ATTEMPTS, THE WHOLE COIL WAS FINALLY FILLED IN THE ANEURYSM. ADDITIONAL INFORMATION RECEIVED ON 01-NOV-2023 INDICATED THAT THE RESISTANCE WAS ENCOUNTERED AT THE DISTAL SHAFT OF THE MICROCATHETER. A MICROPORT COIL HAD BEEN SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. THE EVENT DID NOT RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO MICROCATHETER DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. 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 COIL ADVANCEMENT. THERE WERE NP PROCEDURAL DELAYS DUE TO THE EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129208 ↗
• MalfunctionJan 24, 2023Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN TRIED TO RESHEATH THE COIL BUT NOT POSSIBLE. THE SHEATH RIPPED. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE WAS REPLACED WITH A NEW COIL. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND TO BE SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232733 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT 00971-020), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759585 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT (B)(6),WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208/3053

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759569 ↗
• MalfunctionOct 17, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 6MM X 20CM GALAXY G3 COIL (GLY120620, 30490146) WAS USED AS THE THIRD COIL. HOWEVER, 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 THE COIL WAS STRETCHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614829 ↗
• MalfunctionSep 29, 2022Stretched; Positioning Problem; Material Split, Cut or Torn; Stretched; Positioning Problem; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, AFTER DEPLOYING A PULSE RIDER (8T) A 6MM X 20CM GALAXY G3 COIL (GLY120620, 30452213) WAS USED AS THE FIRST COIL BUT THE FRAMING DID NOT MAKE AS INTENDED. THE PHYSICIAN ATTEMPTED TO ADJUST THE POSITION OF THE CATHETER. THE 6MM X 20CM GALAXY G3 COIL WAS RE-SHEATHED AS PER THE INSTRUCTIONS FOR USE (IFU) BUT THE SHEATH GOT TORN AND THE COMPLAINT COIL WAS UNABLE TO BE RE-SHEATHED. THE COMPLAINT COIL GOT UNRAVELED AS WELL BUT THE UNRAVELED COIL WAS REMOVED FROM THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY. THE COIL WAS REPLACED BY ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THE LESION WAS THE BA TIP. THE LESION WAS THE CEREBRAL HYPOANEURYSM. OTHER CONCOMITANT DEVICES ARE A GUIDEWIRE (SYNCHRO), A MICROCATHETER (EXSELSIOR SL10) AND AN INTERMEDIATE CATHETER (6FR SOFIA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508728 ↗
• InjuryJul 26, 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 59-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF HEADACHES, HYPERLIPIDEMIA, HYPERTENSION, ISCHEMIC STROKE, SMOKING, ALCOHOL ABUSE, AND LIVER STEATOSIS, UNDERWENT COIL EMBOLIZATION OF A RIGHT-SIDED UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 2 ON (B)(6) 2022. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 7.5MM, DOME 7.1MM, MAXIMUM ANEURYSM DIAMETER 5.7MM, NECK SIZE 4.1MM, AND THE DOME-TO-NECK RATIO OF 1.7MM. THE PARENT VESSEL DIAMETER WAS 3.6MM. COIL EMBOLIZATION WAS PERFORMED WITH THE IMPLANTATION OF FIVE (5) CERENOVUS COIL: ONE 6MM X 20CM GALAXY G3 (GLY120620 / 30452213), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L16255), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408 / 30392744), ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308 / 30666660) AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208 / 30452207) VIA A 150CMX5CM, 2MARKERS, 45TIP PROWLER SELECT LPES MICROCATHETER (606S155FX / LOT# UNKNOWN). A 4MM X 24MM NEUROFORM ATLAS® STENT (STRYKER) WAS IMPLANTED. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. IN THE OPINION OF THE INVESTIGATOR, THE TREATMENT OF

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15107715 ↗
• 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 64-YEAR-OLD FEMALE PATIENT (SUBJECT 992-043) 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 03-AUG-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 ATLAS

  Patient problems: Aneurysm

  MAUDE report 14687444 ↗
• MalfunctionMar 26, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) COIL EMBOLIZATION PROCEDURE, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY PUNCTURE WITH A 4 FR SHEATH. THE ANGIO CATHETER WAS TRANSFERRED TO THE CELIAC TRUNK, AND THE MICROCATHETER APPROACHED THE FEEDER FROM THE CELIAC TRUNK, COIL EMBOLIZATION WAS INITIATED. THE 6MM X 20CM GALAXY G3 (GLY120620 / 30683259) WAS OPENED FOR THE PURPOSE OF EMBOLIZATION AND IT WAS INSERTED INTO THE MICROCATHETER. IT WAS ABLE TO MAKE THE SHAPE AS THE PHYSICIAN INTENDED, AND WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, THE CONNECTING CABLE WAS CONNECTED BUT THE ENERGIZING LAMP DID NOT ILLUMINATE. THE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT¿S BODY BECAUSE THE ENERGIZING LAMP REMAINED UNILLUMINATED AFTER SEVERAL RECONNECTION ATTEMPTS. WHEN ANOTHER 6MM X 20CM GALAXY G3 (GLY120620 / LOT# UNKNOWN) WAS USED AND INSERTED, IT MADE THE INTENDED SHAPE AND WHEN IT WAS CONNECTED TO THE CABLE, THE LAMP ILLUMINATED AND THE PHYSICIAN WAS ABLE TO DETACH THE COIL. THE PROCEDURE WAS CONTINUED. AFTER SEVERAL OTHER COILS WERE USED, A 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / 30663153) WAS USED AND INSERTED IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13923596 ↗
• MalfunctionMar 8, 2022Material Rupture; Positioning Problem; Material Rupture; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE FOR A DURAL ARTERIOVENOUS FISTULA (DAVF), AN APPROACH WAS MADE FROM THE LEFT FEMORAL ARTERY WITH A 4FR SHEATH. AN ANGIO CATHETER WAS ADVANCED TOWARD THE LEFT COMMON CAROTID ARTERY (CCA). AN APPROACH WAS MADE FROM THE RIGHT FEMORAL VEIN (FV) WITH A 6FR SHEATH. A GUIDING CATHETER WAS INSERTED AND ADVANCED TOWARD THE LEFT JUGULAR VEIN (JV). FROM THERE, A TACTICS INTERMEDIATE CATHETER ((B)(4)) AND AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WERE ADVANCED TOGETHER TO THE LEFT TRANSVERSE SINUS (TS) AND EMBOLIZATION WAS STARTED. AFTER IMPLANTING SEVERAL COMPETITOR COILS, THE 8MM X 24CM GALAXY G3 COIL (GLY120824 / 30692225) WAS OPENED FOR THE PURPOSE OF IMPLANTATION. IT WAS PREPARED AND INSERTED INTO THE MICROCATHETER. ALTHOUGH THE PHYSICIAN TRIED TO EMBOLIZE THE TARGET SITE, IT HERNIATED FROM THE LESION A LITTLE BIT; AS A RESULT, THE PHYSICIAN TRIED TO RESHEATH THE COIL. IT WAS REPORTED THAT AT THAT TIME, THE INTRODUCER SHEATH DID NOT RETURN TO ITS ORIGINAL SHAPE EVEN WHEN THE RESHEATHING TOOL WAS SLIDING. THE DELIVERY WIRE WAS EXPOSED MIDWAY MAKING IT DIFFICULT TO RESHEATH. AS A RESULT, THE ENTIRE DELIVERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691114 ↗
• MalfunctionDec 16, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, A GALAXY G3 6MM X 20CM COIL (GLY120620, L15745) WAS USED. A PRE DETACHMENT ELECTRICAL CHECK WAS DONE BUT IT WAS NOT CONFIRMED THE COMPLAINT COIL WAS ENERGIZED. IT WAS REPLACED WITH ANOTHER SAME-SIZED CERENOVUS COIL AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS DONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018444 ↗
• MalfunctionAug 24, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AND WHILE THE 6MM X 20CM GALAXY G3 COIL (GLY120620, 30474465) WAS BEING USED, THE PHYSICIAN DECIDED TO PULL IT OUT AFTER A COUPLE OF TRIES DUE TO THE COIL'S SIZE WAS NOT APPROPRIATE WITH THE ANEURYSM. DURING RE-SHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE SHEATH WAS SUPPOSED TO BE CLOSE PROPERLY SO THAT THE COIL WAS SAFELY RETRACTED INSIDE OF THE SHEATH FOR RETRY. A SAME-LIKE PRODUCT WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THERE IS A STRETCHED CONDITION OBSERVED ON THE EMBOLIC COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358492 ↗
• MalfunctionJun 28, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (A-COM), A 6MMX20CM GALAXY COIL (GLY120620, L13267) WAS USED AS THE FIRST COIL BUT THERE WAS AN INTENSIVE RESISTANCE FELT WHEN IT WAS ADVANCED THROUGH A (SL10, STRYKER MICROCATHETER (MC). THE COMPLAINT COIL WAS RE-SHEATHED BUT THERE WAS RESISTANCE DURING RE-SHEATHING. THE PHYSICIAN RETRACTED THE DELIVERY WIRE WITH SOME FORCE, BUT THE COIL GOT UNRAVELED. IT WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075364 ↗
• MalfunctionApr 28, 2021Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRE-EVAR (ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE TARGETING AN ANEURYSM AT THE LEFT INTERNAL ILIAC ARTERY, AN APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY TOWARDS THE LEFT INTERNAL ILIAC ARTERY. AFTER FOUR COILS: A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30422331), A 6MM X 20CM GALAXY G3 COIL (GLY120620 / 30401373), A 6MM X 20CM GALAXY G3 COIL (GLY120620 / 30399453), AND A 10MM X 34CM MICRUSFRAME 18 COIL (MFR181034 / L13774) WERE IMPLANTED, ANOTHER 6MM X 20CM GALAXY G3 COIL (GLY120620 / UNKNOWN LOT) WAS CHOSEN BUT THE COIL WAS NOT ABLE TO GO INTO THE COIL MASS. THE PHYSICIAN ATTEMPTED TO RESHEATH IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). IN THE MEANTIME, THE COIL MASS WAS REPORTED TO HAVE THROMBOSED AND A CONCOMITANT LIGHTHOUSE MICROCATHETER (PIOLAX MEDICAL DEVICES) AND PART OF THE COIL MASS BECAME STUCK TOGETHER; THE COIL MASS DID NOT COME OFF EVEN WHEN THE WIRE WAS REMOVED AND FLUSHED. WHEN THE MICROCATHETER WAS PULLED BACK TO THE TIP OF THE CONTRAST CATHETER AND THE CONTRAST CATHETER WAS TORQUED, THE COIL MASS CAME OFF AND WENT BACK SETTLING AROUND THE ORIGINAL POSITION BY THE FLOW OF THE BLOOD. IT WAS THEN CONFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740291 ↗
• MalfunctionApr 28, 2021Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRE-EVAR (ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE TARGETING AN ANEURYSM AT THE LEFT INTERNAL ILIAC ARTERY, AN APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY TOWARDS THE LEFT INTERNAL ILIAC ARTERY. AFTER FOUR COILS: A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30422331), A 6MM X 20CM GALAXY G3 COIL (GLY120620 / 30401373), A 6MM X 20CM GALAXY G3 COIL (GLY120620 / 30399453), AND A 10MM X 34CM MICRUSFRAME 18 COIL (MFR181034 / L13774) WERE IMPLANTED, ANOTHER 6MM X 20CM GALAXY G3 COIL (GLY120620 / UNKNOWN LOT) WAS CHOSEN BUT THE COIL WAS NOT ABLE TO GO INTO THE COIL MASS. THE PHYSICIAN ATTEMPTED TO RESHEATH IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). IN THE MEANTIME, THE COIL MASS WAS REPORTED TO HAVE THROMBOSED AND A CONCOMITANT LIGHTHOUSE MICROCATHETER (PIOLAX MEDICAL DEVICES) AND PART OF THE COIL MASS BECAME STUCK TOGETHER; THE COIL MASS DID NOT COME OFF EVEN WHEN THE WIRE WAS REMOVED AND FLUSHED. WHEN THE MICROCATHETER WAS PULLED BACK TO THE TIP OF THE CONTRAST CATHETER AND THE CONTRAST CATHETER WAS TORQUED, THE COIL MASS CAME OFF AND WENT BACK SETTLING AROUND THE ORIGINAL POSITION BY THE FLOW OF THE BLOOD. IT WAS THEN CONFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740276 ↗
• MalfunctionAug 25, 2020Unraveled Material; Unraveled Material

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AORTOPULMONARY COLLATERAL ARTERIES (APCA), AN APPROACH WAS MADE TOWARDS THE RIGHT INTERNAL MAMMARY ARTERY. A 6MM X 20CM GALAXY G3 (GLY120620, L10789) WAS USED BUT THE SIZE DID NOT FIT THE LESION AND WINDED REPEATEDLY, WHICH MADE THE COIL UNRAVEL A LITTLE. THE PHYSICIAN RE-SHEATHED IT AND TRIED TO USE IT AT THE CENTRAL SIDE. HOWEVER, IT DID NOT COME OUT FROM THE INTRODUCER SHEATH. A XSFT COIL (3X4) WAS USED AS THE SECOND COIL AND A G3 COIL (5X15) WAS USED AS THE THIRD COIL TO EMBOLIZE THE INTERNAL MAMMARY ARTERY. AFTER THAT, A XSFT COIL (4X10) AND A PUSHABLE COIL EMBOLIZED THE INTERCOSTAL ARTERY. A G3 COIL (6X20) AND A PUSHABLE COIL EMBOLIZED THE BRONCHIAL ARTERIAL ANEURYSM. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. NO ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. THERE WAS NO PROLONGATION IN THE PROCEDURE DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10447841 ↗
• MalfunctionFeb 25, 2020Positioning Problem; Positioning Problem

  AS REPORTED VIA THE STERLING REGISTRY, DURING THE COIL EMBOLIZATION TO THE RIGHT INTERNAL CAROTID ARTERY (ANTERIOR CIRCULATION), THERE WAS POSITIONING DIFFICULTIES WITH A 6MM X 20CM GALAXY G3 COIL (GLY120620, L13267). THERE WAS NO DEVICE-RELATED SERIOUS ADVERSE EVENT. PER THE STUDY INVESTIGATOR, THE DEVICE DID NOT ¿WORK SO WELL¿ BECAUSE THE UNSPECIFIED MICRO CATHETER (MC) WOULD HERNIATE OUTSIDE OF THE ANEURYSM INTO THE PARENT VESSEL WHEN DEPLOYING THE VERY LAST SEGMENT OF THE COIL. THE INITIAL STAGES WERE FINE. THIS NECESSITATED REPEATED CATHETERIZATION OF THE ANEURYSM DOME WITH THE MICROCATHETER AT DEEPER AND DEEPER LEVELS JUST TO KEEP THE COIL WITHIN THE ANEURYSM AND THIS STILL DIDN¿T WORK. IT WAS DECIDED NOT TO CONTINUE WITH COIL EMBOLIZATION BECAUSE THE COIL WAS NOT STABLE AND ENDED UP CONCLUDING THE PROCEDURE WITH A FLOW DIVERSION (PULSERIDER). THE SIDE WALL UNRUPTURED ANEURYSM HAD A PARENT VESSEL DIAMETER OF 3.8MM, HEIGHT 9.2MM AND DOME 7.8MM. MAXIMUM ANEURYSM DIAMETER WAS 9.2MM, NECK SIZE 7.3MM AND DOME TO NECK RATION OF 1.1MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9750934 ↗
• InjuryOct 17, 2019Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION OF A DISSECTING RIGHT INTERNAL CAROID ARTERY (ICA) ANEURYSM, THE PHYSICIAN DEPLOYED A 4MM X 22MM LVIS® STENT (MICROVENTION) VIA THE SEMI-JAILING TECHNIQUE AND THE 7MM X 20CM TARGET XL® 360 SOFT COIL (STRYKER) WAS PLACED AS A FRAMING COIL BEFORE THE 6MM X 20CM GALAXY G3 COIL (GLY120620 / L12287) WAS INSERTED BUT THE MICROCATHETER KICKED BACK SO THE COIL WAS REROLLED TEN TIMES. THE PHYSICIAN FELT AS IF THE COIL HAD PREMATURELY DETACHED FROM THE DELIVERY WIRE; THIS WAS CONFIRMED WHEN THE COIL WAS WITHDRAWN INTO THE MICROCATHETER, BUT THE EXACT TIME WHEN THE PREMATURE DETACHMENT OCCURRED IS NOT KNOWN. THE PHYSICIAN RETRACTED THE DELIVERY WIRE, BUT THE COIL DID NOT MOVE. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE PREMATURELY DETACHED COIL FROM THE MICROCATHETER INTO THE TARGET LESION USING THE GUIDEWIRE, BUT STRONG RESISTANCE WAS ENCOUNTERED, AND THE PHYSICIAN REALIZED THE COIL HAD BECOME UNRAVELED. THE MICROCATHETER WAS REMOVED FROM THE GUIDING CATHETER AND THE COIL WAS PUSHED FROM THE GUIDING CATHETER TOWARD THE DISTAL CAROTID ARTERY. A STENT WAS THEN IMPLANTED BETWEEN THE INTERNAL CAROTID ARTERY AND T

  Patient problems: No Code Available

  MAUDE report 9205658 ↗
• MalfunctionOct 2, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE IC-PC. THE COMPLAINT PRODUCT WAS ATTEMPTED TO BE INSERTED INTO A MICROCATHETER (MC) BUT THE COIL CAME OUT FROM THE CATHETER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL AND THE PROCEDURE COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146547 ↗
• MalfunctionApr 1, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM, THE 6 MM X 20 CM GALAXY G3 COIL (GLY120620/ L12698) WAS SELECTED AND THE PHYSICIAN ATTEMPTED TO PUT A COIL LOOP IN THE TARGET LESION. THE COIL BECAME UNRAVELED WHEN THE PHYSICIAN WAS TRYING TO ACCOMMODATE THE COIL LOOP IN THE ANEURYSM. THE GALAXY G3 COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATIONS; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469780 ↗
• MalfunctionMar 27, 2019Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A MAJOR AORTO-PULMONARY COLLATERAL ARTERY (MAPCA) AT THE INFERIOR PHRENIC ARTERY, THE 6 MM X 20 CM GALAXY G3 COIL (GLY120620 / L12896) WAS INSERTED INTO THE PROWLER SELECT LPES MICROCATHETER, AND THE PHYSICIAN REPORTED THAT IT FELT ABNORMAL AS THE COIL BECAME PREMATURELY DETACHED. TWO PHYSICIANS WERE INVOLVED WITH THE PROCEDURE AND HANDLED THE DEVICE IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). IT WAS REPORTED THAT AFTER THE PREMATURELY DETACHED COIL WAS REMOVED, THE PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457408 ↗
• MalfunctionFeb 21, 2019Entrapment of Device; Entrapment of Device

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RUPTURED ANEURYSM WITH SUBARACHNOID HEMORRHAGE, THE 6MM X 20CM GALAXY G3 (GLY120620/L10789) COIL WAS DELIVERED TO THE TARGET LESION AND THE PHYSICIAN ATTEMPTED TO CHANGE THE SHAPE OF THE COIL, BUT THE COIL BECAME TANGLED AND COULD NO LONGER BE USED. THEREFORE, 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 AT ALL TIMES. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THERE WAS NO REPORT OF THE OTHER DEVICES USED IN THE PROCEDURE. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8357757 ↗
• MalfunctionMay 11, 2017Premature Activation; Stretched; Premature Activation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A GALAXY G3 6X20 COIL STRETCHED AND DETACHED. THE PROCEDURE WAS FOR TREATMENT OF ANTERIOR COMMUNICATING ARTERY ANEURYSM RECANALIZATION. AFTER USING A COMPETITOR¿S COIL, A GALAXY G3 COIL WAS PLACED INTO A COMPETITOR¿S MICROCATHETER, WHEN ADVANCING THE COIL SOME OF THE COIL WAS DEPLOYED INTO THE ANEURYSM. THE CATHETER WAS NOT REPOSITIONED OVER THE COIL WITH THE COIL PARTIALLY DEPLOYED; HOWEVER THE PHYSICIAN WENT BACK AND FORTH WITH THE COIL TO MANEUVER IT INTO THE ANEURYSM. PER THE PHYSICIAN THE COIL MAY HAVE GOTTEN STUCK IN THE MICROCATHETER CAUSING IT TO STRETCH AND THEN DETACH WITH MOST OF IT HANGING FROM THE ANEURYSM. THE PHYSICIAN USED A SNARE TO RETRIEVE THE TAIL OF THE COIL. THE COIL WAS SUCCESSFULLY PULLED OUT ENTIRELY STILL ATTACHED TO THE DELIVERY SYSTEM. AND THE CASE CONTINUED. THE PROCEDURE WAS DELAYED BY 15 MINUTES DUE TO THE REPORTED EVENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE EXPERIENCED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE AND NO RESISTANCE EXPERIENCED WHEN ADVANCING THE COIL THROUGH THE MICROCATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559640 ↗
• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING STENT ASSISTED COILING OF AN UNRUPTURED 6 X 4.5 MM MIDDLE CEREBRAL ARTERY ANEURYSM IN A (B)(6) PATIENT RESISTANCE WAS EXPERIENCED WHEN USING TWO GALAXY COILS (GLX123509/S11635 AND GLY120620/S11514). AFTER SUCCESSFULLY PLACING 23 MM ENTERPRISE 2 STENT, THE SURGEON PLACED A PROWLER LPES MICROCATHER (606S155FX/16068713) INTO THE ANEURYSM. A 5X15 GALAXY G3 COIL WAS DECIDED TO BE PLACED. AFTER SUCCESSFULLY PLACING AND DETACHING THE COIL, THE SURGEON DECIDED TO PLACE A 3.5X9 G3 XTRASOFT COIL (LOT# S11635). UPON INTRODUCING THE COIL INTO THE LPES IT WAS NOTED THAT THERE WAS A FAIR AMOUNT OF RESISTANCE PUSHING THE COIL THROUGH THE MICROCATHETER. HE WAS HOWEVER ABLE TO SUCCESSFULLY PLACE AND DETACH THIS COIL. AT THIS TIME THE SURGEON WAS SATISFIED WITH THE OCCLUSION OF THE ANEURYSM AND PULLED THE LPES OUT INTO M1. UPON FINAL ANGIOGRAM A SLIGHT EXTRAVASATION IN THE M3 TO M4 DISTRIBUTION WAS NOTICED. THE SURGEON DECIDED AT THAT TIME TO TEMPORARILY OCCLUDE THE M1 WITH A 6X20 GALAXY G3 (LOT# S11514) AND TRIED TO ADVANCE THE COIL INTO THE MC BUT IT WOULD NOT ADVANCE. AFTER A COUPLE OF TRIES THE SURGEON ASKED FOR GALAXY 6X20 FILL (640C

  Patient problems: Extravasation

  MAUDE report 6151072 ↗