GALAXY G3 GLY120824Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704077589), received between Aug 30, 2018 and Nov 10, 2025 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 8MM X 24CM GALAXY G3 (GLY120824 / 1952532S) WAS USED, AND IT FILLED THE ANEURYSM. WHEN THE PHYSICIAN ATTEMPTED TO DETACH, THE COIL DID NOT DETACH. THE PHYSICIAN INSPECTED THE INDICATOR LIGHT OF THE DETACHMENT BOX AND OBSERVED THAT IT WAS IN GOOD CONDITION. THE PHYSICIAN CHANGED TO A NEW CONNECTING CABLE AND PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH. THE PHYSICIAN REMOVED THE COIL AND THE SECOND CONNECTOR CABLE FROM THE PATIENT AND REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THE PROCEDURE WAS REPORTEDLY PROLONGED BY 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23519231 ↗
• MalfunctionAug 22, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER WAS IN PLACE AND A GALAXY G3 8MM X 24CM (GLY120824, 30824788) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED INDICATOR LIGHT OF THE DETACHMENT BOX AND CONNECT CABLE, AND OBSERVED ALL WERE IN GOOD CONDITION. DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL WAS STILL FAILED TO DETACH, THEN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-AUG-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DETACHMENT CONTROL BOX AND CABLE WERE 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. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026891 ↗
• MalfunctionFeb 20, 2024Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, AFTER A LIGHTHOUSE MICROCATHETER (MC) WAS PLACED AS PER THE INSTRUCTIONS FOR USE (IFU), COIL EMBOLIZATION WAS INITIATED. A GALAXY G3 8MM X 24CM COIL (GLY120824, 30530863) WAS INSERTED AND GOT STUCK INSIDE THE MICROCATHETER (MC). THE COIL COULD NOT BE ADVANCED, SO IT WAS RETRIEVED. THEN, REPLACED WITH ANOTHER NEW COIL WITH THE SAME SIZE, WHICH WAS IMPLANTED WITH NO ISSUES. AFTER THAT, A FEW ADDITIONAL COILS WERE IMPLANTED. A GALAXY G3 5MM X 15CM COIL (GLY120515, 30860250) WAS USED AND WOUND. ATTEMPTED TO DETACHED, BUT THE LAMP DID NOT ILLUMINATE AND COULD NOT BE DETACHED WHEN ENERGIZED. REPLACED WITH A SECOND GALAXY G3 5MM X 15CM COIL (GLY120515, LOT UNKNOWN) BUT THE LAMP CAME ON AND OFF AND WAS NOT STABLE. SINCE IT WAS UNCLEAR WHETHER THE COIL COULD BE DETACHED, THE COIL WAS RETRIEVED AND REPLACED WITH ANOTHER COIL OF A DIFFERENT SIZE AND IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED ON 08-DEC-2023 INDICATED THAT THE REPLACED COILS WERE USED SUCCESSFULLY WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. BASED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739160 ↗
• MalfunctionNov 15, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A SUBCLAVIAN ARTERY AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), AFTER STENT GRAFT IMPLANTATION IN THE AORTA, COIL EMBOLIZATION OF THE SUBCLAVIAN ARTERY WAS PERFORMED. DURING THE IMPLANTATION OF THE THIRD COIL, AN 8MM X 24CM GALAXY G3 (GLY120824 / 30508870) WAS UNABLE TO BE DETACHED. THE ENPOWER CONTROL CABLE (ECB00018200 / 31000822) WAS REPLACED, BUT THE ISSUE WAS NOT RESOLVED. THE COIL WAS RETRIEVED AND REPLACED WITH A NEW COIL AND THE PROCEDURE WAS COMPLETED WITH THE NEW COIL. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. CONTINUOUS FLUSH WAS NOT MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145824 ↗
• MalfunctionAug 7, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN UNRUPTURED POSTERIOR CEREBRAL ARTERY ANEURYSM, A GALAXY G3 8MM X 24CM COIL (GLY120824, 30526876) WAS PLACED AT THE TARGET LESION. WHEN ATTEMPTED TO DETACH THE COIL, INDICATOR LED ON THE CONTROL BOX DID NOT ILLUMINATE AND THE COIL COULD NOT BE DETACHED. THE GALAXY G3 COIL WAS RETRIEVED, AND ANOTHER COIL WAS INSERTED. THE GALAXY G3 COIL WAS NOT USED ACCORDING TO INSTRUCTIONS FOR USE (IFU) AND WAS NOT CHECKED FOR ELECTRICAL CONTINUITY PRIOR TO INSERT THE COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS POSTERIOR CEREBRAL ARTERY. OTHER CONCOMITANT DEVICES ARE EXSELSIOR SL10 MICROCATHETER, ENPOWER CONTROL CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469524 ↗
• 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 15759650 ↗
• 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 15759518 ↗
• MalfunctionOct 11, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH), AN 8MM X 24CM GALAXY G3 COIL (GLY120824, 30470359) WAS INSERTED AND DELIVERED TO THE LESION. THE COMPLAINT COIL WAS RE-SHEATHED A FEW TIMES BUT GOT PREMATURELY DETACHED EVEN THOUGH THE DETACHMENT CYCLE WAS NOT PERFORMED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THE COMPLAINT COIL WAS INSERTED DESPITE PREMATURE DETACHMENT. AFTER THAT, THREE COILS WERE IMPLANTED, AND THE PROCEDURE WAS COMPLETED. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC). OTHER CONCOMITANT DEVICES ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579946 ↗
• MalfunctionAug 24, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE BASILAR ARTERY ANEURYSM, AN 8MM X 24CM GALAXY G3 COIL (GLY120824, 30490148) WAS PLACED AND IMPLANTED. THE ENPOWER CONTROL CABLE (ECB00018200, 30578775) AND THE DETACHMENT CONTROL BOX (PRODUCT NUMBER UNKNOWN) WERE CONNECTED. HOWEVER, THE INDICATOR LED DID NOT ILLUMINATE, AND DETACHMENT FAILURE OCCURRED. THE ENERGIZATION CHECK WAS PERFORMED AND CONFIRMED LAMP WAS LIT. THE COMPLAINT CABLE AND DCB2 WERE REPLACED BUT THE SAME ISSUE CONTINUED. FINALLY, THE COMPLAINT COIL WAS ALSO REPLACED WITH ANOTHER 8MM GALAXY G3 COIL AND THE REPLACED COIL WAS SUCCESSFULLY DETACHED WITH THE REPLACEMENT CABLE. THERE WAS NO PROBLEM WITH THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE IS A MICROCATHETER (EXSELSIOR SL10).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282552 ↗
• 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 (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 ATLAS

  Patient problems: Aneurysm

  MAUDE report 14687359 ↗
• MalfunctionMar 8, 2022Positioning Failure; Material Rupture; Positioning Failure; Material Rupture

  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 (TECHNOCRAT CORPORATION) 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 EN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691171 ↗
• InjuryApr 28, 2021Premature Separation; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN 8MM RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH), AN 8MM X 24CM GALAXY G3 (GLY120824/30407177) WAS USED AS THE FRAMING COIL AND WINDED ABOUT THREE TIMES, BUT IT PREMATURELY DETACHED. THE PREMATURELY DETACHED COIL WAS SAFELY REMOVED USING A GOOSENECK SNARE. THE COIL WAS REPLACED WITH A COMPETITOR COIL TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED ON 22 APR 2021 INDICATED THAT THE DEVICES WERE REPORTEDLY USED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE COMPLAINT COIL: ECHELON 14 (MEDTRONIC) MICROCATHETER, ROADMASTER (GOODMAN) GUIDE CATHETER, 4MM X 15MM SCEPTER (MICROVENTION) BALLOON CATHETER, AND ENPOWER DETACHMENT CONTROL BOX (DCB2000500). ANONYMIZED PROCEDURAL FILMS ARE NOT AVAILABLE FOR REVIEW. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737436 ↗
• MalfunctionApr 16, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE RIGHT GASTRIC ARTERY, A 12MM X 40CM MICRUSFRAME18 (MFR181240, L16839) WAS ATTEMPTED TO BE USED, BUT ITS SIZE DID NOT FIT AND COULD NOT BE RE-SHEATHED, THEREFORE, THE COIL WAS REMOVED. AFTER THAT, THE FRAMING WAS MADE WITH OTHER MICRUSFRAMES COILS. THEN A 8MM X 24CM GALAXY G3 (GLY120824, L15747) WAS ATTEMPTED TO BE USED AS A FILLING COIL, BUT IT GOT STUCK IN THE MICROCATHETER. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH ANOTHER ONE, AND IT WAS IMPLANTED. THERE WAS ALSO RESISTANCE FELT BETWEEN THE MICROCATHETER AND A 3MM X 8CM GALAXY G3 COIL (GLY120308, L16564). THE PROCEDURE WAS COMPLETED SAFELY. TWO MICROCATHETERS (EXCELCIOR 1018, STRYKER) WERE ALSO USED FOR THIS PROCEDURE. A (MM X 12CM DELTAFILL18 COIL HAD BEEN USED AS THE FIRST COIL. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE 8MM X 24CM GALAXY G3, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967914 ↗
• MalfunctionJan 6, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ARTERIOVENOUS MALFORMATION (AVM) COIL EMBOLIZATION AT THE PULMONAL ARTERY, A 3MM X 8CM GALAXY G3 COIL (GLY120308, L15635), A 4MM X 15CM DELTAFILL18 (DLF180415, L15418) AND A 8MM X 24CM GALAXY G3 COIL (GLY120824,L15932) WERE ATTEMPTED TO BE RE-SHEATHED TO CHANGE THE POSITION OF AN EXCELSIOR 1018 MICROCATHETER (MC) AS THE COILS WERE NOT ABLE TO BE MAKE A SHAPE AS THE PHYSICIAN INTENDED. HOWEVER, THE SHEATH GOT DAMAGED AND THEY WERE NOT ABLE TO BE RE-SHEATHED. THE PROCEDURE WAS COMPLETED WITH OTHER COILS. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552820 ↗
• MalfunctionNov 14, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM, AFTER PLACING A UNKNOWN STENT, THE PHYSICIAN ATTEMPTED TO IMPLANT AND DETACH A 8MM X 24CM GALAXY G3 COIL (GLY120824, L14722) AS THE FIRST FRAMING COIL. HOWEVER, WHEN THE ENPOWER CONTROL CABLE (ECB00018200, L16263) AND THE ENPOWER DCB 2 (DCB2000500, C46055) WERE CONNECTED, THE ENERGIZATION LUMP DID NOT ILLUMINATE. AFTER THAT, THE PHYSICIAN RECONNECTED AND DISCONNECTED THEM SEVERAL TIMES, BUT THE ISSUE CONTINUED. THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER ONE. HOWEVER, THE ISSUE CONTINUED, THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT¿S BODY. AFTER THAT, ANOTHER SAME SIZE COIL WAS IMPLANTED AND ABOUT FIVE COILS WERE ABLE TO DETACH WITHOUT ANY PROBLEMS. WHEN THE 6TH COIL WAS ATTEMPTED TO BE DETACHED," THE ENERGIZATION LUMP ILLUMINATED AND DID NOT ILLUMINATE", BUT THE 6TH COIL WAS ABLE TO DETACH. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321794 ↗
• MalfunctionOct 24, 2019Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A DURAL ARTERIOVENOUS FISTULA (DAVF), AFTER FOUR COILS WERE USE, THE 8MM X 24CM GALAXY G3 COIL (GLY120824 / L12142) WAS CHOSEN AS THE FIFTH COIL. THE GALAXY G3 COIL WAS INSERTED INTO THE SHEATH INTRODUCER BUT THE COIL PREMATURELY DETACHED FROM THE SLIT. THE COIL WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED PATIENT INJURY OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234115 ↗
• InjuryOct 22, 2019Unraveled Material; Migration; Separation Problem; Premature Separation; Unraveled Material; Migration; Separation Problem; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A RUPTURED A1 PENETRATING BRANCH ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), AN 8MM X 24CM GALAXY G3 (GLY120824/L14786) COIL WAS ADVANCED ¾ OR MORE INTO THE ANEURYSM BUT BECAME UNRAVELED WHEN THE PHYSICIAN PULLED BACK ON THE COIL. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL TO ¿AVOID COMING TO THE MAIN VESSEL¿ AND THE CONCOMITANT HEADWAY DUO (TERUMO) MICROCATHETER WAS SLOWLY RETRACTED BUT THE ¿COIL WAS SEPARATED¿. THE COIL WAS IMPLANTED BETWEEN THE TARGET ANEURYSM AND THE INTERNAL CAROTID (IC-TOP) AND IS SCHEDULED TO BE REMOVED VIA CRANIOTOMY AND SURGICAL CLIPPING. IT WAS LAST REPORTED THAT THE PATIENT REMAINS HOSPITALIZED. THE PROCEDURE WAS REPORTEDLY CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ¿FAILURE OF THE (ENPOWER (ECB00018200/L16082) CONTROL] CABLE WAS ALSO CONSIDERED¿. CLIPPING WAS PERFORMED VIA CRANIOTOMY AND THE UNRAVELED COIL WAS NOT REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9218990 ↗
• MalfunctionDec 10, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE VENOUS FISTULA COILING PROCEDURE ON NORMAL VENOUS ANATOMY TARGETING THE TRANSVERSE SINUS, THE 8MM X 24CM GALAXY G3 COIL (GLY120824 / L10800) WAS REPORTED TO HAVE ISSUE ADVANCING FROM THE COIL INTRODUCER. THE COIL WAS FLUSHED AGAIN, BUT IT STILL DID NOT ADVANCE FROM THE COIL INTRODUCER. IT WAS REPORTED THAT THE END USER TRIED TO UNLOCK THE COIL FROM THE LOCKING TOOL, BUT THE COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER. THE COIL DID NOT ENTER THE MICROCATHETER (EXCELSIOR¿ SL-10¿, STRYKER). IT WAS CONFIRMED THAT THERE WAS NO DAMAGE NOTED ON THE GALAXY G3 COIL; NO BEND OR KINKS WERE NOTED ON THE MICROCATHETER. THE GALAXY G3 COIL WAS REMOVED FROM THE PATIENT BUT THE MICROCATHETER WAS LEFT IN THE PATIENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT CONSEQUENCE; THERE WAS NO PROCEDURAL DELAY ASSOCIATED WITH THE REPORTED ISSUE. THE 8MM X 24CM GALAXY G3 COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8149162 ↗
• InjuryAug 30, 2018Material Protrusion/Extrusion; Positioning Problem; Material Protrusion/Extrusion; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING ELECTIVE RECONSTRUCTION-DEVICE ASSISTED COIL EMBOLIZATION OF A 5 MM NECK AND 8 MM X 7 MM DOME BASILAR TIP ARTERY ANEURYSM, THE 3 MM 8 MM ARCH PULSERIDER T (201D/W2554-01) WAS SUCCESSFULLY DEPLOYED EXTRAANEURYSMAL IN THE BIFURCATION AND MULTIPLE COILS, INCLUDING A 6 MM X 20 CM GALAXY G3 (GLY120620/L10238), A 8 MM X 24 CM GALAXY G3 (GLY120824/L10164), A 7 MM X 30 CM MICRUSFRAME10 (MFR100730/L10088), AND AN AXIUM (MEDTRONIC), WERE ATTEMPTED TO BE DEPLOYED BUT THE COILS PROTRUDED INTO THE PARENT ARTERY. THE PULSERIDER ARND FAILED TO MAINTAIN THE EMBOLIC COILS WITHIN THE CONFINES OF THE TARGET ANEURYSM. THE PULSERIDER ARND WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH A PULSERIDER (301D) ARND. THE PRODUCT WAS SUCCESSFULLY DEPLOYED INTRA-ANEURYSMAL. UNSPECIFIED CERENOVUS COILS AND MICROVENTION COILS WERE PLACED SUCCESSFULLY IN THE ANEURYSM. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT; HOWEVER, THE SURGERY WAS DELAYED ONE HOUR. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THE COMPLAINT PULSERIDER ARND WAS DEPLOYED AS INTENDED AT THE ANEURYSM. THERE WAS NO MOVEMENT OF THE PULSERIDER FOLLOWING DEPLOYMENT. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7834927 ↗