GALAXY G3 GLY120412Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886704077480), received between Sep 18, 2018 and Jan 3, 2025 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FILLED THE ANEURYSM WITH A GALAXY G3 4MM X 12CM COIL (GLY120412, 30757512) AND FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE DOCTOR ONLY RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-DEC-2024 INDICATED THAT PRIOR TO THIS COIL, OTHER COILS WERE ABLE TO BE ADVANCED THROUGH THE SAME MICROCATHETER (MC). THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THERE WAS NO RESISTANCE/FRICTION ENCOUNTERED WITH THE DEVICE. THE 10 MINUTES PROCEDURAL DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067515 ↗
• MalfunctionSep 3, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A RUPTURED ANEURYSM, A GALAXY G3 4MM X 12CM COIL (GLY120412, 30737329) WAS INSERTED INTO AN UNSPECIFIED MICROCATHETER (MC) AND BECAME UNRAVELED. THE GALAXY G3 COIL WAS REMOVED FROM THE MICROCATHETER. RESISTANCE WAS FELT AT THE HUB DURING INSERTION. UNRAVELED WAS FOUND PRIOR TO INSERTION INTO THE PATIENT¿S BODY. THERE WAS NO IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126723 ↗
• MalfunctionJun 12, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A MICROCATHETER (OTHER BRAND) WAS IN PLACE AND A GALAXY G3 4MM X 12CM COIL (B)(6) 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 UNDER GOOD CONDITION. DOCTOR PRESSED THE DETACHMENT BUTTON TO DETACH THE COIL AGAIN, BUT THE COIL STILL FAILED TO DETACH, THEN RETRACTED THE COIL AND SWITCHED TO A NEW COIL (OTHER BRAND) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DCB 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 WAS NOT STRETCHED OR DAMAGED WHEN REMOVED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519833 ↗
• MalfunctionFeb 7, 2024Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PEDIATRIC ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER THE LEONIS MOVA MICROCATHETER (SUMIMOTO BAKELITE) WAS INSERTED, COIL EMBOLIZATION WAS INITIATED. TWO (2) 4MM X 12CM GALAXY G3 COILS (GLY120412) FROM TWO DIFFERENT LOTS (30737326 AND 30558380) WERE INSERTED INTO THE MICROCATHETER AND THE DELIVERY WIRES OF BOTH COILS BECAME KINKED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT ¿CONSIDERING THE POSSIBILITY OF NON-ENERGIZED, THE COILS WERE IMMEDIATELY RETRIEVED AND NEW COILS WERE USED.¿ CONTINUOUS FLUSH WAS MAINTAINED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSES. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 07-FEB-2024, THE 4MM X 12CM GALAXY G3 COIL FROM LOT 30737326 WAS OBSERVED IN STRETCHED CONDITION. THIS MEETS US FDA REPORTING CRITERIA UNDER 21 CRF 803 AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664918 ↗
• MalfunctionJan 22, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 4MM X 12CM COIL (GLY120412, 30751852) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553864 ↗
• MalfunctionJun 28, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT AFTER PLACING AN UNSPECIFIED MICROCATHETER, THE GALAXY G3 4MM X 12MM (GLY120412/ 30737329) WAS INSERTED, AND THE PHYSICIAN FELT RESISTANCE INSIDE OF THE MICROCATHETER. THE GALAXY G3 WAS WITHDRAWN (GLY120412/ 30737329). BOTH OF THE GALAXY G3 3MM X 8MM (GLY120308/30737323 AND 30624688) WERE NOT ABLE TO BE INSERTED INTO THE MICROCATHETER. BOTH COILS WERE FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH OTHER NEW COILS SUCCESSFULLY. CONTINUOUS FLUSH WAS DONE. ADDITIONAL EVENT INFORMATION RECEIVED ON 14-MAY-2023 INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER HAD BEEN MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. BASED ON THE PRODUCT ANALYSIS OF ALL THREE COILS RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216550 ↗
• MalfunctionJun 9, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2023, A 4MM X 12CM GALAXY G3 COIL (GLY120412 / 30747551) WAS ¿UNABLE TO POWER OFF.¿ ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA) AND THE ¿UNABLE TO POWER OFF¿ WAS REFERRING TO THE COMPLAINT COIL FAILING TO DETACH. THERE WAS NO ISSUE WITH THE DETACHMENT CONTROL BOX (DCB). THERE WAS NO NEGATIVE PATIENT IMPACT. THE COIL WAS REMOVED AND IT DID NOT APPEAR DAMAGE; THE DEVICE ¿LOOKS OK UNTIL DR. CHANG DETACHED.¿ ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE DETACHMENT CONTROL BOX USED WAS AN ENPOWER DCB 2 (DCB2000500 / 30578781). THE SAME DCB WAS USED TO DETACH SUBSEQUENT COILS. THE CONNECTING CABLE USED WAS AN ENPOWER CONTROL CABLE (ECB00018200 / L16901); THE SAME CONNECTING CABLE WAS USED TO DETACH SUBSEQUENT COILS. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101165 ↗
• MalfunctionApr 21, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ABDOMINAL STENT GRAFTING AND ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH THE TARGET ON THE INTERNAL ILIAC ARTERY (IIA) AND INFERIOR MESENTERY ARTERY (IMA), A CARRY LEÓN MICROCATHETER (UTM) WAS ADVANCED TO THE TARGET LESION USING A ¿COBRA-SHAPED PARENT CATHETER.¿ THE COMPLAINT COIL, A 8MM X 35CM DELTAFILL 18 (DLF180835 / 30915606) COULD NOT BE DETACHED DURING THE EMBOLIZATION OF THE IIA. IT WAS REPORTED THAT THE POWER DISTRIBUTION HAD BEEN CHECKED AT THE BEGINNING OF THE PROCEDURE. WHEN THE DELTAFILL COIL WAS RECONNECTED PRIOR TO DETACHING, IT WAS REPORTED THAT THERE WAS NO RESPONSE. AFTER REPLACING THE ENPOWER CONTROL CABLE (ECB00018200 / 30975218) AND THE DETACHMENT CONTROL BOX, THE ISSUE CONTINUED. ANOTHER DELTAFILL COIL WAS USED AND IT WAS SUCCESSFULLY DETACHED. AFTER THAT, WHEN A 4MM X 12CM GALAXY G3 (GLY120412 / 30792966) WAS ABOUT TO BE USED FOR THE IMA, THE SAME DETACHMENT ISSUE ALSO OCCURRED. HOWEVER, THE 4MM X 12CM GALAXY G3 COIL DID NOT RESPOND TO POWER DISTRIBUTION PRIOR TO USE, IT WAS NOT USED. IT WAS REPORTED THAT ANOTHER COIL WAS USED IN PLACE OF THE 4MM X 12CM GALAXY G3. IT WAS NOT KNOWN IF CONTINUOUS FLUSH W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792419 ↗
• MalfunctionFeb 6, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 4MM X 12CM COIL (GLY120412, K10710) WAS USED BUT UNABLE TO BE DELIVERED INSIDE AN UNSPECIFIED MICROCATHETER (MC). THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. THE LESION WAS THE BACK TUMOR EMBOLUS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. THERE WAS NO DAMAGE TO THE DEVICE. THE DEVICE COULD BE MOVED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL HAS MULTIPLE KINKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16303153 ↗
• 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 16187124 ↗
• MalfunctionDec 5, 2022Stretched; Positioning Problem; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL WAS MADE AWARE OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2022, INVOLVING A 4MM X 12CM GALAXY G3 COIL (GLY120412 / K10710). THE PROCEDURE WAS TARGETING A LESION ON THE INTERNAL ILIAC ARTERY. IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED. AT THE TIME OF THE COMPLAINT INITIATION, LIMITED INFORMATION WAS AVAILABLE. ON (B)(6) 2022 THE CERENOVUS SALES REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION. THE INFORMATION INDICATED THAT THE COMPLAINT COIL WAS USED FOR AN ABDOMINAL VISCERAL ANEURYSM. THE 4MM X 12CM GALAXY G3 COIL WAS USED AFTER ¿SOME GUIDING CATHETERS AND SOME MICROCATHETERS¿ WERE USED INSIDE THE ANEURYSM. THE COMPLAINT COIL WAS RE-SHEATHED BECAUSE IT WAS UNABLE TO BE IMPLANTED AS INTENDED. THE MICROCATHETER(S) WERE REPOSITIONED AND THE COMPLAINT COIL WAS INSERTED AND AN ATTEMPT TO IMPLANT WAS MADE, BUT IT SEEM TO BE ABOUT TO UNRAVEL. IT WAS REPORTED THAT ELECTRICAL CONTINUITY WAS CHECKED. IT WAS INSERTED BUT UNABLE TO BE IMPLANTED. DURING THE RE-SHEATHING ATTEMPT IN PREPARATION FOR RE-INSERTION, THE COIL SEEM ABOUT TO BE UNRAVELED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 01-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919425 ↗
• 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 15759609 ↗
• MalfunctionOct 31, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE THAT TOOK PLACE ON (B)(4) 2021, THE COMPLAINT COIL, A 4MM X 12CM GALAXY G3 COIL (GLY120412 / 30494398) WAS USED WITH THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER) BUT IT WAS NOT ABLE TO BE DETACHED. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT. IT WAS NOT KNOWN IF CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704355 ↗
• MalfunctionOct 1, 2022Product Quality Problem; Material Split, Cut or Torn; Product Quality Problem; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION WITH THE TARGET BEING A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM), AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS INSERTED INTO A BALLOON CATHETER (UNSPECIFIED BRAND) AND COIL EMBOLIZATION WAS STARTED BY INFLATING THE BALLOON CATHETER. THE PHYSICIAN JUDGED THE COIL EMBOLIZATION WAS DIFFICULT ONLY AT THE FEEDER, THEREFORE, ¿A FRAMES¿ COIL WAS USED FROM INSIDE THE SAC. THE COMPLAINT COIL, A 4MM X 12CM GALAXY G3 (GLY120412 / 30747550) WAS USED WHEN THE PROXIMAL BLOOD VESSEL WAS EMBOLIZED BY PACKING INSIDE THE SAC. THE COMPLAINT COIL REPORTEDLY FIT, BUT THE SHAPE WAS NOT PROPER. IT WAS RE-SHEATHED TO ADJUST THE POSITION OF THE MICROCATHETER. HOWEVER, THE SHEATH GOT TORN AND UNABLE TO BE RESTORED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526052 ↗
• 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 (B)(6) FEMALE (SUBJECT 01208-006) 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 ADMINIS

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516642 ↗
• MalfunctionMay 4, 2022Material Rupture; Stretched; Difficult to Advance; Material Rupture; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE LEFT CORONARY ARTERY, A 4MMX12CM GALAXY G3 COIL (GLY120412, 30737325) WAS ATTEMPTED TO BE USED FOR BRANCHES THAT CAME OUT FROM THE ANEURYSM. THE COMPLAINT COIL WAS INSERTED AND WAS BEING ADVANCE THROUGH A PROWLER SELECT LPES MICROCATHETER (CATALOG/LOT UNKNOWN) BUT THERE WAS A RESISTANCE. THE COIL PART CAME OUT OF THE SIDE OF THE COIL SHEATH, THEREFORE IT WAS BEING RE-SHEATHE, BUT THE COIL BECAME UNRAVELED. THERE WAS NO EFFECT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES ARE A SHEATH INTRODUCER (TERUMO), A GUIDEWIRE (MEISTER) AND A Y-CONNECTOR (GOODTECH). TREATMENT OF THE AFM FROM THE CORONARY ARTERY ANEURYSM TO THE PULMONARY ARTERY, INTRA-ANEURYSMAL PACKING AND PROCEDURE OF BRANCHES WERE DONE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE COMPLAINT COIL WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279034 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ischemia Stroke

  MAUDE report 13497459 ↗
• MalfunctionDec 21, 2021Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  AS REPORTED BY THE FIELD, UPON LOADING A GALAXY G3 4MM X 12CM COIL ( GLY120412, 30490143) THE COIL CAME OUT OF THE SIDES. THE COIL WAS TESTED AND NO VISIBLE PROBLEM WHEN INSERTED INTO THE RHV. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE ISSUE IS REPORTED TO HAVE OCCURRED ON THE ATTEMPTED INTRODUCTION INTO THE MICROCATHETER. THE COIL WAS NOT DEPLOYED. IT IS SAID TO HAVE COME OUT OF THE INTRODUCTION TOOL SIDE WALL. AN ADEQUATE CONTINUOUS FLUSH MAINTAINED THROUGH THE SL10 MICROCATHETER (MC). THERE WAS A LEVEL OF RESISTANCE AT THE LEVEL OF THE RHV. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE EVENT. BASED ON THE PRODUCT ANALYSIS ON THE DEVICE RECEIVED, THE EMBOLIC COIL IS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051776 ↗
• MalfunctionDec 3, 2021Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE FEMALE PATIENT UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM. THE PATIENT EXPERIENCED PUNCTURE SITE HEMORRHAGE DURING THE PROCEDURE. AN APPROACH WAS MADE FROM THE RIGHT BRACHIAL ARTERY (BA) WITH A 6F GUIDING SHEATH (BRAND UNSPECIFIED). THE SHEATH WAS ADVANCED TOWARD THE RIGHT VERTEBRAL ARTERY. A GUIDEPOST WAS THEN ADVANCED TO THE BASILAR ARTERY. A PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE / LOT NUMBER) WAS DELIVERED TO THE ANEURYSM NECK. A PULSERIDER 10Y, 3.5 ¿ 4.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (313D / W3662-07) WAS DEPLOYED IN A GOOD POSITION AT THE NECK OF THE ANEURYSM AFTER ITS DIRECTION WAS ADJUSTED SEVERAL TIMES. COIL EMBOLIZATION WAS THEN INITIATED. MULTIPLE ATTEMPTS WERE MADE TO POSITION TWO GALAXY G3 COILS (GLY120412 / 30526869 & GLY120308 / 30546473); HOWEVER, THE COILS WERE NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE PHYSICIAN SELECTED A 3MM X 8CM TARGET 360 SOFT COIL (STRYKER) FOR USE, BUT THIS COIL WAS ALSO NOT ABLE TO BE WINDED. THE PHYSICIAN TRIED TO REMOVE THE COIL, BUT IT BECAME ENTANGLED WITH THE PULSERIDER ANRD. THE DELIVERY WIRE WAS PUSHED SEVERAL T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930233 ↗
• MalfunctionNov 9, 2021Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A (B)(6) FEMALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION OF A LEFT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AND EXPERIENCED A SUBARACHNOID HEMORRHAGE (SAH) SECONDARY TO INTRAOPERATIVE ANEURYSM EXTRAVASATION. HEMOSTASIS WAS ACHIEVED WITH THE PLACEMENT OF SIX COILS. THE PATIENT IS IN STABLE CONDITION WITH NO REBLEEDING. THE PHYSICIAN COMMENTED THAT THE SAH WAS NOT RELATED TO PULSERIDER ANRD. THE EVENT WAS NOT CONSIDERED SERIOUS. APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH AN 8F OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL). AN 0.072¿ NAVIEN DISTAL SUPPORT CATHETER (MEDTRONIC) WAS ADVANCED TO THE DISTAL INTERNAL CAROTID ARTERY (ICA). NEXT, A PHENOM 17 MICROCATHETER (MEDTRONIC) AND A PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE & LOT NUMBER) WERE DELIVERED TO THE ANEURYSM. THE PULSERIDER 8T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D/3053447112) WAS POSITIONED INSIDE THE ANEURYSM SAC. A 4MM X 12CM GALAXY G3 COIL (GLY120412/L16490) WAS THEN USED BUT COULD NOT BE WINDED AS INTENDED (I.E., COULD NOT FRAME THE ANEURYSM). THE COIL INTRODUCER COULD NOT BE RESTORED, AND THE COIL FAILED TO BE

  Patient problems: Aneurysm; Intracranial Hemorrhage; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778528 ↗
• MalfunctionJul 26, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AT THE LEFT GASTRIC ARTERY, A CERENOVUS COIL (PRODUCT CODE, LOT NUMBER UNKNOWN) WAS USED AS THE FIRST COIL AND COIL EMBOLIZATION STARTED. THERE WAS A LITTLE RESISTANCE FELT BETWEEN THE COIL AND A CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS MICROCATHETER BEFORE THE COIL COMES OUT THE BLOOD VESSEL. THE COIL WAS ABLE TO COME OUT FROM THE MICROCATHETER (MC) THEREFORE, IT WAS DETACHED AND IMPLANTED. A GALAXY G3 3MM X 8CM COIL (GLY120308, 30517627) WAS USED AS THE SECOND COIL AND THE SAME ISSUE OCCURRED. IT WAS RE-INSERTED FROM THE MICROCATHETER SEVERAL TIMES TO IMPLANT THE COIL BUT THE COMPLAINT BECAME UNRAVELED. IT WAS REPLACED WITH ANOTHER SAME SIZED COIL AND IT WAS IMPLANTED. AFTER THAT, A GALAXY G3 4MM X 12CMCOIL (GLY120412, 30517630) WAS USED AS THE FOURTH COIL. THE SAME ISSUE OCCURRED; THE PHYSICIAN DID THE SAME MEASURE AS THE FORMER COMPLAINT COIL BUT THE FOURTH COIL BECAME UNRAVELED. IT WAS REPLACED WITH ANOTHER SAME SIZED COIL AND IT WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225678 ↗
• MalfunctionOct 5, 2020Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A POST-OPERATIVE TYPE II ENDOLEAK COIL EMBOLIZATION POST STENT-GRAFT IMPLANTATION, THE COIL EMBOLIZATION STARTED AT THE PERIPHERAL BLOOD VESSEL OF THE SUPERIOR GLUTEAL ARTERY AND THE INFERIOR GLUTEAL ARTERY, THE PHYSICIAN INSERTED A CONCOMITANT MICROCATHETER FOR COILING SUPPORT FROM THE OUTER CYLINDER OF THE PUNCTURE NEEDLE WITH A DIRECT PUNCTURE FROM THE BUTTOCKS, THE 4MM X 12CM GALAXY G3 COIL (GLY120412 / L16577) WAS USED AS THE FOURTH COIL, BUT IT BECAME UNRAVELED WHEN IT WAS ADVANCED TOWARD THE TARGET LESION. THE COMPLAINT COIL WAS REMOVED AND REPLACED WITH ANOTHER 4MM X 12CM GALAXY G3 COIL (GLY120412) AND THE PROCEDURE WAS RESUMED TO COMPLETION. THERE WAS NO REPORT OF ANY BLOOD FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE REPORTED EVENT. THE PHYSICIAN COMMENTED THAT THE COMPLAINT COIL MAY HAVE BEEN CAUGHT IN A WALL THROMBUS INSIDE THE TARGET ANEURYSM. DUE TO INFECTIOUS DISEASE, THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10629828 ↗
• MalfunctionDec 20, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE FOR A PATIENT WHO HAS BEEN HOSPITALIZED FOR HEMOPTYSIS, THE LESIONS WERE TWO COLLATERAL CIRCULATION EXTENDING FROM NEAR THE BRONCHIAL ARTERY. THE 4MM X 12CM GALAXY G3 COIL (GLY120412 / L15615) WAS USED FOR ONE OF THE LESIONS, BUT IT BECAME STUCK IN THE LEONISMOVA MICROCATHETER (SUMITOMO BAKELITE). THE CONCOMITANT MICROCATHETER WAS REMOVED AND REPLACED WITH A PROWLER SELECT PLUS LPES MICROCATHETER, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE 4MM X 12CM GALAXY G3 COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 12/19/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508085 ↗
• MalfunctionJul 17, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 4MM X 12CM GALAXY G3 COIL (GLY120412, L12926) WAS BEING USED AS A FRAMING COIL. THE PHYSICIAN ATTEMPTED TO INSERT GALAXY G3 COIL INTO THE MICROCATHETER, HOWEVER, IT COULD NOT BE INSERTED INTO THE MICROCATHETER (MC). AFTER SEVERAL ATTEMPTS, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COMPLAINT PRODUCT, BUT THE COMPLAINT PRODUCT UNRAVELED IN THE MICROCATHETER. THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WILL NOT BE RETURNED FOR THE INVESTIGATION. THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE. THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800820 ↗
• MalfunctionJul 2, 2019Separation Failure; Separation Failure

  AS REPORTED BY HEALTHCARE PROFESSIONAL, A GALAXY G3 4MM X 12CM COIL (GLY120412, L12634), A MICRUSFRAME10 3.5MM X 6.6CM COIL (MFR100356, LOT UNKNOWN) AND AMICRUSFRAME10 2.5MM X 3.3CM COIL (MFR100253, L10193) COIL WOULD NOT DETACH ONCE DEPLOYED INTO THE ANEURYSM. THERE WAS NO SURGERY DELAY DUE TO THE REPORTED EVENTS. ANOTHER COIL WAS ADVANCED AND DEPLOYED INTO ANEURYSM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754732 ↗