GALAXY G3 GLY120308Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886704077466), received between Oct 20, 2017 and May 5, 2026 — classified as 6 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (DIFFERENT MANUFACTURER) WAS IN PLACE AND THE 3MM X 8CM GALAXY G3 (GLY120308 / 3092403S) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING AN ANEURYSM ON THE C6 SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). TH COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED, IT WAS STILL ON THE DELIVERY WIRE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE PROCEDURE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT WAS ALSO ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTIONS FIT WITHOUT APPLICATION OF EXCESSIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084185 ↗
• MalfunctionJul 22, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE COMPLAINT COIL, A 3MM X 8CM GALAXY G3 COIL (GLY120308 / 30937912) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN INSPECTED THE INDICATOR LIGHT OF THE DETACHMENT BOX AND THE CONTROL CABLE AND OBSERVED THAT ALL WERE IN GOOD CONDITION. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801810 ↗
• MalfunctionDec 29, 2023Stretched; Separation Failure; Difficult to Advance; Stretched; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION ON A PEDIATRIC CASE, A LEONIS MOVA MICROCATHETER (SUMIMOTO BAKELITE) WAS PLACED IN THE LESION. A GALAXY G3 3MM X 8CM COIL (GLY120308, 30637476) WAS PLACED AT THE LESION AND ATTEMPTED TO BE DETACHED BUT COULD NOT. AFTER SEVERAL ATTEMPTS, THE COIL WAS NOT DETACHED, SO IT WAS DECIDED TO RETRIEVE IT. THE RETRIEVED COIL WAS FOUND TO BE UNRAVELED. THE MICROCATHETER (MC) WAS REPLACED WITH ANOTHER NEW ONE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. ADDITIONAL INFORMATION WAS RECEIVED ON 27-DEC-2023 INDICATING THAT THE COIL WAS DETACHED AND REMAINED INSIDE THE MC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419288 ↗
• MalfunctionJun 28, 2023Break; Break

  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 17216600 ↗
• MalfunctionJun 28, 2023Break; Break

  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 17216598 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY (B)(6), A 46-YEAR-OLD FEMALE PATIENT (B)(4) WITH A HISTORY OF HYPERTENSION (CONTROLLED), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY (PCA) SIDE WALL ANEURYSM WITH HUNT & HESS GRADE 2, MODIFIED RANKIN SCALE (MRS) SCORE 0 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 4.5MM, DOME 3.3MM, MAXIMUM ANEURYSM DIAMETER 3.3MM, NECK SIZE 2.1MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.3MM. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PER CRF AND CLINICAL DATABASE, COIL EMBOLIZATION WAS PERFORMED WITH SEVEN (7) CERENOVUS COILS: A 3.5MM X 6CM MICRUSFRAME S (L16863), A GALAXY G3 XTRASOFT 3MM X 4CM (GLX120304/L16554), A 2MM X 3CM GALAXY G3 MINI (GLM920030/L30546463), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30546460), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L30393176), A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/ 30490127) AND A 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/30390770) VIA AN EXCELSIOR SL-10 0165 45 TIP 150 CM MICROCATHETER. HEPARIN HAS BEEN ADMINISTERED DURING THE PROCEDURE. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE

  Patient problems: Aneurysm

  MAUDE report 16194838 ↗
• MalfunctionNov 1, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MAJOR AORTOPULMONARY COLLATERAL ARTERIES, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A SHEATH (4F). AN ANGIO CATHETER WAS ADVANCED TOWARD THE RIGHT SUBCLAVIAN ARTERY. FROM THERE, THE MICROCATHETER (LEONISMOVA STANDARD) WAS ADVANCED TO THE COLLATERAL AND SHUNT POINT APPROACH WAS PERFORMED. EMBOLIZATION WAS STARTED. AFTER SEVERAL UNSPECIFIED COILS WERE IMPLANTED, A GALAXY G3 3MM X 8CM COIL (GLY120308, 30737322) WAS USED AS AN ADDED COIL. HOWEVER, THE COMPLAINT COIL WAS ATTEMPTED TO BE DETACHED WITH THE ENPOWER CONTROL CABLE (ECB00018200, 30789762) BUT THE COMPLAINT COIL WAS UNABLE TO BE DETACHED EVEN THOUGH THE DETACHMENT BUTTON WAS PRESSED. THE POSITION OF THE DELIVERY WIRE WAS CHANGED ABOUT TEN TIMES, BUT THE SAME ISSUE CONTINUED. THE COMPLAINT CABLE WAS ABLE TO HAVE DETACHED OTHER COILS UNTIL THIS DETACHMENT FAILURE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER CABLE AND THE DEPLOYMENT BUTTON WAS PRESSED ABOUT FIVE TIMES AND THE COMPLAINT COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH PERFORMED. THE LESION WAS THE COLLATERAL FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708136 ↗
• MalfunctionOct 31, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING A VERTEBRAL ARTERY DISSECTING ANEURYSM (VADA), THE COMPLAINT COIL, A 3MM X 8CM GALAXY G3 (GLY120308 / LOT# UNKNOWN) WAS USED BUT IT BECAME UNRAVELED. CONTINUOUS FLUSH WAS MAINTAINED. ON 18-OCT-2022, THE CERENOVUS SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: ¿PROBABLY THE INTRODUCER OF THE COMPLAINT COIL WAS UNABLE TO ADVANCE AT THE HUB PART OF THE PHENOM¿ MICROCATHETER (MEDTRONIC) AND THE COMPLAINT COIL SEEMED TO BE STUCK.¿ THE PHYSICIAN KEPT ATTEMPTING TO ADVANCE THE COIL, BUT ADVANCEMENT WAS NOT POSSIBLE. THE COMPLAINT COIL WAS REMOVED AND THE PHYSICIAN NOTICED THAT IT HAD BECOME UNRAVELED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15704302 ↗
• MalfunctionOct 7, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRE-STENT GRAFT COIL EMBOLIZATION AT THE INTERNAL ILIAC ARTERY, ¿A PLUG WAS IMPLANTED AND PLUG-IN COIL WAS PERFORMED.¿ DELTA COIL(S), FRAME COIL(S), AND THE COMPLAINT COIL, A 3MM X 8CM GALAXY G3 (GLY120308 / 30675493) WERE IMPLANTED, HOWEVER, THE COMPLAINT COIL WAS UNABLE TO COME OUT OF THE CONCOMITANT MICROCATHETER (COILING SUPPORT). THE COIL WAS REMOVED AND REPLACED WITH ANOTHER GALAXY G3 COIL; THE REPLACEMENT COIL CAME OUT OF THE MICROCATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NEGATIVE IMPACT TO THE PATIENT. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 07-OCT-2022, THE EVENT HAS BEEN DEEMED REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15567979 ↗
• MalfunctionSep 30, 2022Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR A CAROTID CAVERNOUS FISTULA (CCF), AN APPROACH WAS MADE FROM THE FEMORAL VEIN. THE CCF WAS EMBOLIZED WITH COIL(S) VIA THE RIGHT INFERIOR PETROSAL SINUS (IPS). THERE WERE SOME SHUNT POINTS. THE FIRST SHUNT POINT WAS EMBOLIZED WITH SEVEN COILS. THE SECOND SHUNT POINT WAS ACCESSED AND THE COMPLAINT COIL, A 3MM X 8CM GALAXY G3 (GLY120308 / 30675494) WAS EMBOLIZED. HOWEVER, ATTEMPTS WERE MADE TO RE-SHEATH THE COIL BECAUSE THE BRANCH WAS INCORRECT. THE COMPLAINT COIL GOT UNRAVELED AND ¿THIS UNRAVELING MIGHT HAVE CAUSED BY HAVING ENTANGLED WITH BLOOD VESSEL WALL OF CCF.¿ THE COMPLAINT COIL BECAME PREMATURELY DETACHED. THE UNRAVELED IMPACT MIGHT HAVE CAUSED THIS EARLY DETACHMENT. IT WAS IMPOSSIBLE TO REMOVE THE COMPLAINT COIL. A HEADWAY® MICROCATHETER (MICROVENTION) WAS REMOVED BUT THE COMPLAINT COIL GOT STRETCHED FROM THE CCF AND LEFT IN THE GUIDING CATHETER. THE COMPLAINT COIL WAS UNABLE TO BE REMOVED BECAUSE A 4.2FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC) WAS USED. THEN COIL EMBOLIZATION RESTARTED. AFTER THAT, TWENTY-THREE (23) COILS WERE USED FOR EMBOLIZATION. THE GUIDING CATHETER WAS REMOVED BUT THE UNRAVELED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521487 ↗
• MalfunctionAug 8, 2022Material Rupture; Material Rupture

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA), WHEN THE TARGET VESSEL WAS ACCESSED AND TWO 3MM X 8CM GALAXY G3 COILS (GLY120308, 30641989) WERE INSERTED INTO THE CARNELIAN MARVEL MICROCATHETE (MC). THE ZIP PART OF THE INTRODUCER SHEATHS WERE OPENED AND LEAKED FROM THE SIDE. THE COMPLAINT PRODUCTS BECAME UNUSABLE AND WERE REPLACED WITH ANOTHER COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. INITIALLY, THE PATIENT WAS UNDERGOING STENTGRAFT. BLOOD FROM THE IMA HAD BEEN FLOWED INTO THE ANEURYSM. THE ORIGIN PART OF IMA WAS ACCESSED WITH USING A MARVEL-HIGH FLOW AND A MARVEL. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL THROUGH THE MC. IT WAS NO NOT NECESSARY TO REMOVE THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF ONE OF THE GALAXY G3 COILS RECEIVED, THE CORE WIRE WAS FOUND BROKEN, FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183498 ↗
• InjuryApr 5, 2022Stretched; Migration; Stretched; Migration

  THE EVENT WAS REPORTED VIA THE AAA STUDY, 68-YEAR-OLD PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION AND ACTIVE SMOKING UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 52.4MM ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE PROCEDURE, THE UNRAVELED COIL WAS LEFT BEHIND FROM THE LUMBAR ARTERY TO THE ILIOLUMBAR AND INTERNAL ILIAC ARTERIES, AND A BARE STENT WAS PLACED OVER THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY TO PREVENT COIL MIGRATION. THE PATIENT HAS BEEN ASYMPTOMATIC SINCE THEN. TWO 3MM X 8CM GALAXY G3 COILS (GLY120308 / LOT# UNKNOWN) WERE REPORTED. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE ANEURYSM LOCATION WAS EXTENSION INTO BOTH COMMON ILIAC ARTERIES. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. A TOTAL OF 14 CERENOVUS COILS WERE IMPLANTED AT THE LUMBAR ARTERY. THERE WAS NO REPORT OF PATIENT INJURY. THE COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018101 ↗
• InjuryApr 5, 2022Stretched; Migration; Stretched; Migration

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A 68-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION AND ACTIVE SMOKING UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 52.4MM ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE PROCEDURE, THE UNRAVELED COIL WAS LEFT BEHIND FROM THE LUMBAR ARTERY TO THE ILIOLUMBAR AND INTERNAL ILIAC ARTERIES, AND A BARE STENT WAS PLACED OVER THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY TO PREVENT COIL MIGRATION. THE PATIENT HAS BEEN ASYMPTOMATIC SINCE THEN. TWO 3MM X 8CM GALAXY G3 COILS (GLY120308 / LOT# UNKNOWN) WERE REPORTED. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE ANEURYSM LOCATION WAS EXTENSION INTO BOTH COMMON ILIAC ARTERIES. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. A TOTAL OF 14 CERENOVUS COILS WERE IMPLANTED AT THE LUMBAR ARTERY. THERE WAS NO REPORT OF PATIENT INJURY. THE COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14018100 ↗
• MalfunctionFeb 11, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR A GASTROINTESTINAL BLEED, THE 3MM X 8CM GALAXY G3 COIL (GLY120308 / 30624687) WAS USED, BUT IT WAS UNABLE TO BE DETACHED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT A CONCOMITANT 1.9 FR CARRY LEÓN MICROCATHETER (UTM) WAS USED; IT WAS REPORTED THAT FIVE (5) CERENOVUS COILS WERE USED IN ADDITION TO THE COMPLAINT COIL AND THEY WERE DETACHED WITHOUT ANY ISSUE. THE COMPLAINT INDICATED THAT IT WAS NOT CLEAR IF CONTINUOUS FLUSH WAS MAINTAINED. INFORMATION RELATED TO THE TARGET LESION IS UNKNOWN. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT COIL IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518574 ↗
• 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 12929947 ↗
• MalfunctionAug 31, 2021Positioning Failure; Device Difficult to Setup or Prepare; Material Rupture; Positioning Failure; Device Difficult to Setup or Prepare; Material Rupture

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE MAJOR AORTOPULMONARY COLLATERAL ARTERIES, AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH AN UNSPECIFIED SHEATH (4F). AN ANGIO CATHETER ADVANCED TOWARD THE LEFT INTERNAL THORACIC ARTERY. A PROWLER SELECT PLUS MICROCATHETER (MC) WAS INSERTED INTO THE PATIENT AND ADVANCED TOWARD A SHUNT AND COIL EMBOLIZATION STARTED. AFTER SEVERAL COMPETITIVE COILS WERE IMPLANTED, THE POUCH OF THE COMPLAINT PRODUCT, A 3MM X 8CM GALAXY G3 COIL (GLY120308, 30537008) WAS OPENED FOR ADDITIONAL EMBOLIZATION. IT WAS RE-WINDED SEVERAL TIMES, BUT IT CAME OUT FROM THE LESION A LITTLE, THEREFORE, THE PHYSICIAN RE-SHEATHED. HOWEVER, ON THE WAY, THE ZIPPER STOPPED AND AFTER BEING REPEATED SEVERAL TIMES, THE ZIPPER CAME TO THE FRONT, BUT THE INTRODUCER WAS NOT RESTORED, AND THE WIRE WAS EXPOSED FROM WHERE IT WAS CAUGHT. SINCE IT WAS IMPOSSIBLE TO PUT IT BACK, THE ENTIRE SYSTEM WAS REMOVED, AND THE PROCEDURE PROCEEDED. AFTER THAT, THE CATHETER WAS MODIFIED AT THE PROPER POSITION AND A COIL OF THE SAME CATALOG NUMBER WAS USED AND THE EMBOLIZATION WAS CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391002 ↗
• MalfunctionAug 18, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCAS), A SHEATH (4FR) WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND AN ANGIO CATHETER APPROACHED TO THE RIGHT INTERNAL THORACIC ARTERY. A LEONISMOVA REGULAR, SUMITOMO BAKELITE MICROCATHETER (MC) WAS INSERTED INTO THE PATIENT AND ADVANCED TOWARD A SHUNT. COIL EMBOLIZATION STARTED. SEVERAL COMPETITIVE COILS WERE USED AND THE COMPLAINT COIL, A 3MM X *CM GALAXY G3 COIL (GLY120308, L12973) WAS USED. IT WAS DELIVERED TO THE MC BUT THERE WAS A RESISTANCE FELT. THE COMPLAINT COIL WAS PUSHED BACK AND FORTH REPEATEDLY BUT IT WAS NOT ABLE TO ADVANCE. IT WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS FLUSHED ONCE AND A GUIDEWIRE CROSSED WITHOUT ANY PROBLEMS. ANOTHER COIL WAS USED, AND THE PROCEDURE WAS CONTINUED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337918 ↗
• 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 12225656 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM IN A FEMALE PATIENT, A PULSERIDER 8T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3051697019) WAS ALLEGEDLY DEPLOYED AS PER THE INSTRUCTIONS FOR USE (IFU) IN A HYBRID POSITION FROM THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) TO THE ANEURYSM (I.E., PARTIALLY INTRAANEURYSMAL). A CONCOMITANT SL-10® MICROCATHETER (STRYKER) USED FOR COIL DELIVERY WAS ADVANCED TO THE ANEURYSM VIA TRANS-CELL APPROACH. A 4MM X 10CM GALAXY G3 COIL WAS USED BUT THE SIZE DID NOT FIT SO IT WAS REPLACED WITH A 3MM X 8CM GALAXY G3 COIL. HOWEVER, COIL WAS DEEMED TOO SMALL FOR THE ANEURYSM. THE COIL WAS REPLACED WITH A 3.5MM X 9CM GALAXY G3 COIL (GLY123509 / LOT#: UNKNOWN). THE COIL WAS REWINDED MULTIPLE TIMES, BUT IT WAS NOT ABLE TO FRAME THE ANEURYSM AS INTENDED. THE COIL WAS REPLACED WITH A 3MM X 6CM COMPETITOR COIL, BUT IT WAS ALSO NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE COMPETITOR COIL WAS REMOVED AS WELL. THE GUIDEWIRE (BRAND NOT SPECIFIED) WAS REINSERTED, AND THE PHYSICIAN CHANGED THE POSITION OF THE MICROCATHETER. HOWEVER, ANGIOGRAPHY CONFIRMED THAT BLEED

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12211747 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM IN A FEMALE PATIENT, A PULSERIDER 8T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3051697019) WAS ALLEGEDLY DEPLOYED AS PER THE INSTRUCTIONS FOR USE (IFU) IN A HYBRID POSITION FROM THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) TO THE ANEURYSM (I.E., PARTIALLY INTRAANEURYSMAL). A CONCOMITANT SL-10® MICROCATHETER (STRYKER) USED FOR COIL DELIVERY WAS ADVANCED TO THE ANEURYSM VIA TRANS-CELL APPROACH. A 4MM X 10CM GALAXY G3 COIL WAS USED BUT THE SIZE DID NOT FIT SO IT WAS REPLACED WITH A 3MM X 8CM GALAXY G3 COIL. HOWEVER, COIL WAS DEEMED TOO SMALL FOR THE ANEURYSM. THE COIL WAS REPLACED WITH A 3.5MM X 9CM GALAXY G3 COIL (GLY123509 / LOT#: UNKNOWN). THE COIL WAS REWOUNDED MULTIPLE TIMES, BUT IT WAS NOT ABLE TO FRAME THE ANEURYSM AS INTENDED. THE COIL WAS REPLACED WITH A 3MM X 6CM COMPETITOR COIL, BUT IT WAS ALSO NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE COMPETITOR COIL WAS REMOVED AS WELL. THE GUIDEWIRE (BRAND NOT SPECIFIED) WAS REINSERTED, AND THE PHYSICIAN CHANGED THE POSITION OF THE MICROCATHETER. HOWEVER, ANGIOGRAPHY CONFIRMED THAT BLEE

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12211731 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM IN A FEMALE PATIENT, A PULSERIDER 8T, 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3051697019) WAS ALLEGEDLY DEPLOYED AS PER THE INSTRUCTIONS FOR USE (IFU) IN A HYBRID POSITION FROM THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) TO THE ANEURYSM (I.E., PARTIALLY INTRAANEURYSMAL). A CONCOMITANT SL-10® MICROCATHETER (STRYKER) USED FOR COIL DELIVERY WAS ADVANCED TO THE ANEURYSM VIA TRANS-CELL APPROACH. A 4MM X 10CM GALAXY G3 COIL WAS USED BUT THE SIZE DID NOT FIT SO IT WAS REPLACED WITH A 3MM X 8CM GALAXY G3 COIL. HOWEVER, COIL WAS DEEMED TOO SMALL FOR THE ANEURYSM. THE COIL WAS REPLACED WITH A 3.5MM X 9CM GALAXY G3 COIL (GLY123509 / LOT#: UNKNOWN). THE COIL WAS REWINDED MULTIPLE TIMES, BUT IT WAS NOT ABLE TO FRAME THE ANEURYSM AS INTENDED. THE COIL WAS REPLACED WITH A 3MM X 6CM COMPETITOR COIL, BUT IT WAS ALSO NOT ABLE TO BE WINDED AS INTENDED. THEREFORE, THE COMPETITOR COIL WAS REMOVED AS WELL. THE GUIDEWIRE (BRAND NOT SPECIFIED) WAS REINSERTED, AND THE PHYSICIAN CHANGED THE POSITION OF THE MICROCATHETER. HOWEVER, ANGIOGRAPHY CONFIRMED THAT BLEED

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 12211718 ↗
• MalfunctionMar 8, 2021Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA), AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A SHEATH (4F). AN ANGIO CATHETER WAS ADVANCED TOWARD THE LEFT INTERNAL THORACIC ARTERY. AN UNSPECIFIED CONCOMITANT MICROCATHETER (MC) WAS INSERTED INTO THE PATIENT AND ADVANCED TOWARD A SHUNT. COIL EMBOLIZATION STARTED. AFTER SEVERAL GALAXY G3 COILS WERE IMPLANTED, THE COMPLAINT PRODUCT, A 3MM X 8CM GALAXY G3 (GLY120308, L12341) WAS OPENED FOR ADDITIONAL EMBOLIZATION. BUT THE COMPLAINT PRODUCT CAME OUT FROM THE LESION A LITTLE, THEREFORE, THE POSITION OF THE MICROCATHETER WAS CHANGED. THE PHYSICIAN ATTEMPTED TO RE-SHEATH. HOWEVER, IT WAS NOT ABLE TO BE RE-SHEATHED. THE COMPLAINT PRODUCT WAS REPLACED WITH ANOTHER ONE (SAME CATALOG NUMBER). THE PROCEDURE WAS COMPLETED SAFELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435559 ↗
• MalfunctionDec 31, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING A LESION ON THE LUMBAR ARTERY, THE 3MM X 8CM GALAXY G3 COIL (GLY120308 / 30386784) WAS BEING ADVANCED AS USUAL BUT IT WAS NOT ABLE TO ADVANCE FURTHER WHEN IT WAS INSERTED INTO THE HUB OF THE CONCOMITANT 1.9 FR CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL). IT WAS REPORTED THAT A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RESHEATH AND THE DELIVERY WIRE WAS RETRACTED, BUT THE COIL WAS ALREADY DETACHED. THE INTRODUCER SHEATH WAS REMOVED CAREFULLY TO AVOID HAVING THE COIL LEFT INSIDE THE HUB. THE COIL LEFT AS IF IT WAS STUCK ON THE DISTAL END OF THE SHEATH. IT WAS REPLACED WITH ANOTHER 3MM X 8CM GALAXY G3 COIL AND THE REPLACEMENT COIL ADVANCED WITHOUT ANY ISSUE THROUGH THE SAME CONCOMITANT MICROCATHETER. THE PROCEDURE WAS CONTINUED WITHOUT ANY PROCEDURE DELAY. IT WAS REPORTED THAT THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103114 ↗
• MalfunctionDec 28, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF A MAJOR AORTO-PULMONARY COLLATERAL ARTERY (MAPCA) AT THE INTERNAL THORACIC ARTERY, AN ANGIO CATHETER APPROACHED THE RIGHT INTERNAL THORACIC ARTERY FROM THE RIGHT FEMORAL ARTERY, A CONCOMITANT PROGREAT MICROCATHETER (TERUMO) APPROACHED THE DISTAL PART AN COIL EMBOLIZATION STARTED FROM THE SHUNT PART. A COMPETITOR COIL WAS USED AS THE ANCHORING COIL AND IT WAS IMPLANTED. AFTER THAT, THE 3MM X 8CM GALAXY G3 COIL (GLY120308 / L16660) WAS USED. IT WAS REPORTED THAT THE COIL WAS NOT ABLE TO BE WINDED AS INTENDED AND THE MICROCATHETER WAS RETRACTED. THE COMPLAINT COIL WAS THEN REMOVED BUT IT COULD NOT BE RESHEATHED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER 3MM X 8CM GALAXY G3 COIL AND IT WINDED AS INTENDED AND THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED DEVICE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020 INDICATED THAT THE COMPLAINT COIL FAILED TO ADEQUATELY CONFORM TO THE WALLS OF THE ANEURYSM AND THERE WAS DIFFICULTY DURING THE COIL DEPLOYMENT INTO THE ANEURYSM. THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER. BASED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11084518 ↗
• MalfunctionAug 13, 2020Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMERGENCY ISOLATION COIL EMBOLIZATION AT THE DISTAL SPLENIC ARTERY, AFTER THE 2MM X 8CM GALAXY G3 XTRASOFT COIL WAS IMPLANTED IN THE MAIN SPLENIC ARTERY USING THE CARRY LEON MICROCATHETER (UTM) AND THE CARRY LEON HIGH-FLOW MICROCATHETER (UTM) USING THE COAXIAL TECHNIQUE, THREE MORE COILS OF THE SAME SIZE WAS IMPLANTED AND THEN THE COMPLAINT COIL, A 3MM X 8CM GALAXY G3 COIL (GLY120308 / K10094) WAS INSERTED TO PACK THE PARENT BLOOD VESSEL THAT HAS BEEN PACKED BACK, BUT THE COIL COULD NOT BE DETACHED WITH THE ENPOWER CONTROL CABLE. THE DETACHMENT BUTTON WAS PRESSED REPEATEDLY FOUR TIMES. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT BECAUSE IT WAS PAIRED WITH THE DELIVERY WIRE. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. AFTER CONFIRMING WITH ANGIOGRAPHY THAT THERE WAS EMBOLIZATION, THE PROCEDURE WAS CONSIDERED COMPLETED. THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404738 ↗