GALAXY G3 GLX120410Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886704077718), received between Mar 28, 2018 and Jan 5, 2026 — classified as 15 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER WAS IN PLACE AND A GALAXY G3 XSFT 4MM X 10CM COIL (PRODUCT CODE GLX120410, LOT NUMBER 30772783) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A SECOND NEW NON J&J COIL TO FILL THE ANEURYSM AND DETACHED THE COIL. WHEN THE DOCTOR FILLED THE ANEURYSM AGAIN WITH A THIRD COIL, A GALAXY G3 XSFT HEL 2MM X 4CM (PRODUCT CODE GLX120204, LOT NUMBER 30964875) AND DETACHED IT, THE THIRD COIL WAS UNABLE TO BE DETACHED. THE DOCTOR ONLY RETRACTED THE THIRD COIL ALONE AND SWITCHED TO A FOURTH NEW COIL (NON J&J) TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 26-DEC-2025 INDICATED A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE SAME CABLE WAS NOT USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE EMBOLIC COILS WERE STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COILS DID NOT STRETCH OR WERE DAMAGED WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957462 ↗
• MalfunctionSep 30, 2024Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHEN THE FILLING THE TARGET SITE WITH A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / 30789568), IT WAS FOUND THAT THE COIL WAS UNABLE TO ROTATE RANDOMLY AND THE SHAPE OF THE COIL WAS NOT IDEAL. THE PHYSICIAN RETRACTED THE COIL AND REMOVED THE COIL AND CONCOMITANT MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) FROM THE PATIENT. THE PHYSICIAN REPLACED THE COIL AND USED THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE WHICH WAS PROLONGED BY APPROXIMATELY 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. THE COMPLAINT INCLUDED TWO PROCEDURAL IMAGE VIDEOS THAT WILL UNDERGO INDEPENDENT PHYSICIAN REVIEW. ON 20-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION IS A PHOTO OF A PROCEDURE IMAGE WAS INCLUDED IN THE COMPLAINT; PER THE SALES REPRESENTATIVE, ¿THE PHOTO PROVIDES ADDITIONAL EVIDENCE RELATED TO THE REPORTED FAILURE.¿ THE PHOTO INCLUDED IS A PROCEDURE IMAGE. THIS IMAGE ALONG WITH THE TWO PROCEDURAL VIDEOS WILL UNDERGO INDEPENDENT PHYSICIAN REVIEW. THE ADDITIONAL INFORMATION INDICATED THAT THE INTENDED PROCEDURE / TARGET VESSEL WAS CEREBRAL ARTERIOVENOUS MALFORMATION (AVM) ENDOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340154 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY ((B)(6)), A 49-YEAR-OLD MALE (B)(6) WITH NO RELEVANT MEDICAL HISTORY, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WITH A MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2023. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 6.8MM, DOME 7MM, MAXIMUM ANEURYSM DIAMETER 8.2MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO OF 1.6MM. THE PARENT VESSEL DIAMETER WAS 3.2MM. COIL EMBOLIZATION WAS PERFORMED WITH EIGHT (8) CERENOVUS COILS: A GALAXY G3 6MM X 15CM (GLY120615/30715066), A GALAXY G3 XSFT 2.5MM X 3.5CM (GLX122535/30563820), A GALAXY G3 MINI 2MM X 3CM (GLM920030/30878377), A GALAXY G3 XSFT 4MM X 8CM (GLX120408/30901816), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/30719529), A GALAXY G3 XSFT 3.5MM X 9CM (GLX123509/30571102), A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/30526863), AND A GALAXY G3 MINI 2MM X 4CM (GLM920040/30830570) VIA AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. ANGIOSUITE PACKING DENSITY WAS NOT MENTIONED IN THE CRF. IMMEDIATE

  Patient problems: Aneurysm

  MAUDE report 19448041 ↗
• InjuryFeb 13, 2023Deformation 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

  THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 68-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF ISCHEMIC STROKE, HEADACHES, CONTROLLED HYPERLIPIDAEMIA, CONTROLLED HYPERTENSION, AND HYPOTHYROIDISM UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED FUSIFORM ANEURYSM ON THE SIDEWALL OF THE LEFT INTERNAL CAROTID ARTERY (ICA), WITH THE PARENT ARTERY LOCATION ON C7 (COMMUNICATING SEGMENT); THE SIZE OF THE TARGET ANEURYSM IS AS FOLLOWS: HEIGHT 12.5MM, DOME 9MM, MAXIMUM ANEURYSM DIAMETER 12.5MM, NECK SIZE 2MM, AND DOME-TO-NECK RATIO (DERIVED) 4.5MM. THE MODIFIED RANKIN SCALE (MRS) SCORE OF 2 ON (B)(6)2021. COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING NINE (9) CERENOVUS COILS WERE DELIVERED VIA AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) AND IMPLANTED: A 7MM X 21CM GALAXY G3 (GLY120721 / 30399454), A 6MM X 15CM GALAXY G3 (GLY120615 / 30409555), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L15756), A 4MM X 8CM GALAXY G3 XSFT (GLX120408 / L16656), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30624678), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30490139), A 3MM X 6CM GALAXY G3 XSFT (GLX120306 / 30624678), A 3MM X 4CM GALAXY G3 XSFT (GLX120304 / 30508852), AND A 2.5MM X 5CM GALAXY G3 XSFT (GLX122505 / L1555

  Patient problems: Aneurysm; Hydrocephalus

  MAUDE report 16369002 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT (B)(6)), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987110 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT 01208-010), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987101 ↗
• InjuryDec 7, 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 54-YEAR-OLD MALE PATIENT WITH A HISTORY OF HYPERTENSION AND BEING A CURRENT SMOKER, UNDERWENT COIL EMBOLIZATION OF A MIDLINE RUPTURED ANEURYSM IN THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND A HUNT & HESS GRADE OF 3 (DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT) ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 8MM, DOME 6MM, MAXIMUM ANEURYSM DIAMETER 8MM, NECK SIZE 5MM, AND THE DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 2.7MM. BASED ON THE MODIFIED INFORMATION RECEIVED ON (B)(6) 2022, COIL EMBOLIZATION WAS PERFORMED AND THE FOLLOWING COILS WERE IMPLANTED: AN 8MM X 16.1CM MICRUSFRAME 10 (MFR100816 / L15372), A 5MM X 15CM GALAXY G3 (GLY120515 / 30517632), A 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535 / K10121), A 6MM X 11.9CM MICRUSFRAME 10 (MFR100611 / L16158), A 5MM X 15CM GALAXY G3 (GLY120515 / K10721), A 4MM X 10CM GALAXY G3 XSFT (GLX120410 / K10380), AND A 3MM X 8CM GALAXY G3 XSFT (GLX120308 / L16495) VIA AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). A BALLOON CATHETER (UNSPECIFIED BRAND) WAS ALSO USED. THE IMMEDIATE POST-PROCEDURE IMAGIN

  Patient problems: Aneurysm; Ischemia Stroke

  MAUDE report 15936859 ↗
• MalfunctionDec 5, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED AT THE LEFT GASTRIC ARTERY, THE PARENT CATHETER(S) ACCESSED THE CELIAC AND A PROGREAT® MICROCATHETER (TERUMO) ACCESSED THE TARGET LESION. INTERLOCK(S) AND PUSHABLE COIL(S) EMBOLIZED THE LESION, AND ¿DETACHABLE WAS USED FOR THE PROXIMAL REGION AS WELL.¿ A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410) WAS WINDED AND IMPLANTED. AFTER THAT, THE SAME SIZE COIL(S) WERE USED. HOWEVER, WHEN ONE OF THE COMPLAINT COILS, A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30624682) WAS USED, THERE WAS RESISTANCE FELT INSIDE THE MICROCATHETER AND ¿WINDING WAS IMPOSSIBLE.¿ THE COMPLAINT COIL WAS RESHEATHED, BUT IT BECAME UNRAVELED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REPLACED AND THE COIL WAS REPLACED WITH A 3MM X 6CM GALAXY G3 XSFT COIL (GLX120306 / 30747539), BUT THE REPLACEMENT COIL ALSO BECAME UNRAVELED INSIDE THE REPLACEMENT MICROCATHETER. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. THE MICROCATHETER WAS REPLACED AND COMPETITOR COIL(S) WERE USED. THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 04-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916370 ↗
• InjuryOct 5, 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 68-YEAR-OLD MALE PATIENT WITH A HISTORY OF SMOKING UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE SACCULAR ANEURYSM AT THE BIFURCATION OF THE ANTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. PRE-PROCEDURE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 5.5MM, DOME 8.4MM, MAXIMUM ANEURYSM DIAMETER 8.4MM, NECK SIZE 4.3MM, AND THE DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.8MM. COIL EMBOLIZATION WAS PERFORMED WITH A TOTAL OF TEN (10) COILS. THE FOLLOWING SIX (6) CERENOVUS COILS WERE IMPLANTED: ONE 7MM X 21CM GALAXY G3 (GLY120721 / L15699), ONE 6MM X 15CM GALAXY G3 (GLY120615 / L13589), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410 / L13315), ONE 3.5MM X 7.5CM GALAXY G3 XSFT (GLX123575 / L13521), ONE 3MM X 6CM GALAXY G3 MINI (GLM930060 / L13936) AND ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030 / L13672). IN ADDITION, FOUR (4) 2MM X 3CM TARGET® 360 NANO¿ COIL (STRYKER) WERE ALSO IMPLANTED. ALL COILS WERE DELIVERED VIA THE HEADWAY® 17 MICROCATHETER (MICROVENTION). A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS IMPLANTED. THERE WAS NO INTRA-OPERATIVE ANEURYSM RUPTURE

  Patient problems: Ischemia Stroke

  MAUDE report 15547509 ↗
• 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 24-MAY-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 15107611 ↗
• MalfunctionJul 13, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A SUPERIOR MESENTERIC ARTERY ANEURYSM AND MIDDLE COLIC ARTERY ANEURYSM, AN APPROACH WAS MADE WITH THE CATHETER TOWARD THE MIDDLE COLIC ARTERY ANEURYSM. THE EMBOLIZATION WAS PERFORMED BY PACKING AND RETURNING BRANCHES. THE FIRST AND SECOND BRANCHES WERE EMBOLIZED WITH TARGET XL COILS (STRYKER). THE 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30419315) WAS USED AS THE THIRD COIL. THE COIL WAS TAKEN OUT. WHEN THE COIL WAS USED BY PRESSING AGAINST THE HUB OF THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER) AND REWOUND SEVERAL TIMES, THE COMPLAINT COIL UNRAVELED. THE COMPLAINT COIL WAS REMOVED WITH THE MICROCATHETER; THE MICROCATHETER GAINED ACCESS TO THE EMBOLIZATION POINT AND IMAGING REVEALED THAT THE FLOW HAD STOPPED. THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO PROBLEM WITH THE PATIENT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO RESISTANCE WAS REPORTED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THE REPORTED ISSUE OCCURRED DURING THE REPOSITIONING IN THE ANEURYSM (WITHDRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15004393 ↗
• 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 14687438 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A (B)(6) FEMALE (SUBJECT (B)(6)) WITH A PAST MEDICAL HISTORY OF CONTROLLED HYPERTENSION UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) ON (B)(6)2021. THE PATIENT EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6)2022. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6)2022 SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. SHE SUBSEQUENTLY UNDERWENT ANEURYSM RETREATMENT DUE TO RESIDUAL ANEURYSM ON (B)(6) 2022. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2021 REVEALED A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 6MM, DOME 4MM, MAXIMUM ANEURYSM DIAMETER 6MM, NECK SIZE 4MM, AND DOME-TO-NECK RATIO 1.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED ON (B)(6)2021. A TOTAL OF FOUR CERENOVUS COILS WERE IMPLANTED DURING THE PROCEDURE: GALAXY G3 7MM X 21CM (GLY120721, 30470358), GALAXY G3 XSFT HEL 2MM X 8CM (GLX120208, 3045189), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30504557) AND GALAXY G3 MIN

  Patient problems: Aneurysm

  MAUDE report 14014638 ↗
• MalfunctionMar 23, 2022Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR THE INTRACRANIAL ANCH ANEURYSM, THE PHYSICIAN USED THE DOUBLE CATHETER TECHNIQUE, AND TWO MICROCATHETERS (EXCELSIOR SL10) WERE USED FOR BOTH. AFTER THE IMPLANTATION OF TWO COMPETITIVE COILS, THE USE OF A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410, 30637470) WAS ATTEMPTED. BECAUSE THERE WAS A RESISTANCE FELT BETWEEN THE COMPLAINT PRODUCT AND THE MICROCATHETER DURING INSERTION IN THE MICROCATHETER, THE COIL BECAME UNRAVELED WHEN IT WAS REMOVED FROM THE MICROCATHETER. AFTER THAT, ABOUT FIVE COMPETITIVE COILS WERE USED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO EFFECT ON THE PATIENT. THE PATIENT¿S STATUS IS GOOD. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860868 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Thromboembolism

  MAUDE report 13090775 ↗
• MalfunctionAug 27, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / L13519) WAS USED AS A FRAMING COIL DURING THE PROCEDURE. IT WAS CONNECTED TO THE ENPOWER CONTROL CABLE (ECB00018200 / 30544470) AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THE DETACHMENT BUTTON WAS PRESSED, THE POWER LAMP ON THE DCB2 WAS TURNED ON BUT THE AUDIBLE SIGNAL WAS NOT HEARD. THE COMPLAINT COIL COULD NOT BE DETACHED. THE COIL AND THE CONTROL CABLE WERE BOTH REPLACED AND THE REPLACEMENT COIL DETACHED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 19 AUGUST 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COMPLAINT COIL AND COMPLAINT CONTROL CABLE ¿WERE CONNECTED FOUR OR FIVE TIMES REPEATEDLY BUT NO SOUND AND THE LAMP DID NOT ILLUMINATE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380876 ↗
• InjuryJul 21, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF UNCONTROLLED HYPERTENSION AND ACTIVE SMOKING UNDERWENT COIL EMBOLIZATION OF A RUPTURED WIDE-NECKED LEFT POSTERIOR CEREBRAL ARTERY (PCA) ANEURYSM WITH ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) (HUNT & HESS GRADE 3) ON (B)(6) 2019. AT THE 180-DAY (6-MONTH) FOLLOW-UP VISIT ON (B)(6) 2020, DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED SHOWED MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS IIIB: RESIDUAL ANEURYSM WITH CONTRAST ALONG ANEURYSM WALL. MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. ON (B)(6) 2020, THE PATIENT SUBSEQUENTLY UNDERWENT A BALLOON-ASSISTED COIL EMBOLIZATION DUE TO INCREASE IN ANEURYSM SIZE. A TOTAL OF 19 COMPETITOR COILS WERE IMPLANTED WITH MODIFIED RAYMOND-ROY SCORE OF CLASS IIIB. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON THE FOLLOWING DAY. ON (B)(6) 2019, IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED POSTERIOR CIRCULATION ANEURYSM ON THE LEFT SIDE WALL OF THE PCA WITH THE FOLLOWING DIMENSIONS: HEIGHT 8.7MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 11.1MM, NECK SIZE 6.0MM, AND DOME-TO-NECK RATIO 1.9MM.

  Patient problems: Aneurysm

  MAUDE report 12207741 ↗
• MalfunctionJul 15, 2021Break; Difficult to Advance; Positioning Problem; Break; Difficult to Advance; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PERIPHERAL ARTERIAL OCCLUSION PROCEDURE TARGETING A COLONIC ARTERY ANEURYSM, THE 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30376373) WAS THE FIRST COIL USED; IT WAS RESHEATHED BECAUSE IT COULD NOT BE WINDED AS INTENDED EVENT THOUGH IT WAS RE-WINDED SEVERAL TIMES. THE COMPLAINT COIL WAS RE-INSERTED BUT THERE WAS A SLIGHT RESISTANCE FELT AND PART OF THE SHEATH BECAME DAMAGED AND BECAME DIFFICULT TO DELIVER. THE COIL COMPONENT WAS REPORTED AS NORMAL WITHOUT ANY ISSUE. ANOTHER COIL OF A DIFFERENT SIZE WAS CHOSEN AS A REPLACEMENT AND IT WAS IMPLANTED IN THE TARGET LESION WITHOUT ANY ISSUE. THE PROCEDURE WAS COMPLETED WITH TWO ELECTRONIC COILS AND EIGHT PUSHABLE COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178559 ↗
• 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 11740282 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE STERLING STUDY, A (B)(6)-YEAR OLD FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF FOCAL NEUROLOGICAL DEFICITS, HEADACHES, SMOKING (CURRENT), AND INTRACRANIAL ANEURYSMS (TOTAL OF 4) PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) AND SUBSEQUENTLY UNDERWENT COIL EMBOLIZATION OF A RUPTURED POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY REVEALED A RUPTURED RIGHT POSTERIOR COMMUNICATING ARTERY BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 3.3MM, DOME 5.7MM, MAXIMUM ANEURYSM DIAMETER 7.8MM, NECK SIZE 4.3MM, AND DOME-TO-NECK RATIO 1.3MM. THE PARENT VESSEL DIAMETER WAS 3.4MM. COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L16657), ONE 3MM X 8CM GALAXY G3 MINI (GLM930080/L13408), TWO 3MM X 6CM GALAXY G3 MINI (GLM930060/L14489 & L12012), ONE 2MM X 6CM GALAXY G3 MINI (GLM920060/L16340), AND ONE 2MM X 4CM GALAXY G3 MINI (GLM920040/L15998)) VIA AN ECHELON 10 (MEDTRONIC) MICROCATHETER. THE PATIENT EXPERIENCED A THROMBOEMBOLIC EVENT AT AN UNSPECIFIED TIME DURING THE PROCEDURE, WHICH RESOLVED WITH MEDICATION. THE PATIENT WAS REPORTEDLY A

  Patient problems: Stroke/CVA

  MAUDE report 10677679 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) STUDY, A (B)(6) FEMALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES, MIGRAINES, AND ANXIETY PRESENTED WITH A SUBARACHNOID HEMORRHAGE (HUNT & HESS GRADE 2) ON (B)(6) 2019 AND SUBSEQUENTLY UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) BIFURCATION ANEURYSM ON (B)(6) 2019. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RUPTURED MIDLINE ACOM BIFURCATION ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 5.7MM, DOME 8.1MM, MAXIMUM ANEURYSM DIAMETER 8.1MM, NECK SIZE 2.8MM, AND DOME-TO-NECK RATIO 2.9MM. THE PARENT VESSEL DIAMETER WAS 2.2MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/UNKNOWN LOT #), ONE 2.5MM X 5CM GALAXY G3 XSFT (GLX122505/ L13333), ONE 2MM X 2CM GALAXY G3 XSFT (GLX120202/L13330), ONE 2.5MM X 4.5CM GALAXY G3 MINI (GLM925045/S15174), ONE 1.5MM X 2.5CM GALAXY G3 MINI (GLM915025/L15425), ONE 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L14685), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/L15571), TWO 1MM X 2CM GALAXY G3 MINI (GLM910020/L14855), TWO 1MM X 2.5CM GALAXY G3 MINI (GLM910025/L13971), ONE 1MM X 1.5CM GALA

  Patient problems: Stroke/CVA

  MAUDE report 10391211 ↗
• MalfunctionAug 3, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION TARGETING A 12MM X 8MM MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, WHILE DEPLOYING THE 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / L16657), THE LAST LOOP OF THE COIL WAS PUSHING ON THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) CAUSING THE MICROCATHETER TO RETREAT. THERE WAS NO DIFFICULTY WITH POSITIONING THE COIL IN THE TARGET LESION, THERE WAS NO ISSUE WITH THE COIL CONFORMING TO THE ANEURYSM WALL. IT WAS REPORTED THAT THE COIL WAS WITHDRAWN AND REPOSITIONING TWO TIMES. THE COIL WAS REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM. NO DAMAGE WAS NOTED ON THE COIL WHEN IT WAS REMOVED. THE EMBOLIC COIL AND ITS RESPECTIVE DEVICE POSITIONING UNIT (DPU) DID NOT PROTRUDE FROM THE COIL INTRODUCER. THE PHYSICIAN HAD THE SAME EXPERIENCE WITH THREE OTHER COILS: TWO 7MM X 13.9CM MICRUSFRAME 10 COILS FROM THE SAME LOT (L15689), AND A 6MM X 11.9CM MICRUSFRAME 10 COIL (MFR100611 / L16500). THE PHYSICIAN SWITCHED TO AXIUM COILS (MEDTRONIC) AND WAS ABLE TO DELIVER THE AXIUM COILS USING THE SAME SL-10® MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY SIGNIFICANT PROCEDURAL DELAY; THERE WAS NO REPORT OF ANY PATIENT ADVERS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10360021 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE STERLING STUDY, A (B)(6)-YEAR OLD MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020 REQUIRING REPEAT COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX

  Patient problems: No Code Available

  MAUDE report 10239994 ↗
• MalfunctionDec 4, 2019Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN INTRACRANIAL ANEURYSM, THE PHYSICIAN COULD NOT ADVANCE THE 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / L13065) THROUGH THE SL-10® MICROCATHETER (STRYKER) TO THE TARGET SITE. THE RESISTANCE WAS FELT AT THE SHAFT / DISTAL TIP DURING THE ATTEMPT TO DELIVERY THE COIL TO THE TARGET POSITION. THE COIL AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT AS A SYSTEM; THE COIL DID NOT EXIT THE MICROCATHETER AND DID NOT REACH THE TARGET SITE. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. IT WAS NOT KNOWN IF THE COIL OR THE COIL DELIVERY SYSTEM WAS DAMAGE DUE TO THE RESISTANCE ENCOUNTERED DURING THE ATTEMPT TO ADVANCE TOWARD THE TARGET SITE AS THE COIL WAS STILL INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THERE WAS VISUAL DAMAGE TO THE MICROCATHETER. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413789 ↗
• MalfunctionDec 2, 2019Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EMERGENT COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / L13245) WAS THE SECOND COIL USED BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE HEADWAY® 17 MICROCATHETER (MICROVENTION-TERUMO); THERE WAS ALSO RESISTANCE DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER, THOUGH THE TIMING OF WHEN THIS OCCURRED WAS NOT AVAILABLE. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE PHYSICIAN WAS ACCESSING THE TARGET SITE. THE PHYSICIAN ATTEMPTED TO PULL THE COIL OUT, BUT THE COIL BECAME UNRAVELED. THE COMPLAINT COIL AND THE CONCOMITANT MICROCATHETER WERE REMOVED AS A RESULT. IT WAS REPORTED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. THERE WAS NO REPORT OF PATIENT ADVERSE EVENT OR COMPLICATION, AND NO CLINICALLY SIGNIFICANT PROCEDURE DELAY AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397417 ↗