GALAXY G3 GLY120721Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886704077565), received between Jan 2, 2019 and Oct 16, 2025 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, AFTER THE CONCOMITANT MICROCATHETER (UNSPECIFIED COMPETITOR BRAND) WAS IN PLACE, THE 7MM X 21CM GALAXY G3 (GLY120721 / 30937921) WAS DELIVERED. THE COIL WAS IMPEDED IN THE INTRODUCER, BUT IT WAS STILL ABLE TO BE DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS ABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A NEW COIL (COMPETITOR BRAND) TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23319302 ↗
• MalfunctionMay 23, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A GALAXY G3 7MM X 21CM COIL (GLY120721, 30803154) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH IT, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-MAY-2024 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB AND CABLE WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. NO NECK REMODELING WAS UTILIZED. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WAS NO COIL STRETCHED OR DAMAGED WHEN REMOVED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385680 ↗
• 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 16368998 ↗
• InjuryJan 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA POST-MARKET STUDIES THAT ON (B)(6) 2022 , A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS PERFORMED (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. THE PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 INDICATED THAT THE FOLLOWING CERENOVUS COILS WERE IMPLANTED DURING THE INITIAL ANEURYSM TREATMENT, A

  Patient problems: Aneurysm

  MAUDE report 16138207 ↗
• 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 15547410 ↗
• InjurySep 30, 2022Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED ON THE BASILAR ARTERY (BA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3074237320) WAS DEPLOYED AND AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED VIA TRANSCELL TECHNIQUE. THE COMPLAINT COIL, A 7MM X 21CM GALAXY G3 (GLY120721 / 30357882) WAS USED AS THE FIRST FRAMING COIL. IT WAS REPORTED THAT ¿THERE WAS NO PROBLEM FOR COIL EMBOLIZATION¿ HOWEVER, IT WAS ALSO REPORTED THAT WHEN THE COMPLAINT COIL WAS BEING RE-SHEATHED, THE SHEATH GOT DAMAGED AND THE RE-SHEATHING WAS ¿IMPOSSIBLE.¿ AN ANGIOGRAPHY WAS PERFORMED PRIOR TO DETACHMENT SHOWED THERE WAS BLEEDING. THE INTRACRANIAL HEMORRHAGE EVENT WAS CONSIDERED SERIOUS (MODERATE / MINIMAL) AS THE BLEEDING WAS CONTINUED FOR ABOUT 20 MINUTES. THE COMPLAINT DOCUMENTED THAT ¿SPAINDOLENAGE WAS TAKEN.¿ IT IS NOT KNOWN IF THE EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE COMPLAINT THEN DOCUMENTED THAT ¿THE PROCEDURE WAS COMPLETED BY COIL EMBOLIZATION AND DETACHMENT OF THE PULSERIDER ANRD. THE PHYSICIAN COMMENTED THAT ¿THE RELATIONSHIP WITH THE DEVICES IS UNKN

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15514059 ↗
• MalfunctionSep 24, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET ON THE INTERNAL CAROTID ARTERY (ICA), WHEN THE COMPLAINT COIL, A 7MM X 21CM GALAXY G3 (GLY120721 / 30397646) WAS INSERTED INTO AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER), THERE WAS AN INTENSE RESISTANCE AND THE DELIVERY WIRE WAS UNABLE TO ADVANCE. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED. THE COMPLAINT COIL WAS REMOVED, BUT THE COIL BECAME DETACHED IN THE PROCESS RESULTING IN EARLY DETACHMENT. THE DETACHED COIL WAS INSIDE THE MICROCATHETER; NO FRAGMENTS REMAINED IN THE PATIENT. THE COMPLAINT COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER WITHOUT ANY PROBLEM. THERE WAS NO REPORT OF ANY PATIENT INJURY. ON 12-SEP-2022, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CERENOVUS SALES REPRESENTATIVE THAT THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477630 ↗
• MalfunctionAug 15, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING THE COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA), AN EXSELSIOR SL10 MICROCATHETER WAS USED BY TRANS-CELL TECHNIQUE AFTER A PULSE RIDER WAS IMPLANTED. A 7MM X 21CM GALAXY G3COIL (GLY120721, 30537009) WAS ATTEMPTED TO BE INSERTED INTO THE MICROCATHETER (MC) AS THE FIRST COIL. HOWEVER, THE COMPLAINT COIL GOT STUCK IN THE MICROCATHETER. THE DEVICES WERE REMOVED FROM THE PATIENT AND OBSERVED. THERE WAS RESISTANCE DURING DELIVERING. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED G3 COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15226534 ↗
• MalfunctionMay 18, 2022Difficult to Advance; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A VISCERAL ANEURYSM; TARGETING A LESION AT THE GASTRODUODENAL ARTERY (GDA), THE 7MM X 21CM GALAXY G3 COIL (GLY120721 / 30666677) WAS INSERTED INTO THE PATIENT AND WAS DELIVERED TOGETHER VIA A CONCOMITANT MICROCATHETER (TAKUMI). THERE WAS AN INTENSE RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER FELT AT THE MIDSECTION OF THE MICROCATHETER; IT WAS NOT CLEAR IF CONTINUOUS FLUSH WAS MAINTAINED. IT WAS DOCUMENTED THAT THE DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COMPLAINT COIL WAS REPLACED WITH ANOTHER 7MM X 21CM GALAXY G3 COIL (GLY120721) COIL AND THE REPLACEMENT COIL WAS DELIVERED WITHOUT ANY ISSUES VIA THE SAME MICROCATHETER. SEVERAL COILS WERE USED AND IMPLANTED AFTER THE REPORTED ISSUE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF DAMAGE OBSERVED ON THE MICROCATHETER OR ON THE COMPLAINT DEVICE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. DURING THE MICROSCOPIC INSPECTION, THE COIL WAS OBSERVED TO BE IN A KINKED CONDITION. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430501 ↗
• MalfunctionApr 14, 2022Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED DURING AN EMBOLIZATION OF A FISTULA IN THE ASCENDING AORTA AND THE RIGHT PULMONARY ARTERY, THE 7MM X 21CM GALAXY G3 (GLY120721 / 30537009). WAS CORRECTLY PURGED AND INSERTED INTO A PROWLER 14 MICROCATHETER (606151FX / 30289569). AN ATTEMPT WAS MADE TO RECOVER THE DEVICE WITH THE RESHEATHING TOOL, BUT DURING THE USE OF THE RESHEATHING TOOL, THE HYPOTUBE BROKE WITH NO WAY OF BEING ABLE TO RECOVER THE COIL. NO VISIBLE KINKS NOR OTHER DAMAGES WERE NOTED ON THE MICROCATHETER. THERE WAS NO RESISTANCE EXPERIENCED WHEN THE GUIDEWIRE WAS BEING ADVANCED THROUGH THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (40 ML/HR). ADDITIONAL INFORMATION INDICATED THAT THE HYPOTUBE DID SPLIT INTO TWO PIECES. NO MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE DAMAGED HYPOTUBE. ANOTHER PROWLER 14 MICROCATHETER FROM THE SAME LOT WAS USED WITH THE REPLACEMENT COIL, A 10 MM X 30CM GALAXY G3 (GLY121030 / 30508873). THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115855 ↗
• 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 67-YEAR-OLD FEMALE (SUBJECT 1210-028) 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 31-JUL-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 31-JUL-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 31-JUL-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 GA

  Patient problems: Aneurysm

  MAUDE report 14014533 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE 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 APP

  Patient problems: Ischemia Stroke; Thromboembolism

  MAUDE report 13204758 ↗
• InjuryJan 4, 2022Entrapment of Device; Stretched; Entrapment of Device; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY JUNCTION ANEURYSM, COIL/ANRD ENTANGLEMENT OCCURRED BETWEEN TWO 7MM X 21CM GALAXY G3 COILS (GLY120721/UNKNOWN LOT NUMBERS) AND A PULSERIDER 10T, 3.5MM ¿ 4.5MM ANRD (213-D/UNKNOWN LOT NUMBER). A 7F SHUTTLE SHEATH WAS DELIVERED TO THE IC. A GUIDE POST CATHETER, PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE & LOT NUMBER), AND CHIKAI14 GUIDEWIRE (ASAHI INTECC) WERE DELIVERED TO THE ANEURYSM. THE PULSERIDER ANRD WAS DEPLOYED INSIDE THE ANEURYSM AND COVERED THE ANEURYSM NECK. A TACTICS GUIDING CATHETER (TECHNOCRAT), SL-10 MICROCATHETER (STRYKER), AND THE CHIKAI14 GUIDEWIRE WERE USED, AND THE SL-10 WAS INSERTED INTO THE ANEURYSM VIA TRANS-CELL TECHNIQUE. ANOTHER SL-10 MICROCATHETER WAS INSERTED INTO THE ANEURYSM BY TRANS-CELL TECHNIQUE AND COIL EMBOLIZATION STARTED BY DOUBLE CATHETER TECHNIQUE. ONE OF THE COMPLAINT COILS WAS INSERTED FROM ONE OF THE SL-10 MICROCATHETERS. ANOTHER SAME-SIZED COIL WAS INSERTED FROM THE OTHER SL-10 MICROCATHETER, AND IT WAS ENTANGLED WITH THE OTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152452 ↗
• MalfunctionJan 4, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD)-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY JUNCTION ANEURYSM, COIL/ANRD ENTANGLEMENT OCCURRED BETWEEN TWO 7MM X 21CM GALAXY G3 COILS (GLY120721/UNKNOWN LOT NUMBERS) AND A PULSERIDER 10T, 3.5MM ¿ 4.5MM ANRD (213-D/UNKNOWN LOT NUMBER). A 7F SHUTTLE SHEATH WAS DELIVERED TO THE IC. A GUIDE POST CATHETER, PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE & LOT NUMBER), AND CHIKAI14 GUIDEWIRE (ASAHI INTECC) WERE DELIVERED TO THE ANEURYSM. THE PULSERIDER ANRD WAS DEPLOYED INSIDE THE ANEURYSM AND COVERED THE ANEURYSM NECK. A TACTICS GUIDING CATHETER (TECHNOCRAT), SL-10 MICROCATHETER (STRYKER), AND THE CHIKAI14 GUIDEWIRE WERE USED, AND THE SL-10 WAS INSERTED INTO THE ANEURYSM VIA TRANS-CELL TECHNIQUE. ANOTHER SL-10 MICROCATHETER WAS INSERTED INTO THE ANEURYSM BY TRANS-CELL TECHNIQUE AND COIL EMBOLIZATION STARTED BY DOUBLE CATHETER TECHNIQUE. ONE OF THE COMPLAINT COILS WAS INSERTED FROM ONE OF THE SL-10 MICROCATHETERS. ANOTHER SAME-SIZED COIL WAS INSERTED FROM THE OTHER SL-10 MICROCATHETER, AND IT WAS ENTANGLED WITH THE OTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152451 ↗
• InjuryDec 28, 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) MALE PATIENT WITH A HISTORY OF SMOKING (PREVIOUS) AND MANDIBULAR CANCER UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON (B)(6) 2019 AND EXPERIENCED A THROMBOEMBOLIC EVENT DURING THE PROCEDURE. INTEGRILIN/ASPIRIN WAS ADMINISTERED, AND NEUROFORM ATLAS STENT (STRYKER) WAS IMPLANTED. THE PATIENT WAS ASYMPTOMATIC; THE THROMBOEMBOLIC EVENT WAS ONLY OBSERVED ANGIOGRAPHICALLY. THE PATIENT WAS DISCHARGED HOME WITH SELF-CARE ON (B)(6) 2019 WITH MODIFIED RANKIN SCALE (MRS) SCORE OF 0. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THE DIMENSIONS OF THE BIFURCATION ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 7.5MM, DOME 7.2MM, MAXIMUM ANEURYSM DIAMETER 7.5MM, NECK SIZE 5.9MM, AND DOME-TO-NECK RATIO OF 1.2MM. THE PARENT VESSEL DIAMETER WAS 1.9MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH SIX CERENOVUS COILS: A 7MM X 13.9CM MICRUSFRAME 10 (MFR100713 / L13000), A 7MM X 21CM GALAXY G3 (GLY120721 / L13249), A 5MM X 10CM GALAXY G3 (GLY120510 / L12927), A 3.00MM X 8.00CM GALAXY G3 MINI (GLM930080 / L13613), A 2.00MM X 4.00CM GALAXY G3 MINI (GLM920040 / L11233), AND A 2.00MM X

  Patient problems: Thromboembolism

  MAUDE report 13101695 ↗
• MalfunctionDec 16, 2021Break; Positioning Failure; Break; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM GALAXY G3 COIL (GLY120515 / 30558382) WAS USED; IT WAS RESHEATHED AS PER THE INSTRUCTIONS FOR USE (IFU) BECAUSE ITS SIZE DID NOT FIT THE TARGET LESION. HOWEVER, THE INTRODUCER SHEATH BECAME DAMAGED AND IT COULD NOT BE RESHEATHED. IT WAS REPLACED WITH A 7MM X 21CM GALAXY G3 COIL (GLY120721 / 30530861), BUT IT WAS REPORTED THAT THIS COIL ¿FLEW¿ INTO THE BLOODSTREAM. IT WAS RESHEATHED AS PER THE IFU, BUT THE SHEATH ALSO BECAME DAMAGED AND THE COIL COULD NOT BE RESHEATHED. IT WAS THEN REPLACED WITH THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / 30399412). THIS COIL WAS IMPLANTED BUT IT WAS UNABLE TO BE DETACHED WITH THE ENPOWER CONTROL CABLE (ECB00018200 / 30624693). THE DELIVERY WIRE WAS RETRACTED AND ¿AS IT WAS CUT¿ THEREFORE THE CATHETER KICKED BACK. IT WAS REPORTED THAT COIL EMBOLIZATION WAS STOPPED AND STENT GRAFT INSERTION WAS STARTED. IT WAS REPORTED THAT THE PRODUCTS ARE NOT AVAILABLE TO BE RETURNED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 13 DEC 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020652 ↗
• MalfunctionAug 27, 2021Material Rupture; Stretched; Failure to Advance; Material Rupture; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 7MM X 21CM GALAXY G3 COIL (GLY120721 / L15620) AND THE 5MM X 20CM DELTAFILL 18 COIL (DLF180520 / L16341) WERE INSERTED INTO A CONCOMITANT PROWLER SELECT PLUS MICROCATHETER (CATALOG AND LOT NUMBER UNKNOWN) BUT THERE WAS A SLIGHT RESISTANCE FELT. THE PHYSICIAN KEPT PUSHING THEM BUT THEY WERE NOT ABLE TO ADVANCE. IT WAS REPORTED THAT THE PHYSICIAN CHECKED HIS HAND, HE NOTICED THAT THE SHEATHS ON THE COILS WERE TORN AND THE DELIVERY WIRES WERE PROTRUDING FROM THE SHEATHS. THE PHYSICIAN ATTEMPTED TO RETRACT THE COILS BUT THE COIL COMPONENTS BECAME DAMAGED AND WERE NO LONGER ABLE TO BE USED. IT WAS REPORTED THAT THE COIL COMPONENTS MAY HAVE GOTTEN STUCK ON THE PEEL AWAY PARTS AND BECAME STRETCHED. THE COILS WERE REPLACED AD THE PROCEDURE RESUMED TO COMPLETION. THE COMPLAINT PRODUCTS ARE REPORTED AS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSES. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380466 ↗
• 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 12207736 ↗
• InjuryAug 15, 2019Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE OF AN UNRUPTURED ANEURYSM, AFTER THE STENT WAS IMPLANTED, THE 7MM X 21CM GALAXY G3 COIL (GLY120721 / L12288) WAS SELECTED AS THE FIRST FRAMING COIL, BUT THE COIL FAILED TO DETACH. THE DETACH BUTTON ON THE CONTROL CABLE WAS PRESSED SEVERAL TIMES, BUT THE ISSUE CONTINUED. IT WAS CONFIRMED THAT ALL THE CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT IT BECAME PREMATURELY DETACHED IN THE MICROCATHETER. THE WIRE WAS USED TO PUSH THE PREMATURELY DETACHED COIL INTO THE ANEURYSM. THE PROCEDURE WAS CONCLUDED WITH THE IMPLANTATION OF COMPETITOR COILS. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 8898504 ↗
• MalfunctionJan 2, 2019Off-Label Use; Positioning Problem; Off-Label Use; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INFERIOR MESENTERIC ARTERY (IMA) ANEURYSM, THE 9MM X 33CM MICRUSFRAME18 (MFR180933/S13598) THERMO-MECHANICAL COIL WAS DELIVERED TO THE TARGET LESION, BUT ¿IT COULD NOT MAKE AN ANCHORING¿. THEREFORE, THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COIL, BUT THE DELIVERY WIRE BECAME EXPOSED FROM THE SHEATH AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED. LATER, THE 7MM X 21CM GALAXY G3 (GLY120721/L12844) THERMO-MECHANICAL COIL WAS SELECTED FOR USE BUT THE SAME ISSUE OCCURRED. THE SHEATH BECAME DAMAGED AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN ENPOWER (DCB2000500) DETACHMENT CONTROL BOX WAS USED IN THE CASE. THE PRODUCTS WILL B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210719 ↗
• MalfunctionJan 2, 2019Off-Label Use; Separation Failure; Off-Label Use; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM, THE PHYSICIAN INSERTED THE 7MM X 21CM GALAXY G3 (GLY120721/L12526) THERMO-MECHANICAL COIL INTO THE PATIENT, BUT THE GREEN ¿SYSTEM READY¿ LIGHT WOULD NOT ILLUMINATE, AND COIL COULD NOT BE DETACHED. THEREFORE, THE UNIT POWER WAS TURNED ON AND OFF, AND THE ENPOWER CONTROL CABLE (ECB000182-00/L11302) WAS REPLACED, BUT THE COIL FAILED TO DETACH. THE DEVICES WERE REPLACED, AND THE COIL WAS DETACHED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. OTHER COILS WERE DETACHED WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A CONTRALATERAL APPROACH WAS MADE TOWARDS THE RIGHT INTERNAL ILIAC ARTERY WITH AN UNSPECIFIED MICROCATHETER. THE SUB-PHYSICIAN PREPPED THE COMPLAINT DEVICES AND THE MAIN PHYSICI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209950 ↗