ORBIT GALAXY 640CF0515Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886704030300), received between Mar 8, 2017 and Dec 18, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 31748453) WAS USED AND THE COIL HYPO TUBE BROKE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT AND WITHOUT ANY DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846296 ↗
• MalfunctionDec 5, 2025Material Separation; Difficult to Advance; Material Twisted/Bent; Material Separation; Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 31613390) ENCOUNTERED A LOT OF RESISTANCE AND BECAME BENT AND THE DELIVERY WIRE ¿GOT BROKEN.¿ IT WAS ALSO REPORTED THAT THE 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / 31467308) ENCOUNTERED RESISTANCE DURING THE COIL ADVANCEMENT. THE 132CM EMBOVAC 71 ASPIRATION CATHETER (IC71132CA / 31411520) GOT STUCK IN THE HOOP. THE PROCEDURE WAS DELAYED BY 15 MINUTES. IT WAS SUCCESSFULLY COMPLETED BY USING ¿ANOTHER CATHETER AND COILS.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. BASED ON THE EVENT DESCRIPTION, THE ISSUE REPORTED WITH THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 31613390) MEETS USFDA REPORTING CRITERIA A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730760 ↗
• MalfunctionMar 17, 2025Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, WHEN THE DOCTOR FILLED THE ANEURYSM WITH AN ORBIT GALAXY COIL (640CF0515, 31064353), IT WAS FOUND THAT THE SHAPE OF IT WAS NOT IDEAL. THE DOCTOR ONLY RETRACTED THE COIL AND FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-MAR-2025 INDICATED THAT THERE WAS NO POSITIONING DIFFICULTY. THE COIL DID NOT FAIL TO CONFORM TO THE WALLS OF THE ANEURYSM. THERE WAS NO ANEURYSM CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT. PRIOR TO THIS COIL, THERE WERE OTHER COILS THAT HAD BEEN ABLE TO BE ADVANCED THROUGH THE SAME MICROCATHETER. THE COIL WAS NOT ENTANGLED WITH OTHER IMPLANTED COILS. THE PROCEDURE WAS DELAYS BY 5 MINUTES, RESULTING IN NO CLINICAL SIGNIFICANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619985 ↗
• MalfunctionSep 30, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0515 / 31045530) FILLED THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A COIL EMBOLIZATION PROCEDURE TARGETING A LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. THE COIL WAS STILL ATTACHED TO ITS DELIVERY SYSTEM WHEN IT WAS REMOVED. THE CONCOMITANT MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). PER THE INFORMATION, THE ORBIT GALAXY COIL WAS ¿IN HYDRO-DETACHABLE MODE, THE SYRINGE WAS NORMAL BEFORE USE.¿ ALL CONNECTION FIT WITHOUT APPLICATION OF FORCE. THE REPLACEMENT COIL WAS A 5MM X 10CM AXIUM¿ 3D COIL (MEDTRONIC). THE INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND NO DELAY IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340715 ↗
• MalfunctionApr 1, 2024Material Separation; Failure to Advance; Premature Separation; Material Separation; Failure to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, WHEN THE PHYSICIAN WAS DELIVERY THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 31098557), IT WAS IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED / INTRODUCED INTO THE MICROCATHETER. IT WAS OBSERVED THAT THE COIL WAS PREMATURELY DETACHED IN THE MICROCATHETER; THE COIL WAS DETACHED PREMATURELY FROM THE DELIVERY SYSTEM. A NEW COIL WAS USED AS REPLACEMENT WITH THE ORIGINAL CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO WAS INCLUDED IN THE COMPLAINT. ON 21-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE EMBOLIC COIL DID DETACH AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT. THE INFORMATION INDICATED THAT THE COIL DID BECOME SEPARATED INTO TWO OR MORE PIECES. THE EVENT DID NOT RESULT IN ANY REDUCED / RESTRICTED BLOOD FLOW. THE MICROCATHETER USED WAS A COMPETITOR BRAND; A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE REPLACEMENT COIL WAS ANOTHER 5MM X 15CM ORBIT GALAXY COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19016411 ↗
• MalfunctionMar 21, 2024Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / (B)(6)) GOT DETACHED INSIDE THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) DURING ITS DEPLOYMENT INSIDE THE ANEURYSM. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THE COMPLAINT COIL WAS REMOVED. THERE WAS NO NEGATIVE PATIENT IMPACT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED. ON 12-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET WAS A 5.9MM X 5.2MM INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID ANEURYSM. THE INFORMATION INDICATED THAT THE COIL DID NOT PREMATURELY DETACH AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT; THE COIL DID NOT BECOME SEPARATED INTO TWO OR MORE PIECES. THE MICROCATHETER USED WAS NOT A CERENOVUS MICROCATHETER. THE SAME MICROCATHETER WAS USED WITH THE REPLACEMENT COIL, A 5MM X 10CM ORBIT GALAXY COMPLEX FILL COIL ((B)(6)). THE PHYSICIAN DID NOT CONSIDER THE 5-MINUTE EXTENSION IN THE PROCEDURE TO BE CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956522 ↗
• InjuryJan 17, 2023Fracture; Difficult to Advance; Premature Separation; Fracture; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THE 70-YEAR-OLD FEMALE PATIENT WAS SUFFERING FROM A RUPTURED INTRACRANIAL ANEURYSM HEMORRHAGE UNDERWENT AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE. THE COMPLAINT COIL, A 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 30716733) WAS USED. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING THE COIL DELIVERY PROCESS. WHEN THE PHYSICIAN WAS ADJUSTING THE COIL ANGLE, THE COIL WAS FOUND TO BE BROKEN. IT ALSO PREMATURELY DETACHED WITHOUT THE INITIATION OF THE DETACHMENT PROCESS. THE PHYSICIAN USED AN EV3 STENT RETRIEVER TO COMPLETELY REMOVE THE COIL. IT WAS REPORTED THAT NO PART OF THE COMPLAINT COIL REMAINED IN THE PATIENT. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY ONE (1) HOUR. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE COMPLAINT INCLUDED THREE (3) PHOTOS OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16185513 ↗
• MalfunctionOct 27, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN TRIED TO DEPLOY A 6X20 ORBIT GALAXY COIL (640CR0620, 30558303) THROUGH AN SL10 MICROCATHETER (MC). WHILE DEPLOYING, THE PHYSICIAN ENCOUNTERED RESISTANCE MIDWAY THROUGH THE CATHETER. THE PHYSICIAN TRIED TO ADVANCE UNSPECIFIED COILS BUT FACED RESISTANCE. THEN, THE DOCTOR TRIED TO DEPLOY A 5X15 ORBIT GALAXY (640CF0515, 30668570) AS WELL BUT EXPERIENCED SIMILAR RESISTANCE MIDWAY THROUGH THE MC. THE DOCTOR REMOVED BOTH COILS AND DEPLOYED STRYKER COILS THROUGH THE SAME MICROCATHETER AND FINISHED THE CASE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE 5X15 ORBIT GALAXY (640CF0515, 30668570) RECEIVED, THE EMBOLIC COIL HAS A KINKED CONDITION ON ITS DISTAL END, AND IT WAS NOTED THAT IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679457 ↗
• MalfunctionSep 9, 2022Premature Separation; Premature Separation

  AS REPORTED BY THE HEALTH AUTHORITIES, THIS WAS A COIL EMBOLIZATION OF A SPONTANEOUS SUBARACHNOID ANTERIOR COMMUNICATING ANEURYSM RUPTURE AND HEMORRHAGE. IT WAS FOUND THAT THE SPRING COIL OF A 5X15 ORBIT GALAXY COIL (640CF0515, 30683880) HAD FALLEN OFF IN ADVANCE AND REMAINED IN THE CATHETER. THE DOCTOR IMMEDIATELY TOOK OUT THE FALLEN SPRING COIL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392900 ↗
• MalfunctionSep 2, 2022Break; Separation Failure; Break; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE HUB OF THE COMPLAINT COIL, AN ORBIT GALAXY COMPLEX FILL 5MM X 15CM COIL (640CF0515 / 30512981) HAS BEEN DAMAGED AND AS A RESULT, IT AFFECTED DETACHMENT. THE COIL DETACHMENT WAS NOT SUCCESSFULLY DUE TO THE DAMAGE TO THE HUB. THE PHYSICIAN DECIDED TO RETRACT THE COIL AND USED ¿THE SAME-LIKE PRODUCT.¿ THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351707 ↗
• MalfunctionMay 31, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 5X15 ORBIT GALAXY COIL (640CF0515, 30633037) WAS BRING USED AS THE FIRST COIL. THE PHYSICIAN FELT STRONG RESISTANCE WHILE ADVANCING THE COIL THROUGH THE HEADWAY17 MICROCATHETER (MC). IT WAS PROXIMAL MC AREA. THE PHYSICIAN COULDN'T FIGURE OUT THE REASON OF THE RESISTANCE AND STIFFNESS WHEN HE ADVANCED THE COIL. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547165 ↗
• MalfunctionJun 4, 2021Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ANEURYSM COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 30401399) COULD NOT BE WITHDRAWN BECAUSE THE ZIPPER BECAME STUCK. THE PHYSICIAN SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ADDITIONAL INFORMATION WAS PROVIDED ON 10 MAY 2021. THE INFORMATION INDICATED THAT THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) DROPPED OF THE ANEURYSM AND HAD TO BE ADJUSTED. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE TO THE INTRODUCER SHEATH. THERE WAS NO RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER. THE COIL WAS NOT POSITIONED AT A SHARP ANGLE TO THE MICROCATHETER AND THERE WAS A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND THE DELIVERY SYSTEM VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE REPORTED ISSUE DID NOT RESULT IN ANY BLOOD FLOW RESTRICTION / REDUCTION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943075 ↗
• MalfunctionApr 23, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN COULD NOT DETACH THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 30409476). THE PHYSICIAN ATTEMPTED TO RAISE THE PRESSURE AND CHANGED TO A NEW DETACHMENT SYRINGE, BUT THE COIL COULD NOT BE DETACHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ONE PROCEDURAL IMAGE WAS INCLUDED IN THE COMPLAINT FILE. THE IMAGE UNDERWENT INDEPENDENT PHYSICIAN REVIEW ON 09 APRIL 2021. THE RESULTS ARE AS FOLLOWING: "A SINGLE LATERAL IMAGE IS PROVIDED FOR REVIEW WITH A BRIEF DESCRIPTION OF A COIL FAILURE TO DETACH. THERE IS A PARTIALLY COILED (CAVERNOUS?) ANEURYSM AND WHAT APPEARS TO BE A PROWLER MICROCATHETER IN THE CAROTID WITH THE DISTAL TIP IN THE MIDDLE CEREBRAL ARTERY. THERE IS A SECOND MICROCATHETER IN THE ANEURYSM WITH A COIL IN PLACE AND THE DETACHMENT MARKER AT THE PROXIMAL CATHETER MARKER, APPROPRIATELY POSITIONED. THE PHYSICIAN TRIED TO DETACH THE COIL, RAISED THE PRESSURE, AND ALSO CHANGED THE PUMP AND COIL STILL FAILED TO DETACH. FAILURE TO DETACH IS A KNOWN ISSUE ALTHOUGH IT IS EXTREMELY UNCOMMON. I SEE NO ANATOMIC CAUSE FOR THE DETACHMENT FAILURE. ANALYSIS OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719699 ↗
• MalfunctionApr 23, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / LOT# UNKNOWN) FAILED TO DETACH THE AFTER SEVERAL ATTEMPTS. THE SYRINGE WAS REPORTED TO BE WORKING WITHOUT ANY ISSUE. THERE WAS NO PROCEDURE DELAY AS A RESULT OF THE EVENT; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717526 ↗
• MalfunctionMar 16, 2021Material Separation; Premature Separation; Material Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 30409476) WAS DELIVERED TO THE TARGET ANEURYSM; THE COIL REACHED THE TARGET POSITION FIRST. WHEN THE PHYSICIAN WAS ATTEMPTING TO DETACH THE COIL, THE GUIDING ENVOY DA CATHETER RETRACTED BACK A BIT AND THE CONCOMITANT MICROCATHETER MOVED FROM THE TARGET POSITION. THE PHYSICIAN HAD PLANNED ON REMOVING THE GUIDING CATHETER AND THE MICROCATHETER AND SWITCH TO A NEW GUIDING CATHETER, HOWEVER, WHEN THE PHYSICIAN REMOVED THE COIL, PART OF THE COIL BACKED INTO THE INTRODUCER AND THE COIL BECAME PREMATURELY DETACHED IN THE INTRODUCER. THE PHYSICIAN REPLACED THE COIL WITH ANOTHER 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE FILE. THE PHOTO UNDERWENT REVIEW BY THE PRODUCT ANALYSIS TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495958 ↗
• InjuryDec 7, 2020Failure to Advance; Difficult to Advance; Positioning Problem; Premature Separation; Failure to Advance; Difficult to Advance; Positioning Problem; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF AN INTRACRANIAL ANEURYSM, A 5MM X 15CM ORBIT GALAXY TDL COMPLEX FILL (640CF0515/30298966) COIL PREMATURELY DETACHED AND RELEASED TO THE MIDDLE AND ANTERIOR CEREBRAL ARTERY. A SAB640 STENT RETRIEVER WAS USED IN ATTEMPT TO RETRIEVE THE COIL BUT WAS UNSUCCESSFUL. THEREFORE, A 4.5MM X 22 ENTERPRISE NO TIP ENTERPRISE (ENC452200/11213047) STENT WAS IMPLANTED VIA A PROWLER SELECT PLUS (606-S255X/30378173) MICROCATHETER AT THE MIDDLE CEREBRAL ARTERY (MCA) TO SECURE THE COIL TO THE VESSEL WALL. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE COIL THROUGH THE HEADWAY 17 (MICROVENTION) MICROCATHETER AND THE 6F ENVOY (67025800/30232241) GUIDE CATHETER SUBSEQUENTLY MOVED FROM THE C2 TO THE M1. IT WAS FURTHER STATED THAT THIS MAY HAVE CAUSED THE COIL TO UNINTENDEDLY RELEASE. THE PATIENT HAS BEEN AWAKE. THE VESSELS WERE CONSIDERED NORMAL, WITHOUT ACUTE BENDS OR EXCESSIVE TORTUOSITY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT POST-PROCEDURE ANGIOGRAPHY SHOWED SMOOTH BLOOD FLOW IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA) AND THE ORIGINAL ANEURYSM WAS NO LONGER DEVELOPED. THROMBOSIS WAS NOTED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 10958156 ↗
• MalfunctionOct 26, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT (SG) COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT ILIAC ARTERY, THE ORBIT GALAXY COMPLEX FILL 5MM X 15CM COIL (640CF0515 / 30036030) WAS ONE OF THE COILS USED DURING THE PARENT ARTERY OCCLUSION PORTION OF THE PROCEDURE, BUT THE 5 MM X 15 CM ORBIT GALAXY COIL COULD NOT BE RESHEATHED. THE ZIPPER ON THE COIL COULD NOT BE UNZIPPED. IT WAS CONFIRMED THAT THE PHYSICIAN DID NOT APPLY EXCESSIVE FORCE DURING THE UNSHEATHING AND RESHEATHING OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE ORBIT GALAXY COMPLEX FILL 5MM X 15CM COIL WAS RETURNED FOR EVALUATION AND THE EMBOLIC COIL WAS OBSERVED IN A TANGLED CONDITION AND THE COIL WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8010515 ↗
• MalfunctionOct 10, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMBOLIZATION PROCEDURE, THE ORBIT GALAXY COMPLEX FILL 5MM X 15CM COIL (640CF0515 / 17732800) COULD NOT BE RESHEATHED. IT WAS CONFIRMED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY ISSUE OR DIFFICULTY AND ADEQUATE FLUSH WAS MAINTAINED. THERE WAS NO DIFFICULTY ENCOUNTERED DURING THE UNSHEATHING (STRIPPING AWAY) THE INTRODUCER TUBE FROM THE DELIVERY TUBE ON THE DETACHABLE COIL SYSTEM (DCS). THERE WAS NO REPORT OF PATIENT INJURY OR CONSEQUENCE RELATED TO THE EVENT. THE PRODUCT WAS RETURNED FOR EVALUATION AND THE EMBOLIC COIL WAS NOTED TO BE STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952666 ↗
• MalfunctionOct 4, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AFTER ANEURYSMAL SUBARACHNOID HEMORRHAGE (SAH), THE 5MM X 15CM ORBIT GALAXY TDL COMPLEX FILL (640CF0515/30057852) HYDRAULIC COIL WAS SELECTED FOR USE AS A FRAMING COIL, BUT THE EMBOLIC COIL COULD NOT BE PROPERLY PLACED IN THE ANEURYSM. THE PHYSICIAN TRIED TO RE-SHEATH THE COIL, BUT THE SHEATH BECAME DAMAGED. THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL WHICH FAILED DUE TO THE DAMAGED INTRODUCER SHEATH. THE COIL AND SL-10 (STRYKER) MICROCATHETER WERE REMOVED AS A UNIT FROM THE PATIENT VASCULATURE. THE COIL WAS REMOVED FROM THE MICROCATHETER AND THE MICROCATHETER WAS RE-APPROACHED TO THE LESION WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED TO THE EVENT. THE COMPLAINT PRODUCT WAS 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 DAMAGE/DEFECT WAS NOTED PRIOR TO USE. THE COIL WAS UNSHEATHED WITHOUT ANY ISSUE. NO RESISTANCE WAS ENCOUNTERED BETWEEN THE COIL AND THE MICROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937033 ↗
• MalfunctionJun 28, 2018Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A COIL WAS UNABLE TO BE RE-SHEATHED DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE COIL OR COIL DETACHMENT SYSTEM PRIOR TO THE PROCEDURE OR UPON REMOVAL FROM THE PATIENT. THERE WERE NO KINKS OR BENDS NOTED TO THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DIFFICULTY WAS ENCOUNTERED WHILE UNSHEATHING THE COIL. THE DEVICE WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). REPORTEDLY, THE PATIENT WAS ADMITTED WITH SAH, SEVERE BLEED, AND HEADACHE. NOTE: THIS EVENT WAS DEEMED MDR REPORTABLE AS A RESULT OF DEVICE EVALUATION FINDINGS. PLEASE SEE FOR FURTHER DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646610 ↗
• MalfunctionApr 19, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THREE COILS (ONE OG CMPLX XTRASOFT (640CX2505/17665789) AND TWO OG TDL CMPLX FILL (640CF0412/17468436) (640CF0515/17656467), FAILED TO RESHEATH DURING THE PROCEDURE. THE COILS WERE REPLACED WITH SAME-SIZED COILS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT INJURY. THE PRODUCTS WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7443992 ↗
• MalfunctionFeb 15, 2018Unraveled Material; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM FOR SUBARACHNOID HEMORRHAGE (SAH) INTERNAL CAROTID ARTERY (ICA), THE MICRUSFRAM10 (MFR100626, S11575) WAS INSERTED INTO THE SHEATH INTRODUCER BUT IT GOT STUCK. THE COIL DID NOT MOVE FROM THE BEGINNING OF INSERTION. THE PHYSICIAN TRIED TO INSET THE COIL BUT THERE WAS PEEL BREAKAGE. AN ORBIT GALAXY FILL (640CF0515, 17694769) BECAME UNRAVELED DURING EMBOLIZATION. THE COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 10 MINUTES. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCTS ARE NOT AVAILABLE FOR THE INVESTIGATION. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT¿S VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. A GUIDEWIRE (ASHAHI), A GUIDING CATHETER (MEDTRO), A MICRO CATHETER (SL10,STRYKER) WERE ALSO USED F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7272888 ↗
• MalfunctionDec 6, 2017Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 17625445) BECAME STRETCHED. THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088067 ↗
• MalfunctionMar 8, 2017Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING THE PROCEDURE, AN ORBIT GALAXY COIL (640CF0515/17518425) KINKED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM FOR DURAL ARTERIOVENOUS FISTULA AT THE SIGMOID. THE PATIENT¿S VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. A CONTRALATERAL APPROACH WAS MADE FROM RIGHT TRANSVERSE SIGMOID AND COIL EMBOLIZATION WAS PERFORMED. EMBOLIZATION USING COILS (COMPETITOR'S COILS AND A GALAXY 7*21) WAS PERFORMED. AFTER WHICH THE OG CMPLX FILL (COMPLAINT COIL) WAS USED, HOWEVER IT GOT KINKED. IT WAS UNKNOWN WHEN THE KINK OCCURRED. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6388021 ↗