ORBIT GALAXY 640CF0412Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886704030270), received between Feb 6, 2017 and Aug 16, 2023 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS RESISTANCE WHILE PUSHING AN ORBIT GALAXY COIL (640CF0412, 30842964) IN THE UNSPECIFIED MICROCATHETER (MC), WHEN THE COIL WAS REMOVED IT WAS STRETCHED. THE SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE REPORTED EVENT. ANOTHER COIL WAS USED TO COMPLETE THE SUCCESSFUL PROCEDURE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE MC USED, WAS A PROWLER SELECT LPES 45 DEG TIP (606S155FX, 30763314). THE RESISTANCE WAS ENCOUNTERED AT THE DISTAL SHAFT OF THE MC. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. THE EVENT DID RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING COIL ADVANCEMENT. NO EXCESSIVE FORCE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557203 ↗
• MalfunctionJul 21, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN TRIED TO DEPLOY A 4X12 ORBIT GALAXY COIL (640CF0412, 30706301) THROUGH AN HEADWAY MICROCATHETER (MC). HOWEVER, WHILE ADVANCING THE COIL THROUGH THE CATHETER MIDWAY, THE PHYSICIAN FELT RESISTANCE. THE DOCTOR WAS UNABLE TO PUSH THE COIL FURTHER. AFTER FEW TRIES THE USER REMOVED THE COIL AND DEPLOYED A COMPETITOR¿S COIL. THERE WAS NO SURGERY DELAYS DUE TO THE REPORTED EVENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370990 ↗
• MalfunctionNov 8, 2022Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, 4X12 ORBIT GALAXY COIL (640CF0412, 30729835) DETACHED HALF. IT COULD NOT BE DETACHED COMPLETELY, A NEW SYRINGE WAS REPLACED, THE COIL STILL FAILED TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND IT DETACHED OUTSIDE OF THE PATIENT¿S BODY. THEN A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751228 ↗
• MalfunctionNov 7, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE POSTERIOR COMMUNICATING ARTERY (PCOM) , THE PHYSICIAN TRIED TO DEPLOY A 4X12 ORBIT GALAXY COIL (640CF0412, 30706301) THROUGH AN HEADWAY17 MICROCATHETER (MC). WHILE ADVANCING THE COIL MIDWAY THROUGH THE HEADWAY17, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL. AFTER A FEW TRIES, THE DOCTOR DISCARDED THE COIL AND DEPLOYED COMPETITOR¿S COILS TO FINISH THE CASE. IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MC. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORT OF THE DAMEG TO THE DEVICE OR ANYTHING OBSTRUCTING THE MC. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743013 ↗
• MalfunctionSep 9, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FILLED ANEURYSM WITH A 4X12 ORBIT GALAXY COIL (640CF0412, 30530425), BUT THE SHAPE OF COIL WAS NOT IDEAL. THE DOCTOR ATTEMPTED TO RETRACT THE COIL TO ADJUST, HOWEVER, THE COIL WAS FOUND TO BE IMPEDED IN A NON J&J MICROCATHETER (MC) AND COULD NOT BE RETRACTED. THE PHYSICIAN REMOVED THE COIL WITH MICROCATHETER TOGETHER. A NEW COIL WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE TO THE COIL. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE SHAPE OF THE COIL WAS NOT DIFFERENT THAN EXPECTED. THE COIL DID NOT FAIL TO CONFORM TO ANEURYSM WALL. THE COIL WAS NOT FOUND TO BE HERNIATED OR PROTRUDED OUT OF THE ANEURYSM. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392477 ↗
• InjuryApr 25, 2022Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING AN 8.1MM X 4.3MM RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, A 4MM X 12CM ORBIT GALAXY TDL COMPLEX FILL COIL (640CF0412 / 30596903) PREMATURELY DETACHED IN THE CONCOMITANT MICROCATHETER (SIZE/BRAND NOT SPECIFIED). THE PHYSICIAN IMMEDIATELY USED A HEARTCARE MEDICAL STENT RETRIEVER TO WITHDRAW THE PREMATURELY DETACHED COIL AND THEN SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS STATED THAT WHEN THE PHYSICIAN FILLED THE ANEURYSM WITH THE SECOND COIL, IT WAS FOUND THAT THE COIL HAD PREMATURELY DETACHED IN THE MICROCATHETER. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, A SINGLE MEDICAL IMAGING WAS RETURNED AND FORWARDED TO CERENOVUS SR. MEDICAL AFFAIRS DIRECTOR (NEUROINTERVENTIONALIST) FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196774 ↗
• MalfunctionMar 30, 2022Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, IT WAS REPORTED THAT THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412 / 30596904) MADE A HELICAL SHAPE EVEN THOUGH THIS COIL IS NOT SUPPOSED TO FORM THIS SHAPE. AFTER THIS ISSUE WAS DETECTED DURING THE PROCEDURE MONITORING STEP, THE PHYSICIAN RETRACTED THE COIL AND FULLY REMOVED IT FROM THE PATIENT. THERE WAS NO PROCEDURE DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953849 ↗
• MalfunctionFeb 2, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412 / 30596904) WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE COMPLAINT COIL WAS RETRACTED AND THE COIL WAS OBSERVED TO HAVE BECOME UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COMPLAINT DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 02-FEB-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL WAS RETRACTED AND THE PHYSICIAN SWITCHED TO A NEW DEVICE, ANOTHER 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412) TO COMPLETE THE PROCEDURE. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL ASIDE FROM THE REPORTED STRETCHED / UNRAVELED CONDITION WHEN IT WAS REMOVED. THE COIL WAS NOT DETACHED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13426035 ↗
• InjurySep 2, 2021Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM, A 4MM X 12CM ORBIT GALAXY TDL COMPLEX FILL (640CF0412 / 30440213) WAS DEPLOYED VIA CONCOMITANT EXCELSIOR¿ SL-10¿ MICROCATHETER (STRYKER) IN THE ANEURYSM AS THE FIRST, FRAMING COIL WITH THE PLAN TO DETACH THE COIL AFTER IMPLANTING ADDITIONAL COILS. FOUR ADDITIONAL OPTIMA" COIL SYSTEMS (BALT) WERE SUCCESSFULLY IMPLANTED IN THE ANEURYSM SAC USING THE SAME CONCOMITANT MICROCATHETER. THE OPERATOR THEN ATTEMPTED TO DETACH THE ORBIT GALAXY COIL, BUT THE COIL FAILED TO DETACH. THE OPERATOR REPLACED THE SYRINGE AND ATTEMPTED TO DETACH WITH FOUR NEW SYRINGES, BUT THE COIL STILL FAILED TO DETACH. NEXT, AN NEUROFORM ATLAS¿ STENT SYSTEM (STRYKER) WAS IMPLANTED TO MAINTAIN THE IMPLANTED EMBOLIC COILS WITHIN THE CONFINES OF THE TARGET ANEURYSM. THE OPERATOR THEN DECIDED TO REMOVE THE COMPLAINT COIL FROM THE PATIENT. HOWEVER, WHEN THEY WERE SLOWLY RETRACTING THE COIL INTO THE CONCOMITANT MICROCATHETER THE COIL UNINTENDEDLY DETACHED. APPROXIMATELY 2CM OF THE PREMATURELY DETACHED COIL WAS STILL INSIDE THE MICROCATHETER, SO THE OPERATOR USED A GUIDEWIRE TO PUSH THE COIL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418406 ↗
• MalfunctionJul 13, 2021Product Quality Problem; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY (MCA), WHEN DEPLOYING AN ORBIT GALAXY TDL COMPLEX FILL COIL (640CF0412) INTO THE ANEURYSM, THE ORBIT GALAXY COIL WAS SHAPED AS A HELICAL TYPE, EVEN THOUGH THAT PRODUCT CODE WAS NOT INCLUDED IN HELICAL SIZE. AFTER THIS DETECTION VIA THE MONITOR DURING THE PROCEDURE, THE PHYSICIAN RETRACTED THE COIL AND PULL OUT. ANOTHER ORBIT GALAXY COIL WAS USED (PRODUCT/LOT UNKNOWN). THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION INDICATED THAT THE ANEURYSM WAS DESCRIBED AS A ¿JUST NORMAL SACCULAR ANEURYSM¿. THERE WAS NO DAMAGE OBSERVED ON THE COIL WHEN IT WAS REMOVED FROM THE PATIENT. A EXCELSIOR SL10 MICROCATHETER, STRYKER WAS USED. IMAGES WERE PROVIDED, HOWEVER, THERE ARE NO PHOTOS AVAILABLE OF THE PRODUCT LABEL NOR OF THE ORIGINAL COIL PACKAGING AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158521 ↗
• InjuryOct 5, 2020Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE, THE 4MM X 12CM ORBIT GALAXY TDL COMPLEX FILL COIL (640CF0412 / 30219544) PREMATURELY DETACHED INSIDE THE ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL BUT WAS NOT SUCCESSFUL. TO RESTORE BLOOD FLOW, AN UNSPECIFIED STENT WAS DEPLOYED TO TACK THE COIL NEAR THE ANEURYSM WALL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPORTED GOOD OUTCOME. THE REPORTED EVENT RESULTED IN A 15-MINUTE PROCEDURAL DELAY; HOWEVER, THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Code Available

  MAUDE report 10631808 ↗
• MalfunctionSep 23, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF A CEREBRAL ARTERY ANEURYSM, FOUR COILS, A 5X10 OG TDL CMPLX FILL (640CF0510, 30132962), A 7X25 OG TDL CMPLX FRAME (640CR0725, 30374735), A 4X12 OG TDL CMPLX FILL (640CF0412, 30348520) AND A 3.5X9 OG CMPLX XTRASOFT (640CX3509, 30282523) BECAME STUCK INSIDE THE HUB OF A PROWLER SELECT14 MICROCATHETER (PRODUCT/LOT NUMBER UNKNOWN). THE COILS ¿NEVER WENT PASSED THE MICROCATHETER HUB.¿ THEREFORE, THE MICROCATHETER (MC) NEVER ENTERED THE PATIENT¿S INTRACRANIAL SPACE. THE MICROCATHETER WAS REPLACED RESULTING IN LOSS OF CEREBRAL TARGET POSITIONING ALONG WITH THE FOUR COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT MICROCATHETER, AND REPLACEMENT COILS. THESE COILS WERE NOT IMPLANTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573569 ↗
• MalfunctionMar 17, 2020Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE POSTERIOR COMMUNICATING ARTERY (PCOA) IN THE (B)(6) FEMALE PATIENT, THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412 / 30201509) COULD NOT ADVANCE IN THE SL-10® MICROCATHETER (STRYKER); THE COIL ENCOUNTERED RESISTANCE AFTER IT WAS INTRODUCED INTO THE MICROCATHETER, TO A SMALL PORTION OF THE MICROCATHETER WHERE IT COULD NOT LONGER BE ADVANCED. THE PHYSICIAN WITHDREW THE COIL AND THE CONCOMITANT MICROCATHETER FROM THE PATIENT. IT WAS REPORTED THAT CONTINUOUS FLUS HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE TO THE COIL OR THE COIL DELIVERY SYSTEM WHEN IT WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT. AN ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0306 / 30212140) WAS USED AS REPLACEMENT FOR THE COMPLAINT COIL AND IT WAS DELIVERED AND IMPLANTED WITH THE ORIGINAL MICROCATHETER. THE REPORTED ISSUE RESULTED IN A HALF AN HOUR PROCEDURAL DELAY THAT THE PHYSICIAN DEEMED CLINICALLY SIGNIFICANT BECAUSE IT INCREASES THE RISK OF ANEURYSM RUPTURE AND PROLONG SURGERY TIME MAKES THE PROCEDURE MORE DIFFICULT FOR THE PHYSICIAN. THERE WAS NO REPORT OF ANY PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844587 ↗
• MalfunctionSep 26, 2019Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN INTRACRANIAL ANEURYSM, THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412 / 30176735) COULD NOT BE ADVANCED IN THE MICROCATHETER; THE PHYSICIAN USED X-RAY TO CHECK AND THE COIL WAS REPORTED TO AS ALREADY STRETCHED IN THE MICROCATHETER. CONTINOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER DURING THE ACCESSING OF THE TARGET SITE. IT WAS REPORTED THAT PRIOR TO THIS COIL, ANOTHER COIL WAS ADVANCED THROUGH THE MICROCATHETER, WAS SHAPED AND SUCCESSFULLY IMPLANTED IN THE TARGET SITE. THE PHYSICIAN WITHDREW THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL AND THE MICROCATHETER TOGETHER; THE COIL WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT COIL AND THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY ADVERSE PATIENT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126569 ↗
• MalfunctionSep 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN INTRACRANIAL ANEURYSM, THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412 / 30187277) WAS ADVANCED HALFWAY INTO THE MICROCATHETER AND THEN IT COULD NOT BE ADVANCED FURTHER. CONTINOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER DURING THE ACCESSING OF THE TARGET SITE. IT WAS REPORTED THAT PRIOR TO THIS COIL, ANOTHER COIL WAS ADVANCED THROUGH THE MICROCATHETER, WAS SHAPED AND SUCCESSFULLY IMPLANTED IN THE TARGET SITE. THE PHYSICIAN WITHDREW THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL AND THE MICROCATHETER TOGETHER; THE COIL WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT COIL AND THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY ADVERSE PATIENT COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126566 ↗
• MalfunctionAug 15, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANEURYSM, THE 4MM X 12CM ORBIT GALAXY COMPLEX FILL COIL (640CF0412 / 30029281) WAS USED BUT THE COIL COULD NOT BE DETACHED EVEN THOUGH SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE COIL WAS REPLACED WITH A COMPETITIVE PRODUCT AND THE PROCEDURE WAS COMPLETED. THE REPORTED EVENT DID NOT RESULT IN ANY INTERRUPTION OF BLOOD FLOW. THERE WAS NO REPORT OF PATIENT INJURY / COMPLICATION OR PROCEDURAL DELAY AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8899535 ↗
• MalfunctionJul 24, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN INTERIOR CAROTID-POSTERIOR COMMUNICATING ARTERY ANEURYSM, AN 4X12 ORBIT GALAXY TDL COMPLEX FILL (640CF0412/17732797) HYDRAULIC COIL WAS INSERTED INTO THE PROWLER SELECT PLUS 150/5 CM 45TIP (606-S255FX/17748673) MICROCATHETER BUT STRONG RESISTANCE WAS ENCOUNTERED AND THE COIL DELIVERY SYSTEM COULD NEITHER BE ADVANCED NOR WITHDRAWN. THE COIL DID NOT EXIT THE TIP OF THE MICROCATHETER, SO THE COIL WAS REMOVED AS A UNIT WITH THE MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH A COMPETITOR PRODUCT. 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. THE PRODUCTS WERE DISCARDED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7715159 ↗
• MalfunctionJun 4, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE ORBIT GALAXY TDL COMPLEX FILL COIL 4 X 12 (640CF0412 / 17684995) FAILED TO FLUSH. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE CONFIRMED THAT THE COIL WAS NOT COMPRESSED / CRUSHED, THERE WAS NO KINK OR BENT ON THE COIL AND THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTION FOR USE (IFU) WITH NO DAMAGE OBSERVED ON THE INNER POUCH OF THE PRODUCT. THE ORBIT GALAXY COIL WAS RETURNED FOR FUNCTIONAL ANALYSIS. THE ISSUE REPORTED RELATED TO THE COIL FAILING TO FLUSH WAS NOT CONFIRMED. THE COIL WAS RETURNED AND WAS NOTED TO BE STRETCHED IN CONDITION. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THERE WAS NO PROCEDURAL DELAY; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7566304 ↗
• MalfunctionMay 31, 2018Premature Activation; Material Separation; Physical Resistance; Premature Activation; Material Separation; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A SUPRACLINOID INTERNAL CAROTID ARTERY (ICA ANEURYSM, STRONG RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE 4X12 ORBIT GALAXY TDL COMPLEX FILL (640CF0412/17482867) HYDRAULIC COIL THROUGH THE MIDSHAFT OF THE PROWLER SELECT LPES MICROCATHETER (606S155X/17734584). THE COIL GOT STUCK AND COULD NO LONGER ADVANCE. UPON REMOVAL, THE COIL WAS DETACHED IN THE MIDSHAFT OF THE MICROCATHETER, BEFORE THE PROXIMAL MARKER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EMBOLIC COIL PREMATURELY DETACHED IN THE MICROCATHETER. IT WAS STATED THAT ¿THE COIL GOT BREAK IN THE MIDSHAFT OF MICROCATHETER IT WAS UNABLE TO PUSH FURTHER SO WHEN WE TRIED TO PULL THE DELIVERY WIRE DETACHED COIL WAS NOT MOVING AT ALL¿. THE DIFFICULTY REQUIRED THAT THE COIL AND MICROCATHETER BE REMOVED TOGETHER AS A UNIT. THE COIL AND MICROCATHETER WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE EVENT. THE COMPLAINT COIL WAS THE FIRST COIL USED IN THE CASE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556250 ↗
• MalfunctionMar 29, 2018Difficult To Position; Material Separation; Difficult To Position; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE POST-ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE OF A TYPE 2 ENDOLEAK AT THE LUMBAR ARTERY, AFTER FIVE (5) ORBIT GALAXY TDL COMPLEX FILL COILS 4 X 12 (640CF0412) WERE SUCCESSFULLY PLACED, THE 6TH COIL, ANOTHER ORBIT GALAXY TDL COMPLEX FILL 4 X 12 COIL (640CF0412 / 17468435) WAS USED; THE COIL WAS IN AND OUT OF THE MICROCATHETER (155CM CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS), THE COIL WAS TORN AT THE MIDDLE. THE COIL PORTION STILL ATTACHED TO THE DELIVERY WIRE WAS REMOVED. THE PORTION OF THE COIL THAT REMAINED IN THE BODY WAS PLACED IN THE TARGET LESION AS IS. ANOTHER ORBIT GALAXY COMPLEX FILL COIL (640CF0308) WAS PLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7383911 ↗
• MalfunctionMar 20, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ORBIT GALAXY TDL COMPLEX FILL COIL 4X12 (640CF0412 / 17599449) WAS STRETCHED DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION RELATED TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7356068 ↗
• MalfunctionMar 13, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A LEFT VERTEBRAL ARTERY DISSECTION, THREE COMPETITOR COILS WERE PLACED AT THE TARGET LESION AND THE 4MM X 12 CM ORBIT GALAXY COMPLEX FILL DETACHABLE COIL SYSTEM (DCS) (640CF0412/17673350) WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), BUT THE PURGE COULD NOT BE CONDUCTED. THE TRUFILL DCS SYRINGE II (635002/96331301) SYRINGE WAS RECONNECTED AND THE PHYSICIAN REATTEMPTED TO PURGE BUT THE AIR COULD NOT BE REMOVED. THE COIL WAS REPLACED WITH ANOTHER 4MM X 12 CM ORBIT GALAXY COMPLEX FILL DCS (640CF0412/17673350) BUT THE SAME ISSUE OCCURRED. THE SYRINGE WAS REPLACED BUT THE ISSUE DID NOT IMPROVE. THE COIL WAS SUBSEQUENTLY REPLACED WITH A 5MM X 15 CM ORBIT GALAXY COMPLEX FILL DCS (640CF0515) AND A 3MM X 8 CM ORBIT GALAXY COMPLEX FILL DCS (640CF0308) AND FIVE COMPETITOR COILS WERE THEN PLACED UTILIZING THE FIRST SYRINGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION ARE UNKNOWN. AN UNSPECIFIED 7F SHEATH INTRODUCER, A CHIKAI (

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333718 ↗
• MalfunctionDec 8, 2017Stretched; Stretched

  WHILE ATTEMPTING TO COIL AN ANEURYSM, THE PHYSICIAN LOADED A GALAXY FILL 4X12 INTO A STRYKER SL-10 MICROCATHETER. THE COIL WAS ADVANCED INTO THE ANEURYSM AT WHICH TIME THE PHYSICIAN DECIDED THAT THE COIL WAS TOO SMALL AND WANTED TO USE A LARGER COIL TO START. THE COIL WAS RETRACTED OUT OF THE ANEURYSM AND AN ATTEMPT TO RESHEATH WAS MADE PER THE IFU. THE PHYSICIAN WAS UNABLE TO ZIPPER THE SHEATH BACK OVER THE DELIVERY WIRE AND DURING PRODUCT ANALYSIS, IT WAS DETERMINED THAT THE COIL WAS STRETCHED. HE THEN WENT ON TO COIL THE ANEURYSM WITHOUT ISSUE. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7099030 ↗
• MalfunctionFeb 28, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COILING PROCEDURE OF A PCOM ANEURYSM, THE PHYSICIAN WAS UNABLE TO PUSH TWO 4 X 12 GALAXY COILS (640CF0412/175514192) INTO TWO PROWLER 14 MICROCATHETERS (606151FX/17669016), AND THE COILS AND CATHETERS WERE REPLACED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE GALAXY DELIVERY SYSTEM AND EXPERIENCED A LOT OF FRICTION DURING WITHDRAWAL. THE COIL WAS CONTAINED INSIDE OF THE SHEATH AS THE PHYSICIAN HAD NOT YET ADVANCED IT. WITH SOME FORCE, THE PHYSICIAN WAS ABLE TO PULL THE GALAXY COIL OUT OF THE PROWLER 14 MICROCATHETER. THE PHYSICIAN DISCARDED BOTH THE GALAXY COIL AND THE PROWLER 14 MICROCATHETER AND BEGAN THE PROCESS AGAIN WITH THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER. THE SAME ISSUE HAPPENED AGAIN; THE COIL WOULD NOT ADVANCE AS THE PHYSICIAN SAID IT BECAME STUCK IN THE MICROCATHETER AND THEY HAD TROUBLE PULLING IT BACK OUT. THE PHYSICIAN DISCARDED THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER AND COMPLETED THE PROCEDURE WITH A THIRD PROWLER 14 MICROCATHETER AND GALAXY 3.5X9 COIL. THE DIFFICULTY OCCURRED AT THE DISTAL PART OF THE BODY OF THE CATHETER; THE GALAXY COILS WERE ABLE TO BE ADVANCED TO THE DIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6366516 ↗
• MalfunctionFeb 6, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COILING PROCEDURE OF A PCOM ANEURYSM, THE PHYSICIAN WAS UNABLE TO PUSH TWO 4 X 12 GALAXY COILS (640CF0412/175514192) INTO TWO PROWLER 14 MICROCATHETERS (606151FX/17669016), AND THE COILS AND CATHETERS WERE REPLACED. THE PHYSICIAN WAS UNABLE TO ADVANCE THE GALAXY DELIVERY SYSTEM AND EXPERIENCED A LOT OF FRICTION DURING WITHDRAWAL. THE COIL WAS CONTAINED INSIDE OF THE SHEATH AS THE PHYSICIAN HAD NOT YET ADVANCED IT. WITH SOME FORCE, THE PHYSICIAN WAS ABLE TO PULL THE GALAXY COIL OUT OF THE PROWLER 14 MICROCATHETER. THE PHYSICIAN DISCARDED BOTH THE GALAXY COIL AND THE PROWLER 14 MICROCATHETER AND BEGAN THE PROCESS AGAIN WITH THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER. THE SAME ISSUE HAPPENED AGAIN; THE COIL WOULD NOT ADVANCE AS THE PHYSICIAN SAID IT BECAME STUCK IN THE MICROCATHETER AND THEY HAD TROUBLE PULLING IT BACK OUT. THE PHYSICIAN DISCARDED THE SECOND GALAXY COIL 4X12 AND PROWLER 14 MICROCATHETER AND COMPLETED THE PROCEDURE WITH A THIRD PROWLER 14 MICROCATHETER AND GALAXY 3.5X9 COIL. THE DIFFICULTY OCCURRED AT THE DISTAL PART OF THE BODY OF THE CATHETER; THE GALAXY COILS WERE ABLE TO BE ADVANCED TO THE DIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6305093 ↗