ORBIT GALAXY XTRASOFT 640CX0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886704030607), received between Oct 2, 2017 and Dec 4, 2025 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Stretched” (11 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 3X8 ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE 640CX0308, LOT NUMBER 31634774) FAILED TO DETACH. THE COIL WAS DELIVERED TO THE TARGET SITE AND FILLED THE ANEURYSM, BUT DETACHMENT COULD NOT BE ACHIEVED. THE PHYSICIAN RETRACTED THE COIL AND USED A NEW ONE TO COMPLETE THE SURGERY, WITHOUT REPLACING THE UNSPECIFIED MICROCATHETER. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716544 ↗
• MalfunctionApr 21, 2025Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0308 / 31359784) ENCOUNTERED SOME RESISTANCE IN THE MIDDLE SECTION OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) DURING THE COIL DELIVERY PROCESS. THE PHYSICIAN RETRACTED ONLY THE COIL, AND IT WAS NOTED THAT THE COIL COMPONENT WAS FOUND UNRAVELED / STRETCHED. THE PHYSICIAN REPLACED THE COIL AND COMPLETED THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 07-APR-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING A 4MM X 6MM RUPTURED SACCULAR ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY / POSTERIOR COMMUNICATING ARTERY. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. NO NECK REMODELING WAS USED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WAS RESISTANCE WHEN THE COIL WAS BEING ADVANCED THROUGH THE MIDDLE SECTION OF THE MICROCATHETER. PER THE INFORMATION, THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED (THE NUMBER OF TIMES THIS HAD BEEN DONE WAS NOT REPORTED). THE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878389 ↗
• MalfunctionMar 7, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A NON J&J MICROCATHETER WAS IN PLACE AND A 2.5X5 ORBIT GALAXY XTRASOFT COIL (640CX0308, 31444519) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21550261 ↗
• MalfunctionFeb 25, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN TRIED TO DEPLOY AN ORBIT GALAXY XTRASOFT COIL ( (640CX0308 / 31395228) INTO AN ANEURYSM. WHILE DEPLOYING THE COIL THROUGH A HEADWAY MICROCATHETER (MC) FROM THE MICROVENTION, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE COIL MIDWAY THROUGH THE CATHETER. AFTER FEW TRIES, THE PHYSICIAN REMOVED THE COIL AND FINISHED THE CASE WITH A NON J&J COIL OF THE SAME SIZE. ADDITIONAL EVENT INFORMATION STATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICE DID NOT APPEAR TO BE DAMAGED AT ANY TIME. CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS NOTED STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459414 ↗
• MalfunctionJan 9, 2025Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FILLED THE ANEURYSM WITH AN ORBIT GALAXY XTRASOFT COIL (640CX0308, 31359784), IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 09-JAN-2025 INDICATED THAT PRIOR TO THIS COIL, OTHER COILS HAD BEEN ADVANCED THROUGH THE SAME MICROCATHETER (MC). THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE COIL WAS NOT ENTANGLED WITH OTHER IMPLANTED COILS. THE COIL DID NOT PREMATURELY DETACH. THE 10-MINUTE PROCEDURE DELAY WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112440 ↗
• MalfunctionJan 7, 2025Crack; Device Difficult to Setup or Prepare; Positioning Problem; Crack; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO THE POSTERIOR COMMUNICATING ARTERY, THE PHYSICIAN FILLED THE ANEURYSM WITH A 3X8 ORBIT GALAXY XTRASOFT COIL (640CX0308, 31270225), IT WAS FOUND THAT THE SHAPE WAS NOT IDEAL (NO FURTHER CLARIFICATION WAS AVAILABLE). THE PHYSICIAN STARTED TO RETRACT THE COIL FOR ADJUSTING, BUT THE COIL COULD NOT BE RETRACTED TO THE INTRODUCER SHEATH. THEN, A NEW COIL, 6X20 ORBIT GALAXY (640CF0620, 31359780) WAS USED TO FILL THE ANEURYSM, BUT THE SAME ISSUE AS THE PREVIOUS COIL WAS ENCOUNTERED, WHICH CANNOT BE RETRACTED INTO THE INTRODUCER SHEATH. THE DOCTOR SWITCHED TO NON-J&J COILS TO COMPLETE THE SURGERY. THE NON-J&J MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 15 MINUTES. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 20-DEC-2024 INDICATED THAT POOR CONFORMABILITY LED TO THE RE-SHEATHING OF THE COILS. THE COIL INTRODUCER WAS CRACKED, NO COIL PROTRUSION FROM INTRODUCER. THE COILS WERE NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091450 ↗
• MalfunctionDec 31, 2024Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30184376) PRE-DEPLOYED IN THE CONCOMITANT EXCELSIOR SL-10® MICROCATHETER (STRYKER). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048535 ↗
• MalfunctionDec 26, 2024Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, THE PHYSICIAN FILLED THE ANEURYSM WITH THE COIL, A 3MM X 8CM COMPLEX XTRASOFT (640CX0308 / 31450782), AND FOUND THAT THE COIL HAD UNRAVELED / STRETCHED. THE PHYSICIAN ONLY RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019770 ↗
• MalfunctionMay 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, PRIOR TO THE PROCEDURE, THE PHYSICIAN FLUSHED AN ORBIT GALAXY XTRASOFT COIL (640CX0308, 30868863) WITH SALINE AND OBSERVED THAT FLUID ESCAPED FROM THE END OF THE COIL SYSTEM. THE PHYSICIAN SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19404593 ↗
• MalfunctionMay 1, 2024Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ANTERIOR COMMUNICATING ARTERY (ACOMM) ANEURYSM, AN ORBIT GALAXY XTRASOFT COIL ((B)(4)) WAS UNABLE TO RESHEATH. THE SURGERY WAS DELAYED BY 5 MINUTES DUE TO THE EVENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 23-APR-2024 INDICATED THAT RESHEATING WAS DUE TO POOR COIL CONFORMALITY. THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER, THERE WAS NO SPLIT. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO NECK REMODELING UTILIZED. THE MICROCOIL WAS NOT POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222443 ↗
• MalfunctionMar 22, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX0308, 30775342) WAS USED AS THE FIRST COIL. THE PHYSICIAN FELT STRONG RESISTANCE DURING ADVANCING THE ORBIT GALAXY THROUGH THE SHEATH (INTRODUCER) OF THE COIL. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592052 ↗
• MalfunctionDec 5, 2022Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30494093) WAS NOT FRAMING THE TARGET SUCCESSFULLY. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW ONE TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. HERE WAS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOT NUMBER OF COMPLAINT COIL IS (B)(4). THE TARGET LESION WAS ON THE MIDDLE CEREBRAL ARTERY (MCA). THERE WAS NO DIFFICULTY POSITIONING THE COIL IN THE TARGET SITE; THERE WAS DIFFICULTY IN GETTING THE COIL TO CONFORM TO THE ANEURYSM WALL. THE INFORMATION INDICATED THAT THE COIL COULD NOT BE CONFORMED TO THE ANEURYSM. WHEN THE COIL WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM; IT WAS NOT STRETCHED NOR DAMAGED WHEN IT WAS REMOVED. THE COMPLAINT COIL WAS THE FIRST COIL USED. IT WAS USED WITH THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC), WHICH WAS ALSO USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15921602 ↗
• MalfunctionOct 25, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X8 ORBIT GALAXY XTRASOFT COIL (640CX0308, 30688444) WAS USED AS THE SECOND COIL. THE COIL COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666333 ↗
• MalfunctionJul 25, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3 X 8 ORBIT GALAXY XTRASOFT COIL (640CX0308, 30571051) FAILED TO DETACH AFTER DEPLOYING THE COIL INTO THE ANEURYSM. AFTER THIS, IT WAS RETRACTED AGAIN INTO THE UNSPECIFIED MICROCATHETER. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094240 ↗
• MalfunctionApr 6, 2022Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN FILLED THE ANEURYSM WITH TWO COMPETITIVE COILS AND THEN USED AN ORBIT GALAXY XTRASOFT COIL (640CX0308, 30628888) IN THE TARGET POSITION. THE COIL WAS IMPEDED IN DISTAL OF THE UNSPECIFIED MICROCATHETER (MC). THEN THE DOCTOR TRIED TO RETRACT IT SLIGHTLY FOR ADJUSTING BUT OBSERVED THE COIL DIDN¿T MOVE. THE PHYSICIAN WITHDREW THE DEVICE AND COMPLETED THE SURGERY. THE DOCTOR FLUSHED THE MICROCATHETER AND FOUND THE COIL HAD ALREADY DETACHED IN THE MICROCATHETER. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021985 ↗
• InjuryDec 4, 2021Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, A 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30571051) BECAME PREMATURELY DETACHED WHEN 7/8 OF THE COIL WAS PLACED INTO THE ANEURYSM SAC. AS A RESULT, THE PHYSICIAN PLACED A STENT (SIZE / BRAND / MANUFACTURER NOT SPECIFIED) TO AFFIX THE REMAINING 1/8 OF THE COIL STILL OUTSIDE THE ANEURYSM TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 29-NOV-2021. THE INFORMATION INDICATED THAT THIS WAS AN IRREGULAR ANEURYSM. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930860 ↗
• MalfunctionDec 1, 2021Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE ANTERIOR COMMUNICATING ARTERY (ACOM), THE SIZE SELECTION OF AN ORBIT GALAXY XTRASOFT COIL (640CX0308, 30532544) WAS NOT APPROPRIATE. WITH THIS, IT WAS RETRACTED BUT FAILED TO RE-SHEATH. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROCEDURAL SITUATION THAT LED TO RESHEATHING OF THE COIL WAS POOR CONFORMABILITY. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC. THE COIL WAS L REMOVED FROM THE PATIENT AND IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908310 ↗
• MalfunctionSep 7, 2021Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET 3MM X 3MM X 4MM ANEURYSM LOCATED ON ANTERIOR COMMUNICATING ARTERY (ACOM) WHEN THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30494093) WAS BEING DEPLOYED INTO THE TARGET ANEURYSM, THE COIL 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 REMOVED IT FROM THE PATIENT. IT WAS REPORTED THAT NO DAMAGE WAS OBSERVED ON THE COIL WHEN IT WAS REMOVED FROM THE PATIENT. ANOTHER COIL OF UNSPECIFIED BRAND WAS USED AS A REPLACEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436451 ↗
• MalfunctionJun 2, 2021Break; Separation Failure; Difficult to Advance; Break; Separation Failure; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A PULMONARY ARTERY EMBOLISM, 3X8 ORBIT GALAXY XTRASOFT COIL (640CX0308, 30425579) FAILED TO BE DETACHED. IT WAS REPORTED THAT COIL COULDN¿T BE DETACHED, THEN THE PHYSICIAN WITHDREW IT, AND THE COIL WAS ¿BROKEN¿ WHEN CROSSING THE CONNECTOR Y. THERE WAS NO PATIENT INJURY. PRELIMINARY PICTURES WERE RECEIVED AT THE TIME OF COMPLAINT ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920781 ↗
• MalfunctionMay 10, 2021Packaging Problem; Positioning Problem; Packaging Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT WHEN THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30425579) AND THE 3.5MM X 9CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX3509 / 30498214) WERE REMOVED FROM THEIR RESPECTIVE HOOPS, THE TIP OF THE COILS WERE PROTRUDING FROM THEIR RESPECTIVE INTRODUCERS. THE PHYSICIAN PULLED THE COILS BACK INTO THEIR INTRODUCERS AND WAS ABLE TO ADVANCE THE COILS. HOWEVER, WHEN THE COILS WERE IN THE ANEURYSM, BOTH OF THE COIL TIPS WOULD NOT MAKE ANY SHAPE. THE COILS WERE NOT USED FOR THE PROCEDURE. THE COILS WERE REPLACED AND THE SAME SIZE REPLACEMENT COILS WERE DELIVERED USING THE SAME CONCOMITANT SL-10® MICROCATHETER (STRYKER) WITHOUT ANY ISSUE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED DEVICE ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 28 APRIL 2021. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS OF CONVENTIONAL SPHERICAL SHAPE AND WAS APPROXIMATELY 4 MM IN DIAMETER. THE LOCATION OF THE ANEURYSM WAS NOT KNOWN, BUT IT WAS REPORTED THAT THE ANEURYSM LOCATION DID NOT HAVE ANY IMPACT ON THE REPORTED ISSUE. THERE WAS POSITIONING DIFFICULTY IN THAT WHEN THE COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798654 ↗
• MalfunctionApr 27, 2021Retraction Problem; Stretched; Failure to Advance; Retraction Problem; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION A 3X8 OG CMPLX XTRASOFT COIL (640CX0308, 30425580) COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE UNSPECIFIED MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION, IT TURNED OUT THAT IT WAS STRETCHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731805 ↗
• MalfunctionMar 11, 2021Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X8 ORBIT GALAXY COIL (640CX0308, 30443760) BECAME STRETCHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463602 ↗
• MalfunctionJan 13, 2021Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0308 / 30425580) WAS THE THIRD COIL CHOSEN FOR THE PROCEDURE. THE PHYSICIAN DECIDED THE RETRACT THE COIL FOR REDEPLOYMENT AFTER TRYING ANOTHER COIL OF A DIFFERENT SIZE FIRST. DURING THE RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 3MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL AS REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN DAMAGED CONDITION. BASED ON THE PRODUCT ANALYSIS 13 JANUARY 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168420 ↗
• MalfunctionJul 8, 2020Separation Problem; Premature Separation; Separation Problem; Premature Separation

  AS REPORTED BY THE FIELD, DURING AN ENDO-VASCULAR COILING, WHEN PUTTING A 3X8 OG CMPLX XTRASOFT COIL (640CX0308, 30103629) IN THE ANEURYSM, THE CATHETER CAME OUT. THE USER TRIED TO PUSH IT IN THE ANEURYSM BUT IN THE MANIPULATION OF THE COIL, AND CATHETER AND THE COIL ¿BROKE¿. THE COIL WAS TAKEN OUT WITH DIFFICULTY. THERE WAS A PROCEDURAL DELAY BY ONE HOUR DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10244845 ↗
• MalfunctionFeb 19, 2020Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, WHEN THE PHYSICIAN TRIED DETACHING THE FIRST COIL, A 3X8 OG CMPLX XTRASOFT COIL (640CX0308, 30254263), THE BEEPING SOUND WAS NORMAL BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728419 ↗