ORBIT GALAXY XTRASOFT 640CX2505Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886704030652), received between Jan 13, 2017 and Apr 2, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Stretched” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE MICROCATHETER WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31651278) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL, A 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2505 / 31661861). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; IT WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON 01-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM ON THE INTERNAL CAROTID ARTERY. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO INTERRUPTION OF BLOOD FLOW. THE SYRINGE WAS FILLED WITH SALINE FROM A DEDICATED SOURCE. THE SAME SYRINGE WAS USED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767328 ↗
• MalfunctionJul 7, 2025Retraction Problem; Stretched; Failure to Advance; Retraction Problem; Stretched; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, THE FIRST COIL, AN ORBIT GALAXY XTRASOFT (640CX2505, 31438251) COULD NOT 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 THAT THE COIL WAS 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 22412349 ↗
• 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 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 21549514 ↗
• MalfunctionFeb 18, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 5CM COMPLEX XTRASOFT ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / 31492244) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW DEVICE TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER (UNSPECIFIED BRAND). THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. 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. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 17-FEB-2025, THE EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402862 ↗
• MalfunctionNov 25, 2024Product Quality Problem; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE SHAPE OF AN ORBIT GALAXY XTRASOFT COIL (640CX2505, LOT UNKNOWN) WAS NOT COMPLETE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772031 ↗
• MalfunctionNov 19, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (640CX2505, 31288826) BECAME IMPEDED IN INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO MICROCATHETER (MC). THE PHYSICIAN RETRACTED THE COIL SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722932 ↗
• MalfunctionJul 16, 2024Positioning Failure; Stretched; Failure to Advance; Positioning Failure; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / 31028743) PASSED THROUGH THE TIP OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) FOR A SHORT SECTION, THEN THE MICROCATHETER KICKED BACK. THE PHYSICIAN RETRACTED THE COIL AND RE-DELIVERED IT BUT THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED THE COIL AND IT WAS UNRAVELED / STRETCHED. THE PHYSICIAN REMOVED THE MICROCATHETER AND COIL FROM THE PATIENT AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 09-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE TARGET VESSEL OF THE PROCEDURE WAS THE INTERNAL JUGULAR END. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED ONCE. PRIOR TO THIS COIL, THERE WERE OTHER COILS THAT WENT THROUGH THE SAME MICROCATHETER. THE REPORTED ISSUE OCCURRED DURING THE REPOSITIONING OF THE COIL IN THE ANEURYSM. THE MICROCATHETER WAS REPOSITIONED OV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757200 ↗
• MalfunctionJul 10, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2505 / 31025935) WAS IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO THE MICROCATHETER. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 05-JUN-2024, IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT NO ADDITIONAL INFORMATION CAN BE OBTAINED. THE COMPLAINT DEVICE WAS RETURNED AND RECEIVED ON 21-JUN-2024. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 10-JUL-2024, THE REPORTED ISSUE MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714621 ↗
• MalfunctionOct 30, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO AN ANEURYSM AT THE BASILAR TIP, AN ORBIT GALAXY XTRASOFT COIL (640CX2505, 31025935) WOULD NOT DETACH. THE COIL WAS REMOVED AND ANOTHER BRAND OF COILS WAS SELECTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE SURGERY WAS DELAYS BY 4 MINUTES DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. THE SAME TRUFILL DCS SYRINGE II (635002, 96331437) WAS NO USED TO DETACH THE SUBSEQUENT COILS. THE SYRINGE HAD PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION 3. AFTER THE COIL DID NOT DETACH AT THE SYRINGE GREEN ZONE, IT WAS ATTEMPTED TO DEPLOY THE COIL AT THE SYRINGE RED ALTERNATIVE DETACHMENT ZONE. IT IS UNKNOWN IF PRIOR TO ATTEMPTING TO DETACH, IF IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE SYRINGE LOST SOME PRESSURE ONCE TAKEN UP TO GREEN AND RED. MAY HAVE BEEN A LEAK IN THE SYSTEM BUT UNKNOWN CULPRIT. NECK REMODELING WAS UTILIZED IF AN ATLAS STENT. IT WAS NOT T NECESSARY TO REMOVE THE MICROCATHETER WITH THE COIL. THE COIL WAS COIL STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. APPROACH FROM RIGHT VERTEBRAL ART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029465 ↗
• MalfunctionOct 17, 2022Crack; Crack

  AS REPORTED BY THE FIELD, THE HUB OF TWO 2.5X5 ORBIT GALAXY XTRASOFT COILS (640CX2505, 30692757) WERE ¿BROKEN¿. ALSO, THE PHYSICIAN FOUND THE SALINE WAS LEAKING FROM THE HUB OF BOTH COILS. FOR THIS REASON, THE COILS WEREN'T DETACHED. THOSE COILS WERE THE FIRST AND SECOND TRY AND THESE TWO PRODUCTS HAD THE SAME ISSUE IN ONE CASE. THE PHYSICIAN SUCCESSFULLY TOOK THE COILS OUT OF THE PATIENT¿S BODY. THE THIRD TRY OF THE SAME LIKE PRODUCT HAD NO PROBLEM, SO THE PHYSICIAN COULD SUCCESSFULLY FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614735 ↗
• MalfunctionOct 17, 2022Crack; Crack

  AS REPORTED BY THE FIELD, THE HUB OF TWO 2.5X5 ORBIT GALAXY XTRASOFT COILS (640CX2505, 30692757) WERE ¿BROKEN¿. ALSO, THE PHYSICIAN FOUND THE SALINE WAS LEAKING FROM THE HUB OF BOTH COILS. FOR THIS REASON, THE COILS WEREN'T DETACHED. THOSE COILS WERE THE FIRST AND SECOND TRY AND THESE TWO PRODUCTS HAD THE SAME ISSUE IN ONE CASE. THE PHYSICIAN SUCCESSFULLY TOOK THE COILS OUT OF THE PATIENT¿S BODY. THE THIRD TRY OF THE SAME LIKE PRODUCT HAD NO PROBLEM, SO THE PHYSICIAN COULD SUCCESSFULLY FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614731 ↗
• MalfunctionJun 13, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION, AN ENTERPRISE INTRACRANIAL NEUROVASCULAR 4.5MMD 14MML WITH NO DISTAL TIP STENT (ENC451400, LOT UNKNOWN) BECAME IMPEDED IN AN UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE PHYSICIAN RETRACTED THE STENT AND CHANGED TO A NEW STENT. A 2.5 X 5 ORBIT GALAXY XTRASOFT COIL (640CX2505, LOT UNKNOWN) ALSO BECAME IMPEDED IN THE MICROCATHETER. THE DOCTOR WITHDREW THE COIL DELIVERY SYSTEM AND SWITCHED TO A COMPETITOR¿S COIL TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. PICTURES WERE ACCOMPANIED WITH THE COMPLAINT FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14679416 ↗
• MalfunctionMay 25, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2.5X5 ORBIT GALAXY XTRASOFT COIL (640CX2505, 30633042) WAS BEING USED AS THE FIRST COIL. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL FIRST. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN DECIDED TO PULL IT OUT BECAUSE COIL'S SIZE WAS NOT APPROPRIATE WITH THE ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497258 ↗
• MalfunctionApr 11, 2022Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, THE MICROCATHETER (UNSPECIFIED BRAND) WAS PLACED IN THE TARGET POSITION, THE PHYSICIAN FILLED THE ANEURYSM WITH THE COIL. THE PHYSICIAN WAS NOT SATISFIED WITH THE SHAPE OF THE COIL AND TRIED TO RETRACT THE COIL, BUT IT WAS FOUND TO BE STRETCHED INSIDE THE MICROCATHETER. A NEW DEVICE WAS USED AS REPLACEMENT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. THE COMPLAINT INCLUDED PHOTOS OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078985 ↗
• MalfunctionDec 16, 2021Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING ENDOVASCULAR ANEURYSM COIL EMBOLIZATION PROCEDURE, THE 150CM X 5CM PROWLER SELECT LPES MICROCATHETER (606S155X / UNKNOWN LOT) WAS PLACED IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM THEN THE 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / UNKNOWN LOT) WAS USED TO COIL THE TARGET ANEURYSM. IT WAS REPORTED THAT THE COMPLAINT COIL GOT STUCK IN THE MICROCATHETER. THE COIL WAS REMOVED, BUT IT WAS OBSERVED STRETCHED. AS A RESULT, THE MICROCATHETER AND COIL WERE BOTH REMOVED. ANOTHER MICROCATHETER WAS PLACED AND THE ANEURYSM WAS COILED. THE REPORTED EVENT RESULTED IN A 20-MINUTE PROCEDURE DELAY. THE COIL WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE PATIENT IS DOING FINE. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019451 ↗
• MalfunctionDec 15, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, THE DETACHMENT HUB OF AN ORBIT GALAXY XTRASOFT (640CX2505, 30494095) WAS BROKEN WHEN IT WAS FIRST OPEN. THE PHYSICIAN DECIDED TO USE A SAME-LIKE PRODUCT AND THE CASE WAS SUCCESSFULLY DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE USER EXPLAINED THAT THE LUER SEEMED BROKEN OR CRACKED WHEN IT WAS FIRST OPEN. SHE FELT MORE IT WAS CRACKED WHILE SHE CONNECTED THE COIL HUB AND LUER (LOCKING THE LUER). THE USER IS NOT SURE WHETHER IT¿S BECAUSE SHE PUT MORE PRESSURE THAN RECOMMENDED TO TIGHTEN THEM OR THERE WAS A DAMAGE ALREADY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014320 ↗
• MalfunctionNov 30, 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 MIDDLE CEREBRAL ARTERY (MCA), THE SIZE OF AN ORBIT GALAXY XTRASOFT COIL (640CX2505, 30494095) WAS NOT APPROPRIATE SO IT WAS RETRACTED. BUT THE RE-SHEATHING FAILED. THERE WERE NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT POOR CONFORMABILITY LED TO RESHEATHING THE COIL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE 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 REMOVED FROM THE PATIENT. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12895806 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2.5X5 ORBIT GALAXY XTRASOFT (640CX2505, 30536893), A 3X6 ORBIT GALAXY XTRASOFT (640CX0306, 30383962), AND A 2.5X5 ORBIT GALAXY XTRASOFT COIL (640CX2505, LOT UNKNOWN) COULD NOT DETACH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED AT THE TIME OF THE COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342830 ↗
• MalfunctionAug 19, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2.5X5 ORBIT GALAXY XTRASOFT (640CX2505, 30536893), A 3X6 ORBIT GALAXY XTRASOFT (640CX0306, 30383962), AND A 2.5X5 ORBIT GALAXY XTRASOFT COIL (640CX2505, LOT UNKNOWN) COULD NOT DETACH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED AT THE TIME OF THE COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342812 ↗
• MalfunctionJul 1, 2021Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION WITH THE TARGET 3MM X 3MM X 2MM ANEURYSM LOCATED ON THE INTERNAL CAROTID ARTERY (ICA), WHEN THE 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / 30494095) WAS BEING DEPLOYED INTO THE TARGET ANEURYSM VIA THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER), 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. THERE WAS NO DAMAGE OBSERVED ON THE COIL WHEN IT WAS REMOVED FROM THE PATIENT. THE REPORTED ISSUE DID NOT RESULT IN A PROCEDURE DELAY. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER COIL AS REPLACEMENT WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103787 ↗
• MalfunctionJul 1, 2021Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION WITH THE TARGET 3MM X 3MM X 3MM ANEURYSM LOCATED ON THE MIDDLE CEREBRAL ARTERY (MCA), THE 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / 30536893) WAS STRETCHED WHEN IT WAS BEING ADVANCED INTO THE CONCOMITANT EXCELSIOR® SL-10® MICROCATHETER (STRYKER). CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL HAD NOT BEEN WITHDRAWN AND REPOSITIONED. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET WAS BEING ACCESSED. THE COMPLAINT COIL WAS THE FIRST COIL; IT WAS CHOSEN AS THE FRAMING COIL. THERE WAS NO KINKS ON THE MICROCATHETER THAT MAY HAVE CAUSED THE COIL TO STRETCH. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. THERE WAS A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND THE DELIVERY WIRE THAT WAS VERIFIED WITH FLUORO. THE COIL WAS FULLY WITHDRAWN; ASIDE FROM THE REPORTED STRETCHED CONDITION, NO OTHER DAMAGE WAS NOTED WHEN THE COIL WAS REMOVED. THE COIL WAS NOT DETACHED WHEN IT WAS REMOVED. THERE WAS NO REPORT OF ANY BLOOD FLOW RESTRICTION / REDUCTION AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103676 ↗
• MalfunctionNov 4, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2.5X5 OG CMPLX XTRASOFT COIL (640CX2505, 30254264 WAS BEING USED AS THE FILLING COIL. THE PHYSICIAN DIDN'T JUDGE IMPROPERLY THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785382 ↗
• MalfunctionAug 13, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE FILLING COIL, A 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2505 / 30268669) WAS DEPLOYED, THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404741 ↗
• MalfunctionMay 27, 2020Mechanical Problem; Mechanical Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS A RESHEATHING FAILURE WITH A 2.5X5 OG CMPLX XTRASOFT COIL (640CX2505, 30003311). THE INTRODUCER SYSTEM WAS BROKEN DURING RECAPTURE. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE DEVICE ANALYSIS OF THE 2.5X5 OG CMPLX XTRASOFT, THE COIL WAS FOUND MECHANICALLY DETACHED FROM THE UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092147 ↗
• MalfunctionFeb 19, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2505 / 30254265) WAS THE FIRST COIL USED; THE PHYSICIAN COULD NOT ADVANCE NOR RETRACT THE COIL AND REMOVED BOTH THE COIL AND THE CONCOMITANT MICROCATHETER. INSPECTION AFTER REMOVAL WAS MADE AND THE COIL WAS NOTED TO BE STRETCHED. THE PHYSICIAN USED ANOTHER 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9728311 ↗