ORBIT GALAXY XTRASOFT 640CX2535Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886704030676), received between Dec 9, 2016 and Jan 28, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Stretched” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Retraction Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, AN ORBIT GALAXY XTRASOFT COIL (PRODUCT CODE: 640CX2535, LOT NUMBER: UNKNOWN) COULDN'T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THIS WAS THE FIRST COIL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199819 ↗
• MalfunctionApr 23, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE MICROCATHETER (COMPETITOR BRAND) WAS IN PLACE AND THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2535 / 31507407) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED THE COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT. ON 21-APR-2025, IT WAS REPORTED BY THE CERENOVUS SALES REPRESENTATIVE THAT ADDITIONAL INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895991 ↗
• MalfunctionFeb 18, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2535 / 31471126) 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 21405220 ↗
• MalfunctionFeb 28, 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 AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. AN ORBIT GALAXY XTRASOFT COIL (640CX2535, 30763728) WAS UNABLE TO RESHEATH. THERE WAS A TWO-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 13-FEB-2024 INDICATED THAT COIL HAD TO BE RESHEATHED DUE TO POOR COIL CONFORMABILITY. THERE WAS NO DAMAGE NOTED ON THE SHEATH INTRODUCER. THERE WAS NO SPLIT. THE DELIVERY WIRE OR COIL WERE NOT NOTED TO BE PROTRUDING FROM THE INTRODUCER. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE UNSPECIFIED MICROCATHETER (MC). THERE WAS NO NECK REMODELING UTILIZED. THE MC 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 18798459 ↗
• MalfunctionJan 22, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THERE WAS RESISTANCE WHILE PUSHING THE ORBIT GALAXY XTRASOFT COIL (640CX2535, 30758099) IN THE UNSPECIFIED MICROCATHETER (MC). WHEN THE COIL WAS REMOVED, IT WAS STRETCHED. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS A FIVE-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 13-JAN-2024 INDICATING THAT THE RESISTANCE WAS FIRST FELT INSIDE THE MID SHAFT OF THE PROWLER SELECT LPES LOT (606S155X, 31041133, LOT UNKNOWN) MICROCATHETER. BEFORE THE RESISTANCE, TWO COILS HAD BEEN USED AND AFTER THE ENCOUNTERED RESISTANCE, ONE COIL WAS USED. THE EVENT DID RESULT IN A LOSS OF CEREBRAL TARGET POSITION. THE MC WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THERE WAS NOTHING 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 ADVANCEME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553172 ↗
• MalfunctionAug 31, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WITH AN ANEURYSM UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COMPLAINT COIL, A 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2535 / 30692758) BECAME IMPEDED IN THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND) AND COULD NOT PASS THROUGH . THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE, AND THE COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT¿S ANATOMY. THE PHYSICIAN SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE ANTERIOR CEREBRAL ARTERY (ACA). PRIOR TO THE REPORTED ISSUE, SYNCHRO GUIDEWIRES (STRYKER) SUCCESSFULLY WENT THROUGH THE MICROCATHETER. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE ROTATING HEMOSTASIS VALVE (RHV) DURING THE ADVANCEMENT OF THE DEVICE. THERE WAS NO APPEARANCE OF DAMAGE NOTED ON THE COMPLAINT DEVICE. BASED ON THE ADDITIONAL I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664402 ↗
• MalfunctionOct 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4MM X 8CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX0408 / 30753131) WAS THE FIRST COIL USED. THE PHYSICIAN DECIDED TO PULL IT OUT FOR RE-DEPLOYMENT AFTER TRYING ANOTHER SIZE OF COIL, BECAUSE THE COIL WAS NOT OF AN APPROPRIATE SIZE. DURING THE ATTEMPT TO RE-SHEATH THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER ¿SAME LIKE¿ PRODUCT AS A REPLACEMENT. A 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2535 / 30739311) WAS ALSO DEPLOYED AS THE THIRD COIL. HOWEVER, WHEN THE PHYSICIAN TRIED TO DETACH THE COIL, IT COULD NOT BE DETACHED; THE PHYSICIAN THOUGHT THE HUB APPEARED BROKEN SO THERE WAS NOT ENOUGH PRESSURE DELIVERED TO THE DETACHMENT ZONE. THE PHYSICIAN OBSERVED SALINE LEAKING FROM THE HUB. THE PHYSICIAN REPLACED THIS COIL WITH ANOTHER 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL AND THE REPLACEMENT COIL SUCCESSFULLY DETACHED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15547656 ↗
• MalfunctionAug 8, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2535 / 30688449) COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 05-AUG-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM. THE INFORMATION INDICATED THAT THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL COULD NOT BE DETACHED. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. IT WAS NOT STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED; THE COIL WAS RETRACTED AS A WHOLE. THE REPORTED ISSUE DID NOT RESULT IN AN INTERRUPTION OF BLOOD FLOW. THE SYRINGE USED WAS FILLED WITH SALINE FROM A DEDICATED SOURCE. THE LOT NUMBER OF THE SYRINGE USED WAS 6331410. THE CATALOG NUMBER WAS NOT PROVIDED. THE INFORMATION INDICATED THAT THE SYRINGE HAD BEEN SUCCESSFULLY USED TO DEPLOY TWO COILS PRIOR TO THE REPORTED ISSUE WITH THE COMPLAINT COIL. THE SAME SYRINGE WAS LATER USED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184201 ↗
• MalfunctionMay 25, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 2.5X3.5 ORBIT GALAXY XTRASOFT COIL (640CX2535, 30641872) 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 THE COIL'S SIZE WAS NOT APPROPRIATE WITH ANEURYSM. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED AND THERE WAS NO PATIENT INJURY REPORTED. 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 14496612 ↗
• MalfunctionMar 10, 2022Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COIL INTRODUCER ON THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2535 / 30243165) BECAME KINKED DURING THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT, NO PATIENT COMPLICATION. A PHOTO OF THE COMPLAINT WAS INCLUDED IN THE COMPLAINT FILE. 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 DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL, THE EMBOLIC COIL WAS OBSERVED IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON (B)(6) 2022, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726760 ↗
• MalfunctionFeb 7, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, WHEN A PHYSICIAN TRIED TO INFLATE THE SYRINGE TO DETACH AN ORBIT GALAXY XTRASOFT COIL (640CX2535, 30641872), THE SALINE WAS LEAKING AND DETACHMENT FAILED. THEREFORE, THE PHYSICIAN TRIED TO INCREASE THE PRESSURE OF THE SYRINGE TO GIVE ANOTHER TRY TO DETACH THE COIL, AND THE WIRE NEAR THE HUB BECAME BROKEN. THE PHYSICIAN REPORTED THAT IT WAS A DEFECT OF PRODUCT, OR AN ASSISTANT GAVE TOO MUCH PRESSURE ON IT, BUT BECAUSE OF THE LEAKING PROBLEM, MORE PRESSURE WAS INEVITABLE. THIS COIL WAS TAKEN OUT OF THE PATIENT'S BODY BECAUSE OF DETACHMENT FAILURE. A SAME LIKE PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471103 ↗
• MalfunctionOct 13, 2021Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE TARGET ON THE INTERNAL CAROTID ARTERY (ICA), THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2535 / 30532547) WAS USED, BUT THE PHYSICIAN DECIDED TO REMOVE THE COIL BECAUSE IT WAS DEEMED AN INAPPROPRIATE SIZE FOR THE TARGET ANEURYSM. THE CONCOMITANT MICROCATHETER WAS NOT REMOVED WITH THE COIL. DURING THE RESHEATHING, THE COIL FAILED TO BE RE-ZIPPED AND THE INTRODUCER SHEATH SPLIT. THERE WAS AN ADEQUATE, CONTINUOUS FLUSH THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE AT ANY TIME DURING THE COIL ADVANCEMENT THROUGH THE MICROCATHETER. ADDITIONAL INTERVENTION WAS NOT REQUIRED; THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED ISSUE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON (B)(6) 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628205 ↗
• MalfunctionApr 14, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2.5X3.5 OG CMPLX XTRASOFT COIL (640CX2535, 30092202), THERE WAS A FAILURE TO RESHEATH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957223 ↗
• MalfunctionOct 30, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE ORBIT GALAXY COMPLEX XTRASOFT 2.5MM X 3.5CM COIL (640CX2535 / 17720190) BECAME STRETCHED AND COULD NO LONGER BE USED. THE COIL WAS WITHDRAWN AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020193 ↗
• MalfunctionJan 24, 2018Stretched; Stretched

  A REPORT WAS RECEIVED THAT DURING THE PROCEDURE, THE 2.5MM X 3.5CM ORBIT GALAXY COMPLEX XTRASOFT HYDRAULIC DETACHABLE COIL DELIVERY SYSTEM (DCS) ((B)(4)) COULD NOT BE ADVANCED. THE COIL WAS REMOVED FROM THE PATIENT AND FOUND TO BE STRETCHED. THE COIL WAS REPLACED WITH NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216159 ↗
• MalfunctionOct 16, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE PHYSICIAN PULLED THE ORBIT GALAXY COIL (640CX2535/ 17449396) AND UNSPECIFIED MICROCATHETER AT THE SAME TIME AND AFTER INSPECTION, THE COIL WAS FOUND TO BE STRETCHED. THERE WERE NO POTENTIAL ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950759 ↗
• MalfunctionAug 2, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A PROCEDURE, AN OG CMPLX XTRASOFT COIL (640CX2535/17568149) COULD NOT BE DETACHED AND THERE WAS AN ISSUE WHEN OPENING THE BOX OF THE OG CMPLX XTRASOFT COIL (640CX3575/UNKNOWN). THE PHYSICIAN USED ANOTHER OF THE SAME SIZE DEVICES TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760279 ↗
• MalfunctionMay 15, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE TWO ORBIT GALAXY COMPLEX FILL 4X10 COILS STRETCHED. THE PHYSICIAN REMOVED THE TWO STRETCHED COILS SAFELY. ANOTHER ORBIT GALAXY XTRASOFT 2.5 X 3.5 COIL FAILED TO RESHEATH WHEN THE PHYSICIAN TRIED TO REMOVE THE COIL, ANOTHER COIL OF A DIFFERENT SIZE WAS USED. THE PROCEDURE WAS COMPLETED. THERE WERE NO SERIOUS INJURIES DUE TO THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCTS ARE AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6566205 ↗
• MalfunctionDec 9, 2016Stretched; Stretched

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING THE PROCEDURE THE PHYSICIAN PULLED THE OG COMPLEX XTRASOFT COIL 2.5 X 3.5 (640CX2535/174493996) AND AN UNKNOWN MICROCATHETER AT THE SAME TIME. AFTER INSPECTION THE COIL TURNS OUT TO BE STRETCHED. IT IS UNKNOWN IF THE REPORTED EVENT CAUSED ANY PATIENT HARM OR SURGICAL DELAY. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6159058 ↗