ENVOY 671-258-05DRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10878528000676), received between Jun 2, 2017 and Aug 11, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Physical Resistance/Sticking

  A healthcare professional reported that during the procedure, an ENVOY DA, 6F, 105CM, MPD Guide Catheter (product code: 67125805D, lot number: 31858974) was in place. A Micro-guidewire and microcatheter (both were other brands) were impeded in the middle section of the guide catheter and could not advance any more. The doctor removed the guide catheter, micro-guidewire and microcatheter from the patient together, then switched to a new guide catheter to complete surgery with the original micro-guidewire and microcatheter. There was no patient injury reported.Additional event information received on 31-Jul-2026 indicated that they were able to move the device. They were not able to torque the device. There was no evidence of physical material within the device. There was no difficulty removing the device from the patient. There was no procedure delayed/prolonged due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209540 ↗
• MalfunctionAug 11, 2026Physical Resistance/Sticking

  A healthcare professional reported that during a cerebral arteriovenous malformation embolization, an ENVOY DA, 6F, 105CM, MPD Guide Catheter (product code: 67125805D, lot number: 31892614) was in place and a competitor¿s microcatheter (MC) became impeded in the middle section of the guide catheter and could not advance any more. The doctor only retracted the microcatheter and switched to a second competitor¿s microcatheter. The second microcatheter had the same issue. The doctor removed the guide catheter and the second microcatheter from the patient together, then switched to a new guide catheter to complete surgery with the second microcatheter.Additional event information received on 31-Jul-2026 indicated that they were able to move the device. They were not able to torque the device. There was no evidence of physical material within the device. There was no difficulty removing the device from the patient. There was no procedure delayed/prolonged due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209277 ↗
• MalfunctionApr 23, 2026Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE ENVOY DA, 6F, 105CM, MPD (67125805D / 31434961) WAS DELIVERED IN PLACED AND THEN THE MICROCATHETER WAS DELIVERED IN THE GUIDE CATHETER. THE MICROCATHETER WAS IMPEDED IN THE MIDDLE SECTION OF THE ENVOY GUIDE CATHETER AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN REMOVED THE GUIDE CATHETER AND MICROCATHETER FROM THE PATIENT AND REPLACED THE GUIDE CATHETER TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO. ON 15-APR-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE INTERNAL CAROTID ARTERY (ICA). THE ASSOCIATED MICROCATHETER USED WAS A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE REPLACEMENT GUIDE CATHETER WAS ANOTHER ENVOY DA, 6F, 105CM, MPD (67125805D). THE INFORMATION CONFIRMED NO NEGATIVE IMPACT ON THE PATIENT AND NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968356 ↗
• MalfunctionJan 20, 2026Material Puncture/Hole

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE LEFT INTERNAL CAROTID ARTERY, AFTER THE ENVOY DA, 6F, 105CM, MPD (67125805D / 31159024) WAS IN PLACE, BUBBLES WERE OBSERVED FROM THE TIP OF THE GUIDE CATHETER UNDER IMAGING. THE PHYSICIAN REMOVED THE ENVOY CATHETER AND FOUND THERE WAS A HOLE AT THE TIP OF THE ENVOY CATHETER. THE PHYSICIAN REPLACED THE ENVOY AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. A PHOTO WAS INCLUDED IN THE COMPLAINT. THE PRODUCT ANALYSIS TEAM WILL REVIEW THE PHOTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121345 ↗
• MalfunctionJul 14, 2025Peeled/Delaminated; Peeled/Delaminated

  A HEALTHCARE PROFESSIONAL REPORTED THAT PRIOR TO THE PROCEDURE, THE DOCTOR OPENED THE OUTER PACKAGING OF AN ENVOY DA, 6F, 105CM, MPD CATHETER (67125805D, LOT UNKNOWN) FOR INSPECTION AND OBSERVED THE COATING AT THE DISTAL END OF THE DEVICE HAD FALLEN OFF. THE DEVICE WAS NOT USED IN PATIENT. THE DOCTOR CHANGED TO A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494667 ↗
• MalfunctionJul 10, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ENVOY DA, 6F, 105CM, MPD GUIDE CATHETER (67125805D, 31282758) WAS IMPEDED IN C1 SEGMENT OF CAROTID ARTERY AND COULD NOT DELIVER TO THE TARGET SITE. DOCTOR REMOVED THE GUIDE CATHETER FROM PATIENT AND FOUND THAT THE DISTAL END OF THE GUIDE CATHETER WAS KINKED/BENT. THE DOCTOR SWITCHED TO A NEW GUIDE CATHETER AND DELIVERED IT IN PLACE. THEN A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 31537084) WAS DELIVERED AND PLACED AND THEN AN UNSPECIFIED STENT WAS DELIVERED IN THE MICROCATHETER (MC). THE STENT WAS IMPEDED IN DISTAL END OF MICROCATHETER AND COULD NOT PASS THROUGH THE MICROCATHETER. THE DOCTOR REMOVED THE STENT AND MICROCATHETER FROM THE PATIENT AND SWITCHED TO A NEW MICROCATHETER TO DELIVER THE ORIGINAL STENT AND COMPLETED THE PROCEDURE. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JUL-2025 INDICATED THAT THE STENT WAS AN ENTERPRISE2 4MMX23MM (ENCR402312, LOT UNKNOWN). THERE WAS NO TORQUE DEVICE USED. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE MICROCATHETER WAS NOT KINK/BENT. THERE WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468858 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ENVOY DA, 6F, 105CM, MPD CATHETER HUB (67125805D, LOT UNKNOWN) IS NOT WORKING TO REMOVE AIR INSIDE HUB. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411501 ↗
• MalfunctionMay 29, 2025Peeled/Delaminated; Peeled/Delaminated

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF THE ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING FOR AN ENVOY DA, 6F, 105CM, MPD (67125805D / 31317942) FOR INSPECTION AND OBSERVED THAT THE INTRODUCER AND THE GUIDE CATHETER TIP WERE DEFORMED. THE DEVICE WAS NOT USED IN THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT. A PHOTO OF THE DEVICE WAS INCLUDED IN THE COMPLAINT. ON 29-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE DEVICE WAS FLUSHED AS THE PHOTO INCLUDED IN THE COMPLAINT SHOWS A SUBSTANCE COMING OUT OF THE CATHETER TIP. THERE WAS NO DELAMINATION NOTED. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PACKAGING BOX AND PACKAGING POUCH. THE SEAL HAS NOT BEEN COMPROMISED. THE REPLACEMENT DEVICE WAS ANOTHER ENVOY DA, 6F, 105CM, MPD (67125805D).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106291 ↗
• MalfunctionMay 19, 2025Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, PRIOR TO THE PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING OF AN ENVOY DA, 6F, 105CM, MPD CATHETER (67125805D, 31411030) FOR INSPECTION. THE PROXIMAL PART OF THE GUIDE CATHETER WAS FOUND CRACKED. THE DEVICE WAS NOT USED IN PATIENT. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 16-MAY-2025 INDICTED THAT THERE WAS NO OTHER PHYSICAL DAMAGE NOTED ON THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE AT ANY POINT. THERE HAD NOT BEEN ANY PACKAGING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043645 ↗
• MalfunctionMay 5, 2025Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PREPPING OF A ENVOY DA, 6F, 105CM, MPD GUIDE CATHETER DISTAL ACCESS (67125805D, 31159413) THERE WAS ¿A LITTLE HOLE ON THE GUIDE CATHETER SHAFT¿. THE DEVICE WAS NOT USED IN PATIENT. THE DOCTOR CHANGED TO A NEW GUIDE CATHETER TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED. THE DEVICE OUTER PACKAGING WAS IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 27-APR-2025 INDICATED THAT THERE WERE NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959772 ↗
• MalfunctionDec 13, 2024Crack; Material Twisted/Bent; Crack; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE DEVICE PACKAGING FOR AN ENVOY DA GUIDING CATHETER 6F, 105CM, MPD (67125805D / 31289207) AND THE GUIDE CATHETER WAS OBSERVED KINKED / BENT. THE DEVICE WAS NOT USED FOR THE PROCEDURE IN THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 10-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THERE WAS NO DAMAGE NOTED ON THE DEVICE PACKAGING. THERE WAS NO DIFFICULTY IN REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS CRACKING AT THE SITE OF THE DEFECT. THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE REPORTED ISSUE. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 10-DEC-2024, 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 20926294 ↗
• MalfunctionNov 15, 2024Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PREPARATION FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE OUTER PACKAGING FOR THE DEVICE, AN ENVOY DA, 6F, 105CM, MPD (67125805D / 31176027) FOR INSPECTION AND OBSERVED THAT THE DEVICE HAD BEEN BROKEN. IT WAS NOT USED IN THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW GUIDE CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 30-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTED ¿BROKEN¿ CONDITION OF THE CATHETER WAS CLARIFIED AS FOLLOWS: THERE WAS NO KINK ON THE DEVICE TIP. THE TIP HAS NOT BEEN CRUSHED NOR COMPRESSED. THE DEVICE IS INTACT, NO CRACKS. THERE WAS NO KINK IN THE DEVICE SHAFT. THE SHAFT WAS NOT NOTED TO BE CRUSHED NOR COMPRESSED. THERE WAS NO FRACTURE NOR CRACK IN THE DEVICE MATERIAL INTEGRITY. THE DEVICE IS ¿DIVIDED INTO 2 SEGMENTS.¿ THERE WAS NO CRACK NOR FRACTURE AT THE HUB. THERE WAS NO DAMAGE ON THE DEVICE PACKAGING, AND IT WAS NOT DIFFICULT TO REMOVE THE DEVICE FROM THE PACKAGING. BASED ON THE ADDITIONAL INFORMATION RECEIVED ON 30-OCT-2024, THE REPORTED EVENT HAS BEEN DEEMED USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700546 ↗
• MalfunctionSep 9, 2024Crack; Crack

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO THE RIGHT MIDDLE CEREBRAL ARTERY, AN ENVOY DA, 6F, 105CM, MPD GUIDE CATHETER (67125805D, 31176027) WAS DELIVERED IN THE PATIENT ALONG WITH AN UNSPECIFIED MICRO-GUIDE WIRE. THE PART NEAR THE GUIDE CATHETER¿S HUB (NOT IN PATIENT) WAS BROKEN DURING ITS DELIVERY. THE PHYSICIAN REMOVED THE GUIDE CATHETER FROM THE PATIENT AND SWITCH A NEW GUIDE CATHETER TO COMPLETE THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 25-AUG-2024 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY OR CONSEQUENCE THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE EVENT DID NOT RESULT IN ANY POTENTIAL HARM OR INJURY TO THE PATIENT. IT WAS FURTHER CLARIFIED THAT THE LUER HUB WAS CRACKED OR FRACTURED. THE CATHETER SHAFT WAS NOT CRACKED, PUNCTURED, BENT, OR COMPRESSED. THE DAMAGE DID NOT RESULT IN THE DEVICE SEPARATING INTO 2 OR MORE FRAGMENTS. A CONTINUOUS FLUSH WAS MAINTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169711 ↗
• MalfunctionJul 2, 2024Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED BY THE FIELD, A ¿SHAFT HOLE WAS DRILLED¿ ON AN ENVOY DA, 6F, 105CM, MPD CATHETER (67125805D, LOT UNKNOWN). THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657531 ↗
• MalfunctionJan 19, 2024Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

  AS REPORTED BY THE FIELD, PRIOR TO THE PROCEDURE, THE PHYSICIAN OPENED THE OUTER PACKAGING OF AN ENVOY DA, 6F, 105CM, MPD (67125805D, 31045688) AND FOUND THAT THE STERILE PACKAGE WAS ABSENT. THE DEVICE WAS NOT USED IN PATIENT. A NEW DEVICE WAS SWITCHED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542646 ↗
• MalfunctionDec 31, 2023Failure to Advance; Material Deformation; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Material Twisted/Bent; Physical Resistance/Sticking

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE ENVOY DA, 6F, 105CM, MPD GUIDE CATHETER (67125805D, 31062596) BECAME IMPEDED IN C1-C2 SEGMENT OF INTERNAL CAROTID ARTERY AND COULD NOT ADVANCE ANY MORE. THE PHYSICIAN DELIVERED THE UNSPECIFIED MICROCATHETER (MC) TO THE GUIDE CATHETER, BUT ENCOUNTERED RESISTANCE AND THE MICROCATHETER COULD NOT PASS THROUGH THE GUIDE CATHETER. THE DOCTOR REMOVED THE GUIDE CATHETER AND MICROCATHETER FROM THE PATIENT. THE GUIDE CATHETER SHAFT WAS FOUND TO BE KINKED/BENT AND THE GUIDE CATHETER TIP WAS COMPRESSED. A NEW GUIDE CATHETER WAS SWITCHED TO COMPLETE THE SURGERY WITH THE SAME MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 INDICATED THAT THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT. THERE WERE NO PROCEDURAL DELAYS TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423003 ↗
• MalfunctionOct 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  LEAKAGE. IT WAS REPORTED THAT DURING PROCEDURE, PHYSICIAN FLUSHED GUIDE CATHETER AND OBSERVED THE FLUID ESCAPED FROM AN UNINTENDED LOCATION ON THE GUIDE CATHETER. THE DEVICE WAS NOT USED IN PATIENT. A NEW GUIDE CATHETER WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021922 ↗
• MalfunctionAug 22, 2023Contamination /Decontamination Problem; Material Deformation; Material Twisted/Bent; Contamination /Decontamination Problem; Material Deformation; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE OUTER AND INNER PACKAGING OF THE COMPLAINT DEVICE, AN ENVOY DA, 6F, 105CM, MPD (67125805D / 31045685) FOR INSPECTION AND OBSERVED THE THAT THE GUIDE CATHETER TIP WAS COMPRESSED. THE SHAFT OF THE GUIDE CATHETER WAS KINKED / BENT. THERE WAS SOME LIQUID IN THE INNER PACKAGING. THE DEVICE WAS NOT USED IN THE PROCEDURE. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. TWO (2) PHOTOS OF THE COMPLAINT DEVICE WERE INCLUDED IN THE COMPLAINT. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE HAD BEEN NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597057 ↗
• MalfunctionJan 20, 2023Peeled/Delaminated; Peeled/Delaminated

  THE HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE THE START OF AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE PHYSICIAN OPENED THE PACKAGING CONTAINING AN ENVOY DA, 6F, 105CM, MPD (67125805D / 30517643) FOR INSPECTION. IT WAS REPORTED THAT THE DEVICE WAS OBSERVED TO BE DISCOLORED AND THE SURFACE MATERIAL WAS NOT REGULAR. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED TO SHOW THE REPORTED ISSUE. THE DEVICE WAS NOT USED IN THE PATIENT AS THE REPORTED ISSUE WAS OBSERVED BEFORE THE START OF THE PROCEDURE; THUS, THERE WAS NO NEGATIVE PATIENT IMPACT. THE COMPLAINT PRODUCT IS REPORTED AS NOT AVAILABLE FOR RETURN. ON 16-JAN-2023, THE CERENOVUS SALES REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION. THE INFORMATION INDICATED THAT THE LOT NUMBER OF THE DEVICE IS 30517643. THERE WAS NO DAMAGE ON THE PACKAGING; THE PACKAGING IS REPORTED TO BE INTACT. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED / IT WAS UNDAMAGED. THE INFORMATION INDICATED THAT ANOTHER ENVOY DA, 6F, 105CM, MPD (67125805D) WAS USED. THERE WAS NO REPORTED PROCEDURE DELAY AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218130 ↗
• MalfunctionSep 24, 2022Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 6F, 105CM ENVOY DA GUIDE CATHETER (67125805D / 30490095) ARRIVED AT THE TARGET POSITION AND THE MICROCATHETER WAS DELIVERED INTO THE GUIDE CATHETER. THE MICROCATHETER WAS IMPEDED IN THE GUIDE CATHETER AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED THE GUIDE CATHETER AND FOUND THAT IT HAD BECOME KINKED / BENT. A NEW GUIDE CATHETER WAS USED WITH THE ORIGINAL MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. TWO PHOTOS ON 08-SEP-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL WAS THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). THE CAVERNOUS SINUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) IS UPWARDLY TORTUOUS. THERE WAS A LOSS OF TARGET POSITION WHEN THE GUIDE CATHETER WAS REMOVED FOR REPLACEMENT. BASED ON THE ADDITIONAL INFORMATION, THE EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿ TWO PHOTOS WERE INCLUDED IN THE COMPLAINT. ONE PHOTO IS OF THE PRODUCT LABEL. THE SECOND PHOTO IS OF THE COMPLAINT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478605 ↗
• MalfunctionJul 8, 2022Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE ENVOY DA, 6F, 105CM MPD DISTAL ACCESS CATHETER (67125805D / 30446673) WAS USED AND THE PHYSICIAN ATTEMPTED TO TAKE AN ANGIOGRAM TO OBSERVE ITS POSITION, BUT THE TIP OF THE CATHETER COULD NOT BE DISPLAYED. THE PHYSICIAN RETRACTED THE CATHETER AND REPLACED IT TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OF THE PROCEDURE WAS ON THE C3 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE WIRE OF THE DEVICE WAS VISIBLE. THE REPORTED ISSUE DID NOT RESULT IN INADEQUATE POSITIONING OF THE CONCOMITANT DEVICE. IT WAS REPLACED BY ANOTHER ENVOY DA, 6F, 105CM MPD DISTAL ACCESS CATHETER (67125805D). THE REPORTED ISSUE DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960258 ↗
• MalfunctionJun 7, 2022Nonstandard Device; Material Split, Cut or Torn; Nonstandard Device; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, DURING THE PREPPING OF AN ENVOY DA, 6F, 105CM, MPD (67125805D, 30460072) GUIDE CATHETER, THE PHYSICIAN OBSERVED UNEVEN MATERIALS ON THE TIP OF THE HE CATHETER. THE PHYSICIAN SWITCHED TO A NEW DEVICE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED AS THE DEVICE WAS NOT CLINICALLY USED. A PICTURE WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO PACKAGING ISSUES. THE INNER POUCH WAS SECURELY SEALED. THE DEVICE HAD BEEN STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14625775 ↗
• MalfunctionApr 6, 2020Crack; Crack

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE TIP OF A 6F, 105CM ENVOY DA GUIDE CATHETER (67125805D, E12018) WAS CRACKED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928105 ↗
• MalfunctionAug 15, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 6F ENVOY DA 105 CM MPD (67125805D/E11752) DISTAL ACCESS GUIDING CATHETER WAS CONTAMINATED DUE TO FOREIGN MATERIAL. THERE WAS NO REPORT OF CONSEQUENCE OR CONSEQUENCE OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT. THE PRODUCT AVAILABILITY IS CURRENTLY UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7786245 ↗
• MalfunctionJun 2, 2017Fracture; Fracture

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE TIP OF AN ENVOY DA CATHETER WAS FOUND FRACTURED DURING THE PROCEDURE, PRIOR TO THE DEVICE BEING PLACED IN THE PATIENT. THEY USED A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR PROCEDURE DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6607689 ↗