Navigator M0062502020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729429944), received between Apr 4, 2018 and Nov 17, 2022 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SHEATH WAS BENT, EXPOSING THE WIRE INSIDE. THE PROCEDURE WAS COMPLETED WITH SAME ORIGINAL NAVIGATOR ACCESS SHEATH. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814231 ↗
• MalfunctionOct 20, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE ACCESS SHEATH WAS INSERTED; HOWEVER, THE SCOPE HAD MINIMAL VISIBILITY THROUGH THE SHEATH BECAUSE OF MULTIPLE FIBERS HANGING INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF ONE NAVIGATOR, SHOWING THE PEELED INNER COATING OF THE SHEATH, WAS SUBMITTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639494 ↗
• MalfunctionNov 7, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. IT WAS REPORTED THAT THE INTERNAL LINING OF THE SHEATH WAS PEELING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759229 ↗
• InjurySep 24, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE BLADDER DURING A PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE FLEXIBLE URETEROSCOPE AND SHEATH WERE REMOVED IT WAS NOTICED THAT THERE WERE PLASTIC COATING FROM MULTIPLE AREAS OF THE SHEATH THAT DISINTEGRATED. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF DAMAGE TO ANY OTHER DEVICES USED IN THE PROCEDURE. THE CYSTOSCOPE WAS RE-INTRODUCED INTO THE BLADDER AND MULTIPLE FRAGMENTS WERE IRRIGATED OUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 28, 2021. IT WAS REPORTED THAT CYSTOURETHROSCOPY, LASER LITHOTRIPSY PROCEDURE WAS PERFORMED AND WAS COMPLETED WITH THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525433 ↗
• MalfunctionSep 3, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE BLADDER DURING A CYSTOURETHEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PLASTIC COATING CHIPPED OFF THE BLADDER. IT WAS REPORTED THAT THE CHIPPED PLASTIC COATING WAS IRRIGATED OUT OF THE BLADDER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12420793 ↗
• MalfunctionDec 30, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS APPARENTLY FRAYING INTERNALLY. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020*** IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6)2019. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9529785 ↗
• MalfunctionDec 19, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE NAVIGATOR ACCESS SHEATH WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH FRAYED AND LEFT A HAIR LIKE STING LOOSE IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **CORRECTION** IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9495355 ↗
• MalfunctionDec 18, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH RUPTURED AND THE INNER FILM OF THE DEVICE WAS PEELED DUE TO THE INSERTION OF A URETEROSCOPE IN THE DEVICE. THE PROCEDURE WAS COMPLETED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173877 ↗
• MalfunctionDec 5, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NAVIGATOR ACCESS SHEATH DEVICES WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE INNER FILM OF THE DEVICE WAS PEELED DUE TO THE INSERTION OF A URETEROSCOPE IN THE SHEATH. THE SAME ISSUE OCCURRED WITH THE SECOND NAVIGATOR ACCESS SHEATH DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134433 ↗
• MalfunctionApr 4, 2018Torn Material; Torn Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR URETERAL ACCESS SHEATH WAS USED IN THE URETER DURING AN URETEROSCOPY AND LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE INNER SHEATH SHEARED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396848 ↗