Navigator HD M0062502220Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729837978), received between Jan 16, 2019 and Aug 12, 2026 — classified as 1 death, 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (14 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Device Contaminated During Manufacture or Shipping

  It was reported that a Navigator Access Sheath device was set to be used in a procedure. Reportedly, an eyelash hair was found in the package. There was no patient or procedure involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223055 ↗
• DeathJun 17, 2025Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, THE NAVIGATOR ACCESS SHEATH "BROKE APART WHILE INSIDE THE PATIENT." REPORTEDLY, THE FRAGMENTS WERE REMOVED USING A GRASPER. NINE DAYS LATER, THE PATIENT "CALLED 911 COMPLAINING OF SEVERE ABDOMINAL PAIN, NAUSEA, INCLUDING ABDOMINAL DISTENSION AND FEELINGS OF CONSTIPATION." REPORTEDLY, THESE FEELINGS HAD BEEN "PRESENT SINCE HER DISCHARGE" FOLLOWING THE URETEROSCOPY PROCEDURE. UPON ARRIVAL AT THE EMERGENCY ROOM, IT WAS NOTED THE PATIENT WAS EXPERIENCING HYPOTENSION AND ATRIAL FIBRILLATION. OVER THE NEXT FIVE DAYS THE PATIENT'S "ABDOMINAL COMPLICATIONS WORSENED RAPIDLY." IT WAS NOTED THAT THE PATIENT WAS HAVING "PERITONITIS AND LIKELY AN ISCHEMIC OR INFECTIOUS BOWEL." IT WAS ALSO NOTED THAT THE URINE INPUT WAS SEVERELY LIMITED AND WAS ULTIMATELY DIAGNOSED WITH SEPSIS, SEPTIC SHOCK, AND LACTIC ACIDOSIS. AFTER SEVERAL DAYS, THE PATIENT WAS "UNRESPONSIVE IN HER HOSPITAL BED AND PRONOUNCED DEAD." IT WAS FURTHER REPORTED THAT AN AUTOPSY NOTED "HYPERTENSIVE AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE AND "COMPLICATIONS [FROM] URETEROSCOPY." FURTHER, IT WAS REPORTED THAT "THE P

  Patient problems: Abdominal Pain; Atrial Fibrillation; Constipation; Ischemia; Low Blood Pressure/ Hypotension; Peritonitis; Sepsis; Septic Shock; Urinary Retention

  MAUDE report 22236416 ↗
• MalfunctionDec 2, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A TRANSURETHRAL LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INSERT A URETEROSCOPE INSIDE THE SHEATH, HOWEVER A SEVERE RESISTANCE WAS FELT INSIDE THE LUMEN OF THE SHEATH. THE PHYSICIAN SUSPECTED AN ABRASION OR PEELING OF THE COATING INSIDE THE SHEATH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825334 ↗
• MalfunctionSep 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF A URETEROLITOTOMIA PROCEDURE, WHEN THE DEVICE WAS UNPACKED, IT WAS FOUND THAT THE OUTER SHEATH OF THE NAVIGATOR WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247376 ↗
• MalfunctionJul 9, 2024Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE A NAVIGATOR ACCESS SHEATH DEVICE WAS USED WITH A FLEXIBLE ENDOSCOPE; HOWEVER, AN ABRASION OF THE COATING WAS FOUND INSIDE THE SHEATH. THE DETACHED VINYL WAS RETRIEVED FROM INSIDE THE SHEATH USING A FORCEPS AND IT DID NOT FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702874 ↗
• MalfunctionApr 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS ABOUT TO BE USED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2024. IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE NAVIGATOR HD WAS OPENED, AND THE TIP OF THE OUTER SHEATH WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047397 ↗
• MalfunctionJan 2, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A KIDNEY BIOPSY/STENT PLACEMENT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE HAD A BIG CRACK IN IT WHEN THEY WENT TO USE IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF SHEATH TORN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424496 ↗
• MalfunctionAug 30, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A URETERAL LITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, UPON OPENING THE PACKAGE IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE INNER PACKING. ADDITIONALLY, THE GOODS HAD BACTERIA AND THE SEAL HAS BEEN COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650080 ↗
• MalfunctionAug 1, 2023Peeled/Delaminated; Defective Device; Material Integrity Problem; Peeled/Delaminated; Defective Device; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, A PORTION OF THE SHEATH TOWARDS THE MIDDLE STILL FEELS STICK AND NOT COATED AFTER THE COATING WAS ACTIVATED. ADDITIONALLY, AFTER A FEW BACK AND FORTH PASSES, IT WAS NOTICED THAT THE COATING ON THE SHEATH STARTED TO FLAKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS THAT THE COATING OF THE OUTER SHEATH WAS NOT ACTIVATED IN SEVERAL SECTIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 2, 2023. IT WAS REPORTED THAT IT WAS THE HYDROPHILIC COATING THAT FLAKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435783 ↗
• MalfunctionApr 11, 2023Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A URETERAL DILATATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING INTRODUCTION, IT WAS NOTICED THAT THE DEVICE MALFUNCTIONED. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS DISCONTINUED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714512 ↗
• MalfunctionApr 3, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE RENAL PELVIS DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTED THAT THE SHEATH WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. 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 16665510 ↗
• MalfunctionFeb 27, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR DEVICE WAS USED IN THE KIDNEY, URETER AND BLADDER DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE NURSE REMOVED THE OUTER BOX AND CHECKED THE NAVIGATOR DEVICE, THE INNER PACKAGING HAD A VISIBLE HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR DEVICE SINCE THERE WAS A POSSIBILITY THAT THE DEVICE MAY HAVE BEEN CONTAMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444573 ↗
• MalfunctionJan 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED IN THE RIGHT URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, IT WAS NOTICED THAT THE TIP OF THE SHEATH WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16236106 ↗
• MalfunctionJul 19, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NAVIGATOR HD BREAKS WHILE INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE CUSTOMER PROVIDED TWO PHOTOS; ONE SHOWED THE NAVIGATOR SHEATH (SPLIT INTO TWO) AND THE DILATOR INSIDE A RED PLASTIC BAG. ANOTHER SHOWED THE DEVICE'S ORIGINAL POUCH. IT WAS OBSERVED THAT THE INNER WIRE WAS STRETCHED OUT AND THE SHEATH HAD BENDING MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051082 ↗
• MalfunctionApr 20, 2022Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE URETER DURING A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE HYDROPHILIC COATING OF THE DEVICE HAS COME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHEATH BREAK. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160370 ↗
• MalfunctionJan 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SHEATH BROKE. THERE WERE NO PATIENT COMPLICATIONS 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 13195104 ↗
• MalfunctionJan 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  T WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SHEATH BROKE. THERE WERE NO PATIENT COMPLICATIONS 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 13195059 ↗
• MalfunctionNov 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH WAS USED IN THE URETER DURING A URETEROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE SHEATH WAS FRACTURED IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH 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 12754015 ↗
• MalfunctionOct 19, 2021Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NAVIGATOR HD ACCESS SHEATH DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NAVIGATOR HD ACCESS SHEATH DEVICES WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PLASTIC PART OF THE SHEATH BROKE WHEN THE SCOPE WAS PASSED THROUGH THE DEVICE. THE SAME ISSUE OCCURRED WITH THE SECOND NAVIGATOR HD ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655648 ↗
• MalfunctionOct 13, 2021Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO NAVIGATOR HD ACCESS SHEATH DEVICES USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO NAVIGATOR HD ACCESS SHEATH DEVICES WERE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PLASTIC PART OF THE SHEATH BROKE WHEN THE SCOPE WAS PASSED THROUGH THE DEVICE. THE SAME ISSUE OCCURRED WITH THE SECOND NAVIGATOR HD ACCESS SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 21, 2021: IT WAS CLARIFIED THAT IT WAS THE WHITE PROXIMAL HUB OF THE DEVICE WHICH WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623151 ↗
• MalfunctionSep 27, 2021Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS NOTICED THAT THE TIP AND THE DIAMETER JUNCTION OF THE DEVICE WERE CRACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532116 ↗
• MalfunctionAug 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE INSERTING THE SHEATH IT WAS NOTED THAT THE SHEATH BROKE. REPORTEDLY, THERE WERE NO PIECES LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR ACCESS SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294780 ↗
• MalfunctionAug 5, 2021Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A SOFT URETEROSCOPIC LITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2021. DURING UNPACKING, THE WORKING LENGTH OF THE SHEATH WAS FOUND BROKEN IN TWO SEPARATE PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH 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 12280246 ↗
• MalfunctionMay 12, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS UNPACKED FOR A FLEXIBLE URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6), 2021. DURING UNPACKING, IT WAS NOTICED THAT THE STERILE DEVICE POUCH WAS ALREADY UNSEALED AND OPEN. THERE WAS NO PROBLEM NOTED TO THE DEVICE. THE UNSEALED PACKAGING WAS CONFIRMED VIA A PHOTO SENT BY THE CUSTOMER. THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811825 ↗
• MalfunctionApr 6, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR HD ACCESS SHEATH DEVICE WAS USED DURING A PROCEDURE PERFORMED ON FEBRUARY 21, 2021. DURING THE PROCEDURE, THE ACCESS SHEATH WAS PASSED SUCCESSFULLY INTO THE FIELD INTACT; HOWEVER, IT WAS NOTICED THAT THE SHEATH HAD BROKEN IN THE MIDDLE WHILE IN USED. 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. ADDITIONAL INFORMATION RECEIVED ON APRIL 16, 2021: THE DEVICE WAS USED IN THE RIGHT URETER DURING A RIGHT URETEROSCOPY HOLMIUM LASER STONE EXTRACTION STENT PROCEDURE. REPORTEDLY, THE SHEATH WAS NOTED BROKEN DURING PREPARATION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER NAVIGATOR HD ACCESS SHEATH DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618392 ↗