MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIGATOR HD; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	M0062502220
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Abdominal Pain (1685); Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Sepsis (2067); Septic Shock (2068); Urinary Retention (2119); Peritonitis (2252); Constipation (3274)
Date of Event	07/17/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi)# and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a040506 captures the reportable event of sheath peeled.Patient code e1002 captures the reportable event of abdominal pain.Patient code e1007 captures the reportable event of constipation.Patient code e060102 captures the reportable event of atrial fibrillation.Patient code e1024 captures the reportable event of peritonitis.Patient code e0509 captures the reportable event of ischemia.Patient code e1309 captures the reportable event of urinary retention.Patient code e0306 captures the reportable event of sepsis.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f02 captures the reportable event of patient death.Impact code f1908 captures the reportable event of prolonged surgery.
Event or Problem Description
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 procedure was complicated by disintegration of the ureteroscope cover and severe postoperative hypotension.".
Additional Manufacturer Narrative
Blocks d4, h4: detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h2: additional information: block h6 (patient codes, device codes) block a6 (race).Block h6: device code a0414 captures the reportable event of sheath torn.Patient code e1002 captures the reportable event of abdominal pain.Patient code e1007 captures the reportable event of constipation.Patient code e060102 captures the reportable event of atrial fibrillation.Patient code e1024 captures the reportable event of peritonitis.Patient code e0509 captures the reportable event of ischemia.Patient code e1309 captures the reportable event of urinary retention.Patient code e0306 captures the reportable event of sepsis.Patient code e233605 captures the reportable event of sepsis shock.Patient code e2321 captures the reportable event of hypotension.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f02 captures the reportable event of patient death.Impact code f1908 captures the reportable event of prolonged surgery.Block h11: correction to field d6a (implant date).
Event or Problem Description
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 procedure was complicated by disintegration of the ureteroscope cover and severe postoperative hypotension.".

• Brand Name: NAVIGATOR HD
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22236416
• Report Number: 2124215-2025-39274
• Device Sequence Number: 21092890
• Product Code: FED
• UDI-Device Identifier: 08714729837978
• UDI-Public: (01)08714729837978
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0062502220
• Device Catalogue Number: M0062502220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White