MAUDE Adverse Event Report: Boston Scientific Corporation NAVIGATOR Ureteral Access Sheath Set 11/13; Catheter, Urological

Model Number	M0062502030
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sheath crumbled and began to chip before the item was ever used.

• Brand Name: NAVIGATOR Ureteral Access Sheath Set 11/13
• Common Device Name: Catheter, Urological
• Manufacturer (Section D): Boston Scientific Corporation; spencer IN 47460
• MDR Report Key: 50482721
• Report Number: MW6001590
• Device Sequence Number: 21413514
• Product Code: KOD
• UDI-Device Identifier: 08714729751502
• UDI-Public: (01)08714729751502(17)270319(10)36100056
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0062502030
• Device Lot Number: 36100056
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 154 LB
• Patient Race: Native Hawaiian Or Other Pacific Islander