MAUDE Adverse Event Report: Well Lead Medical Co., Ltd. Ureteral Access Sheath, 12-14 Fr x 36cm

Model Number	XUSM0043
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor split the ureter.He was near the upj and while he was maneuvering the clearpetra sheath, the surgeon split the ureter.The case had to be stopped.A stent was then placed in the patient and the doctor said he would let it heal and come back in a month.The device was disposed.

• Brand Name: Ureteral Access Sheath, 12-14 Fr x 36cm
• Common Device Name: Ureteral Access Sheath, 12-14 Fr x 36cm
• Manufacturer (Section D): Well Lead Medical Co., Ltd.; c-4 jinhu; industrial estate hualong; panyu, guangzhou CN 51 1434; CH CN 511434
• MDR Report Key: 50884594
• Report Number: 2020550-2026-02173
• Device Sequence Number: 9939840
• Product Code: FED
• UDI-Device Identifier: 16944932747927
• UDI-Public: 16944932747927
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: XUSM0043
• Device Catalogue Number: XUSM0043
• Device Lot Number: 2510253702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown