MAUDE Adverse Event Report: WELL LEAD MEDICAL CO., LTD. URETERAL ACCESS SHEATH, 12-14 FR X 46CM

Model Number	XUSM0044
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The legal manufacturer (as documented in sections d3 and f14) had been notified via email regarding this incident.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
The following was reported: "the dr.Placed the guide wire and clear petra sheat to place inside the patient as there was a narrowing in the urethra causing a tear.Had to stop the procedure, abort removing the kidney stones.".

• Brand Name: URETERAL ACCESS SHEATH, 12-14 FR X 46CM
• Common Device Name: URETERAL ACCESS SHEATH, 12-14 FR X 46CM
• 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: 25505497
• Report Number: 2020550-2026-01302
• Device Sequence Number: 13396505
• Product Code: FED
• UDI-Device Identifier: 16944932748023
• UDI-Public: 16944932748023
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026
• Report Date (Section F): 06/15/2026

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: XUSM0044
• Device Catalogue Number: XUSM0044
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• 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