MAUDE Adverse Event Report: Merit Maquiladora Mexico, S. DE R.L. DE C.V. ReSolve ConvertX; STENT, URETERAL

Catalog Number	RCX24-8-038
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction

• Brand Name: ReSolve ConvertX
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer (Section G): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50947121
• Report Number: 3011642792-2026-00237
• Device Sequence Number: 16059627
• Product Code: FAD
• UDI-Device Identifier: 00884450721308
• UDI-Public: 00884450721308
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Device Catalogue Number: RCX24-8-038
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown