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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that while removing the device, the drainage portion of the convertx catheter fractured during conversion.The drainage portion was successfully removed.The stent portion was inspected and showed no defects.There was no patient injury oe medical intervention reported.No additional information is available.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up report will be submitted once investigation and product history review are complete.

• 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, 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, 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 25302723
• Report Number: 3011642792-2026-00077
• Device Sequence Number: 9319232
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown