MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RESOLVE CONVERTX®; STENT, URETERAL

Catalog Number	RCX22-8-038/C
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a patient came in for a two week follow up after a conversion from drain to bilateral stent.Upon initial image the provider observed that both sides looked to have been cut or separated at a location other than where it is intended to detach.The provider attempted to detach the right side and after following all appropriate steps the device did not convert.The physician did not attempt to convert on the left side as they could see it had already separated in a location other than the intended spot.No patent injury.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was returned and a visual inspection was performed.Kinking was found on the catheter and stent and split near the bond between the catheter and the stent, consistent with a cut caused by a sharp instrument.Since the device was returned after use, the exact root cause of the failure is unknown.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.Nonconformance of this nature is monitored by the engineering, quality and management team members.

• Brand Name: RESOLVE CONVERTX®
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 23658622
• Report Number: 1721504-2025-00622
• Device Sequence Number: 21345940
• Product Code: FAD
• UDI-Device Identifier: 00884450721285
• UDI-Public: 00884450721285
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: RCX22-8-038/C
• Device Lot Number: I3264745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown