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

Catalog Number	RCX24-8-038/C
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that the stent would not engage.A new device was deployed within this patient.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Upon inspection the internal thread of the catheter was found to be configured incorrectly.The complaint is confirmed.Root cause is attributed to the manufacturing process.A review of the device history record was performed and no exception documents were identified.A review of the complaint database was performed and no similar complaints for this lot were found.

• Brand Name: RESOLVE CONVERTX®.NEPHROURETERAL.STENT
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18571182
• Report Number: 3011642792-2024-00008
• Device Sequence Number: 20894766
• Product Code: FAD
• UDI-Device Identifier: 00884450721308
• UDI-Public: 884450721308
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 01/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: RCX24-8-038/C
• Device Lot Number: I2671049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown