MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING RESOLVE CONVERTX; NEPHROURETERAL.STENT SYSTEM

Model Number 00884450458648

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

The account alleges that a nephroureteral drain was successfully implanted on (b)(6) 2022.On (b)(6) 2022 the drain was to be converted to a nephroureteral stent.During the final deployment, the stent prematurely detached at an unexpected location.The physician still had access to the deployment string and was able to remove the device without procedural intervention.A new nephroureteral stent was placed for this patient without additional consequences to report.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: RESOLVE CONVERTX
• Type of Device: NEPHROURETERAL.STENT SYSTEM
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14024735
• MDR Text Key: 288696384
• Report Number: 3010665433-2022-00039
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00884450458648
• UDI-Public: 00884450458648
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450458648
• Device Catalogue Number: RCX20-8-038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1