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

Catalog Number	RCX24-8-038/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
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 customer alleges that during nephroureteral stent placement procedure, the stent initially failed to correctly detach and required additional manipulation by the physician.During stent readjustment, the stent was improperly positioned and migrated into the patient's kidney.The patient was transferred to the urology department for stent repositioning.The procedure was completed without consequence to the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.

• Brand Name: RESOLVE CONVERTX STENT SYSTEM.
• Common Device Name: NEPHROURETERAL.STENT SYSTEM.
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• MDR Report Key: 11882691
• Report Number: 3010665433-2021-00036
• Device Sequence Number: 11079187
• Product Code: FAD
• UDI-Device Identifier: 00884450458563
• UDI-Public: 884450458563
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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 Expiration Date: 03/23/2023
• Device Catalogue Number: RCX24-8-038/A
• Device Lot Number: E2082846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1