MAUDE Adverse Event Report: RECOR MEDICAL, INC. PARADISE ULTRASOUND RENAL DENERVATION SYSTEM; ABLATION CATHETER RENAL DENERVATION

Lot Number	M4347
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
There is no indication of any failure of the device.In addition, there is no indication of any misuse of the device.Event: renal artery dissection event description: subject underwent procedure on (b)(6) 2025.After completing treatment in the left main renal artery, cine noted a lesion which was initially suspected to be spasm as per physician.Right renal artery was treated with no issues.After completing bilateral treatment, angiogram noted a flow-limiting dissection in the left renal artery (lra) at the most distal location which was treated with balloon angioplasty and stenting.Post-procedure vitals were stable, and the patient was discharged on the same day.As per physician, unique anatomy with renal artery tortuosity which may cause potential straightening and/or dissection from any device.

• Brand Name: PARADISE ULTRASOUND RENAL DENERVATION SYSTEM
• Common Device Name: ABLATION CATHETER RENAL DENERVATION
• Manufacturer (Section D): RECOR MEDICAL, INC.; 1049 elwell court; palo alto CA 94303
• Manufacturer (Section G): RECOR MEDICAL, INC.; 1049 elwell court; palo alto CA 94303
• Manufacturer Contact: ankita joshi ; 1049 elwell court; palo alto, CA 94303
• MDR Report Key: 23059671
• Report Number: 3010024164-2025-00002
• Device Sequence Number: 15908266
• Product Code: QYI
• UDI-Device Identifier: 00810008950012
• UDI-Public: 00810008950012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: M4347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MDT IMA 7FR GUIDE CATHETER; SCION BLUE WIRE, 0.014 INTRAVASCULAR ULTRASOUND
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female