FDA Adverse Event Injury Summary report: N

PARADISE ULTRASOUND RENAL DENERVATION SYSTEM

MDR report key: 23812610 · Received December 15, 2025

Report

Report Number
3010024164-2025-00004
Event Type
Injury
Date Received
December 15, 2025
Date of Event
November 17, 2025
Report Date
December 15, 2025
Manufacturer
RECOR MEDICAL, INC.
Product Code
QYI
UDI-DI
00810008950005
PMA / PMN Number
P220023
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

EVENT: RENAL ARTERY THROMBOSIS EVENT DESCRIPTION: A FEMALE PATIENT UNDERWENT ULTRASOUND RENAL DENERVATION PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, MULTIPLE ATTEMPTS WERE MADE TO ACCESS THE CHALLENGING, TORTUOUS LEFT RENAL ARTERY USING THREE DIFFERENT PARADISE BALLOONS, WHICH REPEATEDLY DISLODGED DUE TO RESISTANCE CAUSED BY VESSEL TORTUOSITY. PARADISE CATHETER WAS NEVER INFLATED NOR WAS ANY SONICATION PROVIDED THE LEFT RENAL ARTERY. ALTHOUGH THE RETURNED DEVICES HAD TEARS WHICH APPEARED TO BE DUE TO TORTUOUS ANATOMY, THIS IS HIGHLY UNLIKELY RELATED TO THE ADVERSE EVENT. AS PER PHYSICIAN, THE ANTICOAGULATION DOSE WAS INADEQUATE. POST PROCEDURAL RENAL ANGIOGRAM NOTED A CLOT PARTIALLY OCCLUDING THE LEFT RENAL ARTERY. THE CLOT WAS TREATED WITH UNILATERAL THROMBECTOMY USING PENUMBRA PUMP (CAT6) WHICH RESTORED THE BLOOD FLOW. FOLLOWING THE THROMBECTOMY PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE ICU. A CONTRAST-ENHANCED CT SCAN WAS PERFORMED NOTED AREAS OF INFARCTION IN THE LEFT KIDNEY. PATIENT CONDITION IMPROVED AND DISCHARGED UNDER STABLE CONDITION 3 DAYS LATER. SUBOPTIMAL ANTICOAGULATION DOSE ALONG WITH FORCED INSERTION OF PARADISE CATHETERS AGAINST CHALLENGING ANATOMY, ATHEROSCLEROSIS, AND VASCULAR INJURY FROM MULTIPLE DEVICES INCLUDING THE ACCESSORY DEVICES, LIKELY CONTRIBUTED TO THE EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1661850 PARADISE ULTRASOUND RENAL DENERVATION SYSTEM ABLATION CATHETER RENAL DENERVATION QYI RECOR MEDICAL, INC. M4308, M4347, M4733 00810008950005

Patients

Seq Age Sex Outcome Treatment
1 NA Female Required Intervention 014X190 ABBOTT BALANCED MIDDLEWEIGHT GUIDE WIRE| 7FR.X11CM SHEATH| TWO CORDIS RDC (RENAL DOUBLE CURVE) GUIDE CATHETER