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

Model Number	PRDS-065-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	09/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices used in this procedure were not returned to recor for evaluation.However, information that was provided does not indicate that there was a malfunction or abnormality with the equipment.Additional devices used: paradise cartridge ref - prds- ct-02 lot - 025883 exp - 2025-09-11.Connection cable ref - prds- cc-02 lot - m4169 exp - 2026-01-15.
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: hypertensive crisis 46-year-old female enrolled in the gps registry on 03 sep 2024.Past medical history was significant for hypertension since 2014 (last episode of hypertensive crisis on 10 oct 2023), type-ii diabetes, stroke on (b)(6) 2024 and coiling of anterior communicating artery aneurysm.Subject was on 4 anti-htn medications (bisoprolol 5 mg, trandate 200mg, spironolactone 25mg and felodipine 10mg) at the time of consent.On (b)(6) 2024, the subject underwent renal denervation procedure, and the procedure was uneventful.On (b)(6) 2024, 03 days post-procedure, subject presented to hospital with complaints of thunderclap occipital headache and left eye blurring, resulting in hospitalization.On the same day, ct head and ct angiogram were performed, which noted a complete occlusion of previously coiled anterior communicating artery aneurysm.No signs of aneurysmal subarachnoid hemorrhage, acute ischemic infarction, stroke or hydrocephalus were noted.On (b)(6) 2024, a lumbar puncture was performed which showed no evidence of subarachnoid hemorrhage.The headache was attributed to high blood pressure.Bp measurements at the time of the event are not available.Dose of anti-hypertensives medications were unchanged.The subject's condition was improved and was discharged under stable condition on (b)(6) 2024.The event was resolved on 18 sep 2024.On 16 oct 2024, source document was provided by the site.The event was reassessed on 17 oct 2024 and reportability decision was made on same day based on the new information received.

• 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: 20563648
• Report Number: 3010024164-2024-00007
• Device Sequence Number: 20725242
• Product Code: QYI
• UDI-Device Identifier: 00810008950012
• UDI-Public: 00810008950012
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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
• Device Expiration Date: 04/16/2026
• Device Model Number: PRDS-065-02
• Device Catalogue Number: PRDS-065-02
• Device Lot Number: M4310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: AMITRYPTYLINE; BISOPROLOL; EMPAGLIFLOZIN; FELODIPINE; FENTANYL; LINAGLIPTIN; METFORMIN; MIDAZOLAM; SPIRONOLACTONE; TRANDATE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian