MAUDE Adverse Event Report:; Ablation catheter, renal denervation

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

This is our first electronic mdr submission and the report was delayed due to the signup process.We mailed a hard copy to fda on march 13, 2024 which was rejected.

Event Description

There is no indication of any failure of the device.In addition, there is no indication of any misuse of the device.Event: post procedural hematoma.A 64-year-old female patient was successfully treated with urdn procedure on bilateral renal arteries on (b)(6) 2024.On (b)(6) 2024, three days following the procedure, patient had lower abdominal pain.Ct of the abdomen and pelvis was performed which revealed intraparenchymal and subcapsular hematomas of the right kidney and posterior pararenal fascia without evidence of active bleeding.The patient was admitted to the hospital on (b)(6) 2024.Supportive treatment was given.On (b)(6) 2024, patient's condition was improved and patient was discharged under stable condition.

• Type of Device: Ablation catheter, renal denervation
• Manufacturer Contact: dimitri augustin ; 1049, elwell court; palo alto, CA 94303 ; 6509129005
• MDR Report Key: 19044909
• MDR Text Key: 339432274
• Report Number: 3010024164-2024-00001
• Device Sequence Number: 1
• Product Code: QYI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P220023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2024

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 Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: AAS.; ALDACTONE.; ATENOLOL.; ATOZET.; CAPENON HCT.; CARDURAN.; CLOPIDOGREL.; HYDRALAZINE.; RECOR PARADISE RENAL DENERVATION SYSTEM.; TOUJEO.
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female