MAUDE Adverse Event Report: AERIN MEDICAL INC. RHINAER STYLUS; RADIOFREQUENCY PROBE

Model Number FG1393

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Epistaxis (4458)

Event Date 12/24/2022

Event Type  Injury  

Event Description

(b)(6), 2022 the patient was taken to an ambulatory operating room where under general anesthesia the patient underwent a septoplasty, submucous resection of the inferior turbinates, a posterior nasal nerve ablation using the rhinaer stylus, and the left nasal septal swell body was treated.The septoplasty was performed first followed by treatment with rhinaer, and then the submucous resection of the turbinates.The procedure was uneventful with little intraoperative bleeding from any of the procedures.Visualization of the area of the posterior nasal nerves was not compromised by any of the adjunctive procedures.At one-week postoperative, the patient reported improved breathing.On (b)(6), 2022, the physician was contacted by an er stating that the patient had nasal bleeding.The er physicians packed the nose.Bleeding persisted and the patient was transferred to the physician's hospital and admitted.On (b)(6), 2022, the bleeding became severe, and a posterior nasal pack was placed along with rhinorocket nasal packs and a merocel nasal dressing.An interventional neuroradiologic evaluation was performed, it was unremarkable.During that procedure, the right sphenopalatine artery was embolized.The patient was intubated on (b)(6), 2022.The treating ent physician is uncertain why the patient was intubated however believes it was to manage the airway.The patient was extubated on (b)(6), 2022.The patient was discharged without problem and without any additional bleeding on (b)(6), 2023.The ent physician believes the bleeding may have occurred from a delayed separation of an eschar over the rhinaer treatment site.

• Brand Name: RHINAER STYLUS
• Type of Device: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 2565 leghorn st.; mountain view CA 94043
• Manufacturer (Section G): AERIN MEDICAL SINGAPORE PTE. LTD.; 60 albert street #16-01; singapore 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 16281623
• MDR Text Key: 308610118
• Report Number: 3011625895-2023-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male