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

Model Number	FG815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bleeding is a known potential adverse event and documented in the device labeling.
Event or Problem Description
The rhinaer stylus was used to the treat the posterior nasal nerve region of the nasal airway.The procedure was performed bilaterally and relatively unremarkably according to the physician.The physician reported some minor oozing at the end of the case that was controlled with an epi soaked cotton pledget.The patient had some self limited oozing that evening and the next day which stopped within 24 hours of the procedure and did not need any intervention.14 days post-procedure, the patient came into the office with some congestion.There were crusts in both nasal passages that were removed without any bleeding at that time.Three weeks post-procedure, the physician received a call from the er.The patient had started bleeding spontaneously, over 100ml in total.The physician was unable to control the bleeding at the bedside and took the patient to the operating room for right spenopalatine artery ligation.There was a small arterial bleeder at the right treatment site.The last follow-up visit with the patient occurred one month following the bleeding event.The patient has healed now.There was no report of device malfunction by the clinic.

• Brand Name: RHINAER SYTLUS
• Common Device Name: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 232 e caribbean drive; sunnyvale CA 94089
• MDR Report Key: 11619776
• Report Number: 3011625895-2021-00003
• Device Sequence Number: 14272935
• Product Code: GEI
• UDI-Device Identifier: 08886479300184
• UDI-Public: 08886479300184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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 Model Number: FG815
• Device Catalogue Number: CAT821
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Weight: 61