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

Model Number	FG1393
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nose bleeds are a known potential side effect related to the use of radiofrequency energy on tissue in the nose.This side effect is listed in the device labeling.
Event or Problem Description
The patient received treatment with rhinaer by an outside otolaryngologist.He was seen at an outside ed shortly after the procedure for epistaxis and treated with nasal cautery and packing.The patient denied anticoagulant use.He continued to have epistaxis and a rhinorocket was placed in his surgeon's office.He presented to the ed several days later with bleeding from the right naris.Hgb on presentation was 10.7 g/dl.Packing was removed and he had no active bleeding, however there was evidence of recent epistaxis.Merocel packing was placed, and he was admitted for observation.He was discharged home the following day.Three days later he presented to the ed with right sided epistaxis.The merocele packing was removed to reveal brisk bleeding.Bleeding was temporizing with nasopore packing.Hgb at this time was 8.5 g/dl.Cta head/neck did not show active extravasation.He underwent embolization of the right sphenopalatine and angular arteries.During the procedure, vascular blush was noted in bilateral sphenopalatine areas and right angular artery.His hgb was 7.3 g/dl on pod #1 , and he did not receive a blood transfusion.He had no further epistaxis and was discharged home on pod #1.The patient was seen in follow up on pod #8 and denied epistaxis since embolization.He was seen in follow up with neurosurgery one month postoperatively and reported olfactory dysfunction but continued to be free of epistaxis.

• Brand Name: RHINAER STYLUS
• Common Device Name: 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 189969, sgp 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043
• MDR Report Key: 18049953
• Report Number: 3011625895-2023-00005
• Device Sequence Number: 7465199
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 57 YR
• Patient Sex: Male