MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK; BALLOON, NASAL AIRWAY

Catalog Number	RT1640AZ
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ecchymosis (1818); Swelling/ Edema (4577)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who underwent ent (ear, nose & throat) procedure with acclarent devices on (b)(6) 2024 experienced bruising and swelling below the eyes and swelling around the lower jaw.It was also reported that the physician had admitted the patient for a post-op ct scan, and it was confirmed that there was no cribriform plate fracture present.The caller reported that there was no other medical intervention provided to the patient.The caller reported that the patient is in stable condition.There are no reported malfunctions with any acclarent devices used during the case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient identifier and gender were not provided.D.4: the expiration date of the device is not known as the device lot number is not available / not reported.H.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Since this adverse event required hospitalization of the patient and diagnostic intervention to exclude permanent impairment of a body function or permanent damage to a body structure, it is considered serious and reportable.Should additional information become available, this case will be re-assessed and notes will be updated.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM - 1PK
• Common Device Name: BALLOON, NASAL AIRWAY
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park building; rio segundo; alajuela 90109 ; CS 90109
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19105775
• Report Number: 3005172759-2024-00028
• Device Sequence Number: 7268038
• Product Code: QGK
• UDI-Device Identifier: 10705031462649
• UDI-Public: 10705031462649
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

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 Catalogue Number: RT1640AZ
• 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: 03/20/2024
• Initial Report FDA Received Date: 04/15/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown