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

Model Number	RT1640A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that a physician commented that he received a patient with a septal hematoma after undergoing a procedure with a relieva tract procedure to address nasal obstruction.The physician drained the patient and the hematoma was resolved.On 20-jun-2022, detailed additional information was received.The information indicated that on (b)(6) 2022, a male patient underwent a balloon sinuplasty procedure to treat the sinus issue and a relieva tract balloon (rt1640a / lot# unknown) was used during the procedure to create space.The septal hematoma was assumed to have occurred on (b)(6) 2022.It was confirmed on post-operative day 8 by dr.(b)(6) on computed tomography (ct) imaging on (b)(6) 2022.The patient did not have any previous sinus treatment before the index bsp procedure or with the relieva tract; it is unknown if the patient has a history of hematomas.In the physician¿s opinion, the procedure risk and submucosal rupture may have caused or contributed to the septal hematoma.The septal hematoma was treated via successful operative incision and drainage (i&d).The drainage was completed in one visit.The patient is reported to be doing well and was not hospitalized.The relieva tract was dilated one time per side.There was no difficulty manipulating the tract balloon or accessing the sinus during the procedure.There was no device performance issue or malfunction related to the relieva tract during the procedure; the procedure involving the tract balloon was considered successful.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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Septal hematoma is a procedure risk.There is no indication of any device performance or device malfunction related to the event.Since the septal hematoma is a serious injury and the event required surgical intervention via the operative incision and drainage (i&d) to preclude permanent impairment, the event meets mdr reporting criteria.The file will be re-reviewed if additional information is received at a later date.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.
Event or Problem Description
The healthcare professional reported that a physician commented that he received a patient with a septal hematoma after undergoing a procedure with a relieva tract procedure to address nasal obstruction.The physician drained the patient and the hematoma was resolved.On 20-jun-2022, detailed additional information was received.The information indicated that on (b)(6) 2022, a male patient underwent a balloon sinuplasty procedure to treat the sinus issue and a relieva tract balloon (rt1640a / lot# unknown) was used during the procedure to create space.The septal hematoma was assumed to have occurred on (b)(6) 2022.It was confirmed on post-operative day 8 by dr.(b)(6) on computed tomography (ct) imaging on (b)(6) 2022.The patient did not have any previous sinus treatment before the index bsp procedure or with the relieva tract; it is unknown if the patient has a history of hematomas.In the physician¿s opinion, the procedure risk and submucosal rupture may have caused or contributed to the septal hematoma.The septal hematoma was treated via successful operative incision and drainage (i&d).The drainage was completed in one visit.The patient is reported to be doing well and was not hospitalized.The relieva tract was dilated one time per side.There was no difficulty manipulating the tract balloon or accessing the sinus during the procedure.There was no device performance issue or malfunction related to the relieva tract during the procedure; the procedure involving the tract balloon was considered successful.

• Brand Name: RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM
• 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 d3; po box 74-4002; alajuala 20110 ; CS 20110
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14830857
• Report Number: 3005172759-2022-00014
• Device Sequence Number: 20019608
• Product Code: QGK
• UDI-Device Identifier: 10705031462649
• UDI-Public: 10705031462649
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 06/27/2022

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: RT1640A
• Device Catalogue Number: RT1640A
• 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: 06/08/2022
• Initial Report FDA Received Date: 06/27/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White