MAUDE Adverse Event Report: ACCLARENT, INC. INSPIRA AIR BALLOON DILATION SYSTEM, 14X40MM; BRONCHOSCOPE ACCESSORY

Catalog Number	BC1440A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history record (lhr) was reviewed for lot 180817b-pc.No anomalies were found related to this complaint.In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures.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
Acclarent was informed on (b)(6) 2018, of an event that occurred during the airway dilation procedure on (b)(6) 2018, involving the 14 x 40mm inspira air balloon dilation system (bc1440a / 180817b-pc).It was reported that upon the second dilation, the inspira air balloon could not become fully deflated; this issue was reported to have occurred outside of the patient¿s airway.It was reported that the guide/balloon was not flushed prior to use.The inspira balloon was replaced with another 14 x 40mm inspira air balloon and the procedure was continued and successfully completed with the replacement device.There was no report of any patient consequence or adverse event associated with the issue.The inspira air balloon was reported to have been discarded and is not available to be returned for evaluation.

• Brand Name: INSPIRA AIR BALLOON DILATION SYSTEM, 14X40MM
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8214946
• Report Number: 3005172759-2019-00116
• Device Sequence Number: 2745206
• Product Code: LRC
• UDI-Device Identifier: 10705031063310
• UDI-Public: 10705031063310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: BC1440A
• Device Lot Number: 180817B-PC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1