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

Catalog Number BC1440A

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2018

Event Type  malfunction  

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 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
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8214946
• MDR Text Key: 132089619
• Report Number: 3005172759-2019-00116
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031063310
• UDI-Public: 10705031063310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: BC1440A
• Device Lot Number: 180817B-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1