MAUDE Adverse Event Report: ACCLARENT, INC. INSPIRA AIR; BRONCHOSOCPE ACCESSORY

Model Number BC1440A

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2017

Event Type  malfunction  

Event Description

The balloon system was being used to dilate the trachea.The balloon popped when air was inflated into it.

• Brand Name: INSPIRA AIR
• Type of Device: BRONCHOSOCPE ACCESSORY
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr; irvine CA 92618
• MDR Report Key: 7181683
• MDR Text Key: 96972146
• Report Number: 7181683
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC1440A
• Device Catalogue Number: BC1440A
• Device Lot Number: 170607A-PC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR