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

Model Number 5MM X 24 MM

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2014

Event Type  malfunction  

Event Description

Female toddler with a history of respiratory failure, status/post tracheostomy and subglottic stenosis had previously had tracheal dilation and excision of granuloma and laser use.Patient to or for direct laryngoscopy with tracheobronchoscopy, dilation of subglottic trachea and co2 laser excision of suprastomal granuloma.When preparing the balloon dilator for dilation of the trachea, the nurse inflated the balloon and it burst.Patient was not affected.A second dilator was obtained, tested and functioned properly.

• Brand Name: INSPIRA AIR BALLOON DILATION SYSTEM
• Type of Device: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o'brien drive; menlo park CA 94025
• MDR Report Key: 4151029
• MDR Text Key: 17996833
• Report Number: 4151029
• Device Sequence Number: 1
• Product Code: KTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/29/2014

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
• Device Operator: Invalid Data
• Device Model Number: 5MM X 24 MM
• Device Catalogue Number: BC0524A
• Device Lot Number: 140213B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; NO.
• Patient Age: 2 YR
• Patient Weight: 8