MAUDE Adverse Event Report: ACCLARENT INSPIRA AIR BALLOON; AIRWAY BALLOON CATHETER

Catalog Number BC1440A

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/11/2014

Event Type  Injury  

Event Description

The user reported that during a procedure in which the device was being used in the subglottic area when the balloon ruptured and some particles entered the pt's lung.The physician reportedly performed a bronchoscopy and was able to successfully remove all of balloon fragments.No add'l intervention was required; however, the pt remained at the user facility overnight.

Manufacturer Narrative

Acclarent followed up on this report and was informed that the subject device was inflated twice during the procedure, and had been advanced through a bronchoscope at the time of the initial inflation.However, the device was said to be used outside of the bronchoscope when the second inflation occurred.The device referenced is being returned for eval.Review of mfg records associated with the subject device did not detect any anomalies.A supplemental report will be submitted with the results of the eval following receipt of the device.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: INSPIRA AIR BALLOON
• Type of Device: AIRWAY BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson, sr, mgr. ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4024388
• MDR Text Key: 4882021
• Report Number: 3005172759-2014-00018
• Device Sequence Number: 1
• Product Code: LRC
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/14/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: BC1440A
• Device Lot Number: 131031A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK BRAND OF BRONCHOSCOPE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR