MAUDE Adverse Event Report: ACCLARENT, INC. INSPIRA AIR BALLOON DILATION SYSTEM; AIRWAY BALLOON CATHETER

Model Number 14X40MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 03/02/2015

Event Type  Injury  

Event Description

Acclarent was informed of an event in which a patient was said to have developed an airway stenosis following a surgical procedure in which an acclarent inspira air balloon dilation system was used.The patient was noted to have had a web in the subglottic region resulting in airway obstruction prior to the procedure.It was reported that the planned dilation of a stenosis in the trachea went as expected, with no problems reported.The surgeon was said to have used a laser to create incisions in the trachea in an attempt to control the balloon dilation, and injected mitomycin into the surgical site to minimize scarring and restenosis.Hours after the completion of the procedure, the patient was reported to have developed another stenosis.The patient was hospitalized for observation due to persistent airway problems.The second stenosis was treated 4 days later through dilation using an acclarent inspira air balloon dilation system 10x40mm.The patient was discharged the following day, and was reported to have been doing well.

Manufacturer Narrative

The subject device reference in this report was discarded by the user facility and was not available for evaluation.Manufacturing records associated with the inspira air balloon dilation system could not be reviewed since the product's lot number was not available.The acclarent device used during this procedure functioned as expected, and no difficulty was reported with the device.The cause of the second stenosis is unknown.It would be unexpected for a new cicitricial stenosis to form so quickly.It is possible that it existed but was not observed preoperatively, or was the result of edema from the procedure (e.G.Laser, balloon dilation, or injection of mitmycin).The extent to which the subject device may have caused or contributed to the reported event cannot be determined.A supplemental report will be submitted if additional information is received.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: INSPIRA AIR BALLOON DILATION SYSTEM
• Type of Device: AIRWAY BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT, INC.; menlo park CA
• Manufacturer Contact: izabel nielson, sr. mgr. ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4651971
• MDR Text Key: 5613604
• Report Number: 3005172759-2015-00006
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K110218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/05/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 14X40MM
• Device Catalogue Number: BC1440A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MITOMYCIN WAS INJECTED AT THE SURGICAL SITE; LASER TO CREATE INCISIONS IN THE TRACHEA
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 20 YR