MAUDE Adverse Event Report: ACCLARENT, INC. UNKNOWN

Catalog Number UNKNOWN PRODUCT

Device Problem Difficult to Insert (1316)

Patient Problem Pulmonary Emphysema (1832)

Event Type  Injury  

Manufacturer Narrative

Based on complaint information, no product is expected back for evaluation.;unconfirmed - device not returned.

Event Description

This complaint is from a literature source.It was reported that one (b)(6) female patient with a chronic sensation of ear fullness, pressure, pain, and otitic barotrauma underwent bilateral eustachian tube dilation concurrent with endoscopic sinus surgery in 2009.The patient had a difficult balloon insertion on the left side.She had no immediate postoperative complaints, no otalgia, and normal ear examination in the recovery area.On post-op day 2, she noted preauricular emphysema that was limited to the ipsilateral parotid region and still without any otalgia or other symptoms.She was instructed to discontinue nasal saline irrigations and nose blowing for the next 4 days.The subcutaneous emphysema resolved spontaneously within 48 hours, and she remains free of et symptoms after 9 months.The physician's opinion regarding the causality of adverse event was procedure-related.The event did not result in the impairment of a body function or damage to a body structure.Article title: balloon catheter dilatation of eustachian tube: a preliminary study.The objective of study was to review the evolution of transnasal endoscopic balloon dilation of the eustachian tube and study the preliminary outcomes.Seventy (70) patients were enrolled in this study from january 2009 to january 2011.Suspected device is a 5-mm wide and 16-mm long balloon catheter, however model and catalog number is unknown.Bwi tried to contact the author to find out more information about the product, however the author did not recall as the procedure was done in 2009.The authored mentioned that the catheter used in this procedure was not a reprocessed / reused catheter.Concomitant products were used during this study: an f- 70 guide catheter, flexible relieva vortex sinus irrigation catheter.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 5946942
• MDR Text Key: 54581356
• Report Number: 3005172759-2016-00014
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/01/2016

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 Catalogue Number: UNKNOWN PRODUCT
• Device Lot Number: 090611A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52
• Patient Weight: 57