MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA ULTIRRA SINUS BALLOON CATHETER; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number BC0716RU

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

The age of the patient is not known.The device was returned for evaluation and the balloon catheter shaft was confirmed to be separated from the connector.A review of the lot history record for the subject device did not note any anomalies.

Event Description

Acclarent was informed that during a primary balloon sinuplasty procedure, the physician attempted to access the maxillary.The balloon catheter was introduced into the right maxillary sinus.However, upon delivery of the device, the balloon reportedly snapped in half at the hub of the balloon catheter and the connector near the proximal edge of the device.The balloon had been inflated four (4) times prior to the reported phenomenon.The user reported that the balloon broke during "deployment" of the balloon, and not while being inflated.The balloon was reported to have "snapped in half" at the proximal edge, near where the inflation device connects to the balloon.The piece was retrieved with the surgeon's hands.There was no report of patient injury.

• Brand Name: RELIEVA ULTIRRA SINUS BALLOON CATHETER
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497899383
• MDR Report Key: 6167955
• MDR Text Key: 62384083
• Report Number: 3005172759-2016-00018
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2017
• Device Catalogue Number: BC0716RU
• Device Lot Number: 150305E-CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1