MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN BALLOON SINUPLASTY SYSTEM; SINUS BALLOON CATHETER

Catalog Number RS0616M

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

Acclarent was informed of an event wherein the balloon ruptured when the physician was dilating the maxillary sinus.The physician replaced the device and completed the procedure with no reported patient injury.Acclarent received the spin sinuplasty balloon catheter device on (b)(6) 2014 and investigation was completed on (b)(6) 2014.Acclarent noticed that the balloon was missing from the catheter upon receipt.

Manufacturer Narrative

The initial complaint did not include information to indicate the balloon was missing from the catheter.The device evaluation performed upon receipt of the device confirmed the balloon was missing from the catheter.A follow up to the facility was conducted inquiring the location of the missing balloon.The user facility responded that the location of the missing balloon.The user facility responded that the location of the missing balloon is unknown.There was no reported patient injury.Acclarent will continue to monitor this phenomenon for trending purposes.

• Brand Name: RELIEVA SPIN BALLOON SINUPLASTY SYSTEM
• Type of Device: SINUS 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: 4109639
• MDR Text Key: 17613354
• Report Number: 3005172759-2014-00023
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• 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: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2017
• Device Catalogue Number: RS0616M
• Device Lot Number: 140319B-CM
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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