MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number RS0616MFS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/13/2015

Event Type  malfunction  

Manufacturer Narrative

The returned package contained one (1) 6 x 16 mm spin balloon catheter along with the relieva luma sentry¿ sinus illumination system.The packaging pouch was also returned with the device and the reported lot number of 150401a-cm was confirmed.The lot history record review was performed and confirmed that lot 150401a-cm met release specifications.The device evaluation confirmed that the balloon was torn.A portion of the balloon was remained attached to attach to the proximal shaft of the balloon catheter.The distal end of the balloon was torn / burst from the middle and approximately 15 mm of the inner shaft was exposed.The detached portion of the balloon was also returned with the package.Upon visual inspection of the returned guide wire, a minor kink on the distal end was observed, however the light output was confirmed to be within specifications.

Event Description

Acclarent was informed that during a primary balloon sinuplasty procedure, the balloon became detached during the initial inflation of a frontal sinus.Follow-up information from the facility confirmed the balloon was retrieved using forceps during the same procedure an there was no patient or user injury as a result of the reported phenomenon.The user facility reported that no surgery beyond the expected and planned procedure was required.There was no report of patient injury.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• 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: 6167901
• MDR Text Key: 62381716
• Report Number: 3005172759-2016-00017
• 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: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/14/2015

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: 04/01/2018
• Device Catalogue Number: RS0616MFS
• Device Lot Number: 150401A-CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1