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

Catalog Number RS0616F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

The age of the patient is not known.The user facility returned one (1) relieva spin balloon sinuplasty system with a relieva luma sentry¿ sinus illumination system, and an f-70 sinus guide catheter tip.The following observations were noted: the balloon catheter was wrinkled, and the tip was collapsed and detached from the shaft.Upon further inspection under the microscope, it was observed that the inner shaft of the sinus balloon broke off near the middle and a tear was noted on the proximal of the balloon.The shaft was also inspected under the microscope and the broken off edge appeared jagged which was likely caused by excessive force during use.Due to the condition of the returned device, testing of the balloon was not able to be replicated in the testing environment.Based on analysis findings, the reported complaint was confirmed.Product analysis was also conducted on the returned guide wire and guide catheter; however the observations and results of these are unrelated to the alleged complaint.Visual inspection of the guide wire found no anomalies.The guide wire was connected to the xenon light source to verify the light output.The light output was transmitted and the measurement was within specifications.The returned guide catheter was checked under the microscope and delamination on the blue tip was observed.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 balloon catheter popped, detached and got stuck in the right maxillary sinus.The balloon catheter was replaced and the balloon popped again.Additional information was obtained and found that the balloon was completely detached and fell into the maxillary sinus.The balloon was completely retrieved using the takahashi forceps, no further surgery was performed.The patient was reported as doing well following the procedure; there were no complications noted.

• 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: 6168064
• MDR Text Key: 62377622
• Report Number: 3005172759-2016-00021
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• 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: 09/02/2015

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: 04/01/2017
• Device Catalogue Number: RS0616F
• Device Lot Number: 140401B-CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1