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

Catalog Number RSP0616MFS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the lot history record for the subject device did not note any anomalies.The acclarent product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigation analysis is completed, a supplemental 3500a report will be submitted.

Event Description

Acclarent was informed that during a primary hybrid balloon sinuplasty procedure performed on (b)(6) 2016, a small piece of the tip of the frontal guide catheter from the relieva spinplus kit, 3 guides, 6x16mm, 5pk (lot# 160706a-pc) was torn off and was found in the intranasal cavity.The physician removed the piece using regular suction.Unknown brand instrumentation for the ethmoid sinuses was also used during the procedure.Further follow- up information from the acclarent representative confirmed that there was no issue with the procedure performed.There was no report of patient injury or complication.

Manufacturer Narrative

Acclarent received the returned package of the component on 1/6/2017, which consisted of the guide catheter (f-70).Before decontamination, visual inspection was performed.The following observations were noted: the tip of the guide catheter was peeled off and a small piece from the tip tore off / separated.There was no other damage observed on the guide catheter.A small piece of from the tip of the guide catheter was confirmed as being torn off as reported.

• Brand Name: RELIEVA SPINPLUS 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: 6259050
• MDR Text Key: 65038811
• Report Number: 3005172759-2017-00001
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 160706A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1