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 No Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

Acclarent received the complaint package on 11/22/2016, which included the following: a.A spin sinuplasty balloon.B.Balloon slider.C.Wire slider.Before decontamination, visual inspection was performed.The following observations were noted: the balloon and the small portion of the shaft were completely separated; these parts did not get sent back.Further inspection of the shaft indicated that there was no evidence of the shaft being cut with a sharp object.The received balloon catheter is not functional.The integrity of the balloon portion of the balloon catheter cannot be determined due to the missing balloon section on the returned device.The customer complaint has been verified.A review of the lot history record for the subject device did not note any anomalies.

Event Description

Acclarent was informed on (b)(6) 2016, for an event that occurred on (b)(6) 2016, involving a relieva spin 6x16 sinuplasty system, 3 guide kit (lot# 160406a-pc).The reported issue was that the plastic sheath has been detached.No other information is available.

• 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: 6168053
• MDR Text Key: 62470861
• Report Number: 3005172759-2016-00022
• 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: 12/06/2016

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 Catalogue Number: RS0616MFS
• Device Lot Number: 160406A-PC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1