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

Catalog Number RS0616M

Device Problem Leak/Splash (1354)

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

Event Date 10/06/2016

Event Type  malfunction  

Event Description

Acclarent balloon malfunctioned during sinus procedure.Balloon and handpiece were inspected and were completely intact.Malfunction was related to a small leak in the balloon.Handpiece and packaging were sent to the manufacturer for inspection and reporting.

• Brand Name: RELIEVA
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr; irvine CA 92618
• MDR Report Key: 6202133
• MDR Text Key: 63202659
• Report Number: 6202133
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016,11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RS0616M
• Device Lot Number: 150908C-CM
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR