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

Model Number SCT0624MFS

Device Problems Kinked (1339); Material Rupture (1546)

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

Event Date 11/29/2017

Event Type  malfunction  

Event Description

While testing the balloon for proper inflating prior to use the surgeon had the balloon on the device rupture causing the device to kink and not be usable.This same event occurred with a different lot two months prior.However, the same device type and model was used successfully in 15 cases between the two incidence.

• Brand Name: RELIVA SCOUT
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr.; irvine CA 92618
• MDR Report Key: 7185551
• MDR Text Key: 97124282
• Report Number: 7185551
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SCT0624MFS
• Device Catalogue Number: SCT0624MFS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICE BEING USED AT THE TIME.; NO OTHER THERAPIES
• Patient Age: 40 YR