MAUDE Adverse Event Report: ACCLARENT INC. RELIEVA SCOUT SINUS DILATION SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number SCT0624

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem No Information (3190)

Event Date 12/21/2015

Event Type  malfunction  

Event Description

The procedure was a frontal sinus exploration.A relieva scout sinus dilation system package was opened.The nurse was testing the sinus balloon catheter before handing off to the surgeon.The balloon would not inflate to 12 atmospheres.On the second try, the balloon burst at 7 atmospheres.

• Brand Name: RELIEVA SCOUT SINUS DILATION SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT INC.; 33 technology dr; irvine, CA 92618
• MDR Report Key: 5340180
• MDR Text Key: 34908682
• Report Number: 5340180
• 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: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 06/18/2017
• Device Model Number: SCT0624
• Device Lot Number: 150618B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 87