MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. NUVENT EM; NUVENT EM SINUS DILATION SYSTEM

Catalog Number 1830617SPH

Device Problem Inflation Problem (1310)

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

Event Date 01/13/2017

Event Type  malfunction  

Event Description

The balloon would not inflate.

• Brand Name: NUVENT EM
• Type of Device: NUVENT EM SINUS DILATION SYSTEM
• Manufacturer (Section D): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• MDR Report Key: 6409000
• MDR Text Key: 70077780
• Report Number: 6409000
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/10/2017,03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/19/2018
• Device Catalogue Number: 1830617SPH
• Device Lot Number: 0211141642
• Other Device ID Number: M000030B772 A 0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 118