MAUDE Adverse Event Report: MEDTRONIC USA NUVENT; SINUS BALLOON

Model Number 1830707MAX

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 11/18/2016

Event Type  malfunction  

Event Description

During procedure product balloon inflated and popped on its side during a sinus procedure.

• Brand Name: NUVENT
• Type of Device: SINUS BALLOON
• Manufacturer (Section D): MEDTRONIC USA
• MDR Report Key: 6173338
• MDR Text Key: 62550566
• Report Number: MW5066672
• Device Sequence Number: 1
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1830707MAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 YR