MAUDE Adverse Event Report: ACCLARENT ACCLARENT; SINUS BALLOON CATHETER

Catalog Number BC0616RU

Device Problem Burst Container or Vessel (1074)

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

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Balloon popped.Nothing from balloon inside pt.

• Brand Name: ACCLARENT
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; 15250 o'brien drive; menlo park CA 94025
• MDR Report Key: 4824993
• MDR Text Key: 15836555
• Report Number: MW5042951
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BC0616RU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 64