MAUDE Adverse Event Report: ACCLARENT RELIEVA SPIN; BALLOON SINUPLASTY SYS

Model Number RS0616M

Device Problem Inflation Problem (1310)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

Pt undergoing balloon sinuplasty.The balloon on single use sinuplasty catheter failed to inflate.Initial catheter removed and replaced with new catheter.No harm to pt and no further issues with device.

• Brand Name: RELIEVA SPIN
• Type of Device: BALLOON SINUPLASTY SYS
• Manufacturer (Section D): ACCLARENT; menlo park 94025
• MDR Report Key: 4174131
• MDR Text Key: 5155592
• Report Number: MW5038561
• 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: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2014
• Device Model Number: RS0616M
• Device Catalogue Number: RS0616M
• Device Lot Number: 140429B-CM
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 29 YR