MAUDE Adverse Event Report: ACCLARENT RELIEVA SCOUT SINUS DILATION SYS; SINUS BALLOON CATHETER

Catalog Number SCT0624

Device Problem Material Puncture/Hole (1504)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 07/08/2014

Event Type  Injury  

Event Description

Acclarent was informed of an event during a sinus surgical procedure in which the subject device was reported to have been used.The surgeon reportedly performed balloon dilation after having removed bone and tissue with unidentified rigid instrumentation, and stated he noticed clear fluid leaking from the area of frontal recess following dilation and removal of the balloon.A septal mucosal flap was performed to repair the leak during the same procedure.The pt was reportedly doing well following the procedure and did not have further sequelae.

Manufacturer Narrative

The subject device of this report was received and evaluated.A single scout sinus dilation sys was returned for evaluation.The evaluation confirmed that the rail was able rotate, no damage was present on the rail markers or kinks present in the guide wire.The device was unable to be inflated due to a leak that was observed originating from balloon.The device was examined under a microscope and a balloon burst was discovered near proximal side of the balloon working length.The exact root cause of the balloon rupture is unk, and the extent to which the device caused or contributed to the reported event cannot be determined.Acclarent will continue to monitor this phenomenon for trending purposes.This report is being submitted in an abundance of caution.

• Brand Name: RELIEVA SCOUT SINUS DILATION SYS
• Type of Device: SINUS BALLOON CATHETER
• Manufacturer (Section D): ACCLARENT; menlo park CA
• Manufacturer Contact: izabel nielson, sr mgr ; 1525-b o'brien dr.; menlo park, CA 94025 ; 6506874924
• MDR Report Key: 4023969
• MDR Text Key: 4845127
• Report Number: 3005172759-2014-00019
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SCT0624
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK BRAND OF RIGID INSTRUMENT
• Patient Outcome(s): Required Intervention